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NCT03093402 · ClinicalTrials.gov registry record · Phase 2
JBT-101 in Systemic Lupus Erythematosus (SLE)
A Phase 2 study of Systemic Lupus Erythematosus and Lupus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
- 16
- Study locations
NCT03093402 is a Phase 2 study of Systemic Lupus Erythematosus and Lupus that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 109 participants, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (71% lower). The trial reports 16 study locations across 8 states.
The verdict
NCT03093402, a Phase 2 study of Systemic Lupus Erythematosus and Lupus, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
- 16
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG JBT-101
Study Locations (16)
New York
- Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases - Manhasset
- New York University Langone Medical Center: Department of Medicine, Division of Rheumatology - New York
- Columbia University Medical Center: Department of Medicine, Division of Rheumatology - New York
- Bronx-Lebanon Hospital Center: Division of Rheumatology - The Bronx
Pennsylvania
- Penn State MS Hershey Medical Center - Hershey
- University of Pennsylvania - Philadelphia
- Temple University - Philadelphia
- University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology - Pittsburgh
California
- University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology - La Jolla
- UCLA Medical Center: Division of Rheumatology - Los Angeles
- University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center - San Francisco
Connecticut
- Yale University - New Haven
Georgia
- Emory University: Division of Rheumatology - Atlanta
North Carolina
- Duke University - Durham
Ohio
- MetroHealth Medical Center - Cleveland
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2017-12-21 |
| Est. Completion | 2021-07-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03093402
The ClinicalTrials.gov registry entry for NCT03093402 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (71% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03093402 reports 16 study locations spanning 8 distinct geographic areas - top geographies include New York, Pennsylvania, California.
Frequently Asked Questions
What is clinical trial NCT03093402 about?
NCT03093402 is a clinical study titled "JBT-101 in Systemic Lupus Erythematosus (SLE)". 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 syste...
What is the current status of trial NCT03093402?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2017-12-21. Estimated completion is 2021-07-28.
What conditions does trial NCT03093402 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Lupus, SLE.
What interventions are being tested in trial NCT03093402?
The interventions under investigation include: Placebo (DRUG), JBT-101 (DRUG).
Who is sponsoring clinical trial NCT03093402?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03093402 being conducted?
This trial has 16 study locations across California, Connecticut, Georgia, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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