A Study In Adults With Moderate To Severe Dermatomyositis

• ClinicalTrials.gov Identifier: NCT03181893
• Recruitment Status: Recruiting
• First Posted: June 9, 2017
• Last Update Posted: July 9, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Dermatomyositis	Drug: PF-06823859; Drug: Placebo Arm	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS
• Actual Study Start Date: January 23, 2018
• Estimated Primary Completion Date: December 20, 2020
• Estimated Study Completion Date: December 20, 2020

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo ARM	Drug: Placebo Arm; Placebo contains histidine, sucrose, PS80, ethylene diamine, and triacetic acid
Experimental: PF-06823859 Arm	Drug: PF-06823859; A humanized immunoglobulin neutralizing antibody

Outcome Measures

Primary Outcome Measures :

1. CDASI Activity Score [ Time Frame: Change from baseline activitly, (DAY 1) score at week 12 ]

   The Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), a skin-based outcome measure, was developed to systematically assess the extent of cutaneous disease in patients with DM.

   The CDASI scale is a validated DM-specific instrument designed to capture the extent of cutaneous disease. Disease involvement in 15 different anatomical locations is rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia are also captured. The resulting activity and damage scores range from 0 to 100 and 0 to 32, respectively. Higher scores indicate greater disease severity.

Secondary Outcome Measures :

1. CDASI Activity Scores [ Time Frame: Baseline, (DAY 1) - week 12 ]
   Absolute values and change from baseline CDASI activity score through week 12
2. CDASI Damage score [ Time Frame: Baseline, (DAY 1)-week 12 ]
   Absolute values and change from baseline CDASI Damage Score through week 12

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 6 biopsies during the course of the research study

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

Contacts and Locations

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

  Show 25 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here.  To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03181893 History of Changes
• Other Study ID Numbers: C0251002
• First Posted: June 9, 2017
• Last Update Posted: July 9, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dermatomyositis; Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin Diseases