Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,450
Countries
8
Sites
76
nonsegmental vitiligo
Part Ia: 1. To compare the efficacy of ritlecitinib 100 mg QD versus placebo in participants with nonsegmental vitiligo 2. To evaluate the safety and tolerability of ritlecitinib over time in participants with nonsegmental vitiligo Part Ib: To evaluate the long-term safety and tolerability of ritlecitinib 100 mg QD, r…
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 26 Apr 2024 → ongoing
- Decision date (initial)
- 2024-03-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Pfizer Inc.
External identifiers
- EU CT number
- 2022-502518-98-00
- ClinicalTrials.gov
- NCT06072183
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Others
Part Ia:
1. To compare the efficacy of ritlecitinib 100 mg QD versus placebo in participants with nonsegmental vitiligo
2. To evaluate the safety and tolerability of ritlecitinib over time in participants with nonsegmental vitiligo
Part Ib:
To evaluate the long-term safety and tolerability of ritlecitinib 100 mg QD, ritlecitinib 50 mg QD, and placebo in adult participants with nonsegmental vitiligo
Part II:
To evaluate the safety and tolerability of ritlecitinib 100 mg QD in adult participants with nonsegmental vitiligo
Secondary objectives 13
- Part Ia: To compare the efficacy of ritlecitinib 100 mg QD versus placebo on T-VASI50 at Weeks 24, 36, and 52 in participants with nonsegmental vitiligo
- Part Ia: To compare the efficacy of ritlecitinib 100 mg QD versus placebo on Patient Global Impression of Change – Face (PGIC-F) at Weeks 36 and 52 in participants with nonsegmental vitiligo
- Part Ia: To compare the efficacy of ritlecitinib 100 mg QD versus placebo on Patient Global Impression of Change – Overall Vitiligo (PGIC-V) at Weeks 36 and 52 in participants with nonsegmental vitiligo
- Part Ia: To compare the efficacy of ritlecitinib 100 mg QD versus placebo on PGIS-F at Weeks 36 and 52 in participants with nonsegmental vitiligo
- Part Ia: To compare the efficacy of ritlecitinib 100 mg QD versus placebo on PGIS-V at Weeks 36 and 52 in participants with nonsegmental vitiligo
- Part Ia: To compare the efficacy of ritlecitinib 100 mg QD versus placebo on F-VASI75 at Weeks 24 and 36 in participants with nonsegmental vitiligo
- Part Ia: To compare the efficacy of ritlecitinib 100 mg QD versus placebo, ritlecitinib 50 mg QD versus placebo, and ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD as measured by other clinical outcome assessments over time in participants with nonsegmental vitiligo
- Part Ia: To compare the efficacy of ritlecitinib 100 mg QD versus placebo, ritlecitinib 50 mg QD versus placebo, and ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD as measured by patientreported outcomes (PROs) over time in participants with nonsegmental vitiligo
- Part Ib: To evaluate the efficacy of ritlecitinib 100 mg QD, ritlecitinib 50 mg QD, and placebo over time as measured by other clinical outcomes in participants who were previously treated for 52 weeks with ritlecitinib 100 mg QD, ritlecitinib 50 mg QD, or placebo
- Part Ib: To evaluate the efficacy of ritlecitinib 100 mg QD, ritlecitinib 50 mg QD, and placebo over time as measured by PROs in participants who were previously treated for 52 weeks with ritlecitinib 100 mg QD, ritlecitinib 50 mg QD, or placebo
- Part II: To evaluate the efficacy of ritlecitinib 100 mg QD over time in adult participants with nonsegmental vitiligo
- Part II: To evaluate the efficacy of ritlecitinib 100 mg QD as measured by PROs over time in participants with nonsegmental vitiligo
- Part Ib: Response based on F-VASI100 (relative to BL) at all time points in the SoA
Conditions and MedDRA coding
nonsegmental vitiligo
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10047642 | Vitiligo | 100000004858 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall design Study B7981080 is a Phase 3 randomized, double-blind, multicenter study with a 52-week placebo-controlled period (Part Ia) followed by a double-blind 52-week extension period (Part Ib) that includes randomized dose-up/down titration and a de novo 52-week non-randomized open-label cohort (Part II), investigating the efficacy, safety, and tolerability of ritlecitinib 100 mg QD and 50 mg QD compared with placebo in adult participants with nonsegmental active or stable vitiligo.
|
Randomised Controlled | Double | [{"id":179606,"code":1,"name":"Subject"},{"id":179607,"code":2,"name":"Investigator"},{"id":179608,"code":5,"name":"Carer"},{"id":179605,"code":3,"name":"Monitor"}] | Part I - Arm 1: Participants will receive 1 ritlecitinib 100 mg capsule QD and 1 placebo 50 mg capsule QD orally from BL to Week 52 Part I - Arm 2: Participants will receive 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally from BL to Week 52. Part I - Arm 3: Participants will receive placebo orally once daily from BL to Week 52. One placebo 100 mg capsule and 1 placebo 50 mg capsule will be administered per day. Part II - Arm 4: Participants will receive 1 ritlecitinib 100 mg QD orally |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Pharmaceuticals And Medical Devices Agency, Food And Drug Administration, Medicines And Healthcare Products Regulatory Agency
- Plan to share IPD
- Yes
- IPD plan description
- Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Participants must be ≥18 years of age at Screening.
- Eligible participants must have at both Screening and BL: • A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and • Body surface area (BSA) involvement between 4%-60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet; and • BSA ≥0.5% involvement on the face (face is defined as including the area on the forehead to the original hairline, on the cheek vertically to the jawline, and laterally from the corner of the mouth to the tragus. The face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids); and • F-VASI ≥0.5 and T-VASI ≥3; and • Either active or stable nonsegmental vitiligo at both Screening and BL visits. All participants who do not have the features of active vitiligo (defined below) will be classified as having stable disease.
Exclusion criteria 2
- Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin
- History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 8
- Part Ia: Response based on F-VASI75 (defined as at least 75% improvement in Facial Vitiligo Area Scoring Index [F-VASI] from BL) at Week 52a
- Part Ia: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
- Part Ia: Incidence of clinically significant laboratory abnormalities
- Part Ib: Incidence of TEAEs, SAEs, and AEs leading to discontinuation
- Part Ib: Incidence of clinically significant laboratory abnormalities
- Part II: Incidence of TEAEs, SAEs, and AEs leading to discontinuation
- Part II: Incidence of clinically significant laboratory abnormalities.
- Part Ia: Response based on T-VASI50 at all time points in the SoA except for those included as primary and key secondary endpointa
Secondary endpoints 65
- Part Ia: Response based on T-VASI50 at Weeks 24, 36, and 52a
- Part Ia: Response based on PGIC-F (defined as at least “moderately better” reported change in severity of vitiligo on the face from baseline [BL]) at Weeks 36 and 52a
- Part Ia: Response based on PGIC-V (defined as at least “moderately better” reported change in severity of total body vitiligo from BL) at Weeks 36 and 52a
- Part Ia: Response based on improvement in PGIS-Fb at Weeks 36 and 52a
- Part Ia: Response based on improvement in PGIS-Vc at Weeks 36 and 52a
- Part Ia: Response based on F-VASI75 at Weeks 24 and 36a
- Part Ia: Response based on stabilization of disease at all time points after Week 8 in the Schedule of Activities (SoA)
- Part Ia: Response based on F-VASI75 at all time points in the SoA except for those included as primary and key secondary endpointsa
- Part Ia: Response based on T-VASI75 at all time points in the SoA except for that included as a primary endpointa
- Part Ia: Response based on sustained improvement in TVASI (defined as maintenance of ≥T-VASI50 from Week 36 to Week 52)
- Part Ia: Response based on sustained improvement in FVASI (defined as maintenance of ≥F-VASI75 from Week 36 to 52)
- Part Ia: Time to rescue medication use
- Part Ia: Percent change from baseline (CFB) in F-VASI at all time points in the SoA
- Part Ia: Percent CFB in T-VASI at all time points in the SoA
- Part Ia: Response based on T-VASI90 (defined as at least 90% improvement in T-VASI from BL) at all time points in the SoA
- Part Ia: Response based on T-VASI100 (defined as 100% improvement in T-VASI from BL) at all time points in the SoA
- Part Ia: Response based on F-VASI50 (defined as at least 50% improvement in F-VASI from BL) at all time points in the SoA
- Part Ia: Response based on F-VASI75 at all time points in the SoA unless included as primary or secondary endpoints
- Part Ia: Response based on F-VASI90 (defined as at least 90% improvement in F-VASI from BL) at all time points in the SoAa
- Part Ia: Response based on F-VASI100 (defined as 100% improvement in F-VASI from BL) at all time points in the SoA
- Part Ia: Response based on improvement in PGIS-Fe at Week 36 unless included as key secondary endpoint
- Part Ia: Response based on improvement in PGIS-Vf at Week 36 unless included as key secondary endpoint
- Part Ia: Response based on PGIC-F (defined as at least “moderately better” reported change in facial vitiligo from BL) at Weeks 36 and 52 unless included as key secondary endpoint
- Part Ia: Response based on PGIC-V (defined as at least “moderately better” reported change in total body vitiligo from BL) at Weeks 36 and 52 unless included as key secondary endpoint
- Part Ia: CFB in Dermatology Life Quality Index (DLQI) at Week 52
- Part Ia: CFB in the Hospital Anxiety and Depression Scale (HADS) depression subscale at Week 52
- Part Ia: CFB in the HADS anxiety subscale at Week 52
- Part Ia: Response based on a ‘normal’ subscale score indicative of an absence of depression at Week 52 (in participants with BL HADS subscale scores indicative of depression)
- Part Ia: Response based on a ‘normal’ subscale score indicative of an absence of anxiety at Week 52 (in participants with BL HADS subscale scores indicative of anxiety)
- Part Ia: Response based on T-VASI50 at all time points in the SoA except for those included as primary and key secondary endpointa
- Part Ib: Response based on T-VASI75 (relative to BL) at all time points in the SoA
- Part Ib: Response based on F-VASI75 (relative to BL) at all time points in the SoA
- Part Ib: Response based on T-VASI50 (relative to BL) at all time points in the SoA
- Part Ib: Response based on stabilization of disease at all time points after Week 60
- Part Ib: Response based on F-VASI50 (relative to BL) at all time points in the SoA
- Part Ib: Response based on F-VASI90 (relative to BL) at all time points in the SoA
- Part Ib: Response based on T-VASI90 (relative to BL) at all time points in the SoA
- Part Ib: Response based on T-VASI100 (relative to BL) at all time points in the SoA
- Part Ib: Response based on improvement in PGIS-Fc at Week 104
- Part Ib: Response based on improvement in PGIS-Vd at Week 104
- Part Ib: Response based on scoring at least “moderately better” in facial vitiligo on PGIC-F at Week 104
- Part Ib: Response based on scoring at least “moderately better” in total body vitiligo on PGIC-V at Week 104
- Part II: Response based on T-VASI75 at all time points in the SoA
- Part II: Response based on F-VASI75 at all time points in the SoA
- Part II: Response based on T-VASI50 at all time points in the SoA
- Part II: Response based on stabilization of disease at all time points after Week 8 in the SoA
- Part II: Response based on sustained improvement in T- VASI
- Part II: Response based on sustained improvement in F- VASI
- Part II: Time to rescue medication use
- Part II: Percent CFB in F-VASI at all time points in the SoA
- Part II: Percent CFB in T-VASI at all time points in the SoA
- Part II: Response based on T-VASI90 at all time points in the SoA
- Part II: Response based on T-VASI100 at all time points in the SoA
- Part II: Response based on F-VASI50 at all time points in the SoA
- Part II: Response based on F-VASI90 at all time points in the SoA
- Part II: Response based on F-VASI100 at all time points in the SoA
- Part II: Response based on PGIC-F (defined as at least “moderately better” reported change in facial vitiligo from BL) at Weeks 36 and 52
- Part II: Response based on PGIC-V (defined as at least “moderately better” reported change in total body vitiligo from BL) at Weeks 36 and 52
- Part II: Response based on improvement in PGIS-Fb at Weeks 36 and 52
- Part II: Response based on improvement in PGIS-Vc at Weeks 36 and 52
- Part II: CFB in DLQI at Week 52
- Part II: CFB in the HADS depression subscale at Week 52
- Part II: CFB in the HADS anxiety subscale at Week 52
- Part II: Response based on a ‘normal’ subscale score indicative of an absence of depression at Week 52 (in participants with BL HADS subscale scores indicative of depression)
- Part II: Response based on a ‘normal’ subscale score indicative of an absence of anxiety at Week 52 (in participants with BL HADS subscale scores indicative of anxiety)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD9906097 · Product
- Active substance
- Ritlecitinib Tosilate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 18250 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10739137 · Product
- Active substance
- Ritlecitinib Tosilate
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 36400 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
Placebo for PF-06651600-15, 50 mg
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo for PF-06651600-15, 100 mg
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 1
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 96 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 235 East 42nd Street
