← Back to Search

Proof of Concept Study of SAR443122 in Patients With 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%
Viral Upper Respiratory Tract Infection
3%
Back Pain
3%
Tension Headache
3%
Breast Mass
3%
Urinary Tract Infection
3%
Oral Candidiasis
3%
Accidental Overdose
3%
Oral Herpes
3%
Tooth Fracture
3%
Upper Respiratory Tract Infection
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
SAR443122
Placebo

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
2,215 Previous Clinical Trials
4,047,009 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
876 Previous Clinical Trials
2,021,592 Total Patients Enrolled
~17 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top