Data from Pharmawand - Curated by EPG Health - Date added 10 August 2018

Corbus Pharma announced that they will proceed with a Phase III trial evaluating the efficacy and safety of lenabasum for the treatment of dermatomyositis (“DM”)

Dermatomyositis is a rare and serious multisystem inflammatory autoimmune disease affecting muscle and skin. The FDA provided guidance on the overall study design of the trial at a recent end-of-Phase II meeting. The Phase III study is planned to begin at the end of 2018.

The international Phase III trial will be a 1-year, double-blind, randomized, placebo-controlled study testing efficacy and safety of lenabasum in approximately 150 adults with DM. Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome will be American College of Rheumatology (“ACR”)/ European League Against Rheumatism 2016 Total Improvement Score (“TIS”) in myositis, a composite measure of improvement from baseline in 6 endpoints: Physician Global Activity, Patient Global Activity, Health Assessment Questionnaire, Manual Muscle Testing and measurement of muscle enzymes and extra muscular activity. Change in the Cutaneous Dermatomyositis Activity and Severity index (“CDASI”) activity score will be a secondary efficacy outcome.

Comment: Lenabasum was formerly known as anabasum.


You will need to login, to leave a comment. is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

ALP Lab Assessment

ALP Lab Assessment

Discover an overview of hypophosphatasia and details required to facilitate the timely and accurate detection of low alkaline phosphatase.

Acute and Advanced Heart Failure

Acute and Advanced Heart Failure

What are the most effective treatments for acute heart failure? Can you define advanced heart failure? Discover here...

+ 3 more

Allergic Rhinitis

Allergic Rhinitis

Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.

+ 4 more

Load more

Related Content