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Immunomodulator

Cenerimod 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
Participants with a diagnosis of systemic lupus erythematosus who completed the 12-month double-blind treatment period of either of the parent studies (ID-064A301, ID-064A302)
Participants with a diagnosis of systemic lupus erythematosus who did not meet any study treatment stopping criteria during the parent study
Must not have
Women of child-bearing potential planning to become pregnant up to the final study visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (post dose) to a maximum of 3.5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to study the long-term safety and effectiveness of cenerimod in adult patients with moderate to severe systemic lupus erythematosus symptoms. It will investigate if cenerimod

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
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I have lupus and finished a 12-month treatment in a specific study.
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I have lupus and didn't stop treatment in a previous study due to its rules.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a woman who could become pregnant and plan to during the study.

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%
Gastroduodenitis
8%
Nausea
8%
Arthralgia
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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~180

Find a Location

Who is running the clinical trial?

Idorsia Pharmaceuticals Ltd.Lead Sponsor
121 Previous Clinical Trials
35,273 Total Patients Enrolled
Clinical TrialsStudy DirectorIdorsia Pharmaceuticals Ltd.
2,221 Previous Clinical Trials
895,313 Total Patients Enrolled
~453 spots leftby Nov 2027