*Dermatomyositis *Polymyositis
Conditions
Interventions
*Drug: Dazukibart
-anti-interferon beta therapy
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants that completed a qualifying study through Week 52.
Exclusion criteria
Exclusion criteria: *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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *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) | — |
Secondary
| Measure | Time frame |
|---|---|
| *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 | — |
Countries
Argentina, Bulgaria, China, Hungary, India, Israel, Japan, Mexico, Poland, Taiwan, Turkey, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed