Overview

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

Status:
Completed
Trial end date:
2018-02-06
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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