search
Back to results

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

Primary Purpose

Dermatomyositis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenabasum 20 mg
Lenabasum 5 mg
Placebo
Sponsored by
Corbus Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatomyositis focused on measuring dermatomyositis, cannabinoid receptor type 2 agonist, JBT-101, lenabasum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fulfill at least 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 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:

  • 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

Sites / Locations

  • HonorHealth Neurology
  • Mayo Clinic
  • Attune Health Center
  • UCLA Division of Rheumatology
  • Denver Arthritis Clinic
  • Georgetown University
  • Mayo Clinic
  • University of Miami
  • University of South Florida
  • Northwestern University
  • University of Kansas Medical Center
  • DelRicht Research
  • Johns Hopkins Bayview Medical Center
  • University of Michigan
  • University of Minnesota, Division of Rheumatic and Autoimmune Diseases
  • Washington University in St. Louis
  • Hospital for Special Surgery
  • Cleveland Clinic
  • University of Pennsylvania
  • University of Pittsburgh, Division of Rheumatology
  • MUSC: Department of Neurology
  • Austin Neuromuscular Center
  • Rheumatic Disease Center
  • University Hospital "Kaspela" Rheumatology Clinic
  • UMHAT "St. Ivan Rilski"
  • UMHAT
  • University of British Columbia, Dept. of Dermatology and Skin Science
  • Revmatologicky ustav
  • Charite-Universitatsmedizin
  • University Hospital Erlangen Nuremberg
  • University Medical Center Goettingen
  • University of Debrecen
  • University Hospital Policlinico-Vittorio Emanuele
  • Fondazione Policlinico Universitario A.Gemelli-IRCCS
  • Gunma University Hospital
  • Hokkaido University Hospital
  • Yokohama City University Hospital
  • Kyoto University Hospital
  • Tohoku University Hospital
  • Osaka University Hospital
  • Keio University Hospital
  • Nippon Medical School Hospital
  • Wakayama Medical Hospital
  • Inha University Hospital
  • Seoul National University Hospital
  • Hanyang University Hospital
  • Seoul St. Mary's Hospital
  • KLIMED
  • Kliniczny Szpital Wojewodzki Nr 1. im Fryderyka Chopina Klinika Dermatologii
  • KLIMED
  • Vall d'Hebron General Hospital
  • Hospital 12 Octubre
  • Karolinska University Hospital, Rheumatology Clinic
  • King's College Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Lenabasum 20 mg

Lenabasum 5 mg

Placebo

Arm Description

Subjects will receive lenabasum 20 mg twice daily

Subjects will receive lenabasum 5 mg twice daily

Subjects will receive placebo twice daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Subjects who achieve Definition of Improvement (DOI)
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)
Subjects who improve by at least one category on the Investigator Global Assessment (IGA) scale of skin activity
The IGA is used by the investigator to score overall skin disease on a 0 to 4 scale; higher scores indicate greater skin disease.
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score
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.
Subjects who achieve TIS >= 40 (at least moderate improvement)
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.
TIS in subjects receiving immunosuppressive therapies (including corticosteroids) for > 1 year at Baseline
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.
Change in Forced vital capacity (FVC) absolute, in all subjects and those with interstitial lung disease (ILD) at Baseline.
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
Change in Forced vital capacity (FVC) percent predicted, in all subjects and those with interstitial lung disease (ILD) at Baseline.
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
TIS at Visit 10
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.
TIS, lenabasum 5 mg BID versus placebo
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.

