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).
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.