A Study In Adults With Moderate To Severe Dermatomyositis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03181893
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pfizer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pfizer CT.gov Call Center
Principal Investigator Affiliation	Pfizer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Germany, Hungary, Italy, Poland, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Dermatomyositis
Study Website:	View Trial Website

Arms & Interventions

Arms

Placebo Comparator: Placebo ARM

Experimental: PF-06823859 ARM high

Experimental: PF-06823859 ARM low

Interventions

Drug: - PF-06823859 low

A humanized immunoglobulin neutralizing antibody

Drug: - Placebo Arm

Placebo contains histidine, sucrose, PS80, ethylene diamine, and triacetic acid

Drug: - PF-06823859 high

A humanized immunoglobulin neutralizing antibody

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35233

Site Contact

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