Active (not recruiting) Phase 3 2024-515706-77-00

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Phase 3 – large-scale trial before approval

Conditions: Moderate to Severe Plaque Psoriasis

Sponsor: Janssen Cilag International

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Overview

Trial status: Authorised IGA score of 0 or 1 and a ≥2 grade improvement from baseline at Week 16., PASI 90 at Week 16.

Who can participate

Age group: 18-64 years, 65+ years, 0-17 years Gender: Female, Male Target enrollment: 434 participants

Interventions

STELARA 90 mg solution for injection in pre-filled syringe

Drug

Solution for injection without Ustekinumab 45

Drug

JNJ-77242113

Drug

Film-Coated Tablet without JNJ-77242113

Drug

Solution for injection in pre-filled syringe without Ustekinumab 90

Drug

STELARA 45 mg solution for injection

Drug

Locations 8

Austria (1)

Belgium (1)

Denmark (1)

Germany (1)

Hungary (1)

Poland (1)

Portugal (1)

Spain (1)

Status

Active (not recruiting)

Phase

Phase 3

Study type

INTERVENTIONAL

Sex

Male and female

Minimum age

18 Years

Healthy volunteers

Start date

06.05.2025

Registry ID

2024-515706-77-00

Source

euclinicaltrials.eu

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