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Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

NCT03813160 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2022-08-16

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 dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of double-blind treatment with study drug is up to 52 weeks.

Conditions

  • Dermatomyositis

Interventions

DRUG

Lenabasum 20 mg

oral capsule

DRUG

Lenabasum 5 mg

oral capsule

DRUG

Placebo

oral capsule

Sponsors & Collaborators

  • Corbus Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Victoria P Werth, MD · University of Pennsylvania

  • Chester V Oddis, MD · University of Pittsburgh Department of Medicine/Division of Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2021-03-31
Completion
2021-10-05
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Italy
  • Japan
  • Poland
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03813160 on ClinicalTrials.gov