NCT03796858: COSMOS

A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy

Completed Phase 3 Last updated 3 February 2025

What this trial tests

Phase 3 trial testing Guselkumab 100 mg in Arthritis, Psoriatic in 285 participants. Completed in 11 November 2020.

Timeline

22 March 2019

Primary endpoint
11 November 2020

11 November 2020

Quick facts

Lead sponsor	Janssen Pharmaceutica N.V., Belgium
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	285
Start date	22 March 2019
Primary completion	11 November 2020
Estimated completion	11 November 2020
Sites	117 locations across France, Italy, Russia, Greece, Ukraine, Belgium, United Kingdom, Germany

Drugs / interventions tested

• Guselkumab 100 mg — full drug profile →
• Placebo

Conditions studied

• Arthritis, Psoriatic — all drugs for Arthritis, Psoriatic →

Sponsor

Janssen Pharmaceutica N.V., Belgium — full company profile →

Who can join

18 and older, any sex, with Arthritis, Psoriatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS).
   Coates LC, Gossec L, Theander E, Bergmans P, et al · · 2022 · cited 79× · PMID 34819273 · DOI 10.1136/annrheumdis-2021-220991
2. Targeting interleukin-17 in chronic inflammatory disease: A clinical perspective.
   Zwicky P, Unger S, Becher B. · · 2020 · cited 66× · PMID 31727781 · DOI 10.1084/jem.20191123
3. 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.
   Strober B, Coates LC, Lebwohl MG, Deodhar A, et al · · 2024 · cited 36× · PMID 37906417 · DOI 10.1007/s40264-023-01361-w
4. Short-term risk and long-term incidence rate of infection and malignancy with IL-17 and IL-23 inhibitors in adult patients with psoriasis and psoriatic arthritis: a systematic review and meta-analysis.
   Wu S, Xu Y, Yang L, Guo L, et al · · 2023 · cited 22× · PMID 38106423 · DOI 10.3389/fimmu.2023.1294416
5. IL-23 orchestrating immune cell activation in arthritis.
   Najm A, McInnes IB. · · 2021 · cited 18× · PMID 34668017 · DOI 10.1093/rheumatology/keab266
6. Identification of PsA phenotypes with machine learning analytics using data from two phase III clinical trials of guselkumab in a bio-naïve population of patients with PsA.
   Richette P, Vis M, Ohrndorf S, Tillett W, et al · · 2023 · cited 15× · PMID 37001920 · DOI 10.1136/rmdopen-2022-002934
7. Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis.
   Rahman P, Boehncke WH, Mease PJ, Gottlieb AB, et al · · 2023 · cited 13× · PMID 36642439 · DOI 10.3899/jrheum.220928
8. Experimental and Investigational Pharmacotherapy for Psoriatic Arthritis: Drugs of the Future.
   Navarini L, Currado D, Costa L, Tasso M, et al · · 2020 · cited 10× · PMID 33235521 · DOI 10.2147/jep.s265633