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Immunomodulator

Cenerimod 4 mg for Systemic Lupus Erythematosus (OPUS OLE Trial)

Phase 3
Waitlist Available
Research Sponsored by Idorsia Pharmaceuticals Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Signed and dated informed consent form prior to any study-mandated procedure.
* Completed the 12-month double-blind treatment period of either of the parent studies (ID-064A301, ID-064A302).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (post dose) to a maximum of 3.5 years
Awards & highlights

Summary

The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus. The main questions it aims to answer are: * Whether cenerimod causes any adverse effects ('side effects') when given on top of drugs already being given for systemic lupus erythematosus. * How well cenerimod works to reduce symptoms of systemic lupus erythematosus when taken for at least 1 year and up to 3 years. Participants taking part in this study will have already taken part in another study, where they received either cenerimod or placebo (look-alike substance containing no active drug) for 1 year. In this clinical study approximately 680 participants will receive cenerimod (on top of drugs already being given for systemic lupus erythematosus) for at least 1 year and up to 3 years.

Who is the study for?
This trial is for adults with moderate to severe systemic lupus erythematosus who have already participated in a previous study involving cenerimod or placebo. They should be stable on their current lupus medications.
What is being tested?
The study tests the long-term safety and effectiveness of cenerimod, an additional treatment given alongside standard lupus drugs. Participants will take cenerimod for at least one year, possibly extending to three years.
What are the potential side effects?
Potential side effects of cenerimod may include reactions similar to those experienced during the initial study phase, but specific side effects are being studied over the extended period of this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (post dose) to a maximum of 3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (post dose) to a maximum of 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events of special interest
Serious adverse events
Treatment-emergent adverse events

Side effects data

From 2017 Phase 1 & 2 trial • 105 Patients • NCT02472795
8%
Laboratory test abnormal
8%
Arthralgia
8%
Lymphopenia
8%
Gastroduodenitis
8%
Nausea
8%
Respiratory tract infection viral
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cenerimod 4 mgExperimental Treatment1 Intervention
Participants will receive oral cenerimod once daily in addition to background systemic lupus erythematosus therapy, for at least 1 year and up to a maximum of 3 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cenerimod
2015
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Idorsia Pharmaceuticals Ltd.Lead Sponsor
121 Previous Clinical Trials
35,337 Total Patients Enrolled
Clinical TrialsStudy DirectorIdorsia Pharmaceuticals Ltd.
2,211 Previous Clinical Trials
891,998 Total Patients Enrolled
~453 spots leftby Nov 2027