Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
707
Countries
8
Sites
68
Moderate to Severe Plaque Psoriasis
To evaluate the efficacy of JNJ-77242113 compared with placebo in participants with moderate to severe plaque psoriasis.
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 8 May 2025 → ongoing
- Decision date (initial)
- 2025-05-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy, Pharmacokinetic, Pharmacodynamic, Pharmacogenomic, Others
To evaluate the efficacy of JNJ-77242113 compared with placebo in participants with moderate to severe plaque psoriasis.
Conditions and MedDRA coding
Moderate to Severe Plaque Psoriasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10071117 | Plaque psoriasis | 10040785 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1.≥12 years of age at the screening visit.
- 2. Diagnosis of moderate to severe plaque psoriasis, with or without PsA, for at least 26 weeks prior to the first administration of study intervention.
- 3. Total BSA ≥10% at screening and baseline.
- 4. Total PASI ≥12 at screening and baseline.
- 5. Total IGA ≥3 at screening and baseline.
Exclusion criteria 5
- 1.Nonplaque form of psoriasis
- 2.Current drug-induced psoriasis
- 3.A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
- 4.Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients
- 5.Major surgical procedure (eg, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- IGA score of 0 or 1 and a ≥2 grade improvement from baseline at Week 16.
- PASI 90 at Week 16.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10321777 · Product
- Active substance
- JNJ-77242113
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
STELARA 90 mg solution for injection in pre-filled syringe
PRD709637 · Product
- Active substance
- Ustekinumab
- Substance synonyms
- Bmab 1200, CNTO 1275, BAT1406, ABP-654, CNTO-1275, BAT2206, CT-P43
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 28 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC05 — -
- Marketing authorisation
- EU/1/08/494/004
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
STELARA 45 mg solution for injection
PRD3349058 · Product
- Active substance
- Ustekinumab
- Substance synonyms
- Bmab 1200, CNTO 1275, BAT1406, ABP-654, CNTO-1275, BAT2206, CT-P43
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 28 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC05 — -
- Marketing authorisation
- EU/1/08/494/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 3
Solution for injection without Ustekinumab 45
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
Solution for injection in pre-filled syringe without Ustekinumab 90
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
Film-Coated Tablet without JNJ-77242113
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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture, Code 8 |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other, Laboratory analysis, Code 5, Data management |
Locations
8 EU/EEA countries · 68 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 20 | 5 |
| Belgium | Ongoing, recruitment ended | 20 | 2 |
| Denmark | Ongoing, recruitment ended | 15 | 5 |
| Germany | Ongoing, recruitment ended | 102 | 13 |
| Hungary | Ongoing, recruitment ended | 75 | 9 |
| Poland | Ongoing, recruitment ended | 150 | 13 |
| Portugal | Ongoing, recruitment ended | 15 | 5 |
| Spain | Ongoing, recruitment ended | 37 | 16 |
| Rest of world
United Kingdom, Canada, United States, Australia, Argentina
|
— | 273 | — |
Investigational sites
Medical University Of Vienna
Universitätsklinik für Dermatologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Noe LGA Gesundheit Region Mitte GmbH
