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

Last updated: January 31, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Warts

Scalp Disorders

Rash

Treatment

Guselkumab

Placebo

Clinical Study ID

NCT02905331
CR108203
CNTO1959PSO3006
2016-002022-37
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 forat least 12 months or any age with amenorrhea for at least 6 months and a serumfollicle-stimulating hormone level (FSH) >40 International Units Per Liter [IU/L]);permanently sterile (example, tubal occlusion, hysterectomy, bilateralsalpingectomy); or otherwise be incapable of pregnancy, b) Of childbearing potentialand practicing a highly effective method of birth control, consistent with localregulations regarding the use of birth control methods for subjects participating inclinical studies: example, established use of oral, injected or implanted hormonalmethods of contraception; placement of an intrauterine device (IUD) or intrauterinesystem (IUS); barrier methods: condom or occlusive cap (diaphragm or cervical/vaultcaps) plus spermicidal foam/gel/ film/cream/suppository (if available in theirlocale); male partner sterilization (the vasectomized partner should be the solepartner for that participant); true abstinence (when this is in line with thepreferred 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 atscreening and at baseline

  • Have an involved body surface area (BSA) >= 10 percent (%) at screening and atbaseline

Exclusion

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 cardiachospitalization within the last 3 months

  • Has a history of lymphoproliferative disease, including lymphoma; a history ofmonoclonal gammopathy of undetermined significance (MGUS); or signs and symptomssuggestive of possible lymphoproliferative disease, such as lymphadenopathy orsplenomegaly

  • Has a transplanted organ (with exception of a corneal transplant >3 months beforethe 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 therapywithin 3 months before the first administration of study drug

Study Design

Total Participants: 78
Treatment Group(s): 2
Primary Treatment: Guselkumab
Phase: 3
Study Start date:
February 28, 2017
Estimated Completion Date:
February 06, 2018

Connect with a study center

  • Dr. Chih ho Hong Medical

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Dr. Chih-ho Hong Medical

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Eastern Canada Research Associates

    Halifax, Nova Scotia B3H 1Z4
    Canada

    Site Not Available

  • Dermatrials Research

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • DermEdge Research

    Mississauga, Ontario L4Y 4C5
    Canada

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej Osteo-Medic s.c. Artur Racewicz i Jerzy Supronik

    Bialystok, 15 351
    Poland

    Site Not Available

  • Szpital Uniwersytecki nr 1 im Dr A Jurasza

    Bydgoszcz, 85 094
    Poland

    Site Not Available

  • Szpital Uniwersytecki nr 1 im. Dr A. Jurasza

    Bydgoszcz, 85-094
    Poland

    Site Not Available

  • Centrum Medyczne WroMedica

    Wroclaw, 51-685
    Poland

    Site Not Available

  • Wromedica Irena Bielicka, Janusz Szczepanik S.C.

    Wroclaw, 51-685
    Poland

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • Arlington Dermatology

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Arlington Dermatology

    Arlington Hts., Illinois 60005
    United States

    Site Not Available

  • Arlington Dermatology

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Indiana Clinical Trial Center

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Dermatology Specialists

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Hamzavi Dermatology

    Fort Gratiot Township, Michigan 48059
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • University of Pittsburgh Department of Dermatology

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Clinical Partners

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Menter Dermatology Research Institute

    Dallas, Texas 75246
    United States

    Site Not Available

  • Virginia Clinical Research

    Norfolk, Virginia 23502
    United States

    Site Not Available

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