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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
Awards & highlights

Study Summary

This study is evaluating whether a drug called cenerimod can improve symptoms of lupus.

Eligible Conditions
  • Lupus

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline to Month 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score
Secondary outcome measures
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
13%
Headache
10%
COVID-19
8%
Upper respiratory tract infection
6%
Nasopharyngitis
5%
Lymphopenia
5%
Diarrhoea
4%
Dry eye
4%
Nausea
2%
Urinary tract infection
2%
Hypertension
2%
Neutropenia
2%
Pharyngitis
1%
Acid peptic disease
1%
Oral herpes
1%
Abdominal pain
1%
Alanine aminotransferase increased
1%
COVID-19 pneumonia
1%
Pyrexia
1%
Cataract subcapsular
1%
Upper gastrointestinal haemorrhage
1%
Dyspepsia
1%
Hypoglycaemia
1%
Pneumonia
1%
Vomiting
1%
Hypercholesterolaemia
1%
Myalgia
1%
Dyspnoea
1%
Gastritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cenerimod 0.5 mg (Treatment Period 1 & 2)
Cenerimod 1 mg (Treatment Period 1 & 2)
Cenerimod 2 mg (Treatment Period 1 & 2)
Cenerimod 4 mg (Treatment Period 1) & Cenerimod 2 mg (Ex-4 mg; Treatment Period 2)
Placebo (Treatment Period 1 & 2)
Cenerimod 4 mg (Treatment Period 1) & Placebo (Ex-4 mg; Treatment Period 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: 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.
Group VII: 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.
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
Cenerimod 0.5 mg
2018
Completed Phase 2
~530
Cenerimod 1 mg
2018
Completed Phase 2
~430
Cenerimod 2 mg
2018
Completed Phase 2
~430

Find a Location

Who is running the clinical trial?

Idorsia Pharmaceuticals Ltd.Lead Sponsor
118 Previous Clinical Trials
32,030 Total Patients Enrolled
ClinicalTrialsStudy DirectorIdorsia Pharmaceuticals
2 Previous Clinical Trials
1,756 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
2018. "Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03742037.
~67 spots leftby Apr 2025
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