JBT-101 in Systemic Lupus Erythematosus (SLE)

NCT03093402 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: DAIT ALE09NIAID CRMS ID#: 30147UM1AI110494
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 16

Brief 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

Systemic Lupus Erythematosus; SLE; Lupus

Keywords

JBT-101 (also known as lenabasum); efficacy; musculoskeletal disease; randomized trial

Outcome Measures

Primary Outcomes (1)

• Improvement in the Maximum Daily NRS-Pain Score at Day 84

  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. Participants will be asked to call at the same time each day, preferably before bedtime. Longitudinal trends over the course of the treatment period will be modeled and used to estimate difference between means at baseline and Day 84 for each treatment group.

  Day 1 through Day 84

Secondary Outcomes (46)

• Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits

  Visit 1 (Baseline)

• Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits

  Visit 3 (Day 29)

• Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits

  Visit 4 (Day 57)

• Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits

  Visit 5 (Day 85)

• Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits

  Visit 6 (Day 113)

Study Arms (4)

JBT-101: 5 mg Twice Daily

EXPERIMENTAL

Eligible subjects will receive assigned study treatment of JBT-101 5 mg administered twice daily.

Drug: JBT-101

JBT-101: 20 mg & Placebo

EXPERIMENTAL

Eligible subjects will receive assigned study treatment of JBT-101 20 mg (A.M. Study Product) and 20 mg Placebo (P.M. Study Product).

Drug: JBT-101; Drug: Placebo

JBT-101: 20 mg Twice Daily

EXPERIMENTAL

Eligible subjects will receive assigned study treatment of JBT-101 20 mg (A.M. Study Product) and JBT-101 20 mg (P.M. Study Product).

Drug: JBT-101

Placebo + Placebo

PLACEBO COMPARATOR

Eligible subjects will receive assigned study treatment of Placebo (A.M.) and Placebo (P.M.) for (JBT-101).

Drug: Placebo

Interventions

Placebo DRUG

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.

Also known as: JBT-101 placebo, lenabasum placebo

JBT-101: 20 mg & Placebo; Placebo + Placebo

JBT-101 DRUG

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.

Also known as: lenabasum, anabasum, resunab, ajulemic acid, CT-3, IP751, CPL7075

JBT-101: 20 mg & Placebo; JBT-101: 20 mg Twice Daily; JBT-101: 5 mg Twice Daily

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfills the updated American College of Rheumatology (ACR) 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus;
• At least 3 months of treatment with an anti-malarial drug such as hydroxychloroquine or a history of intolerance, contraindication, or unwillingness to take an anti-malarial drug;
• Meets the Safety of Estrogen in Lupus: National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) definition of arthritis (Petri et al., 1999) or mild/moderate arthritis or tendonitis scored as a BILAG B on the updated BILAG 2004;
• Seven-day average of maximum of daily pain Numerical Rating Scale (NRS) scores ≥ 4 out of 10;
• Overlap with polymyositis, systemic sclerosis, Sjögren's syndrome, or rheumatoid arthritis is allowed, if, in the site investigator's judgment, the predominant clinical features are those of Systemic Lupus Erythematosus (SLE);
• Not expected by the site investigator to require a change in potential disease- modifying treatments for SLE from Screening through Visit 6 (Day 112);
• Willing to not start nor stop any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or potential disease-modifying medications or supplements for SLE from Screening through Visit 6 (Day 112), unless a change is recommended by the site investigator or other treating physicians;
• Willing not to use any legal or illegal cannabinoids, including Food and Drug Administration (FDA)-approved cannabinoids or cannabinoid-mimic drugs, or any illegal substance of abuse from Screening through Visit 6 (Day 112);
• If a woman of child-bearing potential, willing to use one of the highly effective (failure rate \< 1% per year) birth control method from Screening through Visit 6 (Day 112) or for 28 ± 3 days after the last dose of study product; and
• Willing to follow instructions, complete study procedures and attend study visits as required by this protocol.

You may not qualify if:

• Severe or unstable Systemic lupus erythematosus (SLE), such as any one of the following:
• A British Isles Lupus Activity Group (BILAG) A score in one or more BILAG domains at Screening;
• Treatment with any intraarticular, intravenous, or intramuscular systemic corticosteroids within 14 days of Screening;
• Treatment with oral prednisone \> 10 mg per day or \> 20 mg every other day (or equivalent dose of another corticosteroid) within 14 days of Screening;
• Increased dose of systemic corticosteroids in the 14 days prior to Screening;
• Treatment with cyclophosphamide or anti-TNFalpha biologic agents within 3 months before Visit 1 (Day 1);
• Treatment with B cell-depleting monoclonal antibodies (rituximab, Ocrelizumab, anti-CD22) within 6 months before Visit 1 (Day 1);
• Treatment with methotrexate, mycophenolate, azathioprine, leflunomide, cyclosporine, belimumab, tacrolimus, or any other immunosuppressive agent not included in 2b.-d. above, when the dose of that immunosuppressive agent has increased within 3 months before Visit 1. Concurrent treatment with any of these medications is allowed as long as the doses have been stable for at least 3 months before Visit 1 (Day 1); or
• Actively listed on an organ transplantation list or have received an organ transplant other than a corneal transplant.
• Significant diseases or conditions other than SLE that may influence response to the study product or safety, such as:
• Active bacterial or viral infection requiring systemic antibiotic or anti-viral treatment within 14 days before Visit 1 (Day 1);
• Acute or chronic hepatitis B or C infection;
• Human immunodeficiency infection (HIV);
• History of active tuberculosis or positive tuberculosis skin or blood test without: 1) completing a course of appropriate treatment; or ) having received at least one month of appropriate treatment prior to Visit 1 (Day 1) and continuing to receive appropriate treatment during the study;
• No elective surgery should be planned from Visit 1 (Day 1) through Visit 6 (Day 112); or

Sponsors & Collaborators

• Corbus Pharmaceuticals Inc.: collaborator
• Autoimmunity Centers of Excellence: collaborator
• Rho Federal Systems Division, Inc.: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (16)

University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology

La Jolla, California, 92093, United States

Location

UCLA Medical Center: Division of Rheumatology

Los Angeles, California, 90095, United States

Location

University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center

San Francisco, California, 94143, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Emory University: Division of Rheumatology

Atlanta, Georgia, 30322, United States

Location

Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases

Manhasset, New York, 11030, United States

Location

New York University Langone Medical Center: Department of Medicine, Division of Rheumatology

New York, New York, 10016, United States

Location

Columbia University Medical Center: Department of Medicine, Division of Rheumatology

New York, New York, 10032, United States

Location

Bronx-Lebanon Hospital Center: Division of Rheumatology

The Bronx, New York, 10457, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Penn State MS Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology

Pittsburgh, Pennsylvania, 15217, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID) website
• Division of Allergy, Immunology, and Transplantation (DAIT) website
• Autoimmunity Centers of Excellence (ACE) website
• Corbus Pharmaceuticals and Clinical Programs in Systemic Lupus Erythematosus

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Musculoskeletal Diseases

Interventions

lenabasum; anabasum

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

3015947669

Study Officials

• Meggan Mackay, M.D., M.S.

  Northwell Health

  STUDY CHAIR

• Robert B. Zurier, M.D.

  Northwell Health

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 28, 2017
• Study Start: December 21, 2017
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: May 6, 2026
• Results First Posted: November 18, 2022

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of the study.
• Access Criteria: Data is available to the public once Individual Participant-Level data is posted to ImmPort.

Locations

US (16)