Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,604
Countries
18
Sites
110
Atopic Dermatitis
To assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult subjects with moderate to severe AD who are candidates for systemic therapy. To assess the long-term (10 years) efficacy and safety of upadacitinib for the treatment of adolescent and …
Key facts
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- 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
- 2 Jan 2019 → ongoing
- Decision date (initial)
- 2023-10-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2022-502937-24-00
- EudraCT number
- 2017-005126-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Efficacy
To assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult subjects with moderate to severe AD who are candidates for systemic therapy.
To assess the long-term (10 years) efficacy and safety of upadacitinib for the treatment of adolescent and adult subjects with moderate to severe AD who are candidates for systemic therapy.
Conditions and MedDRA coding
Atopic Dermatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012438 | Dermatitis atopic | 100000004858 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | 16 week double blind Period Subjects who meet eligibility criteria in the main study will be randomized in a 1:1:1 ratio to receive
concomitant TCS with either daily oral doses of upadacitinib 15 mg (N = 270) or 30 mg (N = 270) or
matching placebo (N = 270). Upon completion of enrollment of 810 subjects in the main study, a
supplemental study will continue to enroll adolescent subjects (adolescent sub-study) until a total of
180 adolescent subjects are enrolled in the overall study (main study + adolescent sub-study).
|
Randomised Controlled | Double | [{"id":169620,"code":4,"name":"Analyst"},{"id":169621,"code":2,"name":"Investigator"},{"id":169618,"code":3,"name":"Monitor"},{"id":169619,"code":1,"name":"Subject"},{"id":169622,"code":5,"name":"Carer"}] | Upadacitinib 15 mg + TCS: Daily oral doses of upadacitinib 15 mg and TCS Upadacitinib 30 mg + TCS: Daily oral doses of upadacitinib 30 mg with TCS Placebo + TCS: Receive placebo with TCS |
| 2 | Extension Period of up to Week 524 At the end of the 16 week DB period, subjects in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 15 mg or upadacitinib 30 mg during the Blinded Extension Period. Subjects originally in the 15 mg QD and 30 mg QD upadacitinib group will continue their treatment into the Blinded Extension Period up to the Week 260 visit. Additionally, subjects who reach Week 260 in Studies M16-047, M16-045, or M18-891 will have the opportunity to roll over to the blinded LTE Period of the M16-047 study and continue the same daily treatment up to Week 524. Subjects who reach 65 years of age or older and are still on study drug at any visit within the Blinded Extension and LTE periods (excluding the premature discontinuation visit and the final visit) will be unblinded and investigators will have the option to change the upadacitinib dose as described in protocol.
|
Randomised Controlled | Double | [{"id":169624,"code":5,"name":"Carer"},{"id":169625,"code":2,"name":"Investigator"},{"id":169626,"code":1,"name":"Subject"},{"id":169628,"code":4,"name":"Analyst"},{"id":169627,"code":3,"name":"Monitor"}] | Upadacitinib 15 mg + TCS: Daily oral doses of upadacitinib 15 mg with TCS Upadacitinib 30 mg + TCS: Daily oral doses of upadacitinib 30 mg with TCS |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-001741-PIP04-17
- Plan to share IPD
- Yes
- IPD plan description
- AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Male or female subjects 12-75 years of age
- Active moderate to severe atopic dermatitis defined by EASI, IGA, BSA, and pruritus
- Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis
- Able to tolerate topical corticosteroids for atopic dermatitis lesions
Exclusion criteria 5
- Prior exposure to any JAK inhibitor
- Unable or unwilling to discontinue current AD treatments prior to the study
- Requirement of prohibited medications during the study
- Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
- Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Proportion of subjects achieving validated IGA scale for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from baseline at Week 16
- Proportion of subjects achieving improvement from baseline of at least 75% on Eczema Area Severity Index (EASI 75) at Week 16.
Secondary endpoints 10
- Proportion of subjects achieving an improvement (reduction) in Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 from Baseline at Week 16 for subjects with Worst Pruritus NRS ≥ 4 at Baseline
- Proportion of subjects achieving a 90% reduction in EASI (EASI 90) at Week 16
- Percent change from Baseline of Worst Pruritus NRS at Week 16
- Percent change in EASI score from Baseline at Week 16.
- Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS ≥ 4 from Baseline at Week 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline
- Proportion of subjects achieving EASI 75 at Week 4
- Proportion of subjects achieving EASI 75 at Week 2
- Proportion of subjects achieving EASI 90 at Week 4
- Proportion of subjects achieving EASI 100 at Week 16 for 30 mg
- Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS ≥ 4 from Baseline at Week 1 for subjects with Worst Pruritus NRS ≥ 4 at Baseline.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD3232826 · Product
- Active substance
- Upadacitinib
- Pharmaceutical form
- MODIFIED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 110040 mg milligram(s)
- Max treatment duration
- 524 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD3232825 · Product
- Active substance
- Upadacitinib
- Pharmaceutical form
- MODIFIED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 55020 mg milligram(s)
- Max treatment duration
- 524 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo for upadacitinib film-coated tablet
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 5
—
SCP6803221 · ATC
- Route of administration
- TOPICAL
- Max daily dose
- 1 d day
- Max total dose
- 21 d day
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- D07AB09 — TRIAMCINOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1993229 · ATC
- Active substance
- Fluocinolone Acetonide
- Route of administration
- TOPICAL
- Max daily dose
- 1 d day
- Max total dose
- 21 d day
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- D07AC04 — FLUOCINOLONE ACETONIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP249333 · ATC
- Active substance
- Pimecrolimus
- Route of administration
- TOPICAL
- Max daily dose
- 1 d day
- Max total dose
- 21 d day
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH02 — PIMECROLIMUS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP58618655 · ATC
- Active substance
- Tacrolimus
- Substance synonyms
- TACROLIMUS ANHYDROUS
- Route of administration
- TOPICAL
- Max daily dose
- 1 d day
- Max total dose
- 21 d day
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH01 — TACROLIMUS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP2138737 · ATC
- Active substance
- Hydrocortisone
- Substance synonyms
- CORTISOL
- Route of administration
- TOPICAL
- Max daily dose
- 1 d day
- Max total dose
- 21 d day
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- D07AA02 — HYDROCORTISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Abbvie Deutschland GmbH & Co. KG
- Sponsor organisation
- Abbvie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Other, Interactive response technologies (IRT) |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Other |
| Cytel Inc. ORG-100042560
|
Waltham, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
Locations
18 EU/EEA countries · 110 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 21 | 5 |
| Belgium | Ongoing, recruitment ended | 8 | 4 |
| Bulgaria | Ongoing, recruitment ended | 6 | 2 |
| Croatia | Ongoing, recruitment ended | 18 | 6 |
| Czechia | Ongoing, recruitment ended | 17 | 3 |
| Finland | Ongoing, recruitment ended | 6 | 1 |
| France | Ongoing, recruitment ended | 36 | 13 |
| Germany | Ongoing, recruitment ended | 41 | 14 |
| Greece | Ongoing, recruitment ended | 39 | 5 |
| Hungary | Ongoing, recruitment ended | 39 | 11 |
| Ireland | Ongoing, recruitment ended | 14 | 4 |
| Italy | Ongoing, recruitment ended | 39 | 10 |
| Netherlands | Ongoing, recruitment ended | 32 | 5 |
| Norway | Ended | 27 | 4 |
| Portugal | Ongoing, recruitment ended | 12 | 6 |
| Slovakia | Ongoing, recruitment ended | 40 | 3 |
| Spain | Ongoing, recruitment ended | 33 | 12 |
| Sweden | Ongoing, recruitment ended | 16 | 2 |
| Rest of world
Japan, United Kingdom, New Zealand, China, Puerto Rico, Australia, United States, Israel, Hong Kong, Canada
|
— | 1,160 | — |
Investigational sites
Noe LGA Gesundheit Region Mitte GmbH
Depatment of Skin and sexually transmitted diseases, Dunant-Platz 1, 3100, St. Poelten
Ordensklinikum Linz GmbH
Dermatology, Fadingerstrasse 1, 4020, Linz
Medical University Of Vienna
Dermatology, Waehringer Guertel 18-20, Alsergrund, Vienna
Kepler Universitaetsklinikum GmbH
Dermatology and Venereology, Krankenhausstrasse 9, 4020, Linz
Medizinische Universitaet Innsbruck
Dermatology, venereology and allergology, Anichstrasse 35, 6020, Innsbruck
Centre hospitalier universitaire de Liege
N/A, Avenue De L'hopital 1, 4000, Liege
Cliniques Universitaires Saint-Luc
N/A, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
N/A, Corneel Heymanslaan 10, 9000, Gent
UZ Brussel
N/A, Laarbeeklaan 101, 1090, Jette
ASMC IPSMC Skin And Venereal Diseases
Ambulatory for Specialized Medical Care for skin and venereal diseases, Ulitsa Persenk 19, Enter B Floor 1 App 13, Sofiya
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Clinic for skin and venereal diseases, Ulitsa Vladimir Vazov 91, 5804, Pleven
Poliklinika Dermaplus
Dermatology department, Kaptol 25, Zagreb, Grad Zagreb
Klinika Za Djecje Bolesti Zagreb
Dermatology department, Ulica Vjekoslava Klaica 16, Zagreb, Grad Zagreb
KBC Split
Dermatology department, Soltanska 1, 21000, Split
NAFTALAN specijalna bolnica za medicinsku rehabilitaciju
Dermatology department, Omladinska Ulica 23a, 10310, Ivanic-Grad
Poliklinika Vlatka Cavka d.o.o.
