A Study In Adults With Moderate To Severe Dermatomyositis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-23

Study Completion Date

2022-11-28

Brief Summary

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

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Detailed Description

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Conditions

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Dermatomyositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo ARM

Group Type PLACEBO_COMPARATOR

Placebo Arm

Intervention Type DRUG

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

PF-06823859 ARM high

Group Type EXPERIMENTAL

PF-06823859 high

Intervention Type DRUG

A humanized immunoglobulin neutralizing antibody

PF-06823859 ARM low

Group Type EXPERIMENTAL

PF-06823859 low

Intervention Type DRUG

A humanized immunoglobulin neutralizing antibody

Interventions

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PF-06823859 low

A humanized immunoglobulin neutralizing antibody

Intervention Type DRUG

Placebo Arm

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

Intervention Type DRUG

PF-06823859 high

A humanized immunoglobulin neutralizing antibody

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Mayo Clinic Arizona Research Pharmacy

Phoenix, Arizona, United States

Site Status

Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Attune Health Research Inc.

Beverly Hills, California, United States

Site Status

Freidenrich Center for Translational Research at Stanford University

Palo Alto, California, United States

Site Status

Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

University Of Miami Hospital

Miami, Florida, United States

Site Status

University of Miami Hospital Clinical Translational Research Site (Infusion site)

Miami, Florida, United States

Site Status

KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)

Fairway, Kansas, United States

Site Status

The University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Brigham and Women's Hospital - ACC

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital - CTC

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital - CTH

Boston, Massachusetts, United States

Site Status