Phase 2 N=24 Treatment

An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study

Dermatomyositis

Bottom Line

View on ClinicalTrials.gov: NCT05192200 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Feb 2025

Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 7; 13; 20 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Anti-Beta Interferon (PF-06823859) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs)	7; 13; 20	—
PRIMARY Number of Participants With Laboratory Abnormalities	8; 14; 22	—
PRIMARY Number of Participants According to Categorization of Changes in Vital Signs	4; 4; 8; 4; 2; 6	—
PRIMARY Number of Participants According to Categorization of Electrocardiogram (ECG) Findings	0; 0; 0; 0; 0; 0	—
SECONDARY Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52	-4.67; -2.51	—
SECONDARY Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48	-5.28; -0.87; -4.11; -0.67; -4.51; -1.40	—
SECONDARY Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52	4.4; 4.4; 5.0; 4.6; 5.5; 3.9	—
SECONDARY Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52	-2.4; -0.8; -1.8; -0.5; -2.3; -0.5	—
SECONDARY Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52	0.9; 1.6; 1.9; 1.9; 1.4; 1.9	—
SECONDARY Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort	15.03; 15.67; 18.17; 19.61; 23.66	—
SECONDARY Change From Baseline in Physician Global Assessment (PhGA) Score at Week 12, 24, 36, 48 and 52: Muscle Cohort	0.17; 0.29; -0.18; -0.48; -0.60	—
SECONDARY Change From Baseline in Patient Global Assessment (PtGA) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort	3.70; -9.63; -9.10; -8.36; -6.28	—
SECONDARY Change From Baseline in Manual Muscle Testing-8 Designated Muscle Groups (MMT-8) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort	-0.06; 1.85; 4.92; 8.00; 9.84	—
SECONDARY Change From Baseline in Health Assessment Questionnaire and Disease Index (HAQ-DI) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort	0.00; -0.10; -0.07; -0.12; -0.18	—
SECONDARY Change From Baseline in Creatine Kinase at Weeks 12, 24, 36, 48 and 52: Muscle Cohort	-98.93; -58.53; -97.62; -72.04; -94.04	—
SECONDARY Change From Baseline in Extramuscular Global Assessment From the Myositis Disease Activity Assessment Tool (MDAAT) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort	0.05; 0.23; 0.01; -0.16; -0.56	—

Summary

The purpose of this research study is to evaluate the long-term safety, and tolerability of PF-06823859 study drug in adult participants with Dermatomyositis (DM) from a qualifying study.

Eligibility Criteria

Inclusion Criteria

Participants aged ≥18 and ≤80 with moderate to severe dermatomyositis (DM), that have completed the treatment period of a qualifying study.
Capable of giving signed informed consent.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion Criteria

Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
Participants who met discontinuation criteria at any point during the participating qualifying studies.
Participants with an ongoing safety event in the qualifying studies which, in the opinion of the investigator or sponsor, is an ongoing safety concern OR the participant has met safety monitoring criteria in the qualifying study that has not resolved.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05192200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.