Klinische Abteilung für Haut- und Geschlechtskrankheiten, Dunant-Platz 1, 3100, St. Poelten
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Abteilung für Dermatologie und Venerologie, Carinagasse 47, 6800, Feldkirch
Klinik Hietzing
Dermatologische Abteilung, Wolkersbergenstrasse 1, Hietzing, Vienna
Johannes Kepler University Linz
Universitätsklinik für Dermatologie und Venerologie, Med Campus III, Krankenhausstrasse 9, Linz
UZ Leuven
Dermatology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Dermatology, Corneel Heymanslaan 10, 9000, Gent
Odense University Hospital
Department of Dermatology, J B Winsloews Vej 4, 5000, Odense C
Region Hovedstaden
Dep. Of Dermato-Venereology and wound healing, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Gentofte Hospital
Department of Dermatology and Allergy, Gentofte Hospitalsvej 1, 2900, Hellerup
Aalborg University Hospital
Afdeling for Hud- og Kønssygdomme, Moelleparkvej 4, 9000, Aalborg
Aarhus University Hospital
Hud og kønssygdomme, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
ISA Interdisciplinary Study Association GmbH
NA, Rankestrasse 33/34, Charlottenburg, Berlin
Thermalsole und Schwefelbad Bentheim GmbH
Fachklinik Bad Bentheim Abteilung für Dermatologie, Am Bade 1, 48455, Bad Bentheim
Rosenpark Research GmbH
NA, Rheinstrasse 14, 64283, Darmstadt
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik), Arnold-Heller-Strasse 3, Brunswik, Kiel
BAG Dres. med. Quist PartG
NA, Haifa-Allee 20, 55128, Mainz
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
NA, Am Bahnhof 1, Mahlow, Blankenfelde-Mahlow
Universitaet Muenster
Universitätsklinikum Münster, Klinik für Hautkrankheiten, Von-Esmarch-Strasse 58, Sentrup, Muenster
Derma-Study-Center Friedrichshafen GmbH
NA, Charlottenstrasse 12/1, 88045, Friedrichshafen
Universitaetsklinikum Augsburg
Klinik fuer Dermatologie und Allergologie, Sauerbruchstrasse 6, Haunstetten, Augsburg
Hautarztpraxis Dr. Hoffmann
NA, Annenstraße 151, 58453, Witten
Studienzentrum an der Hase Weyergraf/Frick/Heiber GbR
NA, Hasestr. 17, 49565, Bramsche
Universitaetsklinikum Bonn AöR
Klinik für Dermatologie und Allergologie, Studienzentrum Dermatologie, Venusberg-Campus 1, Venusberg, Bonn
Studienzentrum Dr. Schwarz
NA, Bismarckstr. 49, 89129, Langenau
Derma-B Kft.
NA, Mester Utca 37 Fszt. 3, 4026, Debrecen
Bacs-Kiskun Varmegyei Oktatokorhaz
Borgyogyaszati Osztaly, Nyiri Ut 38, 6000, Kecskemet
Vasarhelyi Sarkanyfu Kft.
NA, Nagy Sandor Utca 11, 6800, Hodmezovasarhely
Obudai Egeszseguegyi Centrum Kft.
NA, Lajos Utca 74-76, 1036, Budapest III
Gyoengyosi Bugat Pal Koerhaz
Borgyogyaszati szakrendeles, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
Allergo-Derm Bakos Kft.
NA, Baross Utca 20, 5000, Szolnok
University Of Debrecen
Bőrgyógyászat Klinika, Nagyerdei Korut 98, 4032, Debrecen
Uno Medical Trials Kft.
NA, Vecsey Karoly Utca 39, 1152, Budapest XV
Medmare Bt.
NA, Jozsef Attila Utca 15, 8200, Veszprem
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy s.c.
N/A, ul. Zbozowa 2/25, 30-002, Krakow
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
N/A, Ul. Studzienna 35-36/a, 82-300, Elblag
Klinika Ambroziak Sp. z o.o.
Klinika Ambroziak Dermatologia, Ul. Ulica Kosiarzy 9a, 02-953, Warsaw
Specderm Poznanska Sp. j.
N/A, Ul. Prezydenta Ryszarda Kaczorowskiego 7/u 50, 15-375, Bialystok
Centrum Medyczne Oporow
N/A, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Nzoz Zdrowie Osteo-Medic
N/A, ul. Wiejska 81, 15-351, Bialystok
Care Clinic Sp. z o.o.
N/A, Ul. Ligocka 103, 40-568, Katowice
Wromedica I Bielicka A Strzalkowska s.c.
N/A, Ul. Adama Mickiewicza 91, 51-685, Wroclaw
Solumed Sp. z o.o. sp.k.
N/A, Ul. Jana Henryka Dabrowskiego 77a, 60-529, Poznan
Velocity Skierniewice Sp. z o.o.
N/A, Ul. Ogrodowa 21/23, 96-100, Skierniewice
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
N/A, Ul. 1 Maja 13 C, 10-117, Olsztyn
Carpe Diem Centrum Medycyny Estetycznej
N/A, Ul. Ulica Wita Stwosza 48 Lok. 110, 02-661, Warsaw
Dermed Centrum Medyczne Sp. z o.o.
N/A, Ul. Piotrkowska 48, 90-265, Lodz
Unidade Local De Saude De Santo Antonio E.P.E.
Dermatology, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude Do Alto Ave E.P.E.
Dermatology, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Hospital Cuf Descobertas S.A.
Dermatology, Rua Mario Botas 1, 1998-018, Lisbon
Unidade Local De Saude Da Regiao De Leiria E.P.E.
Dermatology, Rua Das Olhalvas, 2410-197, Leiria
Unidade Local De Saude De Sao Jose E.P.E.
Dermatology, Rua Jose Antonio Serrano, 1150-199, Lisbon
Hospital Clinico Universitario Lozano Blesa
Dermatology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Y Politecnico La Fe
Dermatology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Marina Baixa De La Vila Joiosa
Dermatology, Avenida Alcalde En Jaume Botella Mayor 7, 03570, Villajoyosa
Hospital General Universitario Dr. Balmis
Dermatology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitario Miguel Servet
Dermatology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario De Cruces
Dermatology, Cruces Plaza S/n, 48903, Barakaldo
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Dermatology, Calle De Serrano 143, 28006, Madrid
Hospital Universitario 12 De Octubre
Dermatology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Virgen De Valme
Dermatology, Avenida Bellavista S/n, 41014, Sevilla
Hospital Universitario De La Princesa
Dermatology, Calle De Diego De Leon 62, 28006, Madrid
Hospital De Manises
Dermatology, Avinguda De La Generalitat Valenciana 50, 46940, Manises
Hospital Universitario Clinico San Cecilio
Dermatology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Universitario Virgen De La Macarena
Dermatology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Clinic De Barcelona
Dermatology, Calle Villarroel 170, 08036, Barcelona
Complexo Hospitalario Universitario De Santiago
Dermatology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Icr Medical S.L.
Dermatology, Calle Cinca 21, 28002, Madrid
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 | 2025-05-20 | 2025-05-20 | 2025-07-22 | ||
| Denmark | 2025-05-20 | 2025-05-20 | 2025-07-22 | ||
| Germany | 2025-05-08 | 2025-05-08 | 2025-07-22 | ||
| Hungary | 2025-05-08 | 2025-05-08 | 2025-07-22 | ||
| Poland | 2025-05-14 | 2025-05-14 | 2025-07-22 | ||
| Portugal | 2025-05-12 | 2025-05-12 | 2025-07-22 | ||
| Spain | 2025-05-12 | 2025-05-12 | 2025-07-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 186 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | REDACTED_D1_Protocol Contact Form_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D1_Protocol_2024-515706-77 | Am3 |
| Protocol (for publication) | REDACTED_D4_PF Pat Assess of PsA Disease Act_BE_Dut_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Pat Assess of PsA Disease Act_BE_Fre_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Pat Assess of PsA Pain_BE_Dut_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Pat Assess of PsA Pain_BE_Fre_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PSSD diary_24 hr recall_BE_Dut_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PSSD diary_24 hr recall_BE_Fre_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PSSD diary_24h_recall_AT_GER_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PSSD diary_7 day recall_BE_Dut_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PSSD diary_7 day recall_BE_Fre_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PSSD diary_7 day_recall_AT_GER_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF WPAI PSO_BE_Dut_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF WPAI PSO_BE_Fre_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_CDLQI_MULTICOUNTRY_ENG_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_DLQI_MULTICOUNTRY_ENG_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_EQ-5D-5L_MULTICOUNTRY_ENG_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_GenPs-SFQ_MULTICOUNTRY_ENG_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pat Assess of PsA Disease Activity_AT_GER_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pat Assess of PsA Disease Activity_DE_GER_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pat Assess of PsA Disease Activity_EN_ENG_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pat Assess of PsA Disease Activity_ES_SPA_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pat Assess of PsA Disease Activity_HU_HUN_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pat Assess of PsA Disease Activity_PT_POR_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pat Assess of PsA Pain_AT_GER_2014-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pat Assess of PsA Pain_DE_GER_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pat Assess of PsA Pain_EN_ENG_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pat Assess of PsA Pain_ES_SPA_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pat Assess of PsA Pain_HU_HUN_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pat Assess of PsA Pain_PT_POR_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_PEST_MULTICOUNTRY_ENG_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_PSSD diary_24 hr recall_DE_GER_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_PSSD diary_24 hr recall_EN_ENG_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_PSSD diary_24 hr recall_ES_SPA_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_PSSD diary_24 hr recall_HU_HUN_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_PSSD diary_24 hr recall_PT_POR_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_PSSD diary_7 day recall_DE_GER_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_PSSD diary_7 day recall_EN_ENG_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_PSSD diary_7 day recall_ES_SPA_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_PSSD diary_7 day recall_HU_HUN_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_PSSD diary_7 day recall_PT_POR_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_SF-36_MULTICOUNTRY_ENG_2024-515706-77 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_WPAI_PSO_AT_GER_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_WPAI-PSO_DE_GER_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_WPAI-PSO_EN_ENG_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_WPAI-PSO_ES_SPA_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_WPAI-PSO_HU_HUN_2024-515706-77 | 2 |
