CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
PF-06823859 low +2 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Confirmation of DM by investigator plus two of the following: Gottron's papules, Gottron's sign, heliotrope eruption, nailfold changes, photodistributed violaceous erythema, or positive DM serology
  • ✓Skin-predominant: CDASI Activity score ≥14 and failed at least 1 standard of care systemic treatment (e.g., corticosteroids)
  • ✓Muscle-predominant: MMT-8 ≤136/150 and PhGA VAS ≥3 cm, plus sum of PhGA, VAS, PtGA, and extramuscular global assessment VAS scores ≥10 cm
  • ✓Muscle-predominant: failed at least two or more adequate courses of immunosuppressive or immunomodulatory agent, including IVIG, at an effective dose for rheumatologic diseases
Key exclusion· 6
  • ✕Intake of >15 mg prednisone or equivalent per day (skin-predominant) or >20 mg per day (muscle-predominant)
  • ✕Pregnant or breastfeeding; fertile men and women who will not comply with 2 effective birth control methods
  • ✕Pre-existing demyelinating disorder such as multiple sclerosis or other severe neurological deficits
  • ✕Required management of acute or chronic infections

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03181893
NCT03181893Phase 2Completed
CompareCT.gov

A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS

Pfizer·interventional·Posted Jun 9, 2017·Updated Sep 14, 2023

In Brief

A Phase 2 clinical trial evaluating PF-06823859 low, Placebo Arm, and 1 other intervention for Dermatomyositis. Completed, enrolled 75 participants across 41 sites in 5 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatomyositis
CountriesGermany, Hungary, Poland, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 9, 2017
Enrollment StartJan 23, 2018
Primary CompletionMay 27, 2022
Study CompletionNov 28, 2022
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 9.1 years ago

Interventions

PF-06823859 lowdrug

A humanized immunoglobulin neutralizing antibody

Placebo Armdrug

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

PF-06823859 highdrug

A humanized immunoglobulin neutralizing antibody