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

NCT02207231 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CR105047CNTO1959PSO30012014-000719-15
• Study Type: interventional
• Target: 837
• Locations: 10 countries
• Sites: 97

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.

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 areas were 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 (16)

• 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 and 48

  Week 24 and 48

• 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 and 48

  Week 24 and 48

• 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 and 48

  Week 24 and 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

• 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 16

  Week 16

Study Arms (3)

Group I

EXPERIMENTAL

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.

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

Group II

PLACEBO COMPARATOR

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.

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

Group III

ACTIVE COMPARATOR

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.

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

Interventions

Guselkumab 100 mg 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).

Also known as: CNTO 1959

Group I; Group II; Group III

Placebo for guselkumab DRUG

Subcutaneous injections to maintain the blind.

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 47.

Also known as: HUMIRA®

Group III

Placebo for adalimumab DRUG

Subcutaneous injections to maintain the blind.

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 (97)

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Los Angeles, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Aurora, Colorado, United States

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Farmington, Connecticut, United States

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Clearwater, Florida, United States

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Coral Gables, Florida, United States

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Ocala, Florida, United States

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Alpharetta, Georgia, United States

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Rolling Meadows, Illinois, United States

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Plainfield, Indiana, United States

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Boston, Massachusetts, United States

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Troy, Michigan, United States

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New Brighton, Minnesota, United States

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St Louis, Missouri, United States

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East Windsor, New Jersey, United States

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Albuquerque, New Mexico, 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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Austin, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Webster, Texas, United States

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Norfolk, Virginia, United States

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Darlinghurst, Australia

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East Melbourne, Australia

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Hectorville, Australia

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Liverpool, Australia

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Melbourne, Australia

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Westmead, Australia

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Woden, Australia

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Woolloongabba, Australia

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Ajax, Ontario, Canada

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London, Ontario, Canada

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North Bay, Ontario, Canada

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Peterborough, Ontario, Canada

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Montreal, Quebec, Canada

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Berlin, Germany

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Bonn, Germany

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Dresden, Germany

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Essen, Germany

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Frankfurt am Main, Germany

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Gera, Germany

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Hamburg, Germany

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Kiel, Germany

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Lübeck, Germany

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Mahlow, Germany

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Münster, Germany

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Tübingen, Germany

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Budapest, Hungary

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Debrecen, Hungary

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Kaposvár, Hungary

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Kecskemét, Hungary

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Pécs, Hungary

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Szeged, Hungary

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Bialystok, Poland

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Bydgoszcz, Poland

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Lodz, Poland

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Olsztyn, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Kirov, Russia

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Krasnodar, Russia

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Lipetsk, 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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Stavropol, Russia

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Ulyanovsk, Russia

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Yekaterinburg, Russia

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Bundang, South Korea

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Busan, South Korea

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Daejeon, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Barakaldo, Spain

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Barcelona, Spain

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Córdoba, Spain

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Madrid, Spain

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Manises, Spain

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Palma de Mallorca, Spain

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Salamanca, Spain

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San Sebastián de los Reyes, Spain

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Valencia, Spain

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Related Publications (10)

• Puig L, Costanzo A, de Jong EMGJ, Torres T, Warren RB, Wapenaar R, Wegner S, Gorecki P, Gramiccia T, Jazra M, Buyze J, Conrad C. Progression of Quality of Life in Patients with Plaque Psoriasis Who Achieved Three or More Years of Complete Skin Clearance with Guselkumab Treatment: a Post hoc Analysis of the VOYAGE 1 Clinical Trial. Dermatol Ther (Heidelb). 2024 Sep;14(9):2539-2558. doi: 10.1007/s13555-024-01245-6. Epub 2024 Aug 17.

  PMID: 39153060 DERIVED

• Blauvelt A, Langley RG, Branigan PJ, Liu X, Chen Y, DePrimo S, Ma K, Scott B, Campbell K, Munoz-Elias EJ, Papp KA. Guselkumab Reduces Disease- and Mechanism-Related Biomarkers More Than Adalimumab in Patients with Psoriasis: A VOYAGE 1 Substudy. JID Innov. 2024 Jun 5;4(5):100287. doi: 10.1016/j.xjidi.2024.100287. eCollection 2024 Sep.

  PMID: 39114670 DERIVED

• Egeberg A, Conrad C, Gorecki P, Wegner S, Buyze J, Acciarri L, Thaci D. Response Types and Factors Associated with Response Types to Biologic Therapies in Patients with Moderate-to-Severe Plaque Psoriasis from Two Randomized Clinical Trials. Dermatol Ther (Heidelb). 2024 Mar;14(3):745-758. doi: 10.1007/s13555-024-01123-1. Epub 2024 Mar 15.

  PMID: 38485863 DERIVED

• 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

• Puig L, Costanzo A, de Jong EMGJ, Torres T, Warren RB, Wapenaar R, Wegner S, Gorecki P, Gramiccia T, Jazra M, Buyze J, Conrad C. Guselkumab-Treated Patients with Plaque Psoriasis Who Achieved Complete Skin Clearance for >/= 156 Consecutive Weeks: A Post-Hoc Analysis From the VOYAGE 1 Clinical Trial. Am J Clin Dermatol. 2024 Mar;25(2):315-325. doi: 10.1007/s40257-023-00816-1. Epub 2023 Oct 7.

  PMID: 37804472 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

• 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

• 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 48; therefore, there was no concurrent control group within the study after Week 48.

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 26, 2014
• Primary Completion: September 29, 2015
• Study Completion: June 17, 2020
• Last Updated: July 23, 2021
• Results First Posted: October 19, 2017

Record last verified: 2021-07

Locations

CA (10); KR (5); AU (8); TW (5); PL (6); US (26); HU (6); RU (10); ES (9); DE (12)