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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2021-01-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dermatomyositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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JBT-101

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.

Group Type EXPERIMENTAL

JBT-101

Intervention Type DRUG

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.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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JBT-101

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

Placebo

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.

Intervention Type DRUG

Other Intervention Names

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lenabasum

Eligibility Criteria

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Inclusion Criteria

* 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).

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No