Clinical Trial: Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
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 Summary:
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-severely 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.
Sponsor: Corbus Pharmaceuticals Inc.
Current Primary Outcome:
- Number of participants with treatment emergent adverse events as a measure of safety and tolerability [ Time Frame: Part A: 112-day treatment and follow-up period; Part B: 364-day treatment and follow up ]
- Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) from baseline at 84 days for Part A and 364 days for Part B [ Time Frame: Part A: 84-day treatment period; Part B 364-day treatment and follow up ]
Original Primary Outcome:
- Number of participants with treatment emergent adverse events as a measure of safety and tolerability [ Time Frame: 112-day treatment and follow-up period ]
- Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) from baseline at 84 days [ Time Frame: 84-day treatment period ]
Current Secondary Outcome:
- Change in patient-reported outcomes from baseline at 84 days for Part A and at 364 days for Part B [ Time Frame: Part A: 84-day treatment period; Part B: 364-day treatment period ]Patient Global Assessment, Skindex-29+3, PROMIS-29 Short Form
- Change in blood biomarkers of inflammation and disease activity from baseline at 84 days for Part A and at 364 days for Part B [ Time Frame: Part A: 84-day treatment period; Part B: 364-day treatment period ]
- Change in skin biomarkers of inflammation from baseline at 84 days for Part A and at 364 days for Part B [ Time Frame: Part A: 84-day treatment period; Part B: 364-day treatment period ]
- Change in plasma metabolipidomic profiles from baseline at 84 days [ Time Frame: 84-days treatment ]
- Change in JBT-101 plasma concentrations from baseline through 84 days for Part A [ Time Frame: Part A: 84-days treatment ]
Original Secondary Outcome:
- Change in patient-reported outcomes from baseline at 84 days [ Time Frame: 84-day treatment period ]Patient Global Assessment, Skindex-29+3, PROMIS-29 Short Form
- Change in blood biomarkers of inflammation and disease activity from baseline at 84 days [ Time Frame: 84-day treatment period ]
- Change in skin biomarkers of inflammation from baseline at 84 days [ Time Frame: 84-days treatment ]
- Change in plasma metabolipidomic profiles from baseline at 84 days [ Time Frame: 84-days treatment ]
- Change in JBT-101 plasma concentrations from baseline through 84 days [ Time Frame: 84-days treatment ]
Information By: Corbus Pharmaceuticals Inc.
Dates:
Date Received: June 2, 2015
Date Started: June 2015
Date Completion: September 2019
Last Updated: December 21, 2016
Last Verified: December 2016