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Monoclonal Antibodies

PF-06823859 low for Dermatomyositis

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 1, week 4, week 8 and week 12

Awards & highlights

Study Summary

This trial is testing an investigational drug for dermatomyositis in adults. The patients will be given either the drug or a placebo, and the effects will be monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1, week 4, week 8 and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 1, week 4, week 8 and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 4, week 8 and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2)

Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3)

Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)

+2 more

Secondary outcome measures

Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3)

Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)

Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)

+14 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: PF-06823859 ARM lowExperimental Treatment1 Intervention

Group II: PF-06823859 ARM highExperimental Treatment1 Intervention

Group III: Placebo ARMPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-06823859 low

2018

Completed Phase 2

~80

PF-06823859 high

2018

Completed Phase 2

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,568 Previous Clinical Trials

10,911,811 Total Patients Enrolled

3 Trials studying Dermatomyositis

304 Patients Enrolled for Dermatomyositis

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,475 Previous Clinical Trials

8,092,979 Total Patients Enrolled

2 Trials studying Dermatomyositis

294 Patients Enrolled for Dermatomyositis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians welcome in this trial?

"According to the age requirements set out in this trial's inclusion criteria, the youngest participants must be 18 years old while the oldest can be 80."

Answered by AI

Is PF-06823859 a safe medication for human usage?

"PF-06823859 is still being tested for efficacy in Phase 2 trials, so its safety score is lower at a 2."

Answered by AI

For which patients is this clinical trial appropriate?

"This trial is looking for 58 participants that have dermatomyositis and are between 18-80 years old. In addition to meeting those requirements, patients must also have Gottron's sign; Heliotrope eruption; Nailfold changes (dilated capillary loops, capillary dropout, cuticular hypertrophy and/or rugged cuticles); MMT-8 ≤136/150 and PhGA, VAS ≥3 cm (0-10 cm) by visual analog scale (VAS), Must have CDASI Activity score of greater than or equal to 14, and have failed at least 1 standard of"

Answered by AI

Are we still enrolling people in this research project?

"This research study is not actively recruiting participants at this time, according to the latest information available on clinicaltrials.gov. The trial was originally posted on 1/23/2018 and was last updated on 9/7/2022. There are currently 24 other trials looking for patients that you may be eligible for."

Answered by AI

In how many different medical facilities is this research project being conducted today?

"This trial has many enrolling patients, with over 30 locations participating. A few notable enrolment sites for this study include University of Michigan in Ann Arbor, UPMC Montefiore Clinical and Translational Research Center in Dallas, and University of Texas Southwestern Medical Center in Birmingham."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study In Adults With Moderate To Severe Dermatomyositis

2018. "A Study In Adults With Moderate To Severe Dermatomyositis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03181893.