A Study of Dazukibart for Idiopathic Inflammatory Myopathies
This study is looking at how dazukibart works in people who have active idiopathic inflammatory myopathies (IIMs), specifically dermatomyositis (DM) or polymyositis (PM). IIMs are conditions that cause inflammation and weakness in muscles, often in the hips, thighs, upper arms, and neck. DM can also cause a skin rash. This study aims to understand the safety of dazukibart by tracking any side effects, serious side effects, and laboratory changes over 52 weeks. You may be able to join if you are 18 or older and have already completed a qualifying study. The study plans to enroll 211 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment (dazukibart). It plans to enroll 211 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety outcomes for 52 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
At a glance
Conditions
Where it's being run
26 sites across 21 statesStudy leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation52 weeks
An AE is any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are AEs that are absent before treatment or that worsened relative to pretreatment state. Pre-defined AESI for this study are outlined in study protocol.
- Number of participants with clinically significant laboratory abnormalities52 weeks
Clinically significant laboratory abnormalities are those that meet the Common Terminology Criteria for Adverse Events (CTCAE) definition.
- Number of participants with clinically significant abnormalities in vital signs52 weeks
Clinically significant vital sign abnormalities include pulse rate \<40, \>100 or \>120 bpm; systolic blood pressure increase from baseline ≥30 or decrease ≤30 mmHg; diastolic blood pressure increase from baseline ≥20 or decrease ≤20 mmHg.
- Number of participants with clinically significant electrocardiogram (ECG) abnormalities52 weeks
Clinically significant ECG abnormalities include mild (\>450-480 millisecond \[msec\]), moderate (\>480-500 msec or 30-60 msec increase from baseline), and severe (\>500 msec or \>60 msec increase from baseline) QTc prolongation.
- Change from baseline in Forced Vital Capacity (FVC)/Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)52 weeks
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a measure of gas exchange diffusion capacity.
- Absolute values and change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)52 weeks
C-SSRS assesses whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").