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

Phase 2

Terminated

• Conditions: Dermatomyositis
• Interventions: Drug: Placebo; Drug: JBT-101

• Registration Number: NCT02466243
• Lead Sponsor: Corbus Pharmaceuticals Inc.

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-09
• Primary Completion: 2017-08
• Disposition First Submitted: 2019-01-18
• Disposition First Submitted QC: 2019-01-18
• Disposition First Posted: 2019-01-22
• Study Completion: 2021-01-29
• Results First Submitted: 2022-11-29
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-23
• Last Update Submitted: 2022-12-23
• Results First Posted: 2023-01-19
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
JBT-101	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.

Primary Outcome Measures

Name	Time	Method
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A.	Part A: 84-day treatment period (Change from the Baseline CDSAI score at Day 84)	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	Part A: to Day 84	Number of participants with treatment emergent adverse events were assessed as a measure of safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Change in Patient-reported Outcomes From Baseline at 84 Days for Part A	Part A: 84-day treatment period	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.

Trial Locations

Locations (1)

University of Pennsylvania Perlman School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States