WHO ICTRP trial
A phase 2a proof of concept study to evaluate efficacy and safety of SAR443122…
CTRI/2021/08/035384 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2021/08/035384 |
|---|---|
| Public title | 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 |
| Scientific title | A randomized, double-blind, placebo controlled, proof of concept study assessing the efficacy and safety of the RIPK1-inhibitor SAR443122 in patients with moderate to severe subacute or discoid/chronic cutaneous lupus erythematosus - CLEan |
| Primary sponsor | Sanofi Healthcare India Private Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 2 |
| Countries | Argentina;Canada;Chile;Czech Republic;Hungary;India;Italy;Poland;Russian Federation;Spain;United States of America |
| Conditions | Health Condition 1: L931- Subacute cutaneous lupus erythematosus |
| Interventions | Intervention1: SAR443122/ eclitasertib: Dose: SAR443122 100 mg Frequency: 2 intakes (morning and evening) of 3 capsules of 100 mg each Route of Administration: Oral Duration of Therapy: 12 Weeks Control Intervention1: Placebo: Dose… |
| Registration date | Apr 8, 2021 |
| Target size | 88 |
| Secondary IDs | ACT16404, Version number 1, dated 10 Dec 2021 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: