CARE: A Clinical Study Assessing Cenerimod as a Potential New Oral Treatment for Lupus
Study Title
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE).
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Sponsor Name
Idorsia Pharmaceuticals
Purpose of Study
The CARE study is designed to see whether cenerimod, an investigational new drug, reduces the symptoms of lupus. In addition, patients` quality of life and degree of fatigue will also be assessed.
What Does this Study Involve?
- Participation in total will last 18 months, including a 2-month screening period, a 12-month treatment period, and a 4-month follow-up period.
- During the treatment period, 80% of participants will receive cenerimod and 20% of participants will receive placebo.
To Consider Participation in This Study You Must:
- Have a confirmed diagnosis of lupus and symptoms of the disease.
- Be aged 18 years or older.
- Be prepared to maintain your current lupus treatment regimen.
- Not be pregnant or planning to become pregnant during the course of the study.
You May Not Be Able to Participate In the Study, If You Have:
- Active lupus nephritis or central nervous system (CNS) lupus.
- Other protocol-defined exclusion criteria.
Study Type:
- Phase 2 clinical trial.
You can find out more about cenerimod and the CARE study at care4lupus.com. If eligible, submit a request for contact with your nearest study site.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. For more information about clinical trials, visit our page on clinical trials.