Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
NCT ID: NCT04781816
Last Updated: 2025-08-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2021-04-01
2023-06-26
Brief Summary
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* 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
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Detailed Description
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* A screening period of up to 4 weeks
* A treatment period of 12 weeks
* A post treatment follow-up period of 4 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SAR443122
SAR443122 for 12 weeks
SAR443122
Pharmaceutical form: Capsule Route of administration: Oral
Placebo
Matching placebo
Placebo
Pharmaceutical form: Capsule Route of administration: Oral
Interventions
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SAR443122
Pharmaceutical form: Capsule Route of administration: Oral
Placebo
Pharmaceutical form: Capsule Route of administration: Oral
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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GNP Research Site Number : 8400008
Cooper City, Florida, United States
DJL Clinical Research, PLLC Site Number : 8400003
Charlotte, North Carolina, United States
ClinOhio Research Services Site Number : 8400007
Columbus, Ohio, United States
Prolato Clinical Research Center Site Number : 8400010
Houston, Texas, United States
Investigational Site Number : 0320002
CABA, Buenos Aires, Argentina
Investigational Site Number : 0320003
CABA, Buenos Aires, Argentina
Investigational Site Number : 0320001
CABA, Buenos Aires, Argentina
Investigational Site Number : 0320004
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320005
Mendoza, , Argentina
Investigational Site Number : 0360001
Camberwell, Victoria, Australia
Investigational Site Number : 0360002
East Melbourne, Victoria, Australia
Investigational Site Number : 1240001
London, Ontario, Canada
Investigational Site Number : 1240005
Toronto, Ontario, Canada
Investigational Site Number : 1240002
Sherbrooke, Quebec, Canada
Investigational Site Number : 1520009
Valdivia, Los Ríos Region, Chile
Investigational Site Number : 1520006
Osorno, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520007
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 2030002
Brno, , Czechia
Investigational Site Number : 2030004
Náchod, , Czechia
Investigational Site Number : 2030006
Pardubice, , Czechia
Investigational Site Number : 2030005
Prague, , Czechia
Investigational Site Number : 3480001
Budapest, , Hungary
Investigational Site Number : 3480002
Szeged, , Hungary
Investigational Site Number : 3560002
Chandigarh, , India
Investigational Site Number : 3560003
Nagpur, , India
Investigational Site Number : 3560004
Nashik, , India
Investigational Site Number : 3800001
Genova, , Italy
Investigational Site Number : 3800002
Milan, , Italy
Investigational Site Number : 4840003
Benito Juárez, , Mexico
Investigational Site Number : 4840004
Chihuahua City, , Mexico
Investigational Site Number : 4840001
Monterrey, Nuevo León, , Mexico
Investigational Site Number : 4840002
Veracruz, , Mexico
Investigational Site Number : 6160006
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160004
Lublin, Lublin Voivodeship, Poland
Investigational Site Number : 6160007
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 6430004
Krasnodar, , Russia
Investigational Site Number : 6430005
Moscow, , Russia
Investigational Site Number : 6430002
Moscow, , Russia
Investigational Site Number : 6430001
Saint Petersburg, , Russia
Investigational Site Number : 6430003
Stavropol, , Russia
Investigational Site Number : 7240002
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240007
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240001
L'Hospitalet de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240004
Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 8040001
Ivano-Frankivsk, , Ukraine
Investigational Site Number : 8040002
Kyiv, , Ukraine
Investigational Site Number : 8260003
London, London, City of, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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ACT16404 Cutaneous Lupus Erythematosus website
ACT16404 Plain Language Results Summary
Other Identifiers
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U1111-1246-6784
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-004703-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACT16404
Identifier Type: -
Identifier Source: org_study_id
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