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

Study of Investigational Medication for Cutaneous Lupus Erythematosus

Not Recruiting
18 years - 80 years
All
Phase 2
78 participants needed
5 Locations

Study Overview

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

Study Details

Total study duration per participant was 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 Criteria

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

  • Conditions: Cutaneous Lupus Erythematosus
  • Age: 18 years - 80 years
  • Gender: All

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

Updated on 04 Jul 2024. Study ID: NCT04781816

This study investigates the effects of an investigational medication on cutaneous lupus erythematosus (CLE), a skin condition characterized by red, scaly patches. The purpose of the study is to evaluate how well the medication works in reducing disease activity and symptoms such as itch and pain. The study also examines the impact of the medication on the quality of life and its safety and tolerability in patients with CLE.

Participants will undergo various assessments including a physician's global assessment of disease activity, the Investigator's global assessment for CLE, and scoring of skin lesions. The study will also involve checking oral cavities for patients with oral lesions and assessing the pharmacokinetics, which is how the body absorbs, distributes, and eliminates the investigational medication. Participants may receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.

  • Who can participate: Adults with cutaneous lupus erythematosus, characterized by skin lesions and a certain level of disease activity, may participate. Participants must have a confirmed diagnosis and be candidates for systemic treatment. Those with systemic lupus involving major organs or other autoimmune diseases are excluded.
  • Study details: Participants will take the investigational medication or a placebo. They will undergo various assessments to monitor the effects on disease activity and symptoms.
  • Study Timelines: The study will last 20 weeks.