- City
- New York
- Postcode
- 10017-5703
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Locations
8 EU/EEA countries · 76 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 16 | 5 |
| Bulgaria | Ongoing, recruitment ended | 41 | 14 |
| Germany | Ongoing, recruitment ended | 60 | 11 |
| Hungary | Ongoing, recruitment ended | 38 | 10 |
| Italy | Ongoing, recruitment ended | 30 | 7 |
| Poland | Ongoing, recruitment ended | 97 | 11 |
| Slovakia | Ongoing, recruitment ended | 49 | 8 |
| Spain | Ongoing, recruitment ended | 24 | 10 |
| Rest of world
Australia, South Africa, Taiwan, Canada, China, United Kingdom, Turkey, Mexico, Japan
|
— | 1,095 | — |
Investigational sites
CHU De Liege
Dermatology, Avenue De L'hopital 1, 4000, Liege
UZ Leuven
Dermatology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Dermatology, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Dermatology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Hopital Erasme
Dermatology, Lennikse Baan 808, 1070, Anderlecht
Multiprofile Hospital For Active Treatment Pazardzik AD
Dermatology, Ulitsa Bolnichna 15, 4400, Pazardzhik
Diagnostic-Consultative Center Alexandrovska EOOD
Dermatology, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Dkc Fokus-5 Lzip OOD
Dermatology, Ulitsa Hristo Stanchev 15, 1463, Sofiya
Diagnostic Consultative Centre Ascendent OOD
Dermatology, Ulitsa Bacho Kiro 47, 1202, Sofia
ASMC IPSMC Skin And Venereal Diseases
ASMC - IPSMC - Skin and Venereal Diseases, Ulitsa Persenk 19, Enter B Floor 1 App 13, Sofiya
Diagnostic Consultation Center XX-Sofia EOOD
Dermatology, Ulitsa Gen. Stefan Toshev 15, 1618, Sofia
Multiprofile Hospital For Active Treatment St. Panteleimon Yambol AD
Dermatology, Ulitsa Panayot Hitov 30, 8600, Yambol
Medical Center Prolet EOOD
Dermatology, Ulitsa Olimpi Panov 25, 7000, Ruse
Diagnostic And Consulting Center 1 Pernik EOOD
Dermatology, Ulitsa Breznik 2, 2300, Pernik
Umbal - Prof. D-R Stoyan Kirkovich AD
Clinic for Skin and Venereal Diseases, Ulitsa General Stoletov 2, 6003, Stara Zagora
Medical Center Exacta Medica OOD
Dermatology, Ulitsa Todor Kableshkov 35, 5809, Pleven
Ambulatoria Za Specializirana Medicinska Pomosht-Grupova Praktika Po Dermatologia Clinica Evroderma OOD
Dermatology, Bulevard Pencho Slaveykov 4, 1606, Sofiya
Diagnostic And Consulting Center XXVIII-Sofia EOOD
Dermatology, Ilia Beshkov Street 1, 1528, Sofia
Center For Skin And Venereal Diseases Veliko Tarnovo EOOD
Dermatology, Ulitsa Buzludzha 1, 5000, Veliko Tirnovo
Magdeburger Company For Medical Studies & Services GmbH
Dermatology, Franckestrasse 1, Altstadt, Magdeburg
Rosenpark Research GmbH
Dermatology, Rheinstrasse 14, 64283, Darmstadt
Technische Universitat Dresden
Dermatology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Hautarztpraxis Dr. Heiner Neubauer
Dermatology, Brackestrasse 36, 04207, Leipzig
BAG Dres. med. Quist PartG
Helix Medical Excellence Center Mainz, Haifa-Allee 20, 55128, Mainz
Beldio Research GmbH
Dermatology and Allergy, Kramerstrasse 15, 87700, Memmingen
Dr. Niesmann And Dr. Othlinghaus GbR
Dermatology, Alleestrasse 80, Innenstadt, Bochum
CRS Clinical Research Services Management GmbH
Dermatology, Siemensdamm 65, Siemensstadt, Berlin
Praxis Fuer Dermatologie Und Venerologie
Practice for dermatology, Hauptstrasse 36a, Innere Neustadt, Dresden
Klinikum Bielefeld gGmbH
Dermatology and Venerology, An Der Rosenhoehe 27, Brackwede, Bielefeld
Universitaetsklinikum Bonn AöR
Dermatology and Alergology, Venusberg-Campus 1, Venusberg, Bonn
Meditres Ltd.
Meditres Egészségügyi Szolgáltató Kft., Bagoly Utca 1 A, 6000, Kecskemet
Orvostudomanyi Kutato es Fejleszto Kft.
Orvostudományi Kutató és Fejlesztő Kft., Dozsa Gyorgy Utca 25, 4027, Debrecen
Obudai Egeszsegugyi Centrum Kft.
Óbudai Egészségügyi Centrum Kft., Lajos Utca 74-76, 1036, Budapest III
University Of Pecs
Pécsi Tudományegyetem, Klinikai Központ Bőr-, Nemikórtani és Onkodermatológiai Klinika, Akac Utca 1, 7632, Pecs
Derma-B Kft.
DERMA-B Egeszsegugyi es Szolgaltato Kft., Gyepusor Utca 3, 4031, Debrecen
Allergo-Derm Bakos Kft.
Allergo-Derm Bakos Humán Egészségügyi és Szolgáltató Kft., Baross Utca 20, 5000, Szolnok
Derm-Surg Kft.
Derm-Surg Egészségügyi Szolgáltató és Tanácsadó Kft., Grof Apponyi Albert Utca 6, 7400, Kaposvar
University Of Szeged
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ, Koranyi Fasor 6, 6720, Szeged
University Of Debrecen
Debreceni Egyetem Klinikai Központ, Bőrgyógyászati Klinika, Nagyerdei Korut 98, 4032, Debrecen
Trial Pharma Kft.
NA, Gyulai Ut 94-96, 5600, Bekescsaba
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Medical Director, Via Francesco Sforza 28, 20122, Milan
Azienda USL Toscana Centro
Associate Professor, Viale Michelangiolo 41, 50125, Florence
I.F.O. Istituti Fisioterapici Ospitalieri
Dermatology, Via Elio Chianesi N 53, 00144, Rome
Ospedale Israelitico
Dermatology, Via Fulda 14, 00148, Rome
Istituto Dermopatico dell'Immacolata
Dermatology, Via dei Monti di Creta, 104, Rome
Azienda Ospedaliero-Universitaria Di Cagliari
Medical Director, Via Ospedale N. 54, 09124, Cagliari
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
Dermatologia Generale ed Oncologica, Ospedale Regionale San Salvatore, Via Lorenzo Natali 1, L'aquila
Etg Warszawa Sp. z o.o.
ETG Warszawa, Ul. Wynalazek 4, 02-677, Warsaw
Royalderm Agnieszka Nawrocka
Royalderm Agnieszka Nawrocka, Ul. Krzysztofa Kieslowskiego 3b/3, 02-962, Warsaw
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia Szczecinskie Centrum Medyczne, Al. Wyzwolenia 46/16u, 71-500, Szczecin
Dermatoestetica Clinica Professor B.W. Zegarscy
CLINICA DERMATOESTETICA PRYWATNY GABINET DERMATOLOGICZNY I ALERGOLOGICZNY PROF DR HAB MED B ZEGARSKA, ul. Cicha, nr 24
Provita Sp. z o.o.
Centrum Medyczne Angelius Provita, Ul. Fabryczna 13d, 40-611, Katowice
Specderm Poznanska Sp. j.
Specderm Poznanska, Ul. Prezydenta Ryszarda Kaczorowskiego 7/u 50, 15-375, Bialystok
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy Marek Brzewski Paweł Brzewski s.c.
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy, Marek Brzewski Paweł Brzewski sc, ul. Zbozowa 2/25, 30-002, Krakow
Dermed Centrum Medyczne Sp. z o.o.
"DERMED" Centrum Medyczne Sp. z o.o., Ul. Piotrkowska 48, 90-265, Lodz
Klinika Ambroziak Sp. z o.o.
Klinika Ambroziak Dermatologia, Ul. Ulica Kosiarzy 9a, 02-953, Warsaw
Clinicmed Daniluk Nowak Sp. k.
ClinicMed Daniluk, Nowak Spolka komandytowa, Ul. Stoleczna 7/200, 15-879, Bialystok
Krakowskie Centrum Medyczne Sp. z o.o.
Krakowskie Centrum Medyczne, Ul. Mikolaja Kopernika 32 St, 31-501, Cracow
Topskin pro s.r.o.
dermatovenerologická ambulancia, Pri Jazdiarni 1010/1, Stare Mesto, Kosice
F D Roosevelt University General Hospital Of Banska Bystrica
Dermatology, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Poliklinika ProCare Kosice s.r.o.
Dermatology, Jana Pavla II. 5, Sidlisko Kvp, Kosice
Cliniq s.r.o.
Dematovenerological centre, Bezrucova 5, Stare Mesto, Bratislava
BeneDerma s.r.o.
Dermatovenerology, Saratovska 24, 841 02, Dubravka
Derma therapy spol. s r.o.