Dermatology department, Dobri Dol 47, Zagreb, Grad Zagreb
Djecja bolnica Srebrnjak
Dermatology department, Srebrnjak 100, Zagreb, Grad Zagreb
Fakultni Nemocnice Plzen
Dermatovenerology, Edvarda Benese 1128/13, Jizni Predmesti, Plzen 3
Sanatorium Profesora Arenbergera
NA, Bolzanova 7, 110 00, Prague 1
Vseobecna Fakultni Nemocnice V Praze
Dermatovenerology, U Nemocnice 499/2, Nove Mesto, Prague 2
Centre Hospitalier Universitaire De Nice
Dermatology, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Lyon Sud
Service d’allergologie et d’immunologie clinique, Chemin Du Grand Revoyet, 69310, Pierre Benite
Courlancy Sante
Dermatology, 38 Rue De Courlancy, 51100, Reims
Hopital Prive D Antony
Service de Dermatologie, 1 Rue Velpeau, 92160, Antony
CHU De Rouen
Service de Dermatologie, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Bordeaux
Dermatology, 1 Rue Jean Burguet, 33000, Bordeaux
Centre Hospitalier Regional Et Universitaire De Brest
Service de Dermatologie, 2 Avenue Marechal Foch, 29200, Brest
Assistance Publique Hopitaux De Marseille
Dermatology, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Toulouse
Service de Dermatologie, 24 Chemin De Pouvourville, 31400, Toulouse
Centre Hospitalier Regional Universitaire De Tours
Dermatology, 49 Boulevard Beranger, 37000, Tours
Centre Hospitalier Le Mans
Service de Dermatologie, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Du Docteur Ruer S.E.L.A.R.L.
N/A, Le Bateau Blanc 26 Immeuble A, Chemin De Paradis, Martigues
Centre Hospitalier Universitaire De Nantes
Service de Dermatologie, 1 Place Alexis Ricordeau, 44000, Nantes
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
N/A, Am Bahnhof 1, Mahlow, Blankenfelde-Mahlow
TFS Trial Form Support GmbH
N/A, Anckelmannsplatz 1, Hammerbrook, Hamburg
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
N/A, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Dermatologisches Studienzentrum Hunsrück
N/A, Bingener Strasse 23a, 55469, Simmern
Universitaetsklinikum Heidelberg AöR
Hautklinik, Im Neuenheimer Feld 440, Neuenheim, Heidelberg
cms³ Company for Medical Study & Service Selters GmbH
N/A, Kirchstrasse 1, 56242, Selters (Westerwald)
Universitaetsklinikum Bonn AöR
Klinik und Poliklinik fuer Dermatologie und Allergologie, Venusberg-Campus 1, Venusberg, Bonn
Klinikum rechts der Isar der TU Muenchen AöR
Klinik und Poliklinik für Dermatologie und Allergologie, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Muenster AöR
Zentale Studienkoordination fuer innovative Dermatologie, Von-Esmarch-Strasse 58, Sentrup, Muenster
Klinikum Darmstadt GmbH
N/A, Grafenstrasse 9, 64283, Darmstadt
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
N/A, Langenbeckstrasse 1, Oberstadt, Mainz
University Medical Centre Schleswig-Holstein
Zentrum für entzuendliche Hauterkrankungen, Klinik für Dermatologie, Venerologie und Allergologie, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsklinikum Frankfurt AöR
Klinik fuer Dermatologie, Venerologie und Allergologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Medizinische Hochschule Hannover Service GmbH
Klinik fur Dermatologie, Allergologie und Venerologie, Feodor-Lynen-Strasse 15, Gross Buchholz, Hanover
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
University Dermatology Clinic, Dragoumi Ionos 5 I, 161 21, Athens
401 General Military Hospital Of Athens
Dermatology, Panagioti Kanellopoulou Av 1, 115 25, Athens
Ippokratio General Hospital Of Thessaloniki
Dermatology Clinic AUTh, Delfon 124, 546 43, Thessaloniki
General Hospital Of Thessaloniki Papageorgiou
Dermatology Clinic AUTh, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
University General Hospital Attikon
2nd University Department of Dermatology-Venereology NKUA, Rimini Street 1, 124 62, Athens
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
N/A, Szentpeteri Kapu 72-76, 3526, Miskolc
University Of Debrecen
Dermatology, Nagyerdei Korut 98, 4032, Debrecen
Clinexpert Kft.
N/A, Kaszasdulo Utca 5, 1033, Budapest III
SYNEXUS Magyarorszag Kft.
N/A, Becsi Ut 61, 1036, Budapest III
University Of Pecs
Onkodermatology, Akac Utca 1, 7632, Pecs
Gyongyosi Bugat Pal Korhaz
Dermatology, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
DermaMed Research Kft.
