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ALE09 - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if a study drug called JBT-101 is safe and what dose of the drug work bests for people with SLE.

What is the Condition Being Studied?

Systemic Lupus Erythematosus (Lupus, or SLE)

Who Can Participate in the Study?

AAdult men and women age 18-70 who:
- Have lupus and arthritis that causes a lot of pain
- Are not pregnant or breastfeeding

Age Group
Adults

What is Involved?

If you agree to join the study, you will:
- Come for a screening visit to make sure it is safe for you to be in the study. This visit may take up to 4.5 hours
- Be randomized (like drawing numbers from a hat) to one of 4 groups. Each group will be given different doses of a study drug (JBT-101) twice daily.
- Have research lab tests, exams and procedures
- Fill out questionnaires about your health, well-being and quality of life
- Have 7 study visits (including the screening visit) which may take up to 90 minutes each.
- Report your daily pain at the same time every day with a call to our automated phone system

Study Details

Full Title
A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus ACE Protocol: ALE09
Principal Investigator
Protocol Number
IRB:PRO00081565
NCT:NCT03093402
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698