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SAR443122 for Cutaneous Lupus Erythematosus (CLEan Trial)

Phase 2
Waitlist Available
Research Sponsored by Sanofi
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 1 hour before morning dose and 2-5 hours post first morning dose on day 85

Summary

This trial is testing SAR443122, a new medication, to see if it can help patients with cutaneous lupus erythematosus (CLE). The goal is to reduce inflammation and symptoms like skin lesions, itching, and pain.

Eligible Conditions
  • Cutaneous Lupus Erythematosus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour before morning dose and 2-5 hours post first morning dose on day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour before morning dose and 2-5 hours post first morning dose on day 85 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12
Secondary study objectives
Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of SAR443122
Change From Baseline in CLASI Components' Score Over Time
Change From Baseline in Participants Reported Daily Worst Itch Using Peak Pruritus Numerical Rating Scale (Itch-NRS) at Week 12
+15 more

Side effects data

From 2023 Phase 2 trial • 78 Patients • NCT04781816
8%
Nasopharyngitis
5%
Pruritus
5%
Arthralgia
5%
Diarrhoea
5%
Alanine Aminotransferase Increased
5%
Dermatitis Contact
3%
Accidental Overdose
3%
Upper Respiratory Tract Infection
3%
Oral Herpes
3%
Viral Upper Respiratory Tract Infection
3%
Back Pain
3%
Tension Headache
3%
Tooth Fracture
3%
Breast Mass
3%
Urinary Tract Infection
3%
Oral Candidiasis
3%
Influenza Like Illness
3%
Peripheral Swelling
3%
Nail Infection
3%
Maculopathy
3%
Odynophagia
3%
Tooth Abscess
3%
Bronchitis
3%
Covid-19
3%
Nausea
3%
Fatigue
3%
Aspartate Aminotransferase Increased
3%
Neutrophil Count Decreased
3%
Urine Protein/Creatinine Ratio Increased
3%
Neck Pain
3%
Headache
3%
Sciatica
3%
Cough
3%
Cutaneous Lupus Erythematosus
3%
Dermatitis Allergic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
SAR443122

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR443122Experimental Treatment1 Intervention
SAR443122 for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR443122
2020
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,203 Previous Clinical Trials
4,036,617 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
872 Previous Clinical Trials
2,020,710 Total Patients Enrolled
~17 spots leftby Nov 2025
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