NCT05672576 (OPUS-2) is a Phase 3 clinical trial of Cenerimod in Lupus Erythematosus, Systemic, sponsored by Viatris Innovation GmbH.

Who is sponsoring NCT05672576?

NCT05672576 is sponsored by Viatris Innovation GmbH.

What drugs are being tested in NCT05672576?

Interventions in NCT05672576: Cenerimod, Placebo.

What condition does NCT05672576 study?

NCT05672576 studies Lupus Erythematosus, Systemic.

Is NCT05672576 still recruiting?

NCT05672576 is currently active, enrolled. Last updated 2 April 2026.

Last reviewed 2026-04-02 · How we verify

NCT05672576: OPUS-2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus

Active, enrolled Phase 3 Last updated 2 April 2026

What this trial tests

Phase 3 trial testing Cenerimod in Lupus Erythematosus, Systemic in 451 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 June 2023

Primary endpoint
31 October 2026

1 May 2027

Quick facts

Lead sponsor	Viatris Innovation GmbH
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	451
Start date	26 June 2023
Primary completion	31 October 2026
Estimated completion	1 May 2027
Sites	147 locations across Georgia, South Africa, Malaysia, India, Peru, Chile, Serbia, Ukraine

Drugs / interventions tested

Cenerimod — full drug profile →
Placebo

Conditions studied

Lupus Erythematosus, Systemic — all drugs for Lupus Erythematosus, Systemic →

Sponsor

Viatris Innovation GmbH — full company profile →

Who can join

Adults 18 to 75, any sex, with Lupus Erythematosus, Systemic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous in adult patients with moderate to severe symptoms. The main questions it aims to answer are: * How well cenerimod works on top of the treatment already being administered. * How safe cenerimod is for adult patients with Systemic Lupus Erythematosus. Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered. In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.

Publications & conference data

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

Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial.
Askanase AD, D'Cruz D, Kalunian K, Merrill JT, et al · · 2025 · cited 6× · PMID 39586304 · DOI 10.1016/s2665-9913(24)00246-7
T cell trafficking in human chronic inflammatory diseases.
Giovenzana A, Codazzi V, Pandolfo M, Petrelli A. · · 2024 · cited 5× · PMID 39171290 · DOI 10.1016/j.isci.2024.110528
Efficacy and safety study of targeted small-molecule drugs in the treatment of systemic lupus erythematosus.
Wang S, Ning W, Tang H, Mu C, et al · · 2024 · cited 5× · PMID 38730460 · DOI 10.1186/s13075-024-03331-8
Immunotargets and Therapy for Systemic Lupus Erythematosus.
Mok CC. · · 2025 · cited 3× · PMID 40585390 · DOI 10.2147/itt.s485650
Multiple-dose pharmacokinetics of cenerimod and the effect of charcoal on its elimination.
Mueller MS, Juif PE, Charfi H, Dingemanse J. · · 2024 · PMID 39141427 · DOI 10.1002/jcph.6106

Verify or expand the search:

Other trials of Cenerimod

Trials testing the same drug.

NCT05648500 — A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythemat · Phase 3 · recruiting
NCT05004311 — The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics · Phase 1 · completed
NCT04819464 — A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod · Phase 1 · completed
NCT04052360 — Single Oral Dose of 4 mg Cenerimod in Healthy Japanese and Caucasian Subjects · Phase 1 · completed
NCT02914223 — A Study to Evaluate Cenerimod in Healthy Male Subjects · Phase 1 · completed

Other recruiting trials for Lupus Erythematosus, Systemic

Currently open trials in the same condition.

NCT07424261 — NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care · recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07330245 — Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. · recruiting
NCT07015983 — A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite I · Phase 2 · recruiting
NCT06881290 — Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus · Phase 1 · recruiting

Other Viatris Innovation GmbH trials

Trials by the same sponsor.

NCT07301723 — A Trial to Evaluate the Absolute Bioavailability of Cenerimod in Healthy Male Participants · Phase 1 · completed
NCT07133191 — A Trial to Compare What the Body Does to Selatogrel and the Effect of Selatogrel in Japanese and Caucasian Healthy Parti · Phase 1 · completed
NCT05648500 — A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythemat · Phase 3 · recruiting
NCT05004311 — The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics · Phase 1 · completed
NCT04819464 — A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05672576 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Viatris Innovation GmbH
Last refreshed: 2 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05672576.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing