Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)

NCT02319759 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1059642014-003697-17CNTO1959PSA2001
• Study Type: interventional
• Target: 149
• Locations: 7 countries
• Sites: 41

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA).

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; Guselkumab; Ustekinumab; Placebo

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24

  ACR 20 response: at least 20% improvement from baseline in both swollen joint (66 joints) and tender joint (68 joints) counts and at least 20% improvement from baseline in 3 of following 5 assessments: patient's assessment of pain (VAS: 0-100 millimeter \[mm\], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity on arthritis (VAS:0-100mm, 0=excellent and 100=poor), physician's global assessment of disease activity (VAS:0-100mm; 0=no arthritis activity and 100 = extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0=no difficulty, to 3=inability to perform a task in that area) and serum CRP. Treatment Failure (TF) criteria: Discontinued study drug due to lack of efficacy or worsening of PsA, initiated or increased dose of methotrexate or oral corticosteroids, or initiated prohibited PsA treatments. FAS is full analysis set.

  Week 24

Secondary Outcomes (43)

• Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-75 Response at Week 24

  Week 24

• Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24

  Baseline and Week 24

• Percentage of Participants Who Achieved an ACR 20 Response at Week 16

  Week 16

• Percentage of Participants Who an Achieved ACR 50 Response at Week 24

  Week 24

• Percent Change From Baseline in Leeds Enthesitis Index (LEI) Scores Among Participants With Enthesitis at Week 24

  Baseline and Week 24

Study Arms (2)

Guselkumab

EXPERIMENTAL

Participants will receive guselkumab 100 milligram (mg) subcutaneous injection (injected under the skin by way of a needle) at Weeks 0, 4, 12, 20, 28, 36, and 44, and placebo for guselkumab at Week 24 to maintain the blind. Participants who enter early escape at Week 16 will switch to open label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study.

Drug: Guselkumab; Drug: Ustekinumab; Drug: Placebo

Placebo

EXPERIMENTAL

Participants will receive placebo for guselkumab at Weeks 0, 4, 12, and 20, and guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36, and 44. Participants who enter early escape at Week 16 will switch to open label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study.

Drug: Guselkumab; Drug: Ustekinumab; Drug: Placebo

Interventions

Guselkumab DRUG

In the guselkumab group, Guselkumab 100 mg subcutaneous injection will be administered at Weeks 0, 4, 12, 20, 28, 36 and 44. In the placebo group, guselkumab 100 mg subcutaneous injection will be administered at Weeks 24, 28, 36 and 44 for participants remaining on placebo at Week 24.

Guselkumab; Placebo

Ustekinumab DRUG

In both placebo and guselkumab groups, if the participants qualify for early escape, they will switch to receive ustekinumab 45 mg or 90 mg subcutaneous injection at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study.

Guselkumab; Placebo

Placebo DRUG

In placebo group, Placebo subcutaneous injection will be administered at Weeks 0, 4, 12, and 20. In guselkumab group, placebo subcutaneous injection will be administered at Week 24 to maintain the blind.

Guselkumab; Placebo

Eligibility Criteria

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

You may qualify if:

• Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening
• Had active PsA as defined by:
• At least 3 swollen joints and at least 3 tender joints at Screening and at baseline
• C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory
• Has at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
• Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (\>=) 3% at Screening and baseline
• Has active PsA despite current or previous non-biologic disease-modifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
• If using methotrexate (MTX), oral corticosteroids or NSAIDs, the dose must be stable

You may not qualify if:

• Have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease
• Has previously received guselkumab or ustekinumab
• Has received more than 1 type of biologic anti-tumor necrosis factor (TNF) agent previously
• Have received infliximab (or its biosimilars) or golimumab intraveneous (IV) within 12 weeks before the first administration of study drug
• Have received adalimumab (or its biosimilars), golimumab subcutaneous (SC), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (41)

Unknown Facility

Huntsville, Alabama, United States

Location

Unknown Facility

Trumbull, Connecticut, United States

Location

Unknown Facility

Clearwater, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Sandy Springs, Georgia, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Edina, Minnesota, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Wyomissing, Pennsylvania, United States

Location

Unknown Facility

Jackson, Tennessee, United States

Location

Unknown Facility

Arlington, Virginia, United States

Location

Unknown Facility

Barrie, Ontario, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Peterborough, Ontario, Canada

Location

Unknown Facility

Waterloo, Ontario, Canada

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Herne, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Lübeck, Germany

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Elblag, Poland

Location

Unknown Facility

Poznan, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Bataysk, Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Novosibirsk, Russia

Location

Unknown Facility

Ryazan, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Saratov, Russia

Location

Unknown Facility

Ufa, Russia

Location

Unknown Facility

Ulyanovsk, Russia

Location

Unknown Facility

Yaroslavl, Russia

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Sabadell, Spain

Location

Unknown Facility

Santiago de Compostela, Spain

Location

Unknown Facility

Seville, Spain

Location

Related Publications (5)

• 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

• Rahman P, Boehncke WH, Mease PJ, Gottlieb AB, McInnes IB, Shawi M, Wang Y, Sheng S, Kollmeier AP, Theander E, Yu J, Leibowitz E, Marrache AM, Coates LC. Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis. J Rheumatol. 2023 Jun;50(6):769-780. doi: 10.3899/jrheum.220928. Epub 2023 Jan 15.

  PMID: 36642439 DERIVED

• Mease PJ, Gladman DD, Deodhar A, McGonagle DG, Nash P, Boehncke WH, Gottlieb A, Xu XL, Xu S, Hsia EC, Karyekar CS, Helliwell PS. Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study. RMD Open. 2020 Jul;6(2):e001217. doi: 10.1136/rmdopen-2020-001217.

  PMID: 32665433 DERIVED

• Helliwell PS, Deodhar A, Gottlieb AB, Boehncke WH, Xu XL, Xu S, Wang Y, Hsia EC, Gladman DD, Ritchlin CT. Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial. Arthritis Care Res (Hoboken). 2020 Nov;72(11):1579-1588. doi: 10.1002/acr.24046.

  PMID: 31421033 DERIVED

• Deodhar A, Gottlieb AB, Boehncke WH, Dong B, Wang Y, Zhuang Y, Barchuk W, Xu XL, Hsia EC; CNTO1959PSA2001 Study Group. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Lancet. 2018 Jun 2;391(10136):2213-2224. doi: 10.1016/S0140-6736(18)30952-8. Epub 2018 Jun 1.

  PMID: 29893222 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

guselkumab; Ustekinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; 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

Results Point of Contact

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

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 18, 2014
• Study Start: March 27, 2015
• Primary Completion: May 31, 2016
• Study Completion: January 17, 2017
• Last Updated: February 4, 2025
• Results First Posted: October 14, 2020

Record last verified: 2025-01

Locations

ES (5); US (12); PL (4); RO (1); RU (9); DE (6); CA (4)