2023-508992-35-00CompletedPhase 2
A clinical study comparing different doses of a potential new medicine with an inactive medicine for patients with moderate to severe psoriasis
A Phase 2b Multicenter, Randomized, Double-blind, Placebo-controlled Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-81241459 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 May 2024
Brief summary (registry, in English)
To evaluate the efficacy of JNJ-81241459 compared with placebo in participants with moderate to severe plaque psoriasis
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 16 Jan 2024
- Start date
- 29 May 2024
- Lead sponsor
- Janssen Cilag International
- Diseases
- Psoriasis
- EU CT number
- 2023-508992-35-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 100
- 25 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Lab values
- Current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
Other
- Nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ISA - Interdisciplinary Study Association GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Completed |
| Studienzentrum an der Hase GbR Coordinator of this site? Confirm its status | Bramsche | Germany | Completed |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Completed |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Completed |
| Studienzentrum Dr. Schwarz Coordinator of this site? Confirm its status | Langenau | Germany | Completed |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Completed |
| Klinische Forschung Osnabrueck Coordinator of this site? Confirm its status | Osnabrueck | Germany | Completed |
| Klinische Forschung Schwerin GmbH Coordinator of this site? Confirm its status | Schwerin | Germany | Completed |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Completed |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Grupo Dermatológico y Estético Pedro Jaén S.A Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans Cedex 9 | France | Completed |
| Groupement Des Hopitaux De L'Institut Catholique De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Tagast 41 Coordinator of this site? Confirm its status | Nice | France | Completed |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Completed |
| Clinicmed Daniluk Nowak Sp. k. Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Chojnice | Poland | Completed |
| Centrum Medyczne All-Med Badania Kliniczne Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| EMC Instytut Medyczny S.A. Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.