Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
NCT ID: NCT03813160
Last Updated: 2022-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
176 participants
INTERVENTIONAL
2018-12-17
2021-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily
Lenabasum 20 mg
oral capsule
Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily
Lenabasum 5 mg
oral capsule
Placebo
Subjects will receive placebo twice daily
Placebo
oral capsule
Interventions
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Lenabasum 20 mg
oral capsule
Lenabasum 5 mg
oral capsule
Placebo
oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b)
2. ACR/EULAR criteria (Lundberg et al, 2017)
* Disease activity/severity fulfills at least one of the following three criteria:
1. MDGA ≥ 3 cm (0 - 10 cm Visual Analog Scale \[VAS\]) and MMT-8 score ≤ 142 (out of 150 total possible)
2. Sum of MDGA, PtGA and EMGA VAS scores is ≥ 10 cm (0-10 cm VAS for each)
3. MDGA ≥ 3 cm (0-10 cm VAS) and CDASI activity score of \> 14
* Stable doses of immunosuppressive medications for DM as defined by:
1. Unchanged dose of oral corticosteroids ≤ 20 mg per day prednisone or equivalent for ≥ 4 weeks before Visit 1
2. Unchanged dose of immunosuppressive medications other than oral corticosteroids for ≥ 8 weeks before Screening
Exclusion Criteria
* 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:
1. A positive pregnancy test (or at Visit 1)
2. Hemoglobin \< 9 g/dL in males and \< 8 g/dL in females
3. Neutrophils \< 1.0 × 10\^9/L
4. Platelets \< 75 × 10\^9/L
5. 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
18 Years
ALL
No
Sponsors
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Corbus Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Victoria P Werth, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Chester V Oddis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Department of Medicine/Division of Rheumatology
Locations
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HonorHealth Neurology
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Attune Health Center
Beverly Hills, California, United States
UCLA Division of Rheumatology
Los Angeles, California, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Georgetown University
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
DelRicht Research
New Orleans, Louisiana, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota, Division of Rheumatic and Autoimmune Diseases
Minneapolis, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Hospital for Special Surgery
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh, Division of Rheumatology
Pittsburgh, Pennsylvania, United States
MUSC: Department of Neurology
Charleston, South Carolina, United States
Austin Neuromuscular Center
Austin, Texas, United States
Rheumatic Disease Center
Glendale, Wisconsin, United States
University Hospital "Kaspela" Rheumatology Clinic
Plovdiv, , Bulgaria
UMHAT "St. Ivan Rilski"
Sofia, , Bulgaria
UMHAT
Stara Zagora, , Bulgaria
University of British Columbia, Dept. of Dermatology and Skin Science
Vancouver, British Columbia, Canada
Revmatologicky ustav
Prague, , Czechia
Charite-Universitatsmedizin
Berlin, , Germany
University Hospital Erlangen Nuremberg
Erlangen, , Germany
University Medical Center Goettingen
Göttingen, , Germany
University of Debrecen
Debrecen, , Hungary
University Hospital Policlinico-Vittorio Emanuele
Catania, , Italy
Fondazione Policlinico Universitario A.Gemelli-IRCCS
Roma, , Italy
Gunma University Hospital
Gunma, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Yokohama City University Hospital
Kanagawa, , Japan
Kyoto University Hospital
Kyoto, , Japan
Tohoku University Hospital
Miyagi, , Japan
Osaka University Hospital
Osaka, , Japan
Keio University Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
Wakayama Medical Hospital
Wakayama, , Japan
KLIMED
Bialystok, , Poland
Kliniczny Szpital Wojewodzki Nr 1. im Fryderyka Chopina Klinika Dermatologii
Rzeszów, , Poland
KLIMED
Łomża, , Poland
Inha University Hospital
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
Vall d'Hebron General Hospital
Barcelona, , Spain
Hospital 12 Octubre
Madrid, , Spain
Karolinska University Hospital, Rheumatology Clinic
Stockholm, , Sweden
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JBT101-DM-002
Identifier Type: -
Identifier Source: org_study_id
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