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

NCT04781816 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: ACT16404U1111-1246-67842020-004703-14
• Study Type: interventional
• Target: 78
• Locations: 15 countries
• Sites: 50

Brief 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

Conditions

Cutaneous Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12

  The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering 2 dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges for 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. Higher score indicates a more severe skin disease. Baseline was defined as the Day 1 assessment value.

  Baseline (Day 1) and Week 12

Secondary Outcomes (18)

• Percentage of Participants With Physician's Global Assessment of Disease Activity (PhysGA- Disease Activity) of 0 or 1 (Disease Free or Almost Disease Free) at Week 12

  Week 12

• Change From Baseline in Participants Reported Daily Worst Itch Using Peak Pruritus Numerical Rating Scale (Itch-NRS) at Week 12

  Baseline (Day 1) and Week 12

• Change From Baseline in Participants Reported Daily Worst Pain Using Peak Pain Numerical Rating Scale (Pain-NRS) at Week 12

  Baseline (Day 1) and Week 12

• Percentage of CLASI-A50 and CLASI-A75 Responders at Week 12

  Week 12

• Change From Baseline in CLASI Components' Score Over Time

  Baseline (Day 1) and Weeks 4, 8, 12, and 16

Study Arms (2)

SAR443122

EXPERIMENTAL

SAR443122 for 12 weeks

Drug: SAR443122

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

SAR443122 DRUG

Pharmaceutical form: Capsule Route of administration: Oral

SAR443122

Placebo DRUG

Pharmaceutical form: Capsule Route of administration: Oral

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (50)

GNP Research Site Number : 8400008

Cooper City, Florida, 33024, United States

Location

DJL Clinical Research, PLLC Site Number : 8400003

Charlotte, North Carolina, 28211, United States

Location

ClinOhio Research Services Site Number : 8400007

Columbus, Ohio, 43213, United States

Location

Prolato Clinical Research Center Site Number : 8400010

Houston, Texas, 77054, United States

Location

Investigational Site Number : 0320002

CABA, Buenos Aires, C1023AAB, Argentina

Location

Investigational Site Number : 0320003

CABA, Buenos Aires, C1055AAO, Argentina

Location

Investigational Site Number : 0320001

CABA, Buenos Aires, C1111, Argentina

Location

Investigational Site Number : 0320004

Rosario, Santa Fe Province, S2000DBS, Argentina

Location

Investigational Site Number : 0320005

Mendoza, M5500, Argentina

Location

Investigational Site Number : 0360001

Camberwell, Victoria, 3124, Australia

Location

Investigational Site Number : 0360002

East Melbourne, Victoria, 3002, Australia

Location

Investigational Site Number : 1240001

London, Ontario, N6A2C2, Canada

Location

Investigational Site Number : 1240005

Toronto, Ontario, M4W 2W4, Canada

Location

Investigational Site Number : 1240002

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Investigational Site Number : 1520009

Valdivia, Los Ríos Region, 5110683, Chile

Location

Investigational Site Number : 1520006

Osorno, Reg Metropolitana de Santiago, 5311523, Chile

Location

Investigational Site Number : 1520007

Santiago, Reg Metropolitana de Santiago, 7500010, Chile

Location

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 7580206, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 8420383, Chile

Location

Investigational Site Number : 2030002

Brno, 65691, Czechia

Location

Investigational Site Number : 2030004

Náchod, 547 01, Czechia

Location

Investigational Site Number : 2030006

Pardubice, 53002, Czechia

Location

Investigational Site Number : 2030005

Prague, 160 00, Czechia

Location

Investigational Site Number : 3480001

Budapest, 1085, Hungary

Location

Investigational Site Number : 3480002

Szeged, 6720, Hungary

Location

Investigational Site Number : 3560002

Chandigarh, 160015, India

Location

Investigational Site Number : 3560003

Nagpur, 440019, India

Location

Investigational Site Number : 3560004

Nashik, 422101, India

Location

Investigational Site Number : 3800001

Genova, 16132, Italy

Location

Investigational Site Number : 3800002

Milan, 20122, Italy

Location

Investigational Site Number : 4840003

Benito Juárez, 03100, Mexico

Location

Investigational Site Number : 4840004

Chihuahua City, 31000, Mexico

Location

Investigational Site Number : 4840001

Monterrey, Nuevo León, 64460, Mexico

Location

Investigational Site Number : 4840002

Veracruz, 91910, Mexico

Location

Investigational Site Number : 6160006

Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

Investigational Site Number : 6160004

Lublin, Lublin Voivodeship, 20-081, Poland

Location

Investigational Site Number : 6160007

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Investigational Site Number : 6430004

Krasnodar, 350020, Russia

Location

Investigational Site Number : 6430005

Moscow, 115419, Russia

Location

Investigational Site Number : 6430002

Moscow, 125993, Russia

Location

Investigational Site Number : 6430001

Saint Petersburg, 197022, Russia

Location

Investigational Site Number : 6430003

Stavropol, 355020, Russia

Location

Investigational Site Number : 7240002

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Investigational Site Number : 7240007

Barcelona, Barcelona [Barcelona], 08041, Spain

Location

Investigational Site Number : 7240001

L'Hospitalet de Llobregat, Barcelona [Barcelona], 08907, Spain

Location

Investigational Site Number : 7240004

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Investigational Site Number : 8040001

Ivano-Frankivsk, 76018, Ukraine

Location

Investigational Site Number : 8040002

Kyiv, 04209, Ukraine

Location

Investigational Site Number : 8260003

London, London, City of, E11 1NR, United Kingdom

Location

Related Links

• ACT16404 Cutaneous Lupus Erythematosus website
• ACT16404 Plain Language Results Summary

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 4, 2021
• Study Start: April 1, 2021
• Primary Completion: May 25, 2023
• Study Completion: June 26, 2023
• Last Updated: August 27, 2025
• Results First Posted: June 24, 2024

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (4); IN (3); ES (4); CL (6); UA (2); GB (1); AR (5); AU (2); HU (2); RU (5); ME (4); PL (3); IT (2); CA (3); CZ (4)