Trial · NCT06698796
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| 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. |
| Secondary | Percent change from baseline and change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in DM participants | 52 weeks | Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score 0 to 100 with higher scores indicating a worse outcome |
| Secondary | Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Damage Score (CDASI-D) in DM participants | 52 weeks | Cutaneous Dermatomyositis Disease Area and Severity Index Damage Score 0 to 32 with higher scores indicating a worse outcome |
| Secondary | Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF) | 52 weeks | Patient-Reported Outcomes Measurement Information System - Physical Function 0 to 100 with higher scores indicating a better outcome |
| Secondary | Change from baseline in Patient Global Activity (PtGA) | 52 weeks | Patient Global Activity 10-point numeric rating scale with higher scores indicating worse outcome |
| Secondary | Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) | 52 weeks | Health Assessment Questionnaire-Disability Index 20 questions with 0 to 3 scale where higher scores indicate a worse outcome |
| Secondary | Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) | 52 weeks | Functional Assessment of Chronic Illness Therapy - Fatigue 0 to 52 with higher scores indicating a better outcome |
| Secondary | Change from baseline in EuroQoL 5 Dimensions (EQ-5D-5L) and EuroQoL Visual Analog Scale (EQ-VAS) | 52 Weeks | EuroQoL 5 Dimensions and EuroQoL Visual Analog Scale with higher scores indicating a worse outcome |
| Secondary | Change from baseline in Healthcare Resource Utilization Questionnaire (HRU) | 52 weeks | Healthcare Resource Utilization Questionnaire measures the healthcare utilization burden while on treatment |
| Secondary | Change from baseline in 5-D Itch Scale Score in DM participants | 52 weeks | 5-D Pruritis Scale 5 to 25 with higher scores indicating a worse outcome |
| Secondary | Change from baseline in corticosteroid (CS) and non-steroid immunosuppressant/immunomodulator and antimalarial dose | 52 weeks | CS and non-steroid immunosuppressant/immunomodulator and antimalarial dose |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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