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

NCT ID: NCT02905331

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2018-02-06

Brief 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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 (Guselkumab: Placebo)

Participants will receive 100 milligram (mg) guselkumab administered as a 100 milligram per milliliter (mg/mL) solution in a single-use prefilled syringe (PFS) assembled in a SelfDose device at Weeks 0, 4, 12, 20, and 28; liquid placebo for guselkumab 100 mg at Week 16 to maintain the study blind.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device.

Group 2 (Placebo: Guselkumab)

Partcipants will receive placebo at Weeks 0, 4, and 12 followed by guselkumab 100 mg at Weeks 16, 20, and 28.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device.

Interventions

Guselkumab

Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device.

Intervention Type: DRUG

Other Intervention Names

CNTO 1959

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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

Countries

United States; Canada; Poland

References

Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.

Reference Type: DERIVED

PMID: 37906417 (View on PubMed)

Ferris LK, Ott E, Jiang J, Hong HC, Li S, Han C, Baran W. Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study. J Dermatolog Treat. 2020 Mar;31(2):152-159. doi: 10.1080/09546634.2019.1587145. Epub 2019 Mar 19.

Reference Type: DERIVED

PMID: 30887876 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CNTO1959PSO3006

Identifier Type: OTHER

Identifier Source: secondary_id

2016-002022-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108203

Identifier Type: -

Identifier Source: org_study_id