Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis

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.

Timeline

Start

2015-08

Primary completion

2016-10

Completion

2020-12-11

Outcome

Met primary endpoint

Stopped: “Sponsor terminated open-label extension”

release “Difference in CRISS scores between JBT-101 and placebo groups over the trial period was significant (p = 0.044).” corbuspharma.com ↗

release “JBT-101 out-performed placebo in the American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score” corbuspharma.com ↗

release “As previously reported, data showed treatment with lenabasum was associated with improvements across the primary endpoint” corbuspharma.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenabasum	Small molecule	20 mg	—

Indications