Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus (CLEan)

Brief description of study

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

Detailed description of study

Total study duration per participant will be up 20 weeks including:

  • A screening period of up to 4 weeks
  • A treatment period of 12 weeks
  • A post treatment follow-up period of 4 weeks

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cutaneous Lupus Erythematosus
  • Age: Between 18 Years - 80 Years
  • Gender: Male or Female

Inclusion criteria :

  • 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 is candidate for systemic treatment per Investigator's judgement.

Exclusion criteria:

  • 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 is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.

Updated on 17 Feb 2023 . Study ID: NCT04781816

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