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Sphingosine-1-phosphate receptor modulator

Cenerimod 0.5 mg for Lupus

Phase 2

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1) and month 6

Summary

The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).

Eligible Conditions

Lupus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) and month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1) and month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and month 6 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 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score

Secondary study objectives

British Isles Lupus Assessment Group-2004 (BILAG) Disease Activity Index Response at Month 6

Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 6 as Compared to Baseline

Side effects data

From 2022 Phase 2 trial • 427 Patients • NCT03742037

23%

Headache

23%

Hypertension

20%

Lymphopenia

11%

Upper respiratory tract infection

11%

Urinary tract infection

Diarrhoea

Nasopharyngitis

Abdominal pain

Oral herpes

Respiratory tract infection viral

Hypercholesterolaemia

Arthralgia

Myalgia

Hypertensive emergency

Neutropenia

Cataract subcapsular

Vision blurred

Abdominal pain upper

Nausea

COVID-19

Vomiting

Forced expiratory volume decreased

Dyslipidaemia

100%

80%

60%

40%

20%

Study treatment Arm

Cenerimod 4 mg (Treatment Period 1) & Cenerimod 2 mg (Ex-4 mg; Treatment Period 2)

Cenerimod 4 mg (Treatment Period 1) & Placebo (Ex-4 mg; Treatment Period 2)

Cenerimod 0.5 mg (Treatment Period 1 & 2)

Cenerimod 2 mg (Treatment Period 1 & 2)

Cenerimod 1 mg (Treatment Period 1 & 2)

Placebo (Treatment Period 1 & 2)

Cenerimod 4 mg (Treatment Period 1) & Not Re-randomized (Ex-4 mg; Treatment Period 2)

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: Cenerimod 4 mgExperimental Treatment1 Intervention

Participants will received cenerimod 4 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1. The participants randomized to the 4 mg treatment who were still on treatment at Month 6 were re-randomized in a 1:1 ratio to placebo or cenerimod 2 mg to enter Treatment Period 2. The participants who did not complete 6 months of cenerimod 4 mg treatment will be analyzed in the "Non Re-randomized (Ex-4mg)" treatment group.

Group II: Cenerimod 2 mg (Ex-4mg)Experimental Treatment1 Intervention

Half the participants that complete treatment with cenerimod 4 mg in Treatment Period 1 will be re-randomized to cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2. Participants will receive cenerimod 2 mg for 6 months and end study treatment at the Month 12 visit.

Group III: Cenerimod 2 mgExperimental Treatment1 Intervention

Participants will receive cenerimod 2 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 2 mg for a further 6 months and end study treatment at the Month 12 visit.

Group IV: Cenerimod 1 mgExperimental Treatment1 Intervention

Participants will receive cenerimod 1 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 1 mg for a further 6 months and end study treatment at the Month 12 visit.

Group V: Cenerimod 0.5 mgExperimental Treatment1 Intervention

Participants will receive cenerimod 0.5 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 0.5 mg for a further 6 months and end study treatment at the Month 12 visit.

Group VI: PlaceboPlacebo Group1 Intervention

Participants will receive placebo (matching cenerimod) once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with placebo (matching cenerimod) for a further 6 months and end study treatment at the Month 12 visit.

Group VII: Placebo (Ex-4mg)Placebo Group1 Intervention

Half the participants that complete treatment with cenerimod 4 mg in Treatment Period 1 will be re-randomized to placebo (matching cenerimod) once daily in addition to background SLE therapy during Treatment Period 2. Participants will receive cenerimod 2 mg for 6 months and end study treatment at the Month 12 visit.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cenerimod 2 mg (ex-4 mg)

2018

Completed Phase 2

~430

Cenerimod 4 mg

2018

Completed Phase 2

~530