N/A, Kossuth Lajos Utca 19, 5900, Oroshaza
Allergo-Derm Bakos Kft.
Dermatology, Baross Utca 20, 5000, Szolnok
University Of Szeged
N/A, Koranyi Fasor 6, 6720, Szeged
DRC Kft.
N/A, Ady Endre Utca 12/b, 8230, Balatonfured
Derma-B Kft.
Dermatology, Gyepusor Utca 3, 4031, Debrecen
South Infirmary Victoria University Hospital
Dermatology, South Infirmary, Old Blackrock Road, Cork
University Hospital Galway
HRB Clinical Research Facility, Newcastle Road, H91 YR71, Galway
St James's Hospital
Dermatology, James's Street, D08 NHY1, Dublin 8
University Hospital Waterford
Dermatology, Dunmore Road, X91 ER8E, Waterford
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dermatology, Largo Francesco Vito 1, 00168, Rome
Humanitas Research Hospital
Dermatology, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Dermatology, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero Universitaria Pisana
Dermatology, Via Roma 67, 56126, Pisa
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
Dermatology, Via Saragat Localita Campo Di Pile, 67100, L'Aquila
Azienda Ospedaliero-Universitaria Di Cagliari
Dermatology, Strada Statale 554 N. 1, 09042, Monserrato
Azienda Ospedaliero Universitaria Delle Marche
Dermatology, Via Conca 71, 60126, Ancona
Azienda Ospedaliera Universitaria Federico II Di Napoli
Dermatology, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Dermatology, Via Santa Sofia 78, 95123, Catania
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Dermatology, Via Francesco Sforza 28, 20122, Milan
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Dermatology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
University Medical Center Groningen
Dermatology, Hanzeplein 1, 9713 GZ, Groningen
Academisch Medisch Centrum
Dermatology, Meibergdreef 9, 1105 AZ, Amsterdam
University Medical Center Utrecht
Dermatology/ Allergology, Heidelberglaan 100, 3584 CX, Utrecht
Bravis Ziekenhuis
Dermatology, Boerhaaveplein 1, 4624 VT, Bergen Op Zoom
Oslo University Hospital HF
Dermatology, Sognsvannsveien 20, 0372, Oslo
University Hospital Of North Norway HF
Dermatology, P. O. Box 100, 9038, Tromsoe
Helse Bergen HF
Dermatology, Jonas Lies Vei 65, 5021, Bergen
University Hospital Of North Norway HF
Hudpoliklinikken, P. O. Box 100, 9038, Tromsoe
Unidade Local De Saude Da Regiao De Leiria E.P.E.
Dermatology, Rua Das Olhalvas, 2410-197, Leiria
CCAB Centro Clinico Academico Braga Associacao
Dermatology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Santo Antonio E.P.E.
Dermatology, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude De Santa Maria E.P.E.
Dermatology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local de Saude de Sao Joao E.P.E.
Dermatology, Alameda Professor Hernani Monteiro, 4200-319, Porto
Hospital Cuf Descobertas S.A.
Dermatology, Rua Mario Botas 1, 1998-018, Lisbon
Univerzitna Nemocnica Martin
Dermatovenerology, Kollarova 2, 036 01, Martin
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov
Dermatovenerology, Jana Holleho 5898/14, 080 01, Presov
Fakultna Nemocnica S Poliklinikou Nove Zamky
Dermatovenerology, Slovenska 11a, 940 02, Nove Zamky
Hospital Universitario De Puerto Real
Dermatology, Carretera Nacional IV Km 665 S/n, 11510, Puerto Real
Hospital Universitario Clinico San Cecilio
Dermatology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital General Universitario Dr. Balmis
Dermatology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital General Universitario Reina Sofia
Dermatology, Avenida Menendez Pidal S/n, 14004, Cordoba
Sant Joan De Deu Barcelona Hospital
Pediatric Dermatology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital Universitario Infanta Leonor
Dermatology, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Universitario De La Princesa
Dermatology, Calle De Diego De Leon 62, 28006, Madrid
Hospital General Universitario De Valencia
Dermatology, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital De La Santa Creu I Sant Pau
Dermatology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario La Paz
Dermatology, Paseo Castellana 261, 28046, Madrid
Consorci Mar Parc De Salut De Barcelona
Dermatology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital General Universitario Gregorio Maranon
Dermatology, Calle Del Doctor Esquerdo 46, 28007, 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 |
|---|---|---|---|---|---|
| Austria | 2019-02-21 | 2019-03-15 | 2024-11-11 | ||
| Belgium | 2019-03-22 | 2019-09-04 | 2024-09-03 | ||
| Bulgaria | 2024-11-07 | 2024-11-20 | 2024-12-19 | ||
| Croatia | 2024-10-20 | 2024-10-28 | 2025-08-21 | ||
| Czechia | 2019-06-17 | 2019-07-03 | 2024-10-15 | ||
| Finland | 2024-10-30 | 2024-11-07 | 2025-05-21 | ||
| France | 2019-05-06 | 2019-05-09 | 2024-07-31 | ||
| Germany | 2019-05-22 | 2019-06-06 | 2025-01-08 | ||
| Greece | 2019-02-11 | 2019-03-06 | 2024-12-16 | ||
| Hungary | 2019-02-05 | 2019-05-28 | 2025-08-13 | ||
| Ireland | 2019-02-04 | 2019-03-04 | 2025-01-16 | ||
| Italy | 2019-02-14 | 2019-06-05 | 2025-08-07 | ||
| Netherlands | 2019-03-21 | 2019-03-25 | 2020-09-17 | ||
| Norway | 2019-01-02 | 2024-10-15 | 2019-01-08 | 2019-10-23 | |
| Portugal | 2024-09-27 | 2024-10-03 | 2024-12-19 | ||
| Slovakia | 2019-02-20 | 2019-02-25 | 2019-11-19 | ||
