Health Condition 1: M608- Other myositis
Conditions
Interventions
Intervention1: Drug: PF-06823859
(anti-interferon beta therapy): Participants will receive 600 mg IV every 4 weeks
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Pfizer Inc.
MS Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participants that completed a qualifying study through Week 52
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions: 1. 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. 2. 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). 3. Current use of any prohibited concomitant medication(s). 4. Active bacterial, viral, fungal, mycobacterial or other infections. 5. Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved. 6. 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 |
|---|---|
| 1. Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation 2. Number of participants with clinically significant laboratory abnormalities 3. Number of participants with clinically significant abnormalities in vital signs 4. Number of participants with clinically significant electrocardiogram (ECG) abnormalities 5. Change from baseline in Forced Vital Capacity (FVC)/Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) 6. Absolute values and change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)Timepoint: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8) 2. Change from baseline in Physician Global Activity (PhGA) 3. Change from baseline in extramuscular activity or disease activity score and muscle enzyme results 4. Minimal, Moderate, and Major improvement in Total Improvement Score (TIS) and TIS (continuous) score 5. Percent change from baseline and change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in DM participantsTimepoint: 52 weeks;6. Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Damage Score (CDASI-D) in DM participants 7. Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF) 8. Change from baseline in Patient Global Activity (PtGA) 9. Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) 10. Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)Timepoint: 52 weeks;11. Change from baseline in EuroQoL 5 Dimensions (EQ-5D-5L) and EuroQoL Visual Analog Scale (EQ-VAS) 12. Change from baseline in Healthcare Resource Utilization Questionnaire (HRU) 13. Change from baseline in 5-D Itch Scale Score in DM participants 14. Change from baseline in corticosteroid (CS) and non-steroid immunosuppressant/immunomodulator and antimalarial dose 15. Response in CS and non-steroid immunosuppressant/immunomodulator and antimalarial tapering 16. Rescue therapy use assessment 17. Auto antibodies and immunogenicity presence Timepoint: 52 weeks | — |
Countries
Argentina, Belgium, Bulgaria, China, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Republic of Korea, Slovakia, Spain, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Seema Pai
Pfizer Limited
Outcome results
None listed