Full Information

First Posted
January 21, 2019
Last Updated
August 15, 2022
Sponsor
Corbus Pharmaceuticals Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03813160
Brief Title
Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
Acronym
DETERMINE
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
October 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corbus Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatomyositis
Keywords
dermatomyositis, cannabinoid receptor type 2 agonist, JBT-101, lenabasum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenabasum 20 mg
Arm Type
Experimental
Arm Description
Subjects will receive lenabasum 20 mg twice daily
Arm Title
Lenabasum 5 mg
Arm Type
Experimental
Arm Description
Subjects will receive lenabasum 5 mg twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo twice daily
Intervention Type
Drug
Intervention Name(s)
Lenabasum 20 mg
Other Intervention Name(s)
JBT-101, anabasum
Intervention Description
oral capsule
Intervention Type
Drug
Intervention Name(s)
Lenabasum 5 mg
Other Intervention Name(s)
JBT-101, anabasum
Intervention Description
oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral capsule
Primary Outcome Measure Information:
Title
Efficacy of lenabasum 20 mg BID compared to placebo BID as measured by Total Improvement Score (TIS)
Description
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.
Time Frame
Week 28
Secondary Outcome Measure Information:
Title
Subjects who achieve Definition of Improvement (DOI)
Description
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)
Time Frame
Week 28
Title
Subjects who improve by at least one category on the Investigator Global Assessment (IGA) scale of skin activity
Description
The IGA is used by the investigator to score overall skin disease on a 0 to 4 scale; higher scores indicate greater skin disease.
Time Frame
Week 28
Title
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score
Description
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.
Time Frame
Week 28
Title
Subjects who achieve TIS >= 40 (at least moderate improvement)
Description
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.
Time Frame
Week 28
Title
TIS in subjects receiving immunosuppressive therapies (including corticosteroids) for > 1 year at Baseline
Description
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.
Time Frame
Week 52
Title
Change in Forced vital capacity (FVC) absolute, in all subjects and those with interstitial lung disease (ILD) at Baseline.
Description
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
Time Frame
Week 28
Title
Change in Forced vital capacity (FVC) percent predicted, in all subjects and those with interstitial lung disease (ILD) at Baseline.
Description
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
Time Frame
Week 28
Title
TIS at Visit 10
Description
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.
Time Frame
Week 52
Title
TIS, lenabasum 5 mg BID versus placebo
Description
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.
Time Frame
Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria P Werth, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chester V Oddis, MD
Organizational Affiliation
University of Pittsburgh Department of Medicine/Division of Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Attune Health Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
UCLA Division of Rheumatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20001
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Minnesota, Division of Rheumatic and Autoimmune Diseases
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh, Division of Rheumatology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
MUSC: Department of Neurology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Austin Neuromuscular Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Rheumatic Disease Center
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
University Hospital "Kaspela" Rheumatology Clinic
City
Plovdiv
Country
Bulgaria
Facility Name
UMHAT "St. Ivan Rilski"
City
Sofia
Country
Bulgaria
Facility Name
UMHAT
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
University of British Columbia, Dept. of Dermatology and Skin Science
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Revmatologicky ustav
City
Prague
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Charite-Universitatsmedizin
City
Berlin
Country
Germany
Facility Name
University Hospital Erlangen Nuremberg
City
Erlangen
ZIP/Postal Code
D- 91054
Country
Germany
Facility Name
University Medical Center Goettingen
City
Göttingen
Country
Germany
Facility Name
University of Debrecen
City
Debrecen
Country
Hungary
Facility Name
University Hospital Policlinico-Vittorio Emanuele
City
Catania
ZIP/Postal Code
95121
Country
Italy
Facility Name
Fondazione Policlinico Universitario A.Gemelli-IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Gunma University Hospital
City
Gunma
Country
Japan
Facility Name
Hokkaido University Hospital
City
Hokkaido
Country
Japan
Facility Name
Yokohama City University Hospital
City
Kanagawa
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
Country
Japan
Facility Name
Wakayama Medical Hospital
City
Wakayama
Country
Japan
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Hanyang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KLIMED
City
Bialystok
Country
Poland
Facility Name
Kliniczny Szpital Wojewodzki Nr 1. im Fryderyka Chopina Klinika Dermatologii
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
KLIMED
City
Łomża
ZIP/Postal Code
18-404
Country
Poland
Facility Name
Vall d'Hebron General Hospital
City
Barcelona
Country
Spain
Facility Name
Hospital 12 Octubre
City
Madrid
Country
Spain
Facility Name
Karolinska University Hospital, Rheumatology Clinic
City
Stockholm
Country
Sweden
Facility Name
King's College Hospital NHS Foundation Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

We'll reach out to this number within 24 hrs