臨床研究等提出・公開システム

A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)

A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Recruiting

Aug. 13, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Participants that completed a qualifying study through Week 52.

*Any 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.
*Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) or 5 half-lives preceding baseline in this study (whichever is longer).
*Current use of any prohibited concomitant medication(s).
*Active bacterial, viral, fungal, mycobacterial or other infections.
*Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved.
*Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Both

*Dermatomyositis
*Polymyositis

*Drug: Dazukibart
-anti-interferon beta therapy

*Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation
*Number of participants with clinically significant laboratory abnormalities
*Number of participants with clinically significant abnormalities in vital signs
*Number of participants with clinically significant electrocardiogram (ECG) abnormalities
*Change from baseline in Forced Vital Capacity (FVC)/Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
*Absolute values and change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

*Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8)
*Change from baseline in Physician Global Activity (PhGA)
*Change from baseline in extramuscular activity or disease activity score and muscle enzyme results
*Minimal, Moderate, and Major improvement in Total Improvement Score (TIS) and TIS (continuous) score
*Percent change from baseline and change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in DM participants
*Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Damage Score (CDASI-D) in DM participants
*Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF)
*Change from baseline in Patient Global Activity (PtGA)
*Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
*Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
*Change from baseline in EuroQoL 5 Dimensions (EQ-5D-5L) and EuroQoL Visual Analog Scale (EQ-VAS)
*Change from baseline in Healthcare Resource Utilization Questionnaire (HRU)
*Change from baseline in 5-D Itch Scale Score in DM participants
*Change from baseline in corticosteroid (CS) and non-steroid immunosuppressant/immunomodulator and antimalarial dose
-CS and non-steroid immunosuppressant/immunomodulator and antimalarial dose
*Response in CS and non-steroid immunosuppressant/immunomodulator and antimalarial tapering
*Rescue therapy use assessment
*Auto antibodies and immunogenicity presence

+81-3-5213-0028

May. 26, 2025

Yes

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.

Argentina/Bulgaria/China/Hungary/India/Israel/Mexico/Poland/Taiwan/Turkey/United States