Dermatologicka ambulancia, Rusovska Cesta 19, 851 01, Petrzalka
Fakultna Nemocnica Trnava
Dermatovenerology, Andreja Zarnova 11, 917 02, Trnava
Sanare spol. s r.o.
Dermatovenerologicka ambulancia, Hrabova 735/10, 089 01, Svidnik
Hospital Universitario Y Politecnico La Fe
Dermatology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario 12 De Octubre
Dermatology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Infanta Leonor
Dermatology, Avenida Gran Via Del Este 80, 28031, Madrid
Bellvitge University Hospital
Dermatology, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Hospital Universitario Reina Sofia
Dermatology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Unviersitario Miguel Servet
Dermatology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Germans Trias I Pujol
Dermatology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital De La Santa Creu I Sant Pau
Dermatology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Clinica Universidad De Navarra
Dermatology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Gaias Santiago
Dermatology, Rua Do Pintor Xaime Quesada N 2-4, 15702, Santiago De Compostela
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-11-22 | 2025-02-10 | 2025-05-29 | ||
| Bulgaria | 2024-06-13 | 2024-06-26 | 2025-05-29 | ||
| Germany | 2024-06-27 | 2024-07-09 | 2025-05-29 | ||
| Hungary | 2024-05-02 | 2024-05-22 | 2025-05-29 | ||
| Italy | 2024-07-09 | 2024-07-29 | 2025-05-29 | ||
| Poland | 2024-04-26 | 2024-05-20 | 2025-05-29 | ||
| Slovakia | 2024-04-30 | 2024-06-05 | 2025-05-29 | ||
| Spain | 2024-06-03 | 2024-06-11 | 2025-05-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 278 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D10a_B7981080_2022-502518-98-00_HADS_EN_Public | 2 |
| Protocol (for publication) | D10b_B7981080_2022-502518-98-00_HADS_BE_DE_Public | 2 |
| Protocol (for publication) | D10c_B7981080_2022-502518-98-00_HADS_BE_FR_Public | 2 |
| Protocol (for publication) | D10d_B7981080_2022-502518-98-00_HADS_BE_NL_Public | 2 |
| Protocol (for publication) | D10f_B7981080_2022-502518-98-00_HADS_DE_Public | 2 |
| Protocol (for publication) | D10g_B7981080_2022-502518-98-00_HADS_HU_Public | 2 |
| Protocol (for publication) | D10h_B7981080_2022-502518-98-00_HADS_IT_Public | 2 |
| Protocol (for publication) | D10j_B7981080_2022-502518-98-00_HADS_SK_Public | 2 |
| Protocol (for publication) | D10k_B7981080_2022-502518-98-00_HADS_ES_Public | 2 |
| Protocol (for publication) | D10m_B7981080_2022-502518-98-00_HADS_BG_Public | 1 |
| Protocol (for publication) | D10n_B7981080_2022-502518-98-00_HADS_PL_Public | 1 |
| Protocol (for publication) | D11a_B7981080_2022-502518-98-00_Vitiligo Noticeability Scale VNS_EN_Public | 1 |
| Protocol (for publication) | D11b_B7981080_2022-502518-98-00_Vitiligo Noticeability Scale VNS_BE_DE_Public | 1 |
| Protocol (for publication) | D11c_B7981080_2022-502518-98-00_ Vitiligo Noticeability Scale VNS_BE_FR_Public | 1 |
| Protocol (for publication) | D11d_B7981080_2022-502518-98-00_ Vitiligo Noticeability Scale VNS_BE_NL_Public | 1 |
| Protocol (for publication) | D11f_B7981080_2022-502518-98-00_ Vitiligo Noticeability Scale VNS_DE_Public | 1 |
| Protocol (for publication) | D11g_B7981080_2022-502518-98-00_ Vitiligo Noticeability Scale VNS_HU_Public | 1 |
| Protocol (for publication) | D11h_B7981080_2022-502518-98-00_ Vitiligo Noticeability Scale VN _IT_Public | 1 |
| Protocol (for publication) | D11j_B7981080_2022-502518-98-00_ Vitiligo Noticeability Scale VNS_SK_Public | 1 |
| Protocol (for publication) | D11k_B7981080_2022-502518-98-00_ Vitiligo Noticeability Scale VNS _ES_Public | 1 |
| Protocol (for publication) | D12a_B7981080_2022-502518-98-00_TSQM-9_EN_Public | 9 |
| Protocol (for publication) | D12b_B7981080_2022-502518-98-00_TSQM-9_BE_DE_Public | 9 |
| Protocol (for publication) | D12c_B7981080_2022-502518-98-00_TSQM-9_BE_FR_Public | 9 |
| Protocol (for publication) | D12d_B7981080_2022-502518-98-00_TSQM-9_BE_NL_Public | 9 |
| Protocol (for publication) | D12f_B7981080_2022-502518-98-00_TSQM-9_DE_Public | 9 |
| Protocol (for publication) | D12g_B7981080_2022-502518-98-00_TSQM-9_HU_Public | 9 |
| Protocol (for publication) | D12h_B7981080_2022-502518-98-00_TSQM-9_IT_Public | 9 |
| Protocol (for publication) | D12j_B7981080_2022-502518-98-00_TSQM-9_SK_Public | 9 |
| Protocol (for publication) | D12k_B7981080_2022-502518-98-00_TSQM-9_ES_Public | 9 |
| Protocol (for publication) | D13a_B7981080_2022-502518-98-00_Face Color Match Satisfaction_BE_DE_Public | 1 |
| Protocol (for publication) | D13b_B7981080_2022-502518-98-00_Face Color Match Satisfaction_BE_FR_Public | 1 |
| Protocol (for publication) | D13c_B7981080_2022-502518-98-00_Face Color Match Satisfaction_BE_NL_Public | 1 |
| Protocol (for publication) | D13e_B7981080_2022-502518-98-00_Face Color Match Satisfaction_DE_Public | 1 |
| Protocol (for publication) | D13f_B7981080_2022-502518-98-00_Face Color Match Satisfaction_HU_Public | 1 |
| Protocol (for publication) | D13g_B7981080_2022-502518-98-00_Face Color Match Satisfaction_IT_Public | 1 |
| Protocol (for publication) | D13i_B7981080_2022-502518-98-00_Face Color Match Satisfaction_SK_Public | 1 |
| Protocol (for publication) | D13j_B7981080_2022-502518-98-00_Face Color Match Satisfaction_ES_Public | 1 |
| Protocol (for publication) | D1a_B7981080_2022-502518-98-00_Protocol_Public | 2 |
| Protocol (for publication) | D5a_B7981080_2022-502518-98-00_Patient Global Impression of Severity-Face PGIS-F_EN_Public | 1.0 |
| Protocol (for publication) | D5b_B7981080_2022-502518-98-00_Patient Global Impression of Severity-Face PGIS-F_BE_DE_Public | 1 |
| Protocol (for publication) | D5c_B7981080_2022-502518-98-00_Patient Global Impression of Severity-Face PGIS-F_BE_FR_Public | 1 |
| Protocol (for publication) | D5d_B7981080_2022-502518-98-00_Patient Global Impression of Severity-Face PGIS-F_BE_NL_Public | 1 |
| Protocol (for publication) | D5f_B7981080_2022-502518-98-00_Patient Global Impression of Severity-Face PGIS-F_DE_Public | 1 |
| Protocol (for publication) | D5g_B7981080_2022-502518-98-00_Patient Global Impression of Severity-Face PGIS-F_HU_Public | 1 |
| Protocol (for publication) | D5h_B7981080_2022-502518-98-00_Patient Global Impression of Severity-Face PGIS-F_IT_Public | 1 |
| Protocol (for publication) | D5j_B7981080_2022-502518-98-00_Patient Global Impression of Severity-Face PGIS-F_SK_Public | 1 |
| Protocol (for publication) | D5k_B7981080_2022-502518-98-00_Patient Global Impression of Severity-Face PGIS-F_ES_Public | 1 |
| Protocol (for publication) | D6a_B7981080_2022-502518-98-00_ Patient Global Impression of Severity-Vitiligo PGIS-V_EN_Public | 1 |
| Protocol (for publication) | D6b_B7981080_2022-502518-98-00_ Patient Global Impression of Severity-Vitiligo PGIS-V_BE_DE_Public | 1 |
| Protocol (for publication) | D6c_B7981080_2022-502518-98-00_ Patient Global Impression of Severity-Vitiligo PGIS-V_BE_FR_Public | 1 |
