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

NCT ID: NCT02207244

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 992 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-03
• Study Completion Date: 2020-07-01

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 (scaly skin rash).

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. 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 2:1:1 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). From Week 28 up to Week 76, treatment for all participants will be based on their level of response. All participants will receive guselkumab every 8 weeks from Week 76 through Week 252 with a final safety follow-up visit at Week 264 (open label treatment period). The end of the study is defined as the time the last participant completes the Week 264 visit. 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 will receive guselkumab 100 milligram (mg) at Weeks 0, 4, 12 and 20. Starting at Week 28, participants will receive guselkumab 100 mg or placebo through Week 72 depending upon randomized treatment group and PASI response. Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending upon randomized treatment group and PASI response. Placebo for adalimumab \[two 0.8 milliliter (mL) injections\] at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, 5, and every 2 week (q2w) through Week 23 to maintain the blind. All participants will receive guselkumab q8w starting at Week 76 through Week 252.

Group Type: EXPERIMENTAL

Guselkumab 100 mg

Intervention Type: DRUG

100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.

Placebo for guselkumab

Intervention Type: DRUG

Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).

Placebo for adalimumab

Intervention Type: DRUG

Placebo for adalimumab \[two 0.8 milliliter (mL) injections\] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).

Group II

Participants will receive placebo for guselkumab at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response. 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 23. At week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20, starting at week 28, participants will continue to receive guselkumab 100 mg or placebo through week 72 depending upon PASI response. All participants will received guselkumab q8w starting at Week 76 through Week 252.

Group Type: PLACEBO_COMPARATOR

Guselkumab 100 mg

Intervention Type: DRUG

100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.

Placebo for guselkumab

Intervention Type: DRUG

Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).

Placebo for adalimumab

Intervention Type: DRUG

Placebo for adalimumab \[two 0.8 milliliter (mL) injections\] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).

Group III

Participants will receive adalimumab 80 mg (two 40 mg \[0.8 mL\] injections) at Week 0 followed by adalimumab 40 mg at weeks 1, 3, 5, and q2w through week 23 and placebo for guselkumab at weeks 0, 4, 12, 16, and 20. Participants will receive guselkumab or placebo starting at week 28 through week 72 depending upon PASI response. All participants will received guselkumab q8w starting at Week 76 through Week 252.

Group Type: ACTIVE_COMPARATOR

Guselkumab 100 mg

Intervention Type: DRUG

100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.

Placebo for guselkumab

Intervention Type: DRUG

Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).

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 23.

Interventions

Guselkumab 100 mg

100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.

Intervention Type: DRUG

Placebo for guselkumab

Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).

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 23.

Intervention Type: DRUG

Placebo for adalimumab

Placebo for adalimumab \[two 0.8 milliliter (mL) injections\] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).

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

Birmingham, Alabama, United States

Bakersfield, California, United States

Los Angeles, California, United States

San Diego, California, United States

Santa Monica, California, United States

Aurora, Colorado, United States

Coral Gables, Florida, United States

Tampa, Florida, United States

Newnan, Georgia, United States

Sandy Springs, Georgia, United States

Chicago, Illinois, United States

Rolling Meadows, Illinois, United States

Skokie, Illinois, United States

Indianapolis, Indiana, United States

Plainfield, Indiana, United States

Louisville, Kentucky, United States

Andover, Massachusetts, United States

Fort Gratiot, Michigan, United States

Troy, Michigan, United States

St Louis, Missouri, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Gahanna, Ohio, United States

Norman, Oklahoma, United States

Portland, Oregon, United States

Pittsburgh, Pennsylvania, United States

Johnston, Rhode Island, United States

Arlington, Texas, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Seattle, Washington, United States

Spokane, Washington, United States

Benowa, , Australia

Hectorville, , Australia

Melbourne, , Australia

Parkville, , Australia

Westmead, , Australia

Woolloongabba, , Australia

Barrie, Ontario, Canada

Hamilton, Ontario, Canada

Mississauga, Ontario, Canada

Ottawa, Ontario, Canada

Richmond Hill, Ontario, Canada

Toronto, Ontario, Canada

Waterloo, Ontario, Canada

Windsor, Ontario, Canada

Jihlava, , Czechia

Náchod, , Czechia

Pardubice, , Czechia

Pilsen, , Czechia

Prague, , Czechia

Ústí nad Labem, , Czechia

Dresden, , Germany

Gera, , Germany

Hamburg, , Germany

Kiel, , Germany

Leipzig, , Germany

Lübeck, , Germany

Münster, , Germany

Tübingen, , 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

Cherepovets, , Russia

Moscow, , Russia

Rostov-on-Don, , Russia

Ryazan, , Russia

Saint Petersburg, , Russia

Yaroslavl, , Russia

Busan, , South Korea

Daejeon, , South Korea

Gwangju, , South Korea

Incheon, , South Korea

Seongnam, , South Korea

Seoul, , South Korea

Suwon, , South Korea

Badalona, , Spain

Barcelona, , Spain

Bilbao Vizcaya, , Spain

Madrid, , Spain

Murcia, , Spain

Pontevedra, , Spain

Valencia, , Spain

Countries

United States; Australia; Canada; Czechia; Germany; Poland; Russia; South Korea; Spain

References

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Other Identifiers

CNTO1959PSO3002

Identifier Type: OTHER

Identifier Source: secondary_id

2014-000720-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR105048

Identifier Type: -

Identifier Source: org_study_id