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

NCT02207244 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CR105048CNTO1959PSO30022014-000720-18
• Study Type: interventional
• Target: 992
• Locations: 9 countries
• Sites: 93

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).

Conditions

Psoriasis

Keywords

Psoriasis; Plaque-type psoriasis; Guselkumab; Adalimumab; CNTO 1959; Monoclonal antibody

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16

  The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

  Week 16

• Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16

  The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.

  Week 16

Secondary Outcomes (18)

• Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24

  Week 24

• Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24

  Week 24

• Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24

  Week 24

• Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response

  Through Week 48

• Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group

  Baseline, Week 16

Study Arms (3)

Group I

EXPERIMENTAL

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.

Drug: Guselkumab 100 mg; Drug: Placebo for guselkumab; Drug: Placebo for adalimumab

Group II

PLACEBO COMPARATOR

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.

Drug: Guselkumab 100 mg; Drug: Placebo for guselkumab; Drug: Placebo for adalimumab

Group III

ACTIVE COMPARATOR

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.

Drug: Guselkumab 100 mg; Drug: Placebo for guselkumab; Drug: Adalimumab

Interventions

Guselkumab 100 mg 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.

Also known as: CNTO 1959

Group I; Group II; Group III

Placebo for guselkumab 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).

Group I; Group II; Group III

Adalimumab DRUG

80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 23.

Also known as: HUMIRA®

Group III

Placebo for adalimumab 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 I; Group II

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (93)

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Birmingham, Alabama, United States

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Bakersfield, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Aurora, Colorado, United States

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Coral Gables, Florida, United States

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Tampa, Florida, United States

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Newnan, Georgia, United States

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Sandy Springs, Georgia, United States

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Chicago, Illinois, United States

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Rolling Meadows, Illinois, United States

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Skokie, Illinois, United States

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Indianapolis, Indiana, United States

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Plainfield, Indiana, United States

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Louisville, Kentucky, United States

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Andover, Massachusetts, United States

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Fort Gratiot, Michigan, United States

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Troy, Michigan, United States

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St Louis, Missouri, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Gahanna, Ohio, United States

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Norman, Oklahoma, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Johnston, Rhode Island, United States

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Arlington, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Benowa, Australia

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Hectorville, Australia

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Melbourne, Australia

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Parkville, Australia

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Westmead, Australia

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Woolloongabba, Australia

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Barrie, Ontario, Canada

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Hamilton, Ontario, Canada

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Mississauga, Ontario, Canada

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Ottawa, Ontario, Canada

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Richmond Hill, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Windsor, Ontario, Canada

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Jihlava, Czechia

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Náchod, Czechia

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Pardubice, Czechia

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Pilsen, Czechia

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Prague, Czechia

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Ústí nad Labem, Czechia

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Dresden, Germany

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Gera, Germany

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Hamburg, Germany

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Kiel, Germany

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Leipzig, Germany

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Lübeck, Germany

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Münster, Germany

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Tübingen, Germany

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Witten, Germany

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Bialystok, Poland

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Bydgoszcz, Poland

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Gdansk, Poland

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Krakow, Poland

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Lodz, Poland

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Lublin, Poland

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Olsztyn, Poland

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Poznan, Poland

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Torun, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Chelyabinsk, Russia

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Cherepovets, Russia

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Moscow, Russia

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Rostov-on-Don, Russia

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Ryazan, Russia

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Saint Petersburg, Russia

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Yaroslavl, Russia

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Busan, South Korea

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Daejeon, South Korea

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Gwangju, South Korea

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Incheon, South Korea

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Seongnam, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Badalona, Spain

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Barcelona, Spain

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Bilbao Vizcaya, Spain

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Madrid, Spain

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Murcia, Spain

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Pontevedra, Spain

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Valencia, Spain

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Related Publications (10)

• Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.

  PMID: 37906417 DERIVED

• Kim BS, Jo SJ, Youn S, Reich K, Saadoun C, Chang CL, Yang YW, Huang YH, Tsai TF. Five-year Maintenance of Clinical Response and Consistent Safety Profile for Guselkumab in Asian patients with Psoriasis from VOYAGE 1 and VOYAGE 2. Dermatol Ther (Heidelb). 2023 Nov;13(11):2721-2737. doi: 10.1007/s13555-023-01026-7. Epub 2023 Sep 26.