| Protocol (for publication) | D6d_B7981080_2022-502518-98-00_ Patient Global Impression of Severity-Vitiligo PGIS-V_BE_NL_Public | 1 |
| Protocol (for publication) | D6f_B7981080_2022-502518-98-00_ Patient Global Impression of Severity-Vitiligo PGIS-V_DE_Public | 1 |
| Protocol (for publication) | D6g_B7981080_2022-502518-98-00_ Patient Global Impression of Severity-Vitiligo PGIS-V_HU_Public | 1 |
| Protocol (for publication) | D6h_B7981080_2022-502518-98-00_ Patient Global Impression of Severity-Vitiligo PGIS-V_IT_Public | 1 |
| Protocol (for publication) | D6j_B7981080_2022-502518-98-00_ Patient Global Impression of Severity-Vitiligo PGIS-V_SK_Public | 1 |
| Protocol (for publication) | D6k_B7981080_2022-502518-98-00_ Patient Global Impression of Severity-Vitiligo PGIS-V_ES_Public | 1 |
| Protocol (for publication) | D7a_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Face PGIC-F_EN_Public | 2 |
| Protocol (for publication) | D7b_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Face PGIC-F_BE_DE_Public | 2 |
| Protocol (for publication) | D7c_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Face PGIC-F_BE_FR_Public | 2 |
| Protocol (for publication) | D7d_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Face PGIC-F_BE_NL_Public | 2 |
| Protocol (for publication) | D7f_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Face PGIC-F_DE_Public | 2 |
| Protocol (for publication) | D7g_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Face PGIC-F_HU_Public | 2 |
| Protocol (for publication) | D7h_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Face PGIC-F_IT_Public | 2 |
| Protocol (for publication) | D7j_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Face PGIC-F_SK_Public | 2 |
| Protocol (for publication) | D7k_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Face PGIC-F_ES_Public | 2 |
| Protocol (for publication) | D8a_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Vitiligo PGIC-V_EN_Public | 1 |
| Protocol (for publication) | D8b_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Vitiligo PGIC-V_BE_DE_Public | 1 |
| Protocol (for publication) | D8c_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Vitiligo PGIC-V_BE_FR_Public | 1 |
| Protocol (for publication) | D8d_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Vitiligo PGIC-V_BE_NL_Public | 1 |
| Protocol (for publication) | D8f_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Vitiligo PGIC-V_DE_Public | 1 |
| Protocol (for publication) | D8g_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Vitiligo PGIC-V_HU_Public | 1 |
| Protocol (for publication) | D8h_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Vitiligo PGIC-V_IT_Public | 1 |
| Protocol (for publication) | D8j_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Vitiligo PGIC-V_SK_Public | 1 |
| Protocol (for publication) | D8k_B7981080_2022-502518-98-00_ Patient Global Impression of Change-Vitiligo PGIC-V_ES_Public | 2 |
| Protocol (for publication) | D9a_B7981080_2022-502518-98-00_Dermatology Life Quality Index DLQI_EN_Public | 1 |
| Protocol (for publication) | D9b_B7981080_2022-502518-98-00_ Dermatology Life Quality Index DLQI_BE_DE_Public | 1 |
| Protocol (for publication) | D9c_B7981080_2022-502518-98-00_Dermatology Life Quality Index DLQI_BE_FR_Public | 1 |
| Protocol (for publication) | D9d_B7981080_2022-502518-98-00_Dermatology Life Quality Index DLQI_BE_NL_Public | 1 |
| Protocol (for publication) | D9f_B7981080_2022-502518-98-00_Dermatology Life Quality Index DLQI_DE_Public | 1 |
| Protocol (for publication) | D9g_B7981080_2022-502518-98-00_Dermatology Life Quality Index DLQI_HU_Public | 1 |
| Protocol (for publication) | D9h_B7981080_2022-502518-98-00_Dermatology Life Quality Index DLQI_IT_Public | 1 |
| Protocol (for publication) | D9j_B7981080_2022-502518-98-00_ Dermatology Life Quality Index DLQI _SK_Public | 1 |
| Protocol (for publication) | D9k_B7981080_2022-502518-98-00_ Dermatology Life Quality Index DLQI_ES_Public | 1 |
| Recruitment arrangements (for publication) | B7981080_HCP referral letter_Public | 1 |
| Recruitment arrangements (for publication) | B7981080_Patient invite letter_PL PL_Public | 1 |
| Recruitment arrangements (for publication) | B7981080_Patient invite letter_Public | 1 |
| Recruitment arrangements (for publication) | B7981080_Referral fact card_Public | 1 |
| Recruitment arrangements (for publication) | B7981080_Study brochure_PL PL_Public | 1 |
| Recruitment arrangements (for publication) | B7981080_Study brochure_Public | 1 |
| Recruitment arrangements (for publication) | B7981080_Study poster_PL PL_Public | 1 |
| Recruitment arrangements (for publication) | B7981080_Study poster_Public | 1 |
| Recruitment arrangements (for publication) | K1 B7981080_Recruitment-Consent procedure_EN_Public | 2 |
| Recruitment arrangements (for publication) | K1_B7981080_Recruitment Consent procedure_EN_Public | 2 |
| Recruitment arrangements (for publication) | K10 B7981080_Thank You_Patient Thank you Card | 1 |
| Recruitment arrangements (for publication) | K10_B7981080_Dosing Diary_Slate | 1 |
| Recruitment arrangements (for publication) | K10_B7981080_EC-Notes | 4 |
| Recruitment arrangements (for publication) | K11_B7981080 Subject App | 1 |
| Recruitment arrangements (for publication) | K1a_B7981080_Recruitment Arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1a_B7981080_Recruitment arrangements_Public | 2 |
| Recruitment arrangements (for publication) | K1a_B7981080_Recruitment arrangements_Public | 4.0 |
| Recruitment arrangements (for publication) | K1a_B7981080_Recruitment arrangements_Public | 2.0 |
| Recruitment arrangements (for publication) | K1a_B7981080_Recruitment Procedure_EN_PL_Public | 2 |
| Recruitment arrangements (for publication) | K2 B7981080_Appointment card | 1 |
| Recruitment arrangements (for publication) | K2_B7981080_Online Advertisements | 1 |
| Recruitment arrangements (for publication) | K2_B7981080_Online SocialMediaOutreach | 1 |
| Recruitment arrangements (for publication) | K2_B7981080_Recruitment material_Appointment card_Public | 1 |
| Recruitment arrangements (for publication) | K2_B7981080_Recruitment material_Subject Recruitment_Text Modul SMO Sigal | s5 |
| Recruitment arrangements (for publication) | K22_B7981080_Appointment card_ES | 1 |
| Recruitment arrangements (for publication) | K23_B7981080_Retention Item Submission Information_Tote Bag_ES | 1 |
| Recruitment arrangements (for publication) | K24_B7981080_Study brochure_ES | 1 |
| Recruitment arrangements (for publication) | K2a_B7981080_Recruitment material_Study brochure_Public | 1.1 |
| Recruitment arrangements (for publication) | K2a_B7981080_Study poster | 1 |
| Recruitment arrangements (for publication) | K2b_B7981080_Study poster | 1 |
| Recruitment arrangements (for publication) | K3 B7981080_Retention Item Submission Information Tote Bag | 1 |
| Recruitment arrangements (for publication) | K3_B7981080 ClinLife EC Notes_V4_31Mar2023 | 1 |
