A Study of Guselkumab in the Treatment of Participants with Moderate to Severe Plaque-Type Psoriasis

Phase 1

• Conditions: Moderate to Severe Plaque Type Psoriasis; MedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-000719-15-PL
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-22
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

- Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
- Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline
- Have an Investigator’s Global Assessment (IGA) score >=3 at Screening and at Baseline
- Have an involved body surface area (BSA) >=10 percent(%) at Screening and at Baseline
- Must be a candidate for either systemic therapy or phototherapy for psoriasis
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 675
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

-Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- Participants who have ever received guselkumab or adalimumab
- History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the wellbeing) of the participant or that could prevent, limit, or confound the protocol-specified assessments
- Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: • To evaluate the efficacy of guselkumab for the treatment of subjects with moderate to severe plaque-type psoriasis.<br>• To assess the safety and tolerability of guselkumab in subjects with moderate to severe plaque-type psoriasis.<br>;Secondary Objective: • To compare the efficacy of guselkumab to adalimumab in subjects with moderate to severe plaque type psoriasis.<br>• To evaluate the effect of treatment with guselkumab on other measures of signs and symptoms of psoriasis.<br>• To evaluate the effect of treatment with guselkumab on health-related quality of life.;Primary end point(s): The co-primary endpoints are the proportions of subjects who achieve an IGA score of cleared (0) or minimal (1) and the proportion of subjects who achieve a PASI 90 response at Week 16, comparing the guselkumab group and the placebo group.;Timepoint(s) of evaluation of this end point: Week 16