| Spain | 2019-02-12 | 2019-03-13 | 2024-11-04 | ||
| Sweden | 2019-02-04 | 2019-02-13 | 2019-11-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 179 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m16047-protocol-admin-change | 3 |
| Protocol (for publication) | D1_m16047-protocol-redacted | 9.1 EU |
| Protocol (for publication) | D1_m16047-protocol-redacted-GR | 9.1 |
| Recruitment arrangements (for publication) | K1_M16-047 HR Recruitment and ICF Procedures_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_M16-047_AT_Recruitment and ICF Procedures | 2 |
| Recruitment arrangements (for publication) | K1_M16-047_BG_Recruitment and ICF Procedures_Public | 1 |
| Recruitment arrangements (for publication) | K1_M16-047_FI_Recruitment and ICF Procedures_Public | 1 |
| Recruitment arrangements (for publication) | K1_M16-047_PT_Recruitment and ICF Procedures_Public | 1 |
| Recruitment arrangements (for publication) | M16-047 - BE - Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M16-047 CZ Recruitment and ICF Procedures_Public | 1.0 |
| Recruitment arrangements (for publication) | M16-047 ES Recruitment and Informed Consent Procedure Form | 1.0 |
| Recruitment arrangements (for publication) | M16-047 FR Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M16-047 IT Recruitment and ICF Procedures | 2.0 |
| Recruitment arrangements (for publication) | M16-047 NL Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M16-047 SK Recruitment and ICF Procedures public | 1 |
| Recruitment arrangements (for publication) | M16-047_DE Recruitment and ICF Procedures_Public | 1.0 |
| Recruitment arrangements (for publication) | M16-047_EU-CTR recruitment and ICF procedures | 2 |
| Recruitment arrangements (for publication) | M16-047_HU Recruitment and ICF Procedures_public | 1.0 |
| Recruitment arrangements (for publication) | M16-047_IE Recruitment Arrangements | 2.0 |
| Recruitment arrangements (for publication) | M16-047_SE_Recruitment and ICF procedures_public | 1 |
| Subject information and informed consent form (for publication) | L1 M16-047 - FR - -Addendum ICF_ French | 1 |
| Subject information and informed consent form (for publication) | L1 M16-047 ES ICF Main Long Term Extension (LTE)_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1 M16-047 ES ICF Main_Public | 10.1 |
| Subject information and informed consent form (for publication) | L1 M16-047 ES ICF Parent-Guardian (LTE)_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M16-047 AT _ ICF_Pregnant Partner_German _public | 2 |
| Subject information and informed consent form (for publication) | L1_M16-047 AT - ICF Main _German_public | 10 |
| Subject information and informed consent form (for publication) | L1_M16-047 AT - ICF Parent-Guardian - German_public | 8.2 |
| Subject information and informed consent form (for publication) | L1_M16-047 AT - ICF_adolescents 12-15_ German_ public | 5 |
| Subject information and informed consent form (for publication) | L1_M16-047 AT - ICF_adolescents 16-17_German_public | 8.2 |
| Subject information and informed consent form (for publication) | L1_M16-047 HR Assent Form for Adolescents 15-17y_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M16-047 HR Assent Pregnant Subject ICF clean Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M16-047 HR Main ICF_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M16-047 HR Parent ICF_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M16-047 HR Pregnant Subject ICF_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M16-047_AT_Blank document_ICF site contact details_public | 11 |
| Subject information and informed consent form (for publication) | L1_M16-047_AT_LTE_ICF_Addendum_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M16-047_Austria_ICF Optional Research Parents_ German_ public | 4 |
| Subject information and informed consent form (for publication) | L1_M16-047_Austria_ICF Optional Research_ adolescents 16 - 17_German_public | 4 |
| Subject information and informed consent form (for publication) | L1_M16-047_Austria_ICF Optional Research_German_public | 5 |
| Subject information and informed consent form (for publication) | L1_M16-047_BG_ICF Adult Bulgarian Clean_Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_M16-047_BG_ICF Adult English Clean_Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_M16-047_BG_ICF Assent Bulgarian Clean_Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_M16-047_BG_ICF Assent English Clean_Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_M16-047_BG_ICF Parent Bulgarian Clean_Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_M16-047_BG_ICF Parent English Clean_Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_M16-047_BG_ICF Pregnant Partner Bulgarian_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M16-047_BG_ICF Pregnant Partner English_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M16-047_FI_ICF Assent 15 to 17 y.o_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_M16-047_FI_ICF Guardian of 15-17 y.o_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M16-047_FI_ICF Main_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_M16-047_PT_ICF Main_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M16-047_PT_ICF Pregnancy_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M16-047_SK ICF Addendum_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_M16-047_SK ICF Main_Public | 13.0 |
