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NCT Number: NCT03813160

Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital "Kaspela" Rheumatology Clinic, Plovdiv, Bulgaria

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About this study

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 28 will compare lenabasum 20 mg BID to placebo the 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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:
  • 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

Treatment and study plan

Lenabasum 20 mg

Drug

oral capsule

Other names: JBT-101, anabasum

Lenabasum 5 mg

Drug

oral capsule

Other names: JBT-101, anabasum

Placebo

Drug

oral capsule

Primary outcomes

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

    Time frame: Week 28

    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 outcomes

  1. Subjects who achieve Definition of Improvement (DOI)

    Time frame: Week 28

    Defined as ≥ 3 of 6 core set measures improved by ≥ 20% (relative to Baseline) with no more than 2 core set measures worsening by ≥ 25% (MMT-8 may not decrease by ≥ 25% from baseline)

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

    Time frame: Week 28

    The IGA is used by the investigator to score overall skin disease on a 0 to 4 scale; higher scores indicate greater skin disease.

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

    Time frame: Week 28

    CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity and damage (Klein et al, 2007; Yassaee et al, 2010) Disease Activity Score is rated using three activity measures. The activity score ranges from 0 to 100. Higher scores indicate greater disease severity.

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

    Time frame: Week 28

    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.

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

    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.

  6. Change in Forced vital capacity (FVC) absolute, in all subjects and those with interstitial lung disease (ILD) at Baseline.

    Time frame: Week 28

    ILD is defined as a history of fibrosis on chest x-ray, a history of ILD on CT of lungs, and/or FVC% predicted <80% at Screening or Visit 1

  7. Change in Forced vital capacity (FVC) percent predicted, in all subjects and those with interstitial lung disease (ILD) at Baseline.

    Time frame: Week 28

    ILD is defined as a history of fibrosis on chest x-ray, a history of ILD on CT of lungs, and/or FVC% predicted <80% at Screening or Visit 1

  8. TIS at Visit 10

    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.

  9. TIS, lenabasum 5 mg BID versus placebo

    Time frame: Week 28

    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.

Sponsors and collaborators

Lead sponsor

Corbus Pharmaceuticals Inc.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

Acronym: DETERMINE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 23, 2019
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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