MedTrace Logo

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

NCT03398837 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2021-03-29

No results posted yet for this study

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.

Conditions

  • Diffuse Cutaneous Systemic Sclerosis

Interventions

DRUG

Lenabasum 5 mg

Subjects will receive lenabasum 5 mg twice daily.

DRUG

Lenabasum 20 mg

Subjects will receive lenabasum 20 mg twice daily.

OTHER

Placebo oral capsule

Subjects will receive placebo twice daily.

Sponsors & Collaborators

  • Corbus Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Spiera, MD · Professor of Clinical Medicine, Weill Cornell Medical College

  • Chris Denton, MD · Professor of Experimental Rheumatology and Consultant Rheumatologist and Centre Head, Royal Free Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2020-05-27
Completion
2020-12-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Israel
  • Japan
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03398837 on ClinicalTrials.gov