| Subject information and informed consent form (for publication) | L1_M16-047_SK ICF Optional_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M16-047_SK ICF Pregnancy Data Release_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M16-047_SK ICF Privacy_Public | 5.0 |
| Subject information and informed consent form (for publication) | L2 M16-047 ES ICF Assent Long Term Extension (LTE)_Public | 1.1 |
| Subject information and informed consent form (for publication) | M16-047 BE - ICF Assent Country Sample Dutch -public | 7 |
| Subject information and informed consent form (for publication) | M16-047 BE - ICF Assent Country Sample English -public | 7 |
| Subject information and informed consent form (for publication) | M16-047 BE - ICF Assent Country Sample French -public | 7 |
| Subject information and informed consent form (for publication) | M16-047 BE - ICF Main Country Sample Dutch -public | 14.0 |
| Subject information and informed consent form (for publication) | M16-047 BE - ICF Main Country Sample English -public | 14.0 |
| Subject information and informed consent form (for publication) | M16-047 BE - ICF Main Country Sample French-public | 14.0 |
| Subject information and informed consent form (for publication) | M16-047 BE - ICF Optional Research Country Sample Dutch-public | 6 |
| Subject information and informed consent form (for publication) | M16-047 BE - ICF Optional Research Country Sample English -public | 6 |
| Subject information and informed consent form (for publication) | M16-047 BE - ICF Optional Research Country Sample French-public | 6 |
| Subject information and informed consent form (for publication) | M16-047 BE - ICF PregPart Country Sample Dutch-public | 4 |
| Subject information and informed consent form (for publication) | M16-047 BE - ICF PregPart Country Sample English -public | 4 |
| Subject information and informed consent form (for publication) | M16-047 BE - ICF PregPart Country Sample French -public | 4 |
| Subject information and informed consent form (for publication) | M16-047 BE ICF LTE Country Sample Dutch - public | 2.0 |
| Subject information and informed consent form (for publication) | M16-047 BE ICF LTE Country Sample English - public | 2.0 |
| Subject information and informed consent form (for publication) | M16-047 BE ICF LTE Country Sample French - public | 2.0 |
| Subject information and informed consent form (for publication) | M16-047 CZ - ICF Parental ICF_Czech_public | 2 |
| Subject information and informed consent form (for publication) | M16-047 CZ - ICF pregnant partner_adults_Czech_public | 2 |
| Subject information and informed consent form (for publication) | M16-047 CZ - ICF adolescent 15-17- Czech_public | 2 |
| Subject information and informed consent form (for publication) | M16-047 CZ - ICF GDPR _adult Czech_public | 1 |
| Subject information and informed consent form (for publication) | M16-047 CZ - ICF GDPR adolescent 15-17 Czech -public | 1 |
| Subject information and informed consent form (for publication) | M16-047 CZ - ICF Main Czech -public | 6.0 |
| Subject information and informed consent form (for publication) | M16-047 CZ - ICF optional biomarker assent _12-14_Czech_public | 2 |
| Subject information and informed consent form (for publication) | M16-047 CZ - ICF optional biomarker_adolescents 15-17_ Czech_public | 2 |
| Subject information and informed consent form (for publication) | M16-047 CZ - ICF optional biomarkers_adults_Czech_public | 2 |
| Subject information and informed consent form (for publication) | M16-047 CZ - ICF Parental optional biomarker_ Czech_public | 2 |
| Subject information and informed consent form (for publication) | M16-047 CZ - ICF_assent 12-14_Czech-public | 2 |
| Subject information and informed consent form (for publication) | M16-047 CZ - ICF Parental GDPR Czech_public | 1 |
| Subject information and informed consent form (for publication) | M16-047 CZ ICF Main LTE Czech 06Mar2024_Public | 1.0 |
| Subject information and informed consent form (for publication) | M16-047 DE - ICF Main Adult_German_public | 10 |
| Subject information and informed consent form (for publication) | M16-047 DE - ICF_ Main Parents_ german_public | 2 |
| Subject information and informed consent form (for publication) | M16-047 DE - ICF_Optional Research_ German_public | 1 |
| Subject information and informed consent form (for publication) | M16-047 DE - ICF_Pregnant Partner_ German_public | 1 |
| Subject information and informed consent form (for publication) | M16-047 DE Main ICF LTE _Public | 1 |
| Subject information and informed consent form (for publication) | M16-047 DE_ ICF_adolescent 12-17_ German_public | 2.1 |
| Subject information and informed consent form (for publication) | M16-047 ES - ICF_ assent 12-17_ Spanish_public | 2 |
| Subject information and informed consent form (for publication) | M16-047 ES - ICF_ Pregnant Partner_ Spanish_public | 1.1 |
