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JBT-101 for Lupus (ALE09) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the study drug called JBT-101 is safe and to understand how much of the drug is needed in order for it to work best in patients with Lupus.

What is the Condition Being Studied?

Systemic Lupus Erythematosus (Lupus, or SLE)

Who Can Participate in the Study?

Adults age 18 to 70 years of age who:
1. Have Lupus with active arthritis and significant inflammatory pain.
2. Don't have Lupus that is consider by the study doctor to be severe or unstable.
3. Are not pregnant or breastfeeding.

Age Group
Adults

What is Involved?

If you agree to join the study, you will:
1. Be randomly assigned (like the flip of a coin) to one of 4 groups who will be assigned to take different doses of the study drug (JBT-101) twice daily.
2. Have lab tests, exams and procedures for study purposes.
3. Complete questionnaires.
4. Have a total of 7 study visits (including the screening visit). Each clinic visit will last up to 90 minutes except for the Baseline Visit which may last up to 4.5 hours.
5. Be asked to report your daily maximum pain, at the same time every day by calling into an interactive voice response system (IVRS).

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