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Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis

Primary Purpose

Dermatomyositis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JBT-101
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 JBT-101, lenabasum, dermatomyositis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (Part A):

  • CDASI activity score ≥ 14;
  • No difficulty with lifting or walking, and no more than 1.5 x the upper limit of normal of creatine phosphokinase or aldolase;
  • Failed at least 3 months treatment with hydroxychloroquine;
  • Stable treatment for dermatomyositis for at least 28 days before Visit 1 (Day 1).

Inclusion Criteria (Part B):

  • Completion of dosing in Part A without permanent discontinuation of study product because of safety or tolerability reasons

Exclusion Criteria (Part A and B):

  • Significant diseases or conditions other than DM that may influence response to the study product or safety;

  • Any one of the following values for laboratory tests at Screening:

    1. A positive pregnancy test (or at Visit 1);
    2. Hemoglobin < 10 g/dL;
    3. Neutrophils < 1.0 x 10^9/L;
    4. Platelets < 75 x 10^9/L;
    5. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation;
    6. Aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase > 2.5 x upper normal limit;
    7. Total bilirubin ≥ 1.5 x upper limit of normal.
  • Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.

Sites / Locations

  • University of Pennsylvania Perlman School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JBT-101

Placebo

Arm Description

Part A: JBT-101 20 mg capsule once a day on Days 1-28, then 20 mg capsule twice a day on Days 29-84. Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE.

Part A: Placebo capsule once a day on Days 1-28, then placebo capsule twice a day on Days 29-84. Part B: Placebo twice daily on Days 1 - 365 of the OLE.

Outcomes

Primary Outcome Measures

Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A.
The CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity, In the CDASI, DM skin disease activity is scored from 0 to 100 based on the physician's evaluation of erythema, scale, and erosion or ulceration at 15 anatomic locations as well as alopecia, Gottron's sign or papules on the hands, and periungual changes. A 5-point or greater decrease in the CDASI activity score indicates clinically relevant improvement based on statistical analysis using a receiver operating characteristic curve to maximize sensitivity and specificity
Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Number of participants with treatment emergent adverse events were assessed as a measure of safety and tolerability

Secondary Outcome Measures

Change in Patient-reported Outcomes From Baseline at 84 Days for Part A
LS mean (SE) change from baseline to Week 6 (Day 84) for lenabasum vs. placebo using a mixed model repeated measures analysis The CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity and damage, In the CDASI, the Damage Score is scored from 0 to 32 based on the physician's evaluation of poikiloderma and calcinosis. 0 representing no damage and 32 representing the greatest level of damage.

Full Information

First Posted
June 2, 2015
Last Updated
December 23, 2022
Sponsor
Corbus Pharmaceuticals Inc.
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02466243
Brief Title
Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
Official Title
A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor terminated open-label extension.
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
January 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corbus Pharmaceuticals Inc.
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine.
Detailed Description
Part A: An interventional, double-blind, randomized, placebo-control design will be used to test JBT-101 in about 22 eligible male or female subjects ≥ 18 and ≤ 70 years of age with moderate-to-severe active skin-predominant dermatomyositis. Part B: A one-year open-label design to test JBT-101 in subjects who completed Part A without permanent discontinuation of study product because of safety or tolerability reasons.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JBT-101
Arm Type
Experimental
Arm Description
Part A: JBT-101 20 mg capsule once a day on Days 1-28, then 20 mg capsule twice a day on Days 29-84. Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Part A: Placebo capsule once a day on Days 1-28, then placebo capsule twice a day on Days 29-84. Part B: Placebo twice daily on Days 1 - 365 of the OLE.
Intervention Type
Drug
Intervention Name(s)
JBT-101
Other Intervention Name(s)
lenabasum
Intervention Description
Part A: 20 mg once daily on Days 1-28, then 20 mg twice daily on Days 29-84. Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Part A: Once daily on Days 1-28, then twice daily on Days 29-84. Part B: Placebo twice daily on Days 1 - 365 of the OLE.
Primary Outcome Measure Information:
Title
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A.
Description
The CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity, In the CDASI, DM skin disease activity is scored from 0 to 100 based on the physician's evaluation of erythema, scale, and erosion or ulceration at 15 anatomic locations as well as alopecia, Gottron's sign or papules on the hands, and periungual changes. A 5-point or greater decrease in the CDASI activity score indicates clinically relevant improvement based on statistical analysis using a receiver operating characteristic curve to maximize sensitivity and specificity
Time Frame
Part A: 84-day treatment period (Change from the Baseline CDSAI score at Day 84)
Title
Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Description
Number of participants with treatment emergent adverse events were assessed as a measure of safety and tolerability
Time Frame
Part A: to Day 84
Secondary Outcome Measure Information:
Title
Change in Patient-reported Outcomes From Baseline at 84 Days for Part A
Description
LS mean (SE) change from baseline to Week 6 (Day 84) for lenabasum vs. placebo using a mixed model repeated measures analysis The CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity and damage, In the CDASI, the Damage Score is scored from 0 to 32 based on the physician's evaluation of poikiloderma and calcinosis. 0 representing no damage and 32 representing the greatest level of damage.
Time Frame
Part A: 84-day treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (Part A): CDASI activity score ≥ 14; No difficulty with lifting or walking, and no more than 1.5 x the upper limit of normal of creatine phosphokinase or aldolase; Failed at least 3 months treatment with hydroxychloroquine; Stable treatment for dermatomyositis for at least 28 days before Visit 1 (Day 1). Inclusion Criteria (Part B): Completion of dosing in Part A without permanent discontinuation of study product because of safety or tolerability reasons Exclusion Criteria (Part A and B): Significant diseases or conditions other than DM that may influence response to the study product or safety; Any one of the following values for laboratory tests at Screening: A positive pregnancy test (or at Visit 1); Hemoglobin < 10 g/dL; Neutrophils < 1.0 x 10^9/L; Platelets < 75 x 10^9/L; Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation; Aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase > 2.5 x upper normal limit; Total bilirubin ≥ 1.5 x upper limit of normal. Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Werth, M.D.
Organizational Affiliation
University of Pennsylvania Perlman School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Perlman School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35490744
Citation
Werth VP, Hejazi E, Pena SM, Haber J, Zeidi M, Reddy N, Okawa J, Feng R, Bashir MM, Gebre K, Jadoo AS, Concha JSS, Dgetluck N, Constantine S, White B. Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial. J Invest Dermatol. 2022 Oct;142(10):2651-2659.e1. doi: 10.1016/j.jid.2022.03.029. Epub 2022 Apr 29.
Results Reference
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Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis

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