Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

NCT03813160 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: JBT101-DM-002
• Study Type: interventional
• Target: 176
• Locations: 13 countries
• Sites: 54

Brief Summary

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of double-blind treatment with study drug is up to 52 weeks.

Conditions

Dermatomyositis

Keywords

dermatomyositis; cannabinoid receptor type 2 agonist; JBT-101; lenabasum

Outcome Measures

Primary Outcomes (1)

• Efficacy of lenabasum 20 mg BID compared to placebo BID as measured by Total Improvement Score (TIS)

  TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.

  Week 28

Secondary Outcomes (9)

• Subjects who achieve Definition of Improvement (DOI)

  Week 28

• Subjects who improve by at least one category on the Investigator Global Assessment (IGA) scale of skin activity

  Week 28

• Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score

  Week 28

• Subjects who achieve TIS >= 40 (at least moderate improvement)

  Week 28

• TIS in subjects receiving immunosuppressive therapies (including corticosteroids) for > 1 year at Baseline

  Week 52

Study Arms (3)

Lenabasum 20 mg

EXPERIMENTAL

Subjects will receive lenabasum 20 mg twice daily

Drug: Lenabasum 20 mg

Lenabasum 5 mg

EXPERIMENTAL

Subjects will receive lenabasum 5 mg twice daily

Drug: Lenabasum 5 mg

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo twice daily

Drug: Placebo

Interventions

Lenabasum 20 mg DRUG

oral capsule

Also known as: JBT-101, anabasum

Lenabasum 20 mg

Lenabasum 5 mg DRUG

oral capsule

Also known as: JBT-101, anabasum

Lenabasum 5 mg

Placebo DRUG

oral capsule

Placebo

Eligibility Criteria

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

You may qualify if:

• Fulfill at least one of the following criteria for dermatomyositis:
• Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b)
• ACR/EULAR criteria (Lundberg et al, 2017)
• Disease activity/severity fulfills at least one of the following three criteria:
• MDGA ≥ 3 cm (0 - 10 cm Visual Analog Scale \[VAS\]) and MMT-8 score ≤ 142 (out of 150 total possible)
• Sum of MDGA, PtGA and EMGA VAS scores is ≥ 10 cm (0-10 cm VAS for each)
• MDGA ≥ 3 cm (0-10 cm VAS) and CDASI activity score of \> 14
• Stable doses of immunosuppressive medications for DM as defined by:
• Unchanged dose of oral corticosteroids ≤ 20 mg per day prednisone or equivalent for ≥ 4 weeks before Visit 1
• Unchanged dose of immunosuppressive medications other than oral corticosteroids for ≥ 8 weeks before Screening

You may not qualify if:

• Unstable DM or DM with end-stage organ involvement at Screening or Visit 1
• Significant diseases or conditions other than DM that may influence response to the study drug or safety
• Any of the following values for laboratory tests at Screening:
• A positive pregnancy test (or at Visit 1)
• Hemoglobin \< 9 g/dL in males and \< 8 g/dL in females
• Neutrophils \< 1.0 × 10\^9/L
• Platelets \< 75 × 10\^9/L
• Creatinine clearance \< 50 mL/min on screening blood test, per the Modification of Diet in Renal Disease Study or in 24 hour urine creatine clearance measurement

Sponsors & Collaborators

• Corbus Pharmaceuticals Inc.: lead

Study Sites (54)

HonorHealth Neurology

Phoenix, Arizona, 85018, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Attune Health Center

Beverly Hills, California, 90211, United States

Location

UCLA Division of Rheumatology

Los Angeles, California, 90095, United States

Location

Denver Arthritis Clinic

Denver, Colorado, 80230, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20001, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota, Division of Rheumatic and Autoimmune Diseases

Minneapolis, Minnesota, 55455, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh, Division of Rheumatology

Pittsburgh, Pennsylvania, 15261, United States

Location

MUSC: Department of Neurology

Charleston, South Carolina, 29425, United States

Location

Austin Neuromuscular Center

Austin, Texas, 78756, United States

Location

Rheumatic Disease Center

Glendale, Wisconsin, 53217, United States

Location

University Hospital "Kaspela" Rheumatology Clinic

Plovdiv, Bulgaria

Location

UMHAT "St. Ivan Rilski"

Sofia, Bulgaria

Location

UMHAT

Stara Zagora, 6000, Bulgaria

Location

University of British Columbia, Dept. of Dermatology and Skin Science

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Revmatologicky ustav

Prague, 12850, Czechia

Location

Charite-Universitatsmedizin

Berlin, Germany

Location

University Hospital Erlangen Nuremberg

Erlangen, D- 91054, Germany

Location

University Medical Center Goettingen

Göttingen, Germany

Location

University of Debrecen

Debrecen, Hungary

Location

University Hospital Policlinico-Vittorio Emanuele

Catania, 95121, Italy

Location

Fondazione Policlinico Universitario A.Gemelli-IRCCS

Roma, 00168, Italy

Location

Gunma University Hospital

Gunma, Japan

Location

Hokkaido University Hospital

Hokkaido, Japan

Location

Yokohama City University Hospital

Kanagawa, Japan

Location

Kyoto University Hospital

Kyoto, Japan

Location

Tohoku University Hospital

Miyagi, Japan

Location

Osaka University Hospital

Osaka, Japan

Location

Keio University Hospital

Tokyo, Japan

Location

Nippon Medical School Hospital

Tokyo, Japan

Location

Wakayama Medical Hospital

Wakayama, Japan

Location

KLIMED

Bialystok, Poland

Location

Kliniczny Szpital Wojewodzki Nr 1. im Fryderyka Chopina Klinika Dermatologii

Rzeszów, 35-055, Poland

Location

KLIMED

Łomża, 18-404, Poland

Location

Inha University Hospital

Incheon, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hanyang University Hospital

Seoul, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

Vall d'Hebron General Hospital

Barcelona, Spain

Location

Hospital 12 Octubre

Madrid, Spain

Location

Karolinska University Hospital, Rheumatology Clinic

Stockholm, Sweden

Location

King's College Hospital NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

• Kodali N, Diaz D, Dhiman R, Vazquez T, Feng R, Patel J, Dan J, Sprow G, Kleitsch J, Sharma M, Bashir M, Werth VP. Diverse Lenabasum pathway activation in dermatomyositis patients' blood. Sci Rep. 2025 May 18;15(1):17232. doi: 10.1038/s41598-025-92001-z.

  PMID: 40383862 DERIVED

MeSH Terms

Conditions

Dermatomyositis

Interventions

lenabasum; anabasum

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Victoria P Werth, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Chester V Oddis, MD

  University of Pittsburgh Department of Medicine/Division of Rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 23, 2019
• Study Start: December 17, 2018
• Primary Completion: March 31, 2021
• Study Completion: October 5, 2021
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

JP (9); ES (2); GB (1); PL (3); CA (1); IT (2); SE (1); KR (4); CZ (1); HU (1); US (23); DE (3); BU (3)