  PMID: 37750995 DERIVED

• Tillett W, Egeberg A, Sonkoly E, Gorecki P, Tjarnlund A, Buyze J, Wegner S, McGonagle D. Nail psoriasis dynamics during biologic treatment and withdrawal in patients with psoriasis who may be at high risk of developing psoriatic arthritis: a post hoc analysis of the VOYAGE 2 randomized trial. Arthritis Res Ther. 2023 Sep 15;25(1):169. doi: 10.1186/s13075-023-03138-z.

  PMID: 37715294 DERIVED

• Orbai AM, Chakravarty SD, You Y, Shawi M, Yang YW, Merola JF. Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis. Dermatol Ther (Heidelb). 2023 Nov;13(11):2859-2868. doi: 10.1007/s13555-023-01012-z. Epub 2023 Sep 15.

  PMID: 37713133 DERIVED

• Reich K, Gordon KB, Strober BE, Armstrong AW, Miller M, Shen YK, You Y, Han C, Yang YW, Foley P, Griffiths CEM. Five-year maintenance of clinical response and health-related quality of life improvements in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2. Br J Dermatol. 2021 Dec;185(6):1146-1159. doi: 10.1111/bjd.20568. Epub 2021 Sep 8.

  PMID: 34105767 DERIVED

• Reich K, Armstrong AW, Foley P, Song M, Miller M, Shen YK, You Y, Han C, Gordon KB. Maintenance of Response Through up to 4 Years of Continuous Guselkumab Treatment of Psoriasis in the VOYAGE 2 Phase 3 Study. Am J Clin Dermatol. 2020 Dec;21(6):881-890. doi: 10.1007/s40257-020-00555-7.

  PMID: 32910434 DERIVED

• Gordon KB, Armstrong AW, Foley P, Song M, Shen YK, Li S, Munoz-Elias EJ, Branigan P, Liu X, Reich K. Guselkumab Efficacy after Withdrawal Is Associated with Suppression of Serum IL-23-Regulated IL-17 and IL-22 in Psoriasis: VOYAGE 2 Study. J Invest Dermatol. 2019 Dec;139(12):2437-2446.e1. doi: 10.1016/j.jid.2019.05.016. Epub 2019 Jun 15.

  PMID: 31207232 DERIVED

• Reich K, Papp KA, Armstrong AW, Wasfi Y, Li S, Shen YK, Randazzo B, Song M, Kimball AB. Safety of guselkumab in patients with moderate-to-severe psoriasis treated through 100 weeks: a pooled analysis from the randomized VOYAGE 1 and VOYAGE 2 studies. Br J Dermatol. 2019 May;180(5):1039-1049. doi: 10.1111/bjd.17454.

  PMID: 30485400 DERIVED

• Armstrong AW, Reich K, Foley P, Han C, Song M, Shen YK, You Y, Papp KA. Improvement in Patient-Reported Outcomes (Dermatology Life Quality Index and the Psoriasis Symptoms and Signs Diary) with Guselkumab in Moderate-to-Severe Plaque Psoriasis: Results from the Phase III VOYAGE 1 and VOYAGE 2 Studies. Am J Clin Dermatol. 2019 Feb;20(1):155-164. doi: 10.1007/s40257-018-0396-z.

  PMID: 30417277 DERIVED

• Foley P, Gordon K, Griffiths CEM, Wasfi Y, Randazzo B, Song M, Li S, Shen YK, Blauvelt A. Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Dermatol. 2018 Jun 1;154(6):676-683. doi: 10.1001/jamadermatol.2018.0793.

  PMID: 29799960 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab; Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

All participants were on guselkumab after Week 76; therefore, there was no concurrent control group within the study after Week 76.

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 4, 2014
• Study Start: November 3, 2014
• Primary Completion: October 1, 2015
• Study Completion: July 1, 2020
• Last Updated: July 22, 2021
• Results First Posted: November 6, 2017

Record last verified: 2021-06

Locations

DE (9); CZ (6); ES (7); US (32); PL (11); AU (6); CA (8); RU (7); KR (7)