WHO ICTRP trial
A research study to evaluate the efficacy and safety of cenerimod in subjects…
CTIS2024-515871-37-00 · EU Clinical Trials Information System · Not Recruiting
Key facts
| Trial ID | CTIS2024-515871-37-00 |
|---|---|
| Public title | A research study to evaluate the efficacy and safety of cenerimod in subjects suffering from systemic lupus erythematosus |
| Scientific title | OPUS-2 - Oral S1P1 Receptor ModUlation in SLE: A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background… |
| Primary sponsor | Idorsia Pharmaceuticals Ltd. |
| Registry | EU Clinical Trials Information System |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): No Therapeutic confirmatory - (Phase III): Yes Therapeutic use - (Phase IV): No |
| Countries | Serbia;South Africa;Chile;United Kingdom;Japan;China;Georgia;Philippines;United States;Mexico;Peru;Czechia;Germany;Portugal;Spain;Poland |
| Conditions | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1Level: PTClassification code: 10042945Term: Systemic lupus erythematosus Class: 100000004859 MedDRA version: 20.0Level: SOCClassification code: 10028395Term… |
| Interventions | Product Name: Cenerimod matching placebo, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: cenerimod, Product Code:PRD6460345, Pharmaceutical Form… |
| Registration date | Sep 25, 2024 |
| Target size | 420 |
| Secondary IDs | NCT05672576;2022-002815-47;2022-002815-47 |
| Registry page | euclinicaltrials.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: