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A PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS) (A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)])

A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)] (A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)])

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

Oct. 31, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Inclusion Criteria:
*Male or female adults (>=18 years old)
*Active dermatomyositis (DM) or polymyositis (PM) with age of onset
o 18 years old.
*Must be receiving a stable dose of standard of care (SOC) background medications at the time of enrollment.

Exclusion Criteria:
*Myositis due to non-Idiopathic inflammatory myopathies (non-IIM)
*Existing diagnosis of inclusion body myositis (IBM)
*Presence of immune-mediated necrotizing myositis (IMNM)
*Myositis with end-stage organ involvement
*Active bacterial, viral or fungal infections or hospitalizations for serious infections within 60 days prior to enrollment
*Have cancer or a history of cancer within 5 years of screening
*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:
*history of major organ transplant
*acute coronary syndrome or any history of significant cerebrovascular disease within 24 weeks of screening
*preexisting demyelinating disorder such as multiple sclerosis, or other severe neurological disorder
*major surgery within 4 weeks of screening, or scheduled to occur during the study, excluding diagnostic surgery
*history of any lymphoproliferative disorder such as Epstein Barr Virus, history of lymphoma, leukemia, or symptoms of current lymphatic or lymphoid disease
*Clinically significant depression, suicidal ideation, or previous history of suicidal behaviors
*Other medical or laboratory abnormality that may increase the risk of study participation
*Previous administration with an investigational product (drug or vaccine) within 30 days or of the first dose of study medicine
*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
*Prior SOC medication that does not fulfill the criteria
*Certain laboratory results from screening assessments that may interfere with study participation.
*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

Both

Myositis

Drug: PF-06823859
anti-interferon beta therapy

Drug: Placebo
Placebo for PF-06823859

Moderate change in Total Improvement Score (TIS) [Time Frame: 24 weeks outside of the United States (US) and 52 weeks in the US]
Total Improvement Score 0 to 100 with higher scores indicating a better outcome.

Secondary Outcome Measures :
1. Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8) [ Time Frame: 24 weeks outside of the US and 52 weeks in the US ]
Manual Muscle Testing (8 designated muscles) 0 to 150 with higher scores indicating a better outcome

2. Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in participants with dermatomyositis (DM) [ Time Frame: Week 24 outside the US ]
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 >14 will be assessed.

3. Change from baseline in Investigator Global Assessment severity scale (IGA) in participants with dermatomyositis [ Time Frame: 24 and 52 weeks in the US only ]
Investigator Global Assessment severity scale 0 to 4 with higher scores indicating a worse outcome. Only participants with baseline IGA >=2 will be assessed

4. Corticosteroid (CS) dose assessment [ Time Frame: 52 weeks ]
Normalized Area Under the Curve (AUC) of corticosteroid dose

5. Moderate change in Total Improvement Score [ Time Frame: 24 weeks in the US and 52 weeks outside of the US ]
Total Improvement Score 0 to 100 with higher scores indicating a better outcome.

6. Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF) [ Time Frame: 24 weeks outside of the US and 52 weeks in the US ]
Patient-Reported Outcomes Measurement Information System - Physical Function 0 to 100 with higher scores indicating a better outcome

7. Change from baseline in 5-D Itch Scale Score [ Time Frame: 24 weeks outside of the US and 52 weeks in the US ]
5-D Pruritis Scale 5 to 25 with higher scores indicating a worse outcome. Only participants with baseline CDASI-A score >14 will be assessed.

8. Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [ Time Frame: 24 weeks outside of the US and 52 weeks in the US ]
Functional Assessment of Chronic Illness Therapy - Fatigue 0 to 52 with higher scores indicating a better outcome

9. Response in corticosteroid tapering [ Time Frame: 52 weeks US only ]
At least 50% reduction from baseline or reduction in corticosteroid (CS) dose to <7.5 mg/day at Week 52 for participants with baseline CS dose >=10 mg/day.

+81-3-5213-0028

Aug. 18, 2023

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.

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