At a glance
ClinicalIndex Comparison Record- ✓Fulfills updated ACR 1982 Revised Criteria for classification of Systemic Lupus Erythematosus
- ✓At least 3 months of treatment with anti-malarial drug (e.g., hydroxychloroquine) OR history of intolerance/contraindication/unwillingness
- ✓Active arthritis meeting SLEDAI criteria OR mild/moderate arthritis/tendonitis scored as BILAG B
- ✓Seven-day average of maximum daily pain NRS score ≥4 out of 10
- ✕Any BILAG A score in one or more domains at Screening (indicates severe activity)
- ✕Intraarticular, intravenous, or intramuscular corticosteroids within 14 days of Screening
- ✕Oral prednisone >10 mg/day or >20 mg every other day within 14 days of Screening
- ✕Cyclophosphamide or anti-TNF-alpha biologic agents within 3 months before Day 1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus
In Brief
A Phase 2 clinical trial evaluating JBT-101 and Placebo for Systemic Lupus Erythematosus and 2 related conditions. Completed, enrolled 109 participants across 16 sites.
Detailed 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.
Study Details
Timeline
Interventions
Participants will self-administer JBT-101 by mouth (orally), at prescribed dose and frequency per protocol, Days 1-84. Administration of dose(s) should be at least 8 hours apart.
Participants will self-administer JBT-101 placebo by mouth (orally), at prescribed dose and frequency per protocol, Days 1-84. Administration of dose(s) should be at least 8 hours apart.