Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
159
Countries
3
Sites
16
Plaque Psoriasis
The objective of this study is to assess the long-term safety, tolerability, and efficacy of risankizumab in subjects with moderate to severe plaque psoriasis who have completed participation in the preceding study (Study M19-977).
Key facts
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 14 Sep 2022 → ongoing
- Decision date (initial)
- 2022-07-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2022-500408-22-00
- ClinicalTrials.gov
- NCT04862286
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
The objective of this study is to assess the long-term safety, tolerability, and efficacy of risankizumab in subjects with moderate to severe plaque psoriasis who have completed participation in the preceding study (Study M19-977).
Conditions and MedDRA coding
Plaque Psoriasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10037153 | Psoriasis | 100000004858 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall Trial Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks.
|
Not Applicable | None | Risankizumab: Risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks. |
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-001776-PIP01-15
- 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 https://www.abbvieclinicaltrials.com/hcp/data-sharing/. For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
| EU CT number | Title | Sponsor |
|---|---|---|
| 2019-004141-32 | A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients from 6 to Less than 18 Years of Age with Moderate to Severe Plaque Psoriasis |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Participants who have completed participation in study M19-977 and who meet all eligibility criteria for participation in Study M19-973 will be allowed to enroll in study M19-973.
Exclusion criteria 1
- Participants who have developed any discontinuation criteria as defined in Study M19-977.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of Participants With Adverse Events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD9422583 · Product
- Active substance
- Risankizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 935 mg milligram(s)
- Max treatment duration
- 204 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD10369455 · Product
- Active substance
- Risankizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 2550 mg milligram(s)
- Max treatment duration
- 204 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- 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 |
|---|---|---|
| Qd Solutions Inc. ORG-100041849
|
Austin, United States | Other |
| EndPoint Clinical ORL-000002680
|
San Francisco, United States | Interactive response technologies (IRT) |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Labcorp Central Laboratories Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
Locations
3 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 25 | 6 |
| Poland | Ongoing, recruiting | 30 | 5 |
| Spain | Ongoing, recruiting | 15 | 5 |
| Rest of world
United Kingdom, Japan, Canada, United States
|
— | 89 | — |
Investigational sites
Thermalsole- Und Schwefelbad Bentheim GmbH
Klinik fuer Dermatologie und Allergologie, Am Bade 1, 48455, Bad Bentheim
Universitaetsklinikum Carl Gustav Carus An Der Technischen Universitaet Dresden AöR
Klinik und Poliklinik fuer Dermatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsmedizin Der Johannes Gutenberg-Universitat Mainz KöR
CRC Studienzentrum, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Bonn AöR
AoeR Klinik und Poliklinik fuer Dermatologie und Allergologie, Venusberg-Campus 1, Venusberg, Bonn
University Medical Center Schleswig Holstein
Department of Dermatology, Venereology and Allergology, Arnold-Heller-Strasse 3, Brunswik, Kiel
University Hospital Muenster AöR
Zentrale Studienkoordination fuer innovative Dermatologie (ZiD), Von-Esmarch-Strasse 58, Sentrup, Muenster
Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
not applicable, Al. Tadeusza Kosciuszki 93, 90-436, Lodz
Centrum Badań Klinicznych Pi-House Sp. z o.o.
not applicable, Ul. Na Zaspe 3, 80-546, Gdansk
Dorota Bystrzanowska High Med Przychodnia Specjalistyczna
not applicable, Ul. Jana Kasprowicza 27/2, 01-817, Warsaw
Dermed Centrum Medyczne Sp. z o.o.
not applicable, Ul. Piotrkowska 48, 90-265, Lodz
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Klinika Dermatologii i Dermatologii Onkologicznej, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Hospital Universitario 12 De Octubre
Servicio de Dermatologia, Bloque D, Avenida De Cordoba S/n, Madrid
Complexo Hospitalario Universitario De Pontevedra
Servicio de Dermatología, Calle Mourente S/n, 36164, Pontevedra
Gregorio Maranon University Hospital
Servicio de Dermatología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Sant Joan De Déu Barcelona
Dermatologia, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital Universitario Infanta Leonor
Servicio de Dermatologia, Avenida Gran Via Del Este 80, 28031, 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 |
|---|---|---|---|---|---|
| Germany | 2022-12-02 | 2022-12-20 | |||
| Poland | 2022-11-30 | 2022-12-15 | |||
| Spain | 2022-09-14 | 2022-09-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 43 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m19973-protocol-redacted | 5.0 |
| Recruitment arrangements (for publication) | M19-973 DE Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M19-973 ES Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M19-973 PL Recruitment and ICF Procedures | 1 |
| Subject information and informed consent form (for publication) | L1 M19-973 DE Cont Treatment ICF 17 plus | 1 |
| Subject information and informed consent form (for publication) | L1 M19-973 DE Cont Treatment ICF assent | 1 |
| Subject information and informed consent form (for publication) | L1 M19-973 DE Cont Treatment ICF parent | 1 |
| Subject information and informed consent form (for publication) | L1 M19-973 DE ICF 12-16 yrs | 3.0 |
| Subject information and informed consent form (for publication) | L1 M19-973 DE ICF 17 plus yrs | 3.0 |
| Subject information and informed consent form (for publication) | L1 M19-973 DE ICF parent | 3.0 |
| Subject information and informed consent form (for publication) | L1 M19-973 ES Assent ICF_public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M19-973 ES Assent ICF_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1 M19-973 ES CTE Assent_Public | 1 |
| Subject information and informed consent form (for publication) | L1 M19-973 ES CTE ICF v1_Public | 1 |
| Subject information and informed consent form (for publication) | L1 M19-973 ES Main ICF_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M19-973 ES Main ICF_TC | 3.0 |
| Subject information and informed consent form (for publication) | L1 M19-973 ES Parent ICF_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M19-973 ES Parent ICF_TC | 3.0 |
| Subject information and informed consent form (for publication) | L1_M19-973 PL ICF Addendum for Treatment Continuation Main_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M19-973 PL ICF Addendum for Treatment Continuation Minors 13-17_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M19-973 PL ICF Addendum for Treatment Continuation Parents_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M19-973 PL ICF Main Minors 13-17_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M19-973 PL ICF Main Minors 13-17_track changes | 3 to 4 |
| Subject information and informed consent form (for publication) | L1_M19-973 PL ICF Main_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M19-973 PL ICF Main_track changes | 3 to 4 |
| Subject information and informed consent form (for publication) | L1_M19-973 PL ICF Parents Main_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M19-973 PL ICF Parents Main_track changes | 3 to 4 |
| Subject information and informed consent form (for publication) | M19-973 DE ICF 12-15 yrs_Redacted | 1 |
| Subject information and informed consent form (for publication) | M19-973 DE ICF 12-16 yrs Redacted | 1.2 |
| Subject information and informed consent form (for publication) | M19-973 DE ICF 12-16 yrs Redline Redacted | 1.2 to 2 |
| Subject information and informed consent form (for publication) | M19-973 DE ICF 16 plus yrs_Redacted | 1 |
| Subject information and informed consent form (for publication) | M19-973 DE ICF 17 plus yrs Redlines Redacted | 1.2 to 2 |
| Subject information and informed consent form (for publication) | M19-973 DE ICF 6-8 yrs | 1.1 |
| Subject information and informed consent form (for publication) | M19-973 DE ICF 6-8 yrs Redlines | 1.1 |
| Subject information and informed consent form (for publication) | M19-973 DE ICF 9-11 yrs | 1.1 |
| Subject information and informed consent form (for publication) | M19-973 DE ICF 9-11 yrs Redline | 1 to 1.1 |
| Subject information and informed consent form (for publication) | M19-973 DE ICF Adult Redline Redacted | 1.2 to 2 |
| Subject information and informed consent form (for publication) | M19-973 DE ICF age 6-8 Redline | 1 to 1.1 |
| Subject information and informed consent form (for publication) | M19-973 PL Child Assent under 13 yrs | 2 |
| Subject information and informed consent form (for publication) | M19-973 PL Child Assent under 13 yrs redlines | 1 to 2 |
| Synopsis of the protocol (for publication) | D1_m19973-euctr-synopsis-en | 1 |
| Synopsis of the protocol (for publication) | D1_m19973-euctr-synopsis-es-es | 1 |
| Synopsis of the protocol (for publication) | D1_m19973-euctr-synopsis-pl-pl | 1 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-03-28 | Spain | Acceptable 2022-07-14
|
2022-07-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-12-02 | Spain | Acceptable 2023-02-17
|
2023-02-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-03-10 | Spain | Acceptable 2023-02-17
|
2023-03-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-08-23 | Spain | Acceptable 2023-10-11
|
2023-10-11 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-01-31 | Spain | Acceptable | 2024-02-28 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-09-20 | Spain | Acceptable 2024-11-04
|
2024-11-04 |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-10-06 | Spain | Acceptable 2025-12-10
|
2025-12-11 |
| 8 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-01-23 | Spain | Acceptable | 2026-02-20 |