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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Cutaneous Lupus Erythematosus

Treatments: Drug: Placebo; Drug: SAR443122

Study type: Interventional

Funder types: Industry

Identifiers

NCT04781816

U1111-1246-6784 (Other Identifier)

ACT16404

2020-004703-14 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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

Enrollment: 78 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

SAR443122

Experimental group

Description:

SAR443122 for 12 weeks

Treatment:

Drug: SAR443122

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo