Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Summary

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.

Timeline

Start

2017-12-18

Primary completion

2020-05-27

Completion

2020-12-21

Outcome

Missed primary endpoint

Stopped: “Sponsor terminated open-label extension”

release “While we were disappointed that both the RESOLVE-1 systemic sclerosis study and the Phase 2b cystic fibrosis study did not meet their primary endpoints” corbuspharma.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenabasum	Small molecule	5 mg	—
Subject	Lenabasum	Small molecule	20 mg	—

Indications