A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

NCT ID: NCT02203032

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 872 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-07
• Study Completion Date: 2016-05-24

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.

Detailed Description

This is a randomized (assignment of study drug by chance), double-blind (participants nor study staff will know the identity of study drugs), multicenter study to evaluate efficacy and safety of guselkumab for the treatment of participants with moderate to severe plaque-type psoriasis who had an inadequate response to ustekinumab. The study will consist of a screening period, open-label and double-blind treatment periods, and a follow-up period. The treatment period will have 2 phases: an open-label treatment phase during which all participants will receive ustekinumab at Weeks 0 and 4 and a blinded treatment phase during which participants with an inadequate Investigator's Global Assessment response (IGA≥2) to ustekinumab at Week 16 will be randomized to receive either guselkumab or ustekinumab through Week 44. Participants with an IGA response of 0 or 1 (cleared or minimal disease) at Week 16 will continue to receive open-label treatment with ustekinumab every 12 weeks through Week 40. All participants will complete a follow-up phase through Week 52 for efficacy and through Week 60 for safety evaluations. The total duration of the study will be approximately 64 weeks (includes a 4-week screening period). Participants' safety will be monitored throughout the study.

Conditions

Psoriasis

Study Design

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

Study Groups

Open-label ustekinumab

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.

Double-blind guselkumab

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.

Placebo for ustekinumab

Intervention Type: DRUG

Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.

Double-blind ustekinumab

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.

Placebo for guselkumab

Intervention Type: DRUG

Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.

Interventions

Ustekinumab

45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.

Intervention Type: DRUG

Guselkumab

100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.

Intervention Type: DRUG

Placebo for ustekinumab

Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.

Intervention Type: DRUG

Placebo for guselkumab

Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis for at least 6 months before the first 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 Investigator's Global Assessment (IGA) >=3 at Screening and at Baseline
• Have an involved body surface area (BSA) >= 10 percent (%) at Screening and at Baseline
• Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)

Exclusion Criteria

• Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Has unstable cardiovascular disease, defined as a recent clinical deterioration (example [eg], unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
• Currently has a malignancy or has a history of malignancy within 5 years before Screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration)
• Has previously received guselkumab or ustekinumab

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 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

Birmingham, Alabama, United States

Bakersfield, California, United States

Los Angeles, California, United States

Santa Monica, California, United States

Coral Gables, Florida, United States

Ocala, Florida, United States

Alpharetta, Georgia, United States

Atlanta, Georgia, United States

Arlington Heights, Illinois, United States

Chicago, Illinois, United States

Skokie, Illinois, United States

Indianapolis, Indiana, United States

Plainfield, Indiana, United States

Louisville, Kentucky, United States

Boston, Massachusetts, United States

Troy, Michigan, United States

Buffalo, New York, United States

New York, New York, United States

Portland, Oregon, United States

Pittsburgh, Pennsylvania, United States

Johnston, Rhode Island, United States

Nashville, Tennessee, United States

Arlington, Texas, United States

Austin, Texas, United States

Dallas, Texas, United States

San Antonio, Texas, United States

Webster, Texas, United States

Norfolk, Virginia, United States

Spokane, Washington, United States

Fremantle, , Australia

Victoria Park, , Australia

Woden, , Australia

Woolloongabba, , Australia

Surrey, British Columbia, Canada

Vancouver, British Columbia, Canada

Moncton, New Brunswick, Canada

Halifax, Nova Scotia, Canada

Ajax, Ontario, Canada

Richmond Hill, Ontario, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Berlin, , Germany

Bonn, , Germany

Essen, , Germany

Gera, , Germany

Hamburg, , Germany

Leipzig, , Germany

Lübeck, , Germany

Mahlow, , Germany

Münster, , Germany

Witten, , Germany

Bialystok, , Poland

Bydgoszcz, , Poland

Gdansk, , Poland

Krakow, , Poland

Lodz, , Poland

Lublin, , Poland

Olsztyn, , Poland

Poznan, , Poland

Torun, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Chelyabinsk, , Russia

Krasnodar, , Russia

Lipetsk, , Russia

Saint Petersburg, , Russia

Stavropol, , Russia

Ufa, , Russia

Yekaterinburg, , Russia

Anyang, , South Korea

Incheon, , South Korea

Seoul, , South Korea

A Coruña, , Spain

Alcorcón, , Spain

Alicante, , Spain

Barcelona, , Spain

Madrid, , Spain

Taichung, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Dudley, , United Kingdom

Dundee, , United Kingdom

London, , United Kingdom

Salford, , United Kingdom

Countries

United States; Australia; Canada; Germany; Poland; Russia; South Korea; Spain; Taiwan; United Kingdom

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)

Campbell K, Li K, Yang F, Branigan P, Elloso MM, Benson J, Orlovsky Y, Chen Y, Garcet S, Krueger JG. Guselkumab More Effectively Neutralizes Psoriasis-Associated Histologic, Transcriptomic, and Clinical Measures than Ustekinumab. Immunohorizons. 2023 Apr 1;7(4):273-285. doi: 10.4049/immunohorizons.2300003.

Reference Type: DERIVED

PMID: 37071038 (View on PubMed)

Other Identifiers

CNTO1959PSO3003

Identifier Type: OTHER

Identifier Source: secondary_id

2014-000721-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR104918

Identifier Type: -

Identifier Source: org_study_id