Elevara Medicines Limited
This is a Phase 2 randomized, double-blind, placebo-controlled study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit. Approximately 180 participants are planned to be enrolled. The number of participants can be extended to maximally 220 to account for dropouts during the study.
The study has 4 study arms: placebo, 25mg, 75mg and 125mg. The study includes a 4 weeks screening period, a double blind placebo controlled period (weeks 0 to 12), a treatment extension (weeks 12 to 24) and a 4 week safety follow-up.
Inclusion Criteria: 1. Provided written informed consent to participate to the study and are able and willing to adhere to the study protocol. 2. Male or female, 18 to 75 years of age, at the time of signing the informed consent. 3. Body mass index (BMI) between 18.5 and 32.0 kg/m2 and minimum weight of 50 kg at the Screening Visit. 4. Have a diagnosis of adult onset RA and fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (Aletaha et al. 2010) for at least 6 months prior to Screening. 5. Have active RA defined by a DAS2…
25mg from week 0 to week 12 then ELV001 75mg or 125mg per day from week 12 to week 24
75mg from week 0 to week 24
125mg from week 0 to week 24
Placebo from week 0 to week 12, then ELV001 75mg or 125mg per day from week 12 to week 24.