| Subject information and informed consent form (for publication) | M16-047 ES - ICF Optional _ Spanish_public | 4 |
| Subject information and informed consent form (for publication) | M16-047 FR - ICF Adolescents 12_17_French _public | 4 |
| Subject information and informed consent form (for publication) | M16-047 FR - ICF Main Adults _French _ public | 10.1 |
| Subject information and informed consent form (for publication) | M16-047 FR - ICF Parent-Guardian _ French _ public | 8.1 |
| Subject information and informed consent form (for publication) | M16-047 FR ICF Long term extension_French_Public | 1.1 |
| Subject information and informed consent form (for publication) | M16-047 GR - ICF Adolescent 12-13 Main and Optional Research Greek public | 5 |
| Subject information and informed consent form (for publication) | M16-047 GR - ICF Adolescent 14-17 Greek - public | 5 |
| Subject information and informed consent form (for publication) | M16-047 GR - ICF Main Greek public | 10 |
| Subject information and informed consent form (for publication) | M16-047 GR - ICF Optional Research 14-17 Greek public | 4 |
| Subject information and informed consent form (for publication) | M16-047 GR - ICF Optional Research Parents Greek public | 3 |
| Subject information and informed consent form (for publication) | M16-047 GR - ICF optional research_greek_ public | 2 |
| Subject information and informed consent form (for publication) | M16-047 GR - ICF Parents Greek public | 5 |
| Subject information and informed consent form (for publication) | M16-047 GR - ICF Pregnant Partner Greek public | 1 |
| Subject information and informed consent form (for publication) | M16-047 GR - 261404 EU CTR Curriculum Vitae - Aronis | 1 |
| Subject information and informed consent form (for publication) | M16-047 GR ICF Main Greek redlines | 9 to 10 |
| Subject information and informed consent form (for publication) | M16-047 GR ICF Addend Greek | 1 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF Assent _12-17_Hungarian_ public | 7 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF Assent_PIS_ 12-17_ Hungarian_public | 7 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF Main _adults_ Hungarian_ public | 9 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF Main_ PIS_Adults_ Hungarian_ public | 9 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF Parent-Guardian _PIS_ Hungarian_public Redacted | 9 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF Parent-Guardian - Hungarian - public | 9 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF pregnant Partner_Hungarian_public | 1 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF pregnant Partner_PIS _Hungarian_public | 1 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF_Optional Research Genetic Adult PIS_Hungarian_public | 1 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF_Optional Research Genetic Adult_Hungarian_ public | 1 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF_Optional Research Genetic_ Parental_ PIS_Hungarian_ public | 1 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF_Optional Research Genetic_ Parental_Hungarian_ public | 1 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF_Optional Research Genetic_12-17_ PIS_Hungarian_ public | 1 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF Addendum for COVID-19_ PIS_Hungarian_ public | 1 |
| Subject information and informed consent form (for publication) | M16-047 HU - ICF Addendum for COVID-19_Hungarian_ public | 1 |
| Subject information and informed consent form (for publication) | M16-047 HU LTE ICF Parental_public | 1.0 |
| Subject information and informed consent form (for publication) | M16-047 HU LTE PIS_ICF 12-17y_public | 1.0 |
| Subject information and informed consent form (for publication) | M16-047 HU LTE PIS_ICF Adult_public | 1.0 |
| Subject information and informed consent form (for publication) | M16-047 HU Main 12-17y PIS_ICF_public | 8.0 |
| Subject information and informed consent form (for publication) | M16-047 HU Main Adult PIS_ICF_public | 10.0 |
| Subject information and informed consent form (for publication) | M16-047 HU Main Parental PIS_ICF_public | 10.0 |
| Subject information and informed consent form (for publication) | M16-047 IE - ICF Assent- English- 12-15-public | 2 |
| Subject information and informed consent form (for publication) | M16-047 IE - ICF LTE English | 2.0 |
| Subject information and informed consent form (for publication) | M16-047 IE - ICF Main - English - public | 13 |
| Subject information and informed consent form (for publication) | M16-047 IE - ICF Parent - English - public | 13 |
| Subject information and informed consent form (for publication) | M16-047 IE - ICF Pregnant Partner_ English-public | 2 |
| Subject information and informed consent form (for publication) | M16-047 IT - ICF_ assent_12_17_Italian_public | 1 |
| Subject information and informed consent form (for publication) | M16-047 IT - ICF Main_ Italian_public | 2.3 |
| Subject information and informed consent form (for publication) | M16-047 IT - ICF Parent-Guardian - Italian - public | 1 |
| Subject information and informed consent form (for publication) | M16-047 NL - ICF LTE Dutch Public | 1.0 |
| Subject information and informed consent form (for publication) | M16-047 NL - ICF Main Dutch -public | 9.1 |
| Subject information and informed consent form (for publication) | M16-047 NL - ICF Main Dutch public | 10.0 |
| Subject information and informed consent form (for publication) | M16-047 NL - ICF Optional Research Dutch -public | 2 |
| Subject information and informed consent form (for publication) | M16-047 NL - ICF PregPart Dutch -public | 4 |
| Subject information and informed consent form (for publication) | M16-047 NL ICF Addendum Parents Dutch public | 1 |
| Subject information and informed consent form (for publication) | M16-047 NL ICF Addendum_adolescent 12_15_ Dutch _ public | 1 |
| Subject information and informed consent form (for publication) | M16-047 NL ICF Adolescent 12_15_ Dutch _ public | 8.1 |
| Subject information and informed consent form (for publication) | M16-047 NL ICF Parents Dutch_ public | 8.1 |
| Subject information and informed consent form (for publication) | M16-047 SE - ICF Adults_Clean public | 9.1 |
| Subject information and informed consent form (for publication) | M16-047 SE - ICF Assent_12_17_public | 6 |
| Subject information and informed consent form (for publication) | M16-047 SE - ICF Caregiver_public | 6 |
| Subject information and informed consent form (for publication) | M16-047 SE - ICF Continued Treatment Extension_clean public | 1 |
| Subject information and informed consent form (for publication) | M16-047 SE - ICF_Pregnant Partner_public | 2 |
| Subject information and informed consent form (for publication) | M16-047 SE - ICF Adults_redline MS | 8 vs 9 |
| Subject information and informed consent form (for publication) | M16-047_IT ICF Authorization for Pregnancy Data Release Form_italian_public | 2.1 |
| Subject information and informed consent form (for publication) | M16-047_IT_ICF Long Term Extension_italian_public | 1.3 |
| Subject information and informed consent form (for publication) | M16-047_IT_Privacy Long Term Extension ICF_Italian | 1.1 |
| Subject information and informed consent form (for publication) | M16-047_IT_Privacy Main ICF_Italian | 1.1 |
| Synopsis of the protocol (for publication) | D1_m16-047-protocol synopsis-redacted-BG-BG | 9.1 |
| Synopsis of the protocol (for publication) | D1_m16-047-protocol synopsis-redacted-PT-PT | 9.1 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis lay version | 1 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis lay version-BE_DE | 1 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis lay version-BE_FR | 1 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis lay version-BE_NL | 1 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis lay version-NL | 1 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis lay version-SE | 1 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-AT-DE | 9.0 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-BE-DE | 9.0 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-BE-FR | 9.0 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-BE-NL | 9.0 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-CZ | 9.0 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-ES | 9.0 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-FR | 9.0 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-HU | 9.0 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-IT | 9.0 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-NL | 9.0 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-NO | 9.0 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-SE | 9.0 |
| Synopsis of the protocol (for publication) | D1_m16047-protocol synopsis-SK | 9.0 |
Application history
16 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-31 | Italy | Acceptable 2023-09-20
|
2023-09-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-22 | Italy | Acceptable 2024-06-26
|
2024-06-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-16 | Acceptable 2024-06-26
|
2024-07-16 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-07-18 | Acceptable 2024-06-26
|
2024-10-14 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-07-18 | 2024-10-14 | ||
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-07-18 | Acceptable 2024-06-26
|
2024-10-07 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-07-18 | Acceptable 2024-06-26
|
2024-09-10 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-28 | Acceptable 2024-06-26
|
2024-10-28 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-11-05 | Acceptable 2024-06-26
|
2024-11-05 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-18 | Italy | Acceptable 2025-03-10
|
2025-03-10 |
| 11 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-05-09 | Italy | Acceptable 2025-07-14
|
2025-07-14 |
| 12 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-08-01 | Acceptable | 2025-09-05 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-08-12 | Acceptable | 2025-10-02 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-09-05 | Acceptable | 2025-09-17 | |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-11-07 | Acceptable | 2025-11-07 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-11-20 | Italy | Acceptable 2026-02-25
|
2026-02-25 |