Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus

Completed · Phase 2 · Has a placebo group

Conditions studied: Cutaneous Lupus Erythematosus

In brief

Primary Objective: * Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE) Secondary Objectives: * Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity) * Assess the effect of SAR443122 on CLE induced itch and overall pain * Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo * Assess the effect of SAR443122 on the CLASI components score * Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE) * Assess oral cavities for patients with oral lesions * Assess the disease specific quality of life (QoL) * Assess the safety and tolerability of SAR443122 in patients with CLE * Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE

Key facts

Study ID

NCT04781816

Run by

Sanofi

People needed

78

Starts

2021-04-01

Expected to finish

2023-06-26

Last updated by the study team

2025-08-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with cutaneous lupus erythematosus either in the form of discoid/chronic cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus for at least 3 months before Screening.
• Participants with histologically confirmed and documented diagnosis within one year prior to Screening or during Screening period prior to randomization.
• Active cutaneous lupus erythematosus skin lesions and a Cutaneous Erythematosus.
• Disease Area and Severity Index activity (CLASI-A) ≥10 both at Screening and Baseline.
• Participant who was candidate for systemic treatment per Investigator's judgement.

You may not qualify if…

• Systemic lupus erythematosus according to the 2012 SLICC criteria with major organ involvement.
• Suspected or proven drug induced lupus erythematosus, including patients with positive antihistone autoantibody tests.
• Autoimmune disease(s) other than systemic lupus erythematosus.
• Active skin diseases that may interfere with the study or study assessments.
• Exclusion related to tuberculosis, non-tuberculous mycobacterial infections, HIV, HBV, HCV, Herpes zoster, COVID-19 and other recurrent or recent serious infections.
• Prolonged QTcF ≥ 450 ms (by Fridericia formula) or clinically significant findings on electrocardiogram (ECG).
• Cannot avoid excessive UV exposure 4 weeks prior to baseline and during the study. Routine sun exposure through work are permitted but requires the use of sun block to sun exposed areas for at least 4 weeks prior to baseline and during the study.
• Concomitant treatment with topical immunosuppressants beyond a stable regimen of low to medium potency topical corticosteroids and/or topical calcineurin inhibitors during the study and two weeks before baseline visit.
• Initiation and/or changes in dosage of chloroquine/hydroxychloroquine within 12 weeks prior to Screening visit (or during Screening period) and/or the dose exceeding 2.3 mg/kg/day for chloroquine or 400 mg/day for hydroxychloroquine.
• Systemic treatments for cutaneous or systemic lupus erythematosus or immunosuppressive therapy for autoimmune disease other than the study medication.
• Systemic corticosteroids treatment <4 weeks before baseline visit.
• Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study.
• Laboratory abnormalities at the Screening visit.
• The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• GNP Research Site Number : 8400008 — Cooper City, Florida, United States
• DJL Clinical Research, PLLC Site Number : 8400003 — Charlotte, North Carolina, United States
• ClinOhio Research Services Site Number : 8400007 — Columbus, Ohio, United States
• Prolato Clinical Research Center Site Number : 8400010 — Houston, Texas, United States
• Investigational Site Number : 0320002 — CABA, Buenos Aires, Argentina
• Investigational Site Number : 0320003 — CABA, Buenos Aires, Argentina
• Investigational Site Number : 0320001 — CABA, Buenos Aires, Argentina
• Investigational Site Number : 0320004 — Rosario, Santa Fe Province, Argentina
• Investigational Site Number : 0320005 — Mendoza, Argentina
• Investigational Site Number : 0360001 — Camberwell, Victoria, Australia
• Investigational Site Number : 0360002 — East Melbourne, Victoria, Australia
• Investigational Site Number : 1240001 — London, Ontario, Canada
• Investigational Site Number : 1240005 — Toronto, Ontario, Canada
• Investigational Site Number : 1240002 — Sherbrooke, Quebec, Canada
• Investigational Site Number : 1520009 — Valdivia, Los Ríos Region, Chile
• Investigational Site Number : 1520006 — Osorno, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520007 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520003 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520001 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520002 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 2030002 — Brno, Czechia
• Investigational Site Number : 2030004 — Náchod, Czechia
• Investigational Site Number : 2030006 — Pardubice, Czechia
• Investigational Site Number : 2030005 — Prague, Czechia
• Investigational Site Number : 3480001 — Budapest, Hungary

Full record on ClinicalTrials.gov

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