Clinical Trial: Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemi
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.
Detailed Summary:
Part A of the study is an interventional, double-blind, randomized, placebo-control design will be used to test safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in subjects ≥ 18 and ≤ 70 years of age with active diffuse cutaneous systemic sclerosis. The screening period is up to 28 days, with 84 days treatment period and 28 days follow-up off active treatment.
Part B of the study is an interventional, open-label design will be used. All subjects who complete dosing in Part A without permanent discontinuation of study drug and who pass repeat safety screening will be eligible for enrollment. The screening period is up to 28 days, with a 364 day treatment period and 28 day follow up after last dose of JBT-101.
Sponsor: Corbus Pharmaceuticals Inc.
Current Primary Outcome:
- Number of participants with treatment-emergent adverse events from baseline at Day 113 [ Time Frame: Part A: 112 days, with 84 day treatment and 28 day follow-up ]
- Change in Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) from baseline at Day 85 [ Time Frame: Part A: 84 day treatment period ]CRISS responders and its domains of modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index
- Number of participants with treatment-emergent adverse events from baseline at Day 394 [ Time Frame: Part B: 394 days, with 365 day treatment and 28 day follow-up ]
- Change in Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) from baseline at Day 394 [ Time Frame: Part B: 365 day treatment period ]CRISS responders and its domains of modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index
Original Primary Outcome:
- Number of participants with treatment-emergent adverse events from baseline at Day 113 [ Time Frame: 112 days, with 84 days treatment and 28 days follow-up ]
- Change in Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) from baseline at Day 85 [ Time Frame: 84 days treatment period ]CRISS responders and its domains of modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index
Current Secondary Outcome:
- Change in patient-reported outcomes from baseline at Day 85 [ Time Frame: 84 day treatment period ]National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form, the PROMIS-29 Short Form single item pain numerical rating score, the 5-D Itch Score, and a Systemic Sclerosis Skin Questionnaire
- Change in JBT-101 plasma concentrations from baseline at Day 85 [ Time Frame: 84 day treatment period ]
- Change in metabolipidomic profile from baseline at Day 85 [ Time Frame: 84 day treatment period ]
- Change in blood biomarkers of disease activity, inflammation and fibrosis from baseline at Day 85 [ Time Frame: 84 day treatment period ]
- Change in skin biomarkers of inflammation and fibrosis from baseline at Day 85 [ Time Frame: 84 day treatment period ]
Original Secondary Outcome: Same as current
Information By: Corbus Pharmaceuticals Inc.
Dates:
Date Received: June 4, 2015
Date Started: August 2015
Date Completion: October 2018
Last Updated: October 17, 2016
Last Verified: October 2016