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A Study In Adults With Moderate To Severe Dermatomyositis

CompletedPhase 2

Sponsor: Pfizer

Conditions: Dermatomyositis

Interventions: PF-06823859 low, Placebo Arm, PF-06823859 high

Countries: United States, Germany, Hungary, Poland, Spain

A Study looking at Investigational drug and Placebo administered to adult Patients with moderate to severe Dermatomyositis

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria for Patients with Skin Predominant Activity:

* 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:

1. Gottron's papules;
2. Gottron's sign;
3. Heliotrope eruption;
4. Nailfold changes, (dilated capillary loops, capillary dropout, cuticular hypertrophy and/or rugged cuticles;
5. Photodistributed violaceous erythema, (skin that is exposed to sunlight and appears purplish/reddish, and patchy in appearance;
6. 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 8 biopsies during the course of the research study

Inclusion Criteria for Patients with Muscle Predominant Activity:

* MMT-8 ≤136/150 and PhGA, VAS ≥3 cm (0-10 cm) by visual analog scale (VAS)
* Sum of PhGA, VAS, PtGA, and extramuscular global assessment VAS scores is ≥10 cm (0-10 cm) VAS for each.

* Participant has failed at least two or more adequate courses of an immunosuppressive agent or immunomodulatory agent, including IVIG, at a dose known to be effective for rheumatologic diseases.

Exclusion Criteria for Patients with Skin Predominant Activity:

* 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

Exclusion Criteria for Patients with Muscle Predominant Activity:

Similar to patients with skin predominant activity; Intake of \>20 mg oral prednisone/day, or equivalent

Locations (41)

Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Beverly Hills, California, United States
Palo Alto, California, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Fairway, Kansas, United States
Kansas City, Kansas, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Minneapolis, Minnesota, United States
Minneapolis, Minnesota, United States
Minneapolis, Minnesota, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Portland, Oregon, United States
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