| Recruitment arrangements (for publication) | K3_B7981080_ClinLife_EC-Notes | 1 |
| Recruitment arrangements (for publication) | K3_B7981080_Recruitment material_Study brochure_Public | 1 |
| Recruitment arrangements (for publication) | K3_B7981080_Recruitment material_Trial visit guide | 1 |
| Recruitment arrangements (for publication) | K3a_B7981080_Recruitment material_Study brochure_Public | 1.1 |
| Recruitment arrangements (for publication) | K3a_B7981080_Study brochur | 1 |
| Recruitment arrangements (for publication) | K3b_B7981080_Study brochure | 1 |
| Recruitment arrangements (for publication) | K4 B7981080_Study brochure | 1 |
| Recruitment arrangements (for publication) | K4_B7981080_Recruitment material_Study poster_Public | 1 |
| Recruitment arrangements (for publication) | K4_B7981080_Recruitment_material_Study poster | 1 |
| Recruitment arrangements (for publication) | K4_B7981080_Referral fact card | 1 |
| Recruitment arrangements (for publication) | K4a_B7981080_HCP referral letter | 1 |
| Recruitment arrangements (for publication) | K4a_B7981080_Recruitment material_Patient invite letter_Public | 1.1 |
| Recruitment arrangements (for publication) | K4b_B7981080_HCP referral letter | 1 |
| Recruitment arrangements (for publication) | K5 B7981080_Study poster | 1 |
| Recruitment arrangements (for publication) | K5_B7981080_Inclusion Exclusion Card | 1 |
| Recruitment arrangements (for publication) | K5_B7981080_Recruitment material_Thank You_Patient Randomization Card_Public | 1 |
| Recruitment arrangements (for publication) | K5_B7981080_Recruitment_material_Study brochure | 1 |
| Recruitment arrangements (for publication) | K5_B7981080_Study poster_ES | 1 |
| Recruitment arrangements (for publication) | K5_B7981080_Subject Recruitment_OnlineSocialMediaOutreach_PL_PL_Public | 1.0 |
| Recruitment arrangements (for publication) | K5a_B7981080_Recruitment material_Patient invite letter_Public | 1.1 |
| Recruitment arrangements (for publication) | K6 B7981080_Trial visit guide | 1 |
| Recruitment arrangements (for publication) | K6_B7981080_Recruitment material_Thank You_Patient Thank you Card_Public | 1 |
| Recruitment arrangements (for publication) | K6_B7981080_Recruitment_material_Patient invite letter | 1 |
| Recruitment arrangements (for publication) | K6_B7981080_Subject Recruitment_ClinLife Notes_PL_PL_Public | 4.0 |
| Recruitment arrangements (for publication) | K6_B7981080_Subject Recruitment_OnlineSocialMediaOutreach_HU_Public | 1 |
| Recruitment arrangements (for publication) | K6_B7981080_Trial visit guide_ES | 1 |
| Recruitment arrangements (for publication) | K6a_B7981080_Patient invite letter | 1 |
| Recruitment arrangements (for publication) | K6a_B7981080_Recruitment material_Study poster_Public | 1.1 |
| Recruitment arrangements (for publication) | K6b_B7981080_Patient invite letter | 1 |
| Recruitment arrangements (for publication) | K7_B7981080_PECC_ES | 1.0 |
| Recruitment arrangements (for publication) | K7_B7981080_Recruitment material_Online_SocMediaOutreach_Public | 1.0 |
| Recruitment arrangements (for publication) | K7_B7981080_Recruitment material_Online_SocMediaOutreach_Public | 1 |
| Recruitment arrangements (for publication) | K7_B7981080_Subject Recruitment_ClinLife Notes_HU_Public | 4 |
| Recruitment arrangements (for publication) | K7a_B7981080_Recruitment material_Study poster | 1.1 |
| Recruitment arrangements (for publication) | K7b_B7981080_Referral fact card | 1 |
| Recruitment arrangements (for publication) | K8_B7981080_Recruitment material_ClinLife_EC-Notes_Public | 4.0 |
| Recruitment arrangements (for publication) | K8_B7981080_Scoutpass Reloadable_ES_Public | 1.0 |
| Recruitment arrangements (for publication) | K8_B79810810_ClinLife Platform Privacy Policies | 1 |
| Recruitment arrangements (for publication) | K8a_B7981080_Online Social Media Outreach | 1 |
| Recruitment arrangements (for publication) | K8b_B7981080_Online Social Media Outreach | 1 |
| Recruitment arrangements (for publication) | K9 B7981080_Thank You_Patient Randomization Card | 1 |
| Recruitment arrangements (for publication) | K9_B7981080_ClinLife platform Privacy Policies | 1 |
| Recruitment arrangements (for publication) | K9_B7981080_ClinLife_EC-Notes | 4.0 |
| Recruitment arrangements (for publication) | K9b_B7981080_Scoutpass Reloadable_ES_Information_Public | 2.0 |
| Subject information and informed consent form (for publication) | B7981080_A-1426-0219-5270SR-Subject -App-vA_HU_Public | A |
| Subject information and informed consent form (for publication) | B7981080_Doctor Referral Letter_EN_Public | 1 |
| Subject information and informed consent form (for publication) | B7981080_eConsent Glossary_HU_Public | 1.0 |
| Subject information and informed consent form (for publication) | B7981080_eConsent_Glossary_PL_PL_Public | 1.0 |
| Subject information and informed consent form (for publication) | B7981080_Generic Video Storyboard_HU-HU_Public | 1 |
| Subject information and informed consent form (for publication) | B7981080_Generic Video Storyboard_PL-PL_Public | 1.0 |
| Subject information and informed consent form (for publication) | B7981080_Informed consent Procedure_EN_PL_Public | 1 |
| Subject information and informed consent form (for publication) | B7981080_IQVIA Getting Started Patient-facing landing page PL_Public | 1_1 |
| Subject information and informed consent form (for publication) | B7981080_IQVIA Getting Started Patient-facing landing page_Public | 1.1 |
| Subject information and informed consent form (for publication) | B7981080_Optional Digital VASI Tool Development_HU_Public | NAP |
| Subject information and informed consent form (for publication) | B7981080_Optional genetic analysis ICD_HU_Public | NAP |
| Subject information and informed consent form (for publication) | B7981080_Optional genetic analysis SIS_HU_Public | NAP |
| Subject information and informed consent form (for publication) | B7981080_Optional Procedure PPP_PL_Public | 1/1/0 |
| Subject information and informed consent form (for publication) | B7981080_Optional Procedure_Photographs use outside study_HU_Public | NAP |
| Subject information and informed consent form (for publication) | B7981080_Optional Training SIS and ICD_HU_Public | NAP |
| Subject information and informed consent form (for publication) | B7981080_Part I Optional Procedure Retained Research_PL_Public | 1/2/0 |
| Subject information and informed consent form (for publication) | B7981080_Part II Optional Procedure Retained Research_PL_Public | 1/2/0 |
| Subject information and informed consent form (for publication) | B7981080_Patient ID Card sample Justification letter_HU_Public | 1 |
| Subject information and informed consent form (for publication) | B7981080_PPRIF_HU_Public | 1.1 |
| Subject information and informed consent form (for publication) | B7981080_Pregnant Partner Release of Information Form _PL_Public | 4/1/0 |
| Subject information and informed consent form (for publication) | B7981080_Scout Email Communication_HU_Public | 1.0 |
