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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 : Recruiting
First Posted : January 23, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.

Study Description
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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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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) ]

Eligibility Criteria
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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
Contacts and Locations
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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


Contacts
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Contact: Lindsey Smith 1-617-963-0707 DMpatients@corbuspharma.com
Contact: Barbara White, MD 1-617-977-5077 DMphysicians@corbuspharma.com

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Locations
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United States, Arizona
HonorHealth Neurology Recruiting
Phoenix, Arizona, United States, 85018
Contact: Jade Stohl    602-258-2863    jstohl@honorhealth.com   
Principal Investigator: Todd Levine, MD         
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Narcelle Jean-Louis    480-301-4714    JeanLouis.Narcelle@mayo.edu   
Principal Investigator: Aaron R Mangold, MD         
United States, California
Attune Health Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Laura Palmas    310-652-0010    laura.palmas@attunehealth.com   
Principal Investigator: Swamy Venuturupalli, MD, FACR         
UCLA Division of Rheumatology Recruiting
Los Angeles, California, United States, 90095
Contact: Eileen Callahan    310-794-2466    ecallahan@mednet.ucla.edu   
Principal Investigator: Elizabeth Volkmann, MD         
United States, Colorado
Denver Arthritis Clinic Recruiting
Denver, Colorado, United States, 80230
Contact: Theresa Hernandez    303-394-2828 ext 177    THernandez@DACdenver.com   
Principal Investigator: Christopher R Antolini, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Allison Ready    203-785-6631    allison.ready@yale.edu   
Principal Investigator: Fotios Koumpouras, MD         
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20001
Contact: Sabrina Elliott    202-444-6210    Se510@georgetown.edu   
Principal Investigator: Virginia Steen, MD         
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Jany Paulett, CCRC    904-953-6912    paulett.jany@mayo.edu   
Principal Investigator: Jaimin Shah, MD         
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Bethly Aubourg    305-243-8567    baubourg@med.miami.edu   
Principal Investigator: Eric L Greidinger, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Kathleen Aren    312-503-1824    kathleen.aren@northwestern.edu   
Principal Investigator: Christine Hsieh, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Samantha Colgan    913-945-9938    scolgan@kumc.edu   
Principal Investigator: Mazen Dimachkie, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Stacey Anderson    734-998-1271    staceaan@med.umich.edu   
Principal Investigator: Elena Schiopu, MD         
United States, Minnesota
University of Minnesota, Division of Rheumatic and Autoimmune Diseases Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Mandi DeGrote    612-626-7609    carl1032@umn.edu   
Principal Investigator: Jerry Molitor, MD         
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jennifer Bruns    314-747-5366    brunsj@wustl.edu   
Principal Investigator: Heather Jones, MD         
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Jesse Ojeda    212-774-2048    ojedaj@hss.edu   
Principal Investigator: David Fernandez, MD, PhD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Beverly Doyle    216-636-1196    Doyleb4@ccf.org   
Principal Investigator: Anthony Fernandez, MD, PhD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Josef Concha, MD    215-615-2940    Josef.Concha@uphs.upenn.edu   
Principal Investigator: Victoria P Werth, MD         
University of Pittsburgh, Division of Rheumatology Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Diane Koontz    412-383-8671    dik4@pitt.edu   
Principal Investigator: Chester V. Oddis, MD         
United States, South Carolina
MUSC: Department of Neurology Recruiting
Charleston, South Carolina, United States, 29425
Contact: Aparna Choudhury    843-792-2845    choudhur@musc.edu   
Principal Investigator: Katherine Ruzhansky, MD         
United States, Texas
Austin Neuromuscular Center Recruiting
Austin, Texas, United States, 78756
Contact: Nawar Hussin    512-920-0140    nawar@austinneuromuscle.com   
Principal Investigator: Yessar Hussain, MD         
United States, Wisconsin
Rheumatic Disease Center Recruiting
Glendale, Wisconsin, United States, 53217
Contact: Lynn Kritter    414-351-4009 ext 38    lynn.kritter@rdcwi.com   
Principal Investigator: Mary E Cronin, MD         
Bulgaria
University Hospital "Kaspela" Rheumatology Clinic Recruiting
Plovdiv, Bulgaria
Contact: Anastas Batalov, MD, PhD    +359 32 602273    abatalov@hotmail.com   
Contact: Mobile    +359 888 370497      
Principal Investigator: Anastas Batalov, MD, PhD         
Hungary
University of Debrecen Recruiting
Debrecen, Hungary
Contact: Anett Vincze    36307178948    anett.vincze93@gmail.com   
Principal Investigator: Katalin Dankó, Dr.         
Department of Rheumatology and Immunology, Clinical Centre, University of Pecs Recruiting
Pécs, Hungary
Contact: Cecilia Varju, MD, PhD    +36-72-536-802    varju.cecilia@pte.hu   
Contact    +36-30-213-4820    cecilia.varju@gmail.com   
Principal Investigator: Cecilia Varju, MD, PhD         
Poland
IRMED Recruiting
Piotrków Trybunalski, Poland
Contact: Iwona Klimkiewicz    +48 605 908 809    iwona.klimkiewicz@ir-med.pl   
Principal Investigator: Agnieszka Walkowiak, MD         
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
More Information
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Responsible Party: Corbus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03813160     History of Changes
Other Study ID Numbers: JBT101-DM-002
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
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