Psoriasis Clinical Trial

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.

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Full Description

This is a randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo- (inactive substance identical in appearance to study drug) and active-comparator-controlled (use of an approved drug to compare with study drug) study of guselkumab in participants with moderate to severe plaque-type psoriasis (scaly skin rash). The active comparator study drug is adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis. Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1:2 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III (adalimumab at standard psoriasis dosing). All participants will receive guselkumab every 8 weeks (q8w) from Week 52 through Week 252 (open label treatment period).The end of the study is defined as the time the last participant completes the Week 264 visit. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score of 0 or 1 and Psoriasis Area and Severity Index (PASI) 90 Response at Week 16. The total duration of the study will be approximately 268 weeks (includes a 4-week screening period). Participants will be monitored for safety throughout the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
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) score >=3 at Screening and at Baseline
Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
Must be a candidate for either systemic therapy or phototherapy for psoriasis

Exclusion Criteria:

Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Participants who have ever received guselkumab or adalimumab
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 any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

837

Study ID:

NCT02207231

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There is 1 Location for this study

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Los Angeles California, , United States

San Diego California, , United States

San Francisco California, , United States

Aurora Colorado, , United States

Farmington Connecticut, , United States

Clearwater Florida, , United States

Coral Gables Florida, , United States

Ocala Florida, , United States

Alpharetta Georgia, , United States

Rolling Meadows Illinois, , United States

Plainfield Indiana, , United States

Boston Massachusetts, , United States

Troy Michigan, , United States

New Brighton Minnesota, , United States

Saint Louis Missouri, , United States

East Windsor New Jersey, , United States

Albuquerque New Mexico, , United States

Portland Oregon, , United States

Pittsburgh Pennsylvania, , United States

Johnston Rhode Island, , 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

Darlinghurst , , Australia

East Melbourne , , Australia

Hectorville , , Australia

Liverpool , , Australia

Melbourne , , Australia

Westmead , , Australia

Woden , , Australia

Woolloongabba , , Australia

Calgary Alberta, , Canada

Edmonton Alberta, , Canada

Vancouver British Columbia, , Canada

St. John's Newfoundland and Labrador, , Canada

Halifax Nova Scotia, , Canada

Ajax Ontario, , Canada

London Ontario, , Canada

North Bay Ontario, , Canada

Peterborough Ontario, , Canada

Montreal Quebec, , Canada

Berlin , , Germany

Bonn , , Germany

Dresden , , Germany

Essen , , Germany

Frankfurt/ Main , , Germany

Gera , , Germany

Hamburg , , Germany

Kiel , , Germany

Lubeck , , Germany

Mahlow , , Germany

Munster , , Germany

Tübingen , , Germany

Budapest , , Hungary

Debrecen , , Hungary

Kaposvar , , Hungary

Kecskemet , , Hungary

Pecs , , Hungary

Szeged , , Hungary

Bundang , , Korea, Republic of

Busan , , Korea, Republic of

Daejeon , , Korea, Republic of

Seoul , , Korea, Republic of

Suwon , , Korea, Republic of

Bialystok , , Poland

Bydgoszcz , , Poland

Lodz , , Poland

Olsztyn , , Poland

Warszawa , , Poland

Wroclaw , , Poland

Ekaterinburg , , Russian Federation

Kirov , , Russian Federation

Krasnodar , , Russian Federation

Lipetsk , , Russian Federation

Moscow , , Russian Federation

Rostov-on-Don , , Russian Federation

Ryazan , , Russian Federation

St. Petersburg , , Russian Federation

Stavropol , , Russian Federation

Ulyanovsk , , Russian Federation

Baracaldo , , Spain

Barcelona , , Spain

Cordoba , , Spain

Madrid , , Spain

Manises , , Spain

Palma de Mallorca , , Spain

Salamanca , , Spain

San Sebastian de los Reyes , , Spain

Valencia , , Spain

Kaohsiung , , Taiwan

Taichung City , , Taiwan

Tainan , , Taiwan

Taipei City , , Taiwan

Taipei , , Taiwan

Taoyuan , , Taiwan

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

837

Study ID:

NCT02207231

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

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