| Subject information and informed consent form (for publication) | B7981080_Scout Email Communication_PL-PL_Public | 1_0 |
| Subject information and informed consent form (for publication) | B7981080_Scout Study Brochure_HU_Public | 1.0 |
| Subject information and informed consent form (for publication) | B7981080_Scout Study Brochure_PL-PL_Public | 1_0 |
| Subject information and informed consent form (for publication) | B7981080_ScoutPass Reloadable Card_HU_Public | 2.0 |
| Subject information and informed consent form (for publication) | B7981080_ScoutPass Reloadable Information_HU_Public | 1.0 |
| Subject information and informed consent form (for publication) | B7981080_ScoutPass Reloadable Information_PL-PL_Public | 1_0 |
| Subject information and informed consent form (for publication) | B7981080_ScoutPass_Reloadable_Card_PL-PL_Public | 2_0 |
| Subject information and informed consent form (for publication) | B7981080_Short description of submitted ICDs_HU_Public | 1 |
| Subject information and informed consent form (for publication) | B7981080_SIC_HU_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1-1a_B7981080_Part I Main ICD with Digital Imaging_PL_Public | 3 |
| Subject information and informed consent form (for publication) | L1-2a_B7981080_Part I Main ICD without Digital Imaging_PL_Public | 3 |
| Subject information and informed consent form (for publication) | L10 B7981080 GP letter_Italy_Final | 1 |
| Subject information and informed consent form (for publication) | L10_B7981080_SIS and ICF_Pregnant partner ICD_Public | 1.0 |
| Subject information and informed consent form (for publication) | L11 B7981080_eConsent Submission Letter | 1 |
| Subject information and informed consent form (for publication) | L11_B7981080_SIS and ICF_Pregnant partner ICD_Public | 1.0 |
| Subject information and informed consent form (for publication) | L12 B7981080_Glossary | 1 |
| Subject information and informed consent form (for publication) | L12_B7981080_SIS and ICF_Pregnant partner ICD_Public | 1.0 |
| Subject information and informed consent form (for publication) | L13 B7981080_TrialMax App Activation Guidelines | 1 |
| Subject information and informed consent form (for publication) | L13_B7981080_SIS and ICF_eConsent Submission Letter | 1.0 |
| Subject information and informed consent form (for publication) | L14 B7981080_QRG v1 | 1 |
| Subject information and informed consent form (for publication) | L14_B7981080_SIS and ICF_eConsent Submission Letter | 1.0 |
| Subject information and informed consent form (for publication) | L15 B7981080_SR-Subject-App | 1 |
| Subject information and informed consent form (for publication) | L15_B7981080_ICF_Optional Photographs_ DIGITAL VASI TOOL DEVELOPMENT_PL_Public | 1 |
| Subject information and informed consent form (for publication) | L15_B7981080_SIS and ICF_IQVIA Complete Consent Security_Reference Guide_Public | 1.3 |
| Subject information and informed consent form (for publication) | L16 B7981080_Device label | 1 |
| Subject information and informed consent form (for publication) | L16_B7981080_ICF_Optional Photographs use outside study_Trainings_PL_Public | 1 |
| Subject information and informed consent form (for publication) | L16_B7981080_SIS and ICF_IQVIA Getting Started Patient-facing landing page_Public | 1.1 |
| Subject information and informed consent form (for publication) | L17_B7981080_SIS and ICF_IQVIA Getting Started Patient-facing landing page_Public | 1.1 |
| Subject information and informed consent form (for publication) | L18_B7981080_SIS and ICF_Pfizer_B7981080_Glossary | 1.0 |
| Subject information and informed consent form (for publication) | L19_B7981080_SIS and ICF_Pfizer_B7981080_Glossary | 1.0 |
| Subject information and informed consent form (for publication) | L1a_B7981080_Main SIS and ICD Part I_HU_Public | NAP |
| Subject information and informed consent form (for publication) | L1a_B7981080_SIS and ICF_Main ICD_Part I_Public | 5 |
| Subject information and informed consent form (for publication) | L1a_B7981080_SIS and ICF_Main Part I_Public | 5.1.0 |
| Subject information and informed consent form (for publication) | L1a_B7981080_SIS and ICF_Part I_Main ICD_Public | 5.4.0 |
| Subject information and informed consent form (for publication) | L1b_B7981080_Italy ICD Adult_Part I__TC | NA |
| Subject information and informed consent form (for publication) | L1b_Main ICD Part I_B7981080_ES_ES_Public | NA |
| Subject information and informed consent form (for publication) | L1c B7981080_Country ICD_Part I | 5.3.0 |
| Subject information and informed consent form (for publication) | L1c B7981080_Main Model ICD_ESP Part I_V1_1_TC_PLACEHOLDER | NA |
| Subject information and informed consent form (for publication) | L1d B7981080_Country ICD_Part I | 5.3.0 |
| Subject information and informed consent form (for publication) | L1e B7981080_Country ICD_Part I_BG_TC_20Jan2024 | 4.2.0 |
| Subject information and informed consent form (for publication) | L1f B7981080_Country ICD_Part I_EN_TC_20Jan2024 | 4.2.0 |
| Subject information and informed consent form (for publication) | L2-1a_B7981080_Part II Main ICD with Digital Imaging_PL_Public | 3 |
| Subject information and informed consent form (for publication) | L2-2a_B7981080_Part II Main ICD without Digital Imaging_PL_Public | 3 |
| Subject information and informed consent form (for publication) | L20_B7981080_SIS and ICF_Pfizer_Generic Video Storyboard | 1 |
| Subject information and informed consent form (for publication) | L21_B7981080_SIS and ICF_Pfizer_Generic Video Storyboard | 1 |
| Subject information and informed consent form (for publication) | L21c B7981080_Italy ICD Adult_Part I | NA |
| Subject information and informed consent form (for publication) | L22a_B7981080_Italy ICD Adult_Part II_TC | NA |
| Subject information and informed consent form (for publication) | L2a_B7981080_Main SIS and ICD Part II_HU_Public | NAP |
| Subject information and informed consent form (for publication) | L2a_B7981080_SIS and ICF_Main ICD_Part II_Public | 5 |
| Subject information and informed consent form (for publication) | L2a_B7981080_SIS and ICF_Main Part II_Public | V5.1.0 |
| Subject information and informed consent form (for publication) | L2a_B7981080_SIS and ICF_Part I_Main ICD_Public | 5.4.0 |
| Subject information and informed consent form (for publication) | L2b_Main ICD Part II_B7981080_ES_ES_Public | NA |
| Subject information and informed consent form (for publication) | L2c B7981080_Country ICD_Part II | 5.3.0 |
| Subject information and informed consent form (for publication) | L2c B7981080_Italy ICD Adult_Part II | NA |
| Subject information and informed consent form (for publication) | L2c B7981080_Main Model ICD_ESP Part II_V1_1_TC_PLACEHOLDER | NA |
| Subject information and informed consent form (for publication) | L2d B7981080_Country ICD_Part II | 5.3.0 |
