Psoriasis Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

872

Study ID:

NCT02203032

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There is 1 Location for this study

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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

Quebec , , Canada

Berlin , , Germany

Bonn , , Germany

Essen , , Germany

Gera , , Germany

Hamburg , , Germany

Leipzig , , Germany

Lübeck , , Germany

Mahlow , , Germany

Munster , , Germany

Witten , , Germany

Anyang , , Korea, Republic of

Incheon , , Korea, Republic of

Seoul , , Korea, Republic of

Bialystok , , Poland

Bydgoszcz , , Poland

Gdansk , , Poland

Krakow , , Poland

Lodz , , Poland

Lublin , , Poland

Olsztyn , , Poland

Poznan , , Poland

Poznań , , Poland

Torun , , Poland

Warszawa , , Poland

Wroclaw , , Poland

Łódź , , Poland

Chelyabinsk , , Russian Federation

Ekaterinburg , , Russian Federation

Krasnodar , , Russian Federation

Lipetsk , , Russian Federation

St-Petersburg , , Russian Federation

Stavropol , , Russian Federation

Ufa , , Russian Federation

Alcorcon , , Spain

Alicante , , Spain

Barcelona , , Spain

La Coruña , , Spain

Madrid , , Spain

Taichung , , Taiwan

Tainan , , Taiwan

Taipei , , Taiwan

Taoyuan , , Taiwan

Dudley , , United Kingdom

Dundee , , United Kingdom

London , , United Kingdom

Salford , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

872

Study ID:

NCT02203032

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

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