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Cenerimod for Systemic Lupus Erythematosus (OPUS-2 Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by Idorsia Pharmaceuticals Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-dose baseline) to month 12
Awards & highlights
Pivotal Trial

Summary

This trial will test the effectiveness and safety of cenerimod to reduce symptoms of SLE in adults.

Who is the study for?
Adults with moderate to severe Systemic Lupus Erythematosus (SLE) who have been on stable SLE medications for at least a month can join. They must not be pregnant, planning pregnancy, or breastfeeding and agree to regular pregnancy tests and effective contraception if applicable. Excluded are those with certain heart conditions, liver diseases, recent use of specific drugs like rituximab or anifrolumab, severe respiratory issues, cancer history (with exceptions), or major organ involvement by SLE.
What is being tested?
The trial is testing the effectiveness and safety of Cenerimod compared to a placebo in reducing SLE symptoms over 12 months. Participants will continue their current treatments while adding either Cenerimod or a placebo. The study aims to enroll around 420 participants split evenly between the two groups.
What are the potential side effects?
While specific side effects for Cenerimod aren't listed here, common risks may include immune system changes leading to increased infection risk, potential heart rate reduction given exclusion criteria related to cardiac health, possible liver function alterations due to liver disease exclusions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-dose baseline) to month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (pre-dose baseline) to month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to Month 12 in the modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score
Secondary study objectives
Response on Systemic Lupus Erythematosus Responder Index (SRI) at Month 12
Time to first confirmation of a 4-month sustained modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) response
Time to first confirmation of a 4-month sustained response in mucocutaneous manifestations

Side effects data

From 2017 Phase 1 & 2 trial • 105 Patients • NCT02472795
8%
Arthralgia
8%
Gastroduodenitis
8%
Nausea
8%
Respiratory tract infection viral
8%
Lymphopenia
8%
Laboratory test abnormal
8%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cenerimod 1 mg
Cenerimod 0.5 mg
Cenerimod 2 mg
Cenerimod 4 mg
Matching Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cenerimod 4 mgExperimental Treatment1 Intervention
Participants will receive cenerimod once daily in addition to background SLE therapy.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo once daily in addition to background SLE therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cenerimod
2015
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

Idorsia Pharmaceuticals Ltd.Lead Sponsor
121 Previous Clinical Trials
35,533 Total Patients Enrolled
Clinical TrialsStudy DirectorIdorsia Pharmaceuticals Ltd.
2,225 Previous Clinical Trials
895,970 Total Patients Enrolled

Media Library

Cenerimod 4 mg Clinical Trial Eligibility Overview. Trial Name: NCT05672576 — Phase 3
Systemic Lupus Erythematosus Research Study Groups: Cenerimod 4 mg, Placebo
Systemic Lupus Erythematosus Clinical Trial 2023: Cenerimod 4 mg Highlights & Side Effects. Trial Name: NCT05672576 — Phase 3
Cenerimod 4 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05672576 — Phase 3
~182 spots leftby Jan 2026
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