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

  • STATUS
    Recruiting
  • End date
    Apr 24, 2024
  • participants needed
    88
  • sponsor
    Sanofi
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Updated on 17 February 2023
See if I qualify

Summary

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

Description

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

Details
Condition Cutaneous Lupus Erythematosus
Treatment Placebo, SAR443122
Clinical Study IdentifierNCT04781816
SponsorSanofi
Last Modified on17 February 2023

Eligibility

 Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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