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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

Pivotal Trial

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (post dose) to a maximum of 3.5 years

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

Gastroduodenitis

Nausea

Respiratory tract infection viral

Arthralgia

Lymphopenia

Laboratory test abnormal

Pneumonitis

100%

80%

60%

40%

20%

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met