A phase 2a proof of concept study to evaluate efficacy and safety of SAR443122 in patients with moderate to severe subacute or discoid/chronic cutaneous lupus erythematosus
- Conditions
- Health Condition 1: L931- Subacute cutaneous lupus erythematosus
- Registration Number
- CTRI/2021/08/035384
- Lead Sponsor
- Sanofi Healthcare India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
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 CLASI-A =10 both at Screening and Baseline.
Participant who is candidate for systemic treatment per Investigator’s judgement.
ll Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
a) Male participants
Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 5 days after the last dose of IMP, corresponding to time needed to eliminate study intervention(s) (eg, 5 terminal half-lives)
Refrain from donating sperm
PLUS, either:
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
OR
Must agree to use contraception/barrier as detailed below:
A male condom and an additional highly effective contraceptive method as described in Appendix 4 Contraceptive and barrier guidance (Section 10.4) when
having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
b) Female participants
A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies
Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 4 Contraceptive and barrier guidance (Section 10.4).
OR
Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, as described in
Appendix 4 Contraceptive and barrier guidance (Section 10.4) during the study intervention period and for at least 2 days, corresponding to the time needed to eliminate any study intervention(s) (eg, 5 terminal half-lives) plus 30 days (a menstrual cycle) after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
A WOCBP must have a negative highly sensitive pregnancy test (urine and/or serum as required by local regulations) at Screening and Baseline visits before the first administration of study intervention.
Pregnancy testing.
If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Local regulations regarding contraception for male and female participants
Capable of giving signed informed consent. In countries where legal age of majority is above 18 years, a specific ICF must also be signed by the participant’s legally authorized representative.
Suspected or proven drug induced lupus erythematosus, including patients with positive antihistone autoantibody tests.
Diagnosed with certain subtypes of CCLE (such as Lupus erythematosus tumidus, Chilblain, lupus panniculitis, lichenoid cutaneous lupus/lichen planus overlap syndrome).
Autoimmune disease(s) other than systemic lupus erythematosus (eg, systemic sclerosis, myositis, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, multiple sclerosis, Behcet’s disease etc).
Active skin diseases that may interfere with the study or study assessments (eg, Psoriasis).
History of any malignancy except history of adequately treated basal cell carcinoma or in situ cervical carcinoma.
History of HIV infection or positive HIV serology at screening.
History of recurrent or recent serious infection (eg pneumonia, septicemia) within 4 weeks of screening, infection requiring hospitalization or intravenous antibiotics, antivirals or antifungals within 4 weeks of screening or chronic bacterial infections deemed unacceptable, as per Investigator’s judgement.
Surgery within 4 weeks prior to the screening visit or with planned surgery during the study.
Positive COVID-19 screening test, suspected of COVID-19 infection or known exposure to COVID-19 during the screening period.
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.
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.
Participation in another clinical study 60 days before baseline visit.
Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
Any country-related specific regulation that would prevent the participant from entering the study.
Individuals with established dependency on drugs or alcohol, per the judgement of the investigator.
Any specific situation during study implementation/course that may rise ethics considerations.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change from baseline in Cutaneous Erythematosus Disease Area and Severity Index activity (CLASI-A) sub-score at Week 12Timepoint: Week 12
- Secondary Outcome Measures
Name Time Method Proportion of patients with PhysGA – disease activity of 0 or 1 (disease free or almost disease free) at Week 12 <br/ ><br>Change from baseline in patients reported daily worst itch using Peak Pruritus Numerical Rating Scale (itch-NRS) at Week 12. <br/ ><br>Change from baseline in patients reported daily worst pain using Peak Pain Numerical Rating Scale (Pain-NRS) at Week 1. <br/ ><br>Proportion of CLASI-A50 and CLASI-A75 responders at Week 12. <br/ ><br>Timepoint: Week 12