Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus (NCT04781816) | Clinical Trial Compass
CompletedPhase 2
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
United States, Argentina, Australia78 participantsStarted 2021-04-01
Plain-language 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 leas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12