A Long-Term Extension Study of JNJ-77242113 in Participants with Moderate-to-Severe Plaque Psoriasis

Phase 1

• Conditions: Plaque Psoriasis; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-004320-16-PL
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-31
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Must have completed the Week 16 visit in Protocol 77242113PSO2001.
2. In the opinion of the investigator, may benefit from inclusion in this LTE study.
3. Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
4. Must agree to discontinue all topical therapies that could affect psoriasis or the PASI or IGA evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention.
5. A woman of childbearing potential must have a negative urine pregnancy test at Week 0 prior to dispensing study intervention.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 216
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

1. Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason.
2. Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001.
3. Has received any phototherapy or systemic treatment, with the exception of systemic corticosteroids taken <2 weeks in duration, that could impact the assessment of psoriasis (PASI/IGA) since completion of the originating study, 77242113PSO2001, and within 4 weeks of the first administration of study intervention.
4. Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention. For exclusions related to the bacille Calmette-Guerin (BCG) vaccine, see Exclusion 5.
5. Has received the BCG vaccine within 12 months of the first administration of study intervention.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified