Proof of concept study of SAR443122 in patients with cutaneous lupus erythematosus

Phase 1

• Conditions: Cutaneous Lupus Erythematosus; MedDRA version: 21.1Level: PTClassification code 10056509Term: Cutaneous lupus erythematosusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-004703-14-IT
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 135

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 115
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
- 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 Frederica formulation) 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified