New Study Looking for People with Active Lupus to See if an Investigational Oral Treatment May Reduce Symptoms of The Disease
The IM014-029 Study for systemic lupus erythematosus is a Phase 2a, randomized, double-blind, placebo-controlled research study of the safety and efficacy of the oral investigational drug in patients with active systemic lupus erythematosus.
Purpose of Study:
The IM014-029 Study is a research study evaluating an oral investigational drug to see if it may reduce symptoms of active lupus. If you have been diagnosed with active lupus for 6 months or more, you may qualify to take part in this study. During the study, you may be able to continue taking your current medication in addition to the oral investigational drug.
What Does this Study Involve?:
- The study lasts approximately 32 weeks and includes about 10 visits to a study doctor
- If you are eligible for the study and decide to participate, you will receive either the study drug or a placebo that will be taken orally every day for up to 2 years
- There is a 3 in 4 chance you will receive the oral investigational drug and a 1 in 4 chance you will receive the placebo
- During the study treatment and follow-up phases, the study team will perform routine physical exams and a variety of other assessments to see if the oral investigational drug is safe and effective
- Your lupus symptoms and overall health will be monitored by the study team throughout the study
- You will also be asked to fill out questionnaires
To Consider Participation in This Study You Must:
- Be 18 to 75 years old
- Have been diagnosed with active lupus for 6 months or more
- There may be other requirements to participate
You May Not Be Able to Participate in the Study, If You Have Any of the Following:
- Certain other autoimmune diseases and overlap syndromes
- History of any significant drug allergy
- Active infection or significant coexisting medical condition
- Other protocol defined exclusion criteria could apply
- Phase 2a
- Global –10 countries are taking part
- Multicenter – 50 clinical sites are taking part
- Double-blind – neither you nor your study doctor will know what study treatment you receive
- Placebo-controlled – you will receive either oral investigational drug (branebrutinib) or a placebo (with no active ingredients)
Learn more and to see if you may qualify at LivingwithSLE.
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 Featured Research Studies page.