A Study In Adults With Moderate To Severe Dermatomyositis
A Study looking at Investigational drug and Placebo administered to adult Patients with moderate to severe Dermatomyositis
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Must have CDASI Activity score of greater than or equal to 14, and have failed at least 1 standard of care systemic treatment, (eg, corticosteroids).
- Confirmation of DM by the investigator and two of the following:
- Gottron's papules;
- Gottron's sign;
- Heliotrope eruption;
- Nailfold changes, (dilated capillary loops, capillary dropout, cuticular hypertrophy and/or rugged cuticles;
- Photodistributed violaceous erythema, (skin that is exposed to sunlight and appears purplish/reddish, and patchy in appearance;
- Positive DM serology -
- Post DM diagnosis; standard of care workup for DM must have been completed prior to entry into this research study.
- Willing to provide 6 biopsies during the course of the research study
- Investigator site staff or members of their family.
- Acute and Chronic present medical conditions
- Intake of greater than 15 mg of prednisone or equivalent per day
- Pregnant or breastfeeding females. Fertile men and women who will not comply with the use of 2 effective birth control methods as per the research protocol
- Have required management of acute or chronic infections
- Have pre existing demyelinating disorder such as multiple sclerosis, or other severe neurological deficits.
- Clinically significant lab abnormalities
- Any health condition that may be worsened by immunosuppression
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Triple (Participant, Investigator, Outcomes Assessor)
- Active, not recruiting