Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.

Key facts

Study ID: NCT02905331
Run by: Janssen Research & Development, LLC
People needed: 78
Starts: 2017-02-28
Expected to finish: 2018-02-06
Last updated by the study team: 2025-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

A woman of childbearing potential must have a negative urine pregnancy test (beta-human chorionic gonadotropin) at screening and at Week 0
Before randomization, a woman must be either: a) Not of childbearing potential: premenarchal; postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle-stimulating hormone level (FSH) >40 International Units Per Liter [IU/L]); permanently sterile (example, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy, b) Of childbearing potential and practicing a highly effective method of birth control, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/ film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant)
Agree not to receive a Bacillus Calmette Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
Have a Psoriasis Area and Severity Index (PASI) greater than or equal to [>=] 12 at screening and at baseline
Have an involved body surface area (BSA) >= 10 percent (%) at screening and at baseline

You may not qualify if…

Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
Has a transplanted organ (with exception of a corneal transplant >3 months before the first administration of study drug)
Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
Has received any anti-tumor necrosis factor alpha (TNF-alpha) biologic therapy within 3 months before the first administration of study drug

Where it is running

Renstar Medical Research — Ocala, Florida, United States
Arlington Dermatology — Rolling Meadows, Illinois, United States
Indiana Clinical Trial Center — Plainfield, Indiana, United States
Dermatology Specialists — Louisville, Kentucky, United States
Hamzavi Dermatology — Fort Gratiot, Michigan, United States
University of Pittsburgh Department of Dermatology — Pittsburgh, Pennsylvania, United States
Clinical Partners — Johnston, Rhode Island, United States
Virginia Clinical Research — Norfolk, Virginia, United States
Dr. Chih ho Hong Medical — Surrey, British Columbia, Canada
Dermatrials Research — Hamilton, Ontario, Canada
DermEdge Research — Mississauga, Ontario, Canada
Niepubliczny Zaklad Opieki Zdrowotnej Osteo-Medic s.c. Artur Racewicz i Jerzy Supronik — Bialystok, Poland
Szpital Uniwersytecki nr 1 im Dr A Jurasza — Bydgoszcz, Poland
Wromedica Irena Bielicka, Janusz Szczepanik S.C. — Wroclaw, Poland

Full record on ClinicalTrials.gov

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