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Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis (DETERMINE)

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ClinicalTrials.gov Identifier: NCT03813160
Recruitment Status : Active, not recruiting
First Posted : January 23, 2019
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.

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 treatment with study drug is 52 weeks.

Condition or disease Intervention/treatment Phase
Dermatomyositis Drug: Lenabasum 20 mg Drug: Lenabasum 5 mg Drug: Placebo Phase 3

Detailed Description:
Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 52 will be Total Improvement Score (TIS), which is a weighted composite measure of improvement from baseline in six endpoints: Physician Global Assessment of Disease Activity, Physician Assessment of Extramuscular Disease Activity, Patient Global Assessment of Disease Activity, Health Assessment Questionnaire (patient-reported disability), Manual Muscle Testing (MMT), and muscle enzymes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022


Arm Intervention/treatment
Experimental: Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily
Drug: Lenabasum 20 mg
oral capsule
Other Names:
  • JBT-101
  • anabasum

Experimental: Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily
Drug: Lenabasum 5 mg
oral capsule
Other Names:
  • JBT-101
  • anabasum

Placebo Comparator: Placebo
Subjects will receive placebo twice daily
Drug: Placebo
oral capsule




Primary Outcome Measures :
  1. Efficacy of lenabasum compared to placebo as measured by Total Improvement Score (TIS) [ Time Frame: Week 52 ]
    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.


Secondary Outcome Measures :
  1. Efficacy of lenabasum compared to placebo as measured by Mean MMT-8 Score [ Time Frame: Week 52 ]
    Strength in 8 muscle groups will be assessed on a 0 - 10 point scale; lower score is "weaker" and higher score is "stronger."

  2. Efficacy of lenabasum compared to placebo as measured by Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score [ Time Frame: Week 52 ]
    The CDASI is a validated outcome measure that systematically quantifies cutaneous DM activity. Disease involvement in 15 different anatomical locations is rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia are also captured. Disease activity is scored from 0 to 100; higher scores indicate greater disease severity.

  3. Efficacy of lenabasum compared to placebo as measured by Investigator Global Assessment (IGA) scale of skin activity [ Time Frame: Week 52 ]
    The IGA is used by the investigator to score overall skin disease on a 0 to 4 scale; higher scores indicate greater skin disease.

  4. Efficacy of lenabasum compared to placebo as measured by Short Form-36 (SF-36) physical functioning domain score [ Time Frame: Week 52 ]
  5. Efficacy of lenabasum compared to placebo as measured by corticosteroid dose [ Time Frame: Week 52 ]
  6. Efficacy of lenabasum compared to placebo as measured by Forced Vital Capacity (FVC) % predicted [ Time Frame: Week 52 ]
  7. Safety of lenabasum compared to placebo as measured by Adverse Events (AEs) associated with lenabasum treatment [ Time Frame: From initiation of treatment (Day 1) to end of treatment (Week 52) ]
  8. Tolerability of lenabasum compared to placebo as measured by number of subjects who permanently discontinue study product due to AEs probably- or definitely-related to treatment [ Time Frame: From initiation of treatment (Day 1) to end of treatment (Week 52) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fulfill one of the following criteria for dermatomyositis:

    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 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:

  • 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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813160


Locations
Hide Hide 54 study locations
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United States, Arizona
HonorHealth Neurology
Phoenix, Arizona, United States, 85018
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
Attune Health Center
Beverly Hills, California, United States, 90211
UCLA Division of Rheumatology
Los Angeles, California, United States, 90095
United States, Colorado
Denver Arthritis Clinic
Denver, Colorado, United States, 80230
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20001
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
University of Miami
Miami, Florida, United States, 33136
University of South Florida
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Louisiana
DelRicht Research
New Orleans, Louisiana, United States, 70115
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota, Division of Rheumatic and Autoimmune Diseases
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh, Division of Rheumatology
Pittsburgh, Pennsylvania, United States, 15261
United States, South Carolina
MUSC: Department of Neurology
Charleston, South Carolina, United States, 29425
United States, Texas
Austin Neuromuscular Center
Austin, Texas, United States, 78756
United States, Wisconsin
Rheumatic Disease Center
Glendale, Wisconsin, United States, 53217
Bulgaria
University Hospital "Kaspela" Rheumatology Clinic
Plovdiv, Bulgaria
UMHAT "St. Ivan Rilski"
Sofia, Bulgaria
UMHAT
Stara Zagora, Bulgaria, 6000
Canada, British Columbia
University of British Columbia, Dept. of Dermatology and Skin Science
Vancouver, British Columbia, Canada, V5Z 4E8
Czechia
Revmatologicky ustav
Prague, Czechia, 12850
Germany
Charite-Universitatsmedizin
Berlin, Germany
University Hospital Erlangen Nuremberg
Erlangen, Germany, D- 91054
University Medical Center Goettingen
Göttingen, Germany
Hungary
University of Debrecen
Debrecen, Hungary
Italy
University Hospital Policlinico-Vittorio Emanuele
Catania, Italy, 95121
Fondazione Policlinico Universitario A.Gemelli-IRCCS
Roma, Italy, 00168
Japan
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
Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Hanyang University Hospital
Seoul, Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Poland
KLIMED
Bialystok, Poland
Kliniczny Szpital Wojewodzki Nr 1. im Fryderyka Chopina Klinika Dermatologii
Rzeszow, Poland, 35-055
KLIMED
Łomża, Poland, 18-404
Spain
Vall d'Hebron General Hospital
Barcelona, Spain
Hospital 12 Octubre
Madrid, Spain
Sweden
Karolinska University Hospital, Rheumatology Clinic
Stockholm, Sweden
United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Corbus Pharmaceuticals Inc.
Investigators
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Principal Investigator: Victoria P Werth, MD University of Pennsylvania
Principal Investigator: Chester V Oddis, MD University of Pittsburgh Department of Medicine/Division of Rheumatology
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Responsible Party: Corbus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03813160    
Other Study ID Numbers: JBT101-DM-002
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corbus Pharmaceuticals Inc.:
dermatomyositis
cannabinoid receptor type 2 agonist
JBT-101
lenabasum
Additional relevant MeSH terms:
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Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases