Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
200
Countries
4
Sites
26
Plaque Psoriasis
To evaluate the efficacy of JNJ-81241459 compared with placebo in participants with moderate to severe plaque psoriasis
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- completed 21 Jun 2024
- Decision date (initial)
- 2024-05-13
- 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: Pharmacokinetic, Efficacy, Pharmacogenetic, Pharmacodynamic, Safety, Dose response, Pharmacogenomic
To evaluate the efficacy of JNJ-81241459 compared with placebo in participants with moderate to severe plaque psoriasis
Conditions and MedDRA coding
Plaque Psoriasis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Be ≥18 (or the legal age of consent if it is higher in the jurisdiction in which the study is taking place) years of age at screening, inclusive.
- Diagnosis of plaque psoriasis
- Total BSA ≥10% at screening and baseline.
- Total PASI ≥12 at screening and baseline.
- Total IGA ≥3 at screening and baseline.
Exclusion criteria 5
- Nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular).
- Current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
- 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.
- A current diagnosis or history of IBD.
- Known allergies, hypersensitivity, or intolerance to JNJ-81241459 or its excipients (refer to the JNJ-81241459 IB).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PASI 75 at Week 12
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11026111 · Product
- Active substance
- JNJ-81241459
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JOHNSON & JOHNSON ENTERPRISE INNOVATION INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11026109 · Product
- Active substance
- JNJ-81241459
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JOHNSON & JOHNSON ENTERPRISE INNOVATION INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
JNJ-81241459 200mg, placebo 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
JNJ-81241459 50mg, placebo 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
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 4
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other, Laboratory analysis, Code 5, Data management |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture, Code 8 |
| Canfield Scientific Inc. ORG-100042834
|
Parsippany, United States | Other |
Locations
4 EU/EEA countries · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 6 | 4 |
| Germany | Ended | 27 | 10 |
| Poland | Ended | 60 | 6 |
| Spain | Ended | 7 | 6 |
| Rest of world
Canada, United Kingdom, Japan, United States
|
— | 100 | — |
Investigational sites
Groupement Des Hopitaux De L'Institut Catholique De Lille
Dermatology, Boulevard De Belfort, P. O. Box 387, Lille Cedex
Centre Hospitalier Le Mans
Dermatologie, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Tagast 41
Dermatology and Venerology Centre Azur - Nice, 2 Boulevard Victor Hugo, 06000, Nice
Centre Hospitalier Universitaire De Saint Etienne
Service de Dermatologie - Hôpital Nord, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Universitaetsklinikum Tuebingen AöR
Psoriasiszentrum, Liebermeisterstrasse 25, Innenstadt, Tuebingen
Universitaetsklinikum Schleswig-Holstein AöR
Institut fuer Entzuendungsmedizin, Ratzeburger Allee 160, 23538, Luebeck
Klinische Forschung Osnabrueck
KLIFOS - Klinische Forschung Osnabrueck, Hakenstrasse 1, Innenstadt, Osnabrueck
Klinische Forschung Schwerin GmbH
NA, Friedrichstrasse 1, Altstadt, Schwerin
Universitaetsklinikum Bonn AöR
Klinik fuer Dermatologie und Allergologie, Venusberg-Campus 1, Venusberg, Bonn
Studienzentrum an der Hase GbR
NA, Hasestraße 17, 49565, Bramsche
Universitaetsklinikum Schleswig-Holstein AöR
Klinik fuer Dermatologie, Allergologie und Venerologie (Hautklinik), Arnold-Heller-Strasse 3, Brunswik, Kiel
Studienzentrum Dr. Schwarz
NA, Bismarkstraße 49, 89129, Langenau
ISA Interdisciplinary Study Association GmbH
NA, Rankestrasse 33/34, Charlottenburg, Berlin
Universitaetsklinikum Erlangen AöR
Hautklinik, Ulmenweg 18, Innenstadt, Erlangen
Centrum Medyczne All-Med Badania Kliniczne
N/A, Ul. Henryka Sienkiewicza 23, 30-033, Cracow
Clinicmed Daniluk Nowak Sp. k.
N/A, Ul. Stoleczna 7/200, 15-879, Bialystok
EMC Instytut Medyczny S.A.
N/A, Ul. Lowiecka 24, 50-220, Wroclaw
EMC Instytut Medyczny S.A.
N/A, Ul. Pilczycka 144/148, 54-144, Wroclaw
Pratia S.A.
N/A, Ul. Przemyslowa 3, 89-600, Chojnice
Pratia S.A.
N/A, Ul. Wojciecha Lochowskiego 7a, 85-796, Bydgoszcz
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Dermatology, Calle De Serrano 143, 28006, Madrid
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 Gregorio Maranon
Dermatology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Clinico San Carlos
Dermatology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital De La Santa Creu I Sant Pau
Dermatology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-33385
- Event date
- 2024-06-21
- Submission date
- 2024-07-05
- Member states affected
- France, Germany, Spain, Poland
- Event description
- New non-clinical finding
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Reason of cancellation SUM-86579
|
2025-06-13T15:11:41 | Submitted | Summary of Results |
Documents 1 file
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Summary of results (for publication) | Reason of Cancellation- 2023-508992-35-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-16 | Spain | Acceptable 2024-05-07
|
2024-05-07 |