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

Phase 2

Completed

• Conditions: Plaque psoriasis; Skin and Connective Tissue Diseases; Psoriasis vulgaris

• Registration Number: ISRCTN15135908
• Lead Sponsor: Janssen (Belgium)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-11
• Study Completion: 2023-11-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

1. Must have completed the Week 16 visit in Protocol 77232114PSO2001
2. In the opinion of the investigator, may benefit from inclusion in this long-term extension (LTE) study
3. Must agree to avoid prolonged sun exposure and avoid the 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 psoriasis area severity index (PASI) or Investigator’s global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention.
5. Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of the study intervention

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 live virus or bacterial vaccination within 12 weeks before the first administration of study intervention
4. Has received the bacille Clamette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention
5. Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (antiHCV) positive, or has another clinically active liver disease, or tests positive for HBsAg or anti-HCV

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants achieving Psoriasis Area Severity Index (PASI) 75 score (=75% improvement in PASI from baseline of the originating study [77242113PSO2001]) at Week 36. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.