JBT-101 in Systemic Lupus Erythematosus (SLE)
Public ClinicalTrials.gov record NCT03093402. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03093402
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 109 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 21, 2017 (Actual)
- Primary completion
- Jul 28, 2021 (Actual)
- Completion
- Jul 28, 2021 (Actual)
- Last update posted
- May 6, 2026
2017 – 2021
United States locations
- U.S. sites
- 16
- U.S. states
- 8
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology | La Jolla | California | 92093 | — |
| UCLA Medical Center: Division of Rheumatology | Los Angeles | California | 90095 | — |
| University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center | San Francisco | California | 94143 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Emory University: Division of Rheumatology | Atlanta | Georgia | 30322 | — |
| Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases | Manhasset | New York | 11030 | — |
| New York University Langone Medical Center: Department of Medicine, Division of Rheumatology | New York | New York | 10016 | — |
| Columbia University Medical Center: Department of Medicine, Division of Rheumatology | New York | New York | 10032 | — |
| Bronx-Lebanon Hospital Center: Division of Rheumatology | The Bronx | New York | 10457 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Penn State MS Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Temple University | Philadelphia | Pennsylvania | 19140 | — |
| University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology | Pittsburgh | Pennsylvania | 15217 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03093402, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 6, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03093402 live on ClinicalTrials.gov.