DAZUKIBART for Idiopathic inflammatory myopathy|Dermatomyositis|Polymyositis

Inclusion criteria

• {"criterion_text":"- Participants who have completed the treatment period of a qualifying study and did not discontinue study treatment early will be eligible to receive study drug (OL Treatment Groups). From C0251006 study, participants must have completed the 52-week treatment period of the study to receive study drug in this study."}

Exclusion criteria

• {"criterion_text":"- 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 or, in the investigator’s judgment, make the participant inappropriate for the study."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Current use of any prohibited concomitant medication(s)."}
• {"criterion_text":"- Active bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis (TB) and atypical mycobacterial disease)."}
• {"criterion_text":"- Participants with an ongoing adverse event in a qualifying study which, in the opinion of the investigator or sponsor, is an ongoing safety concern and makes the participant inappropriate for the study, OR the participant has met safety monitoring criteria in a qualifying study that have not resolved."}

Primary endpoints

• {"endpoint_text":"- TEAEs, SAEs, AESIs, and AEs leading to treatment discontinuation; Clinically significant abnormalities in laboratory tests, ECG measurements, and vital signs; Change from baseline in FVC/DLCO; Absolute values and change from baseline in C-SSRS at all scheduled timepoints.","definition_or_measurement_approach":"Safety assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to treatment discontinuation; clinically significant abnormalities in laboratory tests, ECGs, and vital signs monitored; pulmonary function change measured as change from baseline in FVC/DLCO; suicidality measured by C-SSRS absolute values and change from baseline at all scheduled timepoints."}

Secondary endpoints

• {"endpoint_text":"- Cohort 1 (DM) and Cohort 2 (PM): • Change from baseline* in MMT-8 score at all scheduled timepoints. • Change from baseline* in PhGA at all scheduled timepoints. • Change from baseline* in extramuscular activity or disease activity score at all scheduled timepoints. • Change from baseline* in results in muscle enzymes at all scheduled timepoints. • Minimal, Moderate, and Major improvement in TIS at all scheduled timepoints. • TIS (continuous) at all scheduled timepoints.","definition_or_measurement_approach":"Efficacy measures include change from baseline in MMT-8 (manual muscle testing), Physician Global Assessment (PhGA), extramuscular/disease activity scores, muscle enzyme results; TIS improvement categories and TIS continuous scores evaluated at scheduled visits."}
• {"endpoint_text":"- Cohort 1 (DM) and Cohort 2 (PM): Change from baseline at all scheduled timepoints in: PROMIS-PF, PtGA, HAQ-DI, FACIT-F, EQ-5D-5L and EQ-VAS, HRU questionnaire; Cohort 1 (DM) only: Change from baseline at all scheduled timepoints in: 5D-Itch Scale","definition_or_measurement_approach":"Patient-reported outcomes assessed by PROMIS-PF, Patient Global Assessment (PtGA), HAQ-DI, FACIT-F, EQ-5D-5L/EQ-VAS, and health resource utilization (HRU) questionnaire; itch assessed in DM cohort by 5D-Itch Scale; all measured as change from baseline at scheduled timepoints."}
• {"endpoint_text":"- Change from baseline in corticosteroid dose over time; Response over time based on participants achieving: Corticosteroid dose ≤5 mg/day, Corticosteroid free; Change from baseline in non-steroid immunosuppressant/immunomodulator and antimalarial dose over time. Response over time based on participants achieving: Non-steroid immunosuppressants/immunomodulator and antimalarial free.","definition_or_measurement_approach":"Background medication use tracked over time; corticosteroid and non-steroid immunosuppressant/antimalarial doses measured and change from baseline calculated; responder definitions include achieving ≤5 mg/day corticosteroid or steroid-free status, and freedom from non-steroid immunosuppressants/immunomodulators/antimalarials."}
• {"endpoint_text":"- Receive rescue therapy (yes or no) during the study; Number/cycles of rescue therapy received during the study.","definition_or_measurement_approach":"Record of whether participant received rescue therapy and count/number of rescue therapy cycles during study participation."}
• {"endpoint_text":"- Auto antibodies (eg. TIF1-γ/P155, NXP2/P140, SAE, JO-1 and MDA-5).","definition_or_measurement_approach":"Assessment of myositis-specific autoantibodies (examples listed) measured at baseline and follow-up timepoints."}
• {"endpoint_text":"- Baseline* and post-treatment ADAs and Nabs.","definition_or_measurement_approach":"Immunogenicity assessed by anti-drug antibodies (ADAs) and neutralising antibodies (Nabs) at baseline and post-treatment visits."}
• {"endpoint_text":"- To be continued - secondary endpoint for secondary objective nr.1: Cohort 1 (DM) Only: Percent change from baseline and change from baseline in CDASI-A score at all scheduled timepoints; Change from baseline in CDASI-D score at all scheduled timepoints.","definition_or_measurement_approach":"Dermatologic assessment in DM cohort using CDASI activity (CDASI-A) and damage (CDASI-D) scores; percent change and absolute change from baseline measured at scheduled visits."}

Hungary

Earliest CTIS Part Ii Submission Date

20-11-2024

Latest Decision Or Authorization Date

29-01-2025

Processing Time Days

70

Number Of Sites

1

Number Of Participants

4

Sweden

Earliest CTIS Part Ii Submission Date

24-07-2025

Latest Decision Or Authorization Date

29-07-2025

Processing Time Days

5

Number Of Sites

1

Number Of Participants

2

Italy

Earliest CTIS Part Ii Submission Date

30-10-2025

Latest Decision Or Authorization Date

14-11-2025

Processing Time Days

15

Number Of Sites

1

Number Of Participants

1

Bulgaria

Earliest CTIS Part Ii Submission Date

16-10-2024

Latest Decision Or Authorization Date

22-01-2025

Processing Time Days

98

Number Of Sites

2

Number Of Participants

5

Poland

Earliest CTIS Part Ii Submission Date

18-09-2025

Latest Decision Or Authorization Date

26-10-2025

Processing Time Days

38

Number Of Sites

4

Number Of Participants

9

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Premier Research

Responsibilities

Dictionary Coding

Name

Ppd Inc.

Responsibilities

Biospecimen testing

Name

Signant Health Global Solutions Limited

Responsibilities

Electronic COA (eCOA) Support Services

Name

Medpace Inc.

Responsibilities

ECG - Central Reader/Reading Service

Name

Labcorp Central Laboratory Services LP

Responsibilities

Central laboratory services

Third parties

• {"country":"United States","full_name":"Premier Research","duties_or_roles":"Dictionary Coding","organisation_type":"Industry"}
• {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"Biospecimen testing","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"Electronic COA (eCOA) Support Services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medpace Inc.","duties_or_roles":"ECG - Central Reader/Reading Service","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central laboratory services","organisation_type":"Pharmaceutical company"}