| Subject information and informed consent form (for publication) | L2e B7981080_Country ICD_Part II_BG_TC_20Jan2024 | 4.2.0 |
| Subject information and informed consent form (for publication) | L2f B7981080_Country ICD_Part II_EN_TC_20Jan2024 | 4.2.0 |
| Subject information and informed consent form (for publication) | L3 B7981080 PPRF | 1 |
| Subject information and informed consent form (for publication) | L3_B7981080_Optional Procedure ICD_Photographs_ES | 1.0 |
| Subject information and informed consent form (for publication) | L3_B7981080_SIS and ICF_Optional Photograph | 1.2.0 |
| Subject information and informed consent form (for publication) | L3_B7981080_SIS and ICF_Optional Procedure ICD_Retained_Research_Samples_Part I_Public | 2 |
| Subject information and informed consent form (for publication) | L3a_B7981080_SIS and ICF_Part I_Main ICD_Public | 5.4.0 |
| Subject information and informed consent form (for publication) | L4 B7981080_Italy Optional Procedure Informed Consent_Photographs | 1 |
| Subject information and informed consent form (for publication) | L4_B7981080_PPRIF_ES | 1.0 |
| Subject information and informed consent form (for publication) | L4_B7981080_SIS and ICF_Optional Procedure ICD Retained_Research_Samples Part II_Public | 2 |
| Subject information and informed consent form (for publication) | L4a_B7981080_SIS and ICF_Part II_ Main ICD_Public | 5.4.0 |
| Subject information and informed consent form (for publication) | L4a_B7981080_SIS and ICF_Pregnant Partner_Public | 1.2 |
| Subject information and informed consent form (for publication) | L4b_B7981080 Pregnant Partner Release of Information Form_Clean | 1.0 |
| Subject information and informed consent form (for publication) | L5 B7981080_Italy ICD_Appendix B_Part I | 1.1.0 |
| Subject information and informed consent form (for publication) | L5a_B7981080_SIS and ICF_Part II_Main ICD_Public | 5.4.0 |
| Subject information and informed consent form (for publication) | L5a_B7981080_SIS and ICF_Retained Research_Public | 1.1 |
| Subject information and informed consent form (for publication) | L5c B7981080_Pfizer_ECC_Standard | 1 |
| Subject information and informed consent form (for publication) | L5d B7981080_Pfizer_ECC_Standard | 1 |
| Subject information and informed consent form (for publication) | L6 B7981080_Italy ICD_Appendix B Part II | 1.1.0 |
| Subject information and informed consent form (for publication) | L6_B7981080_SIS and ICF_Pregnant Partner Release of Information Form_Public | 2 |
| Subject information and informed consent form (for publication) | L6a_B7981080_SIS and ICF_Part II_Main ICD_Public | 5.4.0 |
| Subject information and informed consent form (for publication) | L6c B7981080_ScoutPass Reloadable_EUR | 1 |
| Subject information and informed consent form (for publication) | L6d B7981080_ScoutPass Reloadable_EUR | 1 |
| Subject information and informed consent form (for publication) | L7 B7981080_Italy ICD_Appendix A Part I | 1.1.0 |
| Subject information and informed consent form (for publication) | L7_B7981080_SIS and ICF_Optional Procedure Photographs_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L7_B7981080_SIS and ICF_PRIVACY SUPPLEMENT_Public | 2.0 |
| Subject information and informed consent form (for publication) | L7c B7981080_ScoutPass_Reloadable_Information | 2 |
| Subject information and informed consent form (for publication) | L7d B7981080_ScoutPass_Reloadable_Information | 2 |
| Subject information and informed consent form (for publication) | L8 B7981080_Italy ICD_Appendix A Part II | 1.1.0 |
| Subject information and informed consent form (for publication) | L8_B7981080_SIS and ICF_Optional Procedure Photographs_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L9 B7981080_PECC | 1 |
| Subject information and informed consent form (for publication) | L9_B7981080_SIS and ICF_Optional Procedure Photographs_Public | 1.1.0 |
| Synopsis of the protocol (for publication) | D2a_B7981080_2022-502518-98-00_Protocol Synopsis_EN_Public | 2 |
| Synopsis of the protocol (for publication) | D3a_B7981080_2022-502518-98-00_Protocol Synopsis_BE_DE_Public | 2 |
| Synopsis of the protocol (for publication) | D3c_B7981080_2022-502518-98-00_Protocol Synopsis_BE_FR_Public | 2 |
| Synopsis of the protocol (for publication) | D3e_B7981080_2022-502518-98-00_Protocol Synopsis_BE_NL_Public | 2 |
| Synopsis of the protocol (for publication) | D3g_B7981080_2022-502518-98-00_Protocol Synopsis_BG_Public | 2 |
| Synopsis of the protocol (for publication) | D3k_B7981080_2022-502518-98-00_Protocol Synopsis_HU_Public | 2 |
| Synopsis of the protocol (for publication) | D3m_B7981080_2022-502518-98-00_Protocol Synopsis_IT_Public | 2 |
| Synopsis of the protocol (for publication) | D3o_B7981080_2022-502518-98-00_Protocol Synopsis_PL_Public | 2 |
| Synopsis of the protocol (for publication) | D3q_B7981080_2022-502518-98-00_Protocol Synopsis_SK_Public | 2 |
| Synopsis of the protocol (for publication) | D3s_B7981080_2022-502518-98-00_Protocol Synopsis_ES_Public | 2 |
Application history
22 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-24 | Germany | Acceptable 2024-03-25
|
2024-03-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-19 | Acceptable 2024-03-25
|
2024-04-19 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-07 | Acceptable 2024-03-25
|
2024-05-07 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-15 | Germany | Acceptable 2024-10-11
|
2024-10-11 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-10-28 | 2024-10-28 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-28 | Acceptable | 2025-01-20 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-31 | Acceptable | 2024-12-02 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-11-19 | Acceptable | 2025-01-16 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-01-28 | Acceptable | 2025-01-28 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-03-31 | Acceptable | 2025-05-05 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-05-16 | Germany | Acceptable | 2025-05-16 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2025-06-09 | Acceptable | 2025-06-09 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-06-18 | Acceptable | 2025-07-30 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-06-18 | Acceptable | 2025-08-25 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-06-18 | Acceptable | 2025-07-24 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-10-06 | Acceptable | 2025-11-17 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-10-06 | |||
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2025-11-24 | 2025-11-24 | ||
| 19 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-12-15 | Acceptable | 2026-02-18 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-12-19 | Acceptable | 2026-02-04 | |
| 21 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2026-03-06 | Germany | Acceptable | 2026-03-06 |
| 22 | SUBSTANTIAL MODIFICATION | SM-16 | 2026-04-07 | Acceptable | 2026-05-25 |