Trial · NCT06698796
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
NCT06698796, Phase 3, Recruiting, Pfizer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies. Trials, record NCT06698796. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06698796
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
- NCT number
- NCT06698796
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 211 participants, estimated
- Lead sponsor
- Pfizer
- Conditions
- Dermatomyositis, Polymyositis
- Interventions
- Dazukibart
- First posted
- 2024-11-21
- Last updated
- 2026-08-25
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation | 52 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. |
| Primary | Number of participants with clinically significant laboratory abnormalities | 52 weeks | Clinically significant laboratory abnormalities are those that meet the Common Terminology Criteria for Adverse Events (CTCAE) definition. |
| Primary | Number of participants with clinically significant abnormalities in vital signs | 52 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. |
| Primary | Number of participants with clinically significant electrocardiogram (ECG) abnormalities | 52 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. |
| Primary | 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. |
| Primary | 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"). |
| Secondary | Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8) | 52 weeks | Manual Muscle Testing (8 designated muscles) 0 to 150 with higher scores indicating a better outcome |
| Secondary | Change from baseline in Physician Global Activity (PhGA) | 52 weeks | Physician Global Activity 0 to 10 scale with higher scores indicating a worse outcome |
| Secondary | Change from baseline in extramuscular activity or disease activity score and muscle enzyme results | 52 weeks | Results come from Total Improvement Score 0 to 100 with higher scores indicating a better outcome and laboratory values |
| Secondary | Minimal, Moderate, and Major improvement in Total Improvement Score (TIS) and TIS (continuous) score | 52 weeks | Total Improvement Score 0 to 100 with higher scores indicating a better outcome. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06698796
GET https://conductscience.org/api/trials/v1/NCT06698796/registered?page=2