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

NCT02905331 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: CR108203CNTO1959PSO30062016-002022-37
• Study Type: interventional
• Target: 78
• Locations: 3 countries
• Sites: 14

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

  The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. Participants who discontinued study drug due to lack of efficacy, an adverse event (AE) of worsening of psoriasis, or who started a protocol-prohibited medication/therapy during study that could improve psoriasis were considered as treatment failures for the study.

  Week 16

• Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16

  The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent (%) to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.

  Week 16

Secondary Outcomes (8)

• Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16

  Week 16

• Percentage of Participants Who Achieve a PASI 100 Response at Week 16

  Week 16

• Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16

  Week 16

• Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16

  Week 16

• Percent Improvement From Baseline in PASI Score at Week 16

  Baseline and Week 16

Study Arms (2)

Group 1 (Guselkumab: Placebo)

EXPERIMENTAL

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.

Drug: Guselkumab; Drug: Placebo

Group 2 (Placebo: Guselkumab)

EXPERIMENTAL

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

Drug: Guselkumab; Drug: Placebo

Interventions

Guselkumab DRUG

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

Also known as: CNTO 1959

Group 1 (Guselkumab: Placebo); Group 2 (Placebo: Guselkumab)

Placebo DRUG

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

Group 1 (Guselkumab: Placebo); Group 2 (Placebo: Guselkumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (14)

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

Indiana Clinical Trial Center

Plainfield, Indiana, 46168, United States

Location

Dermatology Specialists

Louisville, Kentucky, 40241, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

University of Pittsburgh Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Partners

Johnston, Rhode Island, 02919, United States

Location

Virginia Clinical Research

Norfolk, Virginia, 23502, United States

Location

Dr. Chih ho Hong Medical

Surrey, British Columbia, V3R 6A7, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1Y2, Canada

Location

DermEdge Research

Mississauga, Ontario, L4Y 4C5, Canada

Location

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

Bialystok, 15 351, Poland

Location

Szpital Uniwersytecki nr 1 im Dr A Jurasza

Bydgoszcz, 85 094, Poland

Location

Wromedica Irena Bielicka, Janusz Szczepanik S.C.

Wroclaw, 51-685, Poland

Location

Related Publications (2)

• 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.

  PMID: 37906417 DERIVED

• 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.

  PMID: 30887876 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senior Director, Immunology General
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: February 28, 2017
• Primary Completion: February 6, 2018
• Study Completion: February 6, 2018
• Last Updated: February 4, 2025
• Results First Posted: September 6, 2018

Record last verified: 2025-01

Locations

US (8); CA (3); PL (3)