Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of Systemic Lupus Erythematosus and Lupus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants will be asked to report their maximum daily pain using the NRS-Pain. Participants will call into an interactive voice response e diary system (IVRS) and record the number that best reflects their maximum amount of pain experienced in the last 24 hours. Participant
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 |
What the finished NCT03093402 record still lists
NCT03093402 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (71% lower).
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 lists 16 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03093402's enrollment target sits among peer trials
109 54th of 99 higher than 46 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
RECRUITING · Phase 2
-
The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD
RECRUITING · Phase 2
-
A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
RECRUITING · Phase 2
-
Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine
RECRUITING · Phase 2
-
Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases
RECRUITING · Phase 2
-
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02421380 · 109 participants · NA
Characterization of Hyperpolarized Pyruvate MRI Reproducibility
- NCT04526600 · 109 participants · NA
Fidgeting and Attentional and Emotional Regulation in ADHD
- NCT04835584 · 109 participants · Phase 1
KRT-232 and TKI Study in Chronic Myeloid Leukemia
- NCT06626516 · 109 participants · Phase 1
Tebentafusp-tebn With LDT in Metastatic UM
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI