JBT-101 in Systemic Lupus Erythematosus (SLE)
Summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of JBT-101 (also known as lenabasum) in systemic lupus erythematosus (SLE). * One hundred adults with active joint disease and at least moderate pain will be enrolled in this study to evaluate treatment of their systemic lupus erythematosus (SLE) with JBT-101. JBT-101 is a synthetic endocannabinoid receptor type 2 (CB2) agonist and an activator of the body's normal processes, to resolve innate immune responses without immunosuppression. * Participants will receive 2 doses of JBT-101 by mouth (three groups of varying doses) or, placebo, for 84 days and will continue to be followed for an additional 28 days. Participant visits to assess endpoints occur on Day 1, then every 2 weeks twice, then every 4 weeks three times, for a total of six visits. * The change in maximum daily pain Numerical Rating Scale (NRS) score from Baseline (Visit 1) will be assessed at every visit.
Timeline
- Start
- 2017-12-21
- Primary completion
- 2021-07-28
- Completion
- 2021-07-28
Outcome
Missed primary endpoint
registry analysis (superiority test); High: JBT-101 20mg/20mg vs Medium: JBT-101 20mg/Placebo vs Low: JBT-101 5mg/5mg vs Placebo; p = 0.4190 NCT03093402 ↗
release “lenabasum in Systemic Lupus Erythematosus (SLE) did not meet its primary endpoint” corbuspharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenabasum | Small molecule | 5 mg | Oral |
| Subject | Lenabasum | Small molecule | 20 mg | Oral |