Approval Probability
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Adjusted LOA
ML Risk
Dazukibart · 1 trial · 2 indications
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.
Clinically significant laboratory abnormalities are those that meet the Common Terminology Criteria for Adverse Events (CTCAE) definition.
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.
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.
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.
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").
| Arm | Type | Description |
|---|---|---|
| Dazukibart | EXPERIMENTAL | Participants will receive dazukibart via intravenous infusion every 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Dazukibart | DRUG | anti-interferon beta therapy |
Inclusion Criteria: * Participants that completed a qualifying study through Week 52. Exclusion Criteria: * 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...
Dazukibart is an investigational small molecule being developed for dermatomyositis, a rare autoimmune disease that causes muscle weakness and skin rash. It is also being studied in polymyositis, another type of idiopathic inflammatory myopathy. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Dazukibart is being developed by Pfizer, Inc., a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting a Phase 3 clinical trial to evaluate the drug's effects in people with idiopathic inflammatory myopathies, including dermatomyositis and polymyositis.
Dazukibart is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 3 trial is currently recruiting participants and is designed to understand how the study medicine works in people with idiopathic inflammatory myopathies.
Dazukibart is being studied in a Phase 3 clinical trial registered as NCT06698796, titled "A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies." The trial is currently recruiting and aims to enroll 211 participants across multiple countries, including the United States, China, Japan, and several European nations.
No alternative names for Dazukibart have been reported. The drug is identified solely by its name, Dazukibart, in clinical trial registries and company communications. It is a distinct investigational compound being developed by Pfizer for the treatment of idiopathic inflammatory myopathies.
The specific molecular target of Dazukibart has not been disclosed in available clinical trial information. As a small molecule being studied for dermatomyositis and polymyositis, it is believed to modulate immune pathways involved in these autoimmune conditions, but the exact mechanism of action remains under investigation in the ongoing Phase 3 trial.