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.
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.
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
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There is 1 Location for this study
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
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