Health Condition 1: M60- Myositis
Conditions
Interventions
Intervention1: Drug: PF-06823859 (anti-interferon beta therapy): Participants will receive PF-06823859 via intravenous infusion every 4 weeks.
Control Intervention1: Placebo : Placebo for PF-06823859:
Sponsors
Pfizer Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female adults (greater than equal to 18 years old) 2. Active dermatomyositis (DM) or polymyositis (PM) with age of onset: a) 18 years old 3. Must be receiving a stable dose of standard of care (SOC) background medications at the time of enrollment.
Exclusion criteria
Exclusion criteria: 1. Myositis due to non-Idiopathic inflammatory myopathies (non-IIM) 2. Existing diagnosis of inclusion body myositis (IBM) 3. Presence of immune-mediated necrotizing myositis (IMNM) 4. Myositis with end-stage organ involvement 5. Active bacterial, viral or fungal infections or hospitalizations for serious infections within 60 days prior to enrollment 6. Have cancer or a history of cancer within 5 years of screening 7. Significant current or prior disease conditions that may interfere with the response to or safety of the study medicine, including but not l limited to: 8. history of major organ transplant 9. acute coronary syndrome or any history of significant cerebrovascular disease within 24 weeks of screening 10. preexisting demyelinating disorder such as multiple sclerosis, or other severe neurological disorder 11. major surgery within 4 weeks of screening, or scheduled to occur during the study, excluding diagnostic surgery 12. history of any lymphoproliferative disorder such as Epstein Barr Virus, history of lymphoma, leukemia, or symptoms of current lymphatic or lymphoid disease 13. Clinically significant depression, suicidal ideation, or previous history of suicidal behaviors 14. Other medical or laboratory abnormality that may increase the risk of study participation 15. Previous administration with an investigational product (drug or vaccine) within 30 days or of the first dose of study medicine 16. Current use or incomplete appropriate washout period of any prohibited medication(s), including known exposure to anti-interferon beta (PF-06823859) or any type of anti-interferon beta therapy 17. Prior SOC medication that does not fulfill the criteria 18. Certain laboratory results from screening assessments that may interfere with study participation. 19. Investigator site staff directly involved in the conduct of the study and their family members, site staff and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Improvement Score 0 to 100 with higher scores indicating a better outcome.Timepoint: 24 weeks outside of the United States (US) and 52 weeks in the US | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in 5-D Itch Scale Score 5-D Pruritis Scale 5 to 25 with higher scores indicating a worse outcome. Only participants with baseline CDASI-A score more than 14 will be assessed.Timepoint: 24 weeks outside of the US and 52 weeks in the US;Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in participants with dermatomyositis (DM) Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score 0 to 100 with higher scores indicating a worse outcome. Only participants with baseline CDASI-A score more than 14 will be assessed. Timepoint: Week 24 outside the US;Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Functional Assessment of Chronic Illness Therapy - Fatigue 0 to 52 with higher scores indicating a better outcomeTimepoint: 24 weeks outside of the US and 52 weeks in the US;Change from baseline in Investigator Global Assessment severity scale (IGA) in participants with dermatomyositis Investigator Global Assessment severity scale 0 to 4 with higher scores indicating a worse outcome. Only participants with baseline IGA more than equal to 2 will be assessedTimepoint: 24 and 52 weeks in the US only;Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8) Manual Muscle Testing (8 designated muscles) 0 to 150 with higher scores indicating a better outcomeTimepoint: 24 weeks outside of the US and 52 weeks in the US;Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF) Patient-Reported Outcomes Measurement Information System - Physical Function 0 to 100 with higher scores indicating a better outcomeTimepoint: 24 weeks outside of the US and 52 weeks in the US;Corticosteroid (CS) dose assessment Normalized Area Under the Curve (AUC) of corticosteroid dose Timepoint: 52 weeks;Moderate change in Total Improvement Score Total Improvement Score 0 to 100 wit | — |
Countries
Argentina, Belgium, Bulgaria, China, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Republic of Korea, Slovakia, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Seema Pai
Pfizer Limited
Outcome results
None listed