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

NCT ID: NCT02207231

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 837 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-26
• Study Completion Date: 2020-06-17

Brief 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.

Detailed 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.

Conditions

Psoriasis

Study Design

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

Study Groups

Group I

Participants received Guselkumab 100 milligram (mg) at Weeks 0, 4, and 12 and every 8 weeks (q8w) thereafter through Week 252, placebo for guselkumab at Week 16, and placebo for adalimumab (two 0.8 milliliter \[mL\] injections) at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, and 5, and every 2 weeks (q2w) thereafter through Week 47.

Group Type: EXPERIMENTAL

Guselkumab 100 mg

Intervention Type: DRUG

100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).

Placebo for guselkumab

Intervention Type: DRUG

Subcutaneous injections to maintain the blind.

Placebo for adalimumab

Intervention Type: DRUG

Subcutaneous injections to maintain the blind.

Group II

Participants received Placebo for guselkumab at Weeks 0, 4, and 12, and placebo for adalimumab (two 0.8 mL injections) at Week 0, followed by one 0.8 mL injection at Weeks 1, 3, and 5, and q2w through Week 15. At Week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20 and q8w thereafter through Week 252, as well as placebo for adalimumab at Weeks 17, 19, 21, and 23, and q2w thereafter through Week 47.

Group Type: PLACEBO_COMPARATOR

Guselkumab 100 mg

Intervention Type: DRUG

100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).

Placebo for guselkumab

Intervention Type: DRUG

Subcutaneous injections to maintain the blind.

Placebo for adalimumab

Intervention Type: DRUG

Subcutaneous injections to maintain the blind.

Group III

Participants received Adalimumab 80 mg at Week 0 (two 40 mg \[0.8 mL\] injections) and 40 mg at Weeks 1, 3, 5, and q2w thereafter through Week 47, placebo for guselkumab at Weeks 0, 4, 12, 16, and 20, and q8w thereafter through Week 44 and guselkumab 100 mg at Weeks 52, 60, and q8w thereafter through Week 252.

Group Type: ACTIVE_COMPARATOR

Guselkumab 100 mg

Intervention Type: DRUG

100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).

Placebo for guselkumab

Intervention Type: DRUG

Subcutaneous injections to maintain the blind.

Adalimumab

Intervention Type: DRUG

80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47.

Interventions

Guselkumab 100 mg

100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).

Intervention Type: DRUG

Placebo for guselkumab

Subcutaneous injections to maintain the blind.

Intervention Type: DRUG

Adalimumab

80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47.

Intervention Type: DRUG

Placebo for adalimumab

Subcutaneous injections to maintain the blind.

Intervention Type: DRUG

Other Intervention Names

CNTO 1959; HUMIRA®

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

• 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

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

St 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 am Main, , Germany

Gera, , Germany

Hamburg, , Germany

Kiel, , Germany

Lübeck, , Germany

Mahlow, , Germany

Münster, , Germany

Tübingen, , Germany

Budapest, , Hungary

Debrecen, , Hungary

Kaposvár, , Hungary

Kecskemét, , Hungary

Pécs, , Hungary

Szeged, , Hungary

Bialystok, , Poland

Bydgoszcz, , Poland

Lodz, , Poland

Olsztyn, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Kirov, , Russia

Krasnodar, , Russia

Lipetsk, , Russia

Moscow, , Russia

Rostov-on-Don, , Russia

Ryazan, , Russia

Saint Petersburg, , Russia

Stavropol, , Russia

Ulyanovsk, , Russia

Yekaterinburg, , Russia

Bundang, , South Korea

Busan, , South Korea

Daejeon, , South Korea

Seoul, , South Korea

Suwon, , South Korea

Barakaldo, , Spain

Barcelona, , Spain

Córdoba, , Spain

Madrid, , Spain

Manises, , Spain

Palma de Mallorca, , Spain

Salamanca, , Spain

San Sebastián de los Reyes, , Spain

Valencia, , Spain

Kaohsiung City, , Taiwan

Taichung, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Countries

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

References

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Other Identifiers

CNTO1959PSO3001

Identifier Type: OTHER

Identifier Source: secondary_id

2014-000719-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR105047

Identifier Type: -

Identifier Source: org_study_id