| Protocol (for publication) | REDACTED_D4_PF_WPAI-PSO_PT_POR_2024-515706-77 | 2 |
| Recruitment arrangements (for publication) | Placeholder_K1_Recruitment Arragements_HU_ENG_2024-515706-77-00 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _DE_ENG_2024-515706-77 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_AT_ENG_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_BE_Eng_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_DK_Eng_2024-515706-77 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_ES_ENG_2024-515706-77 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_PL_POL_2024-515706-77 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_PT_ENG_2024-515706-77 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Adol Social Media-Web Post_BE_Dut_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Adol Social Media-Web Post_BE_Fre_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Adolescent Patient Flyer_AT_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Adolescent Patient Flyer_BE_Dut_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Adolescent Patient Flyer_BE_Fre_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Adolescent Patient Flyer_DE_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Adolescent Patient Flyer_ES_SPA_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Adolescent Patient Flyer_PL_POL_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Adolescent Social Med Web AD_AT_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Adolescent Social Med Web poster_AT_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Adolescent Social Media and Web_DE_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Adolescent Social Media Web Post_PL_POL_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Caregiver and Adolescent Brochure_DE_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Caregiver and Adolescent Brochure_ES_SPA_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Caregiver and Adolescent Brochure_PL_POL_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Caregiver-Adolescent Brochure_BE_Dut_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Caregiver-Adolescent Brochure_BE_Fre_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Dear Parent Email_AT_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Dear Parent Email_BE_Dut_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Dear Parent Email_BE_Fre_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Dear Parent Email_ES_SPA_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Dear Parent Letter_AT_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Dear Parent Letter_BE_Dut_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Dear Parent Letter_BE_Fre_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Dear Parent Letter_ES_SPA_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Flyer_AT_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Patient Flyer_BE_Dut_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Patient Flyer_BE_Fre_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Flyer_DE_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Flyer_DK_Dan_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Flyer_PL_POL_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Flyer_PT_POR_2024-515706-77 | 1.1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Social Media and Web Post_BE_Dut_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Social Media and Web Post_BE_Fre_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Social Media and Web Post_DE_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Social Media and Web Post_PL_POL_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Study Info Brochure_BE_Dut_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Study Info Brochure_BE_Fre_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Study Info Brochure_PT_POR_2024-515706-77 | 1.1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Study Information Brochure_AT_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Study Information Brochure_DE_GER_2024-515706-77 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Study information brochure_DK_Dan_2024-515706-77 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Study Information Brochure_ES_SPA_2024-515706-77 | 1.1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Study Information Brochure_PL_POL_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF _Optional Genetic Adult ICF_ES_SPA_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Adolescent Assent_PL_POL_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Adult Substudy Photography_BE_Dut_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Adult Substudy_BE_Dut_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Adult Substudy_BE_Fre_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Assent Adolescent _DE_GER_2024-515706-77 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Assent Adolescent Substudy_BE_Dut_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Assent Adolescent Substudy_BE_Fre_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Assent Adolescent_BE_Dut_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Assent Adolescent_BE_Fre_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical _DE_GER_2024-515706-77 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_DK_Dan_2024-515706-77 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PL_POL_2024-515706-77 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PT_POR_2024-515706-77 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Adult_BE_Fre_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_AT_GER_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Dut_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Photography Sub-Study _DE_GER_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Photography Substudy_PT_POR_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample Assent Adolescent _DE_GER_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample Assent_PL_POL_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample Parent Guardian _DE_GER_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample Parent_PL_POL_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_PL_POL_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sub Study_DE_GER_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sub-Study_DK_dan_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sub-Study_PT_POR_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional SubStudy_PL_POL_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Parent Guardian _DE_GER_2024-515706-77 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Parent Guardian_ES_SPA_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Parent Guardian_PL_POL_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Parent_legal Guard Opt Sample_AUT_GER_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Parents Substudy_BE_Dut_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Parents Substudy_BE_Fre_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Parents_BE_Dut_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Parents_BE_Fre_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_BE_Dut_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_BE_Fre_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_PT_POR_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant _ES_SPA_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner _DE_GER_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_AUT_GER_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_DK_Dan_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PL_POL_2024-515706-77 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Right to Reject Knowledge_DK_dan_2024_515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal _DE_GER_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_AT_GER_2024-515706-77 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PL_POL_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PT_POR_2024-515706-77 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Adult _Withdrawal_HU_HUN_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Adult Main_HU_HUN_2024-515706-77 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Adult Optional Genetic_HU_HUN_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Adult Photography_HU_HUN_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Adult Pregnant Partner_HU_HUN_2024-515706-77 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Assent Adolescent_ES_SPA_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Assent Main_HU_HUN_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | Redacted_L1_SIS and ICF_Assent Optional Genetic_HU_HUN_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Clinical_ES_SPA_2024-515706-77 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Genetic Sample Parent-Guardian_ES_SPA_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_ICF Contact Data Sheet_AT_ENG_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Optional Genetic Sample Assent Adolescent_ES_SPA_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Optional Sub Study Photo_ES_SPA_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Parent_Guardian _AUT_GER_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Parent_Main_HU_HUN_2024-515706-77 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Parent_Optional Genetic_HU_HUN_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal_ES_SPA_2024-515706-77 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS_ICF Adolescent Assent_AUT_GER_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS_ICF Child Assent_AT_GER_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS_ICF Optional Sample Assent Adolescent _2024-515706-77_AT_GER | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS_ICF Optional Sample Assent Child_AT_GER_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS_ICF Optional Sub-study_AT_GER_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_AT_GER | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DE_GER_2024-515706-77 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DK_Dan_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_ES_SPA_2024-515706-77 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_HU_HUN_2024-515706-77 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_POL_2024-515706-77 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PT_PT_2024-515706-77 | 2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_AT_GER_2024-515706-77 | Am2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Dut_2024-515706-77 | Am3 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Fre_2024-515706-77 | Am3 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Ger_2024-515706-77 | Am3 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_SPA_2024-515706-77 | Am3 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_HU_HUN_2024-515706-77 | Am3 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PL_POL_2024-515706-77 | Am3 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PT_POR_2024-515706-77 | Am3 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-15 | Germany | Acceptable 2025-05-05
|
2025-05-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-13 | Acceptable | 2025-05-19 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-04 | Germany | Acceptable | 2025-08-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-16 | Germany | Acceptable 2026-04-13
|
2026-04-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-22 | Acceptable | 2026-05-18 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-04-27 | Acceptable | 2026-05-01 |