What side effects are associated with this type of intervention?

Common treatments for Systemic Lupus Erythematosus (SLE) include glucocorticoids, immunosuppressive agents, and biologics. Glucocorticoids can cause side effects such as hyperglycemia, increased infection risk, bone loss, and neuropsychiatric issues. Immunosuppressive agents like mycophenolate mofetil and azathioprine may lead to gastrointestinal disturbances, increased infection risk, and hematologic abnormalities. Biologics, such as rituximab, can cause infusion reactions, serum-sickness-like reactions, and rare but severe complications like progressive multifocal leukoencephalopathy. Treatments similar to Cenerimod, such as other S1P1 receptor modulators, may have side effects including headache, nausea, and potential cardiovascular effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Systemic Lupus Erythematosus (SLE), including biologic agents such as belimumab, which is a monoclonal antibody targeting B-lymphocyte stimulator (BLyS). Rituximab, another biologic agent targeting CD20 on B cells, has been used off-label for SLE but has not received FDA approval specifically for this indication. While Cenerimod, an S1P1 receptor modulator, is still under investigation, it represents a novel approach compared to these existing biologic therapies. Other treatments for SLE include conventional immunosuppressive agents like mycophenolate mofetil and cyclophosphamide.

What other types of research exist?

Promising novel alternatives to Cenerimod for Systemic Lupus Erythematosus patients include biologic agents such as belimumab (a monoclonal antibody targeting B-lymphocyte stimulator) and anifrolumab (an interferon receptor antagonist). These treatments have shown efficacy in clinical trials for SLE and are considered promising options for patients seeking new therapies in 2024.

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Cenerimod for Systemic Lupus Erythematosus (OPUS-1 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 at month 12 compared to day 1 (pre-dose baseline)

Awards & highlights

Pivotal Trial

Summary

This trial is testing cenerimod, a medication aimed at reducing symptoms of Systemic Lupus Erythematosus (SLE) in adults with moderate to severe symptoms. Researchers want to see if cenerimod can help when added to existing treatments. The medication works by calming the overactive immune system, which may reduce inflammation and other symptoms.

Who is the study for?

Adults with moderate to severe Systemic Lupus Erythematosus (SLE) who have been diagnosed at least 6 months prior and are on stable SLE medications can join. They need a certain level of disease activity and organ involvement, and women must agree to pregnancy tests and use effective contraception. Excluded are those with heart rate issues, certain heart conditions, severe respiratory diseases, liver problems, recent serious cardiovascular events or treatments that could interfere.

What is being tested?

The trial is testing Cenerimod's effectiveness in reducing SLE symptoms compared to a placebo over 12 months. It will involve around 420 participants split into two groups: one receiving Cenerimod and the other receiving a placebo pill without active medication.

What are the potential side effects?

While specific side effects for Cenerimod aren't listed here, common ones for new oral medicines may include gastrointestinal discomfort, headaches, potential liver impact or allergic reactions. The study aims to assess safety thoroughly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at month 12 compared to day 1 (pre-dose baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at month 12 compared to day 1 (pre-dose baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 12 compared to day 1 (pre-dose baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline

Secondary study objectives

Response on BILAG-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline

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 (i.e., rash, alopecia, mucosal ulcers)

Side effects data

From 2017 Phase 1 & 2 trial • 105 Patients • NCT02472795

Arthralgia

Gastroduodenitis

Nausea

Respiratory tract infection viral

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.

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: Matching 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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Systemic Lupus Erythematosus (SLE) include immunosuppressive drugs like cyclophosphamide, mycophenolate mofetil, and azathioprine, which work by inhibiting the proliferation of immune cells and reducing inflammation. Biologic agents such as rituximab target specific components of the immune system, like B cells, to decrease autoantibody production. Cenerimod, an S1P1 receptor modulator, works by preventing lymphocytes from exiting lymph nodes, thereby reducing their presence in the bloodstream and inflamed tissues. These mechanisms are crucial for SLE patients as they help control the hyperactive immune response, reduce organ damage, and improve quality of life.

Pharmacotherapy of lupus nephritis in children: a recommended treatment approach.