Trial · NCT05785624
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohorts 1 and 2: Absolute Change From Baseline in Forced Vital Capacity (FVC) | Baseline up to Week 52 | FVC is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function. |
| Secondary | Cohorts 1 and 2: Absolute Change From Baseline in 6-Minute Walk Test (6MWT) Distance | Baseline up to Week 52 | The 6MWT test is performed indoors on a flat, straight corridor with a hard surface at least 30 meters (m) in length. 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes. 6MWT measure will be calculated as the simple difference between baseline distance walked over 6 minutes and week 52 distance walked over 6 minutes as measured in meters. |
| Secondary | Cohorts 1 and 2: Absolute Change From Baseline in Percentage of Predicted FVC | Baseline up to Week 52 | FVC is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function. |
| Secondary | Cohorts 1 and 2: Change From Baseline in Diffusion Capacity of the Lung for Carbon Monoxide Adjusted for Hemoglobin (DLco [Hb]) | Baseline up to Week 52 | DLCO measures the ability of the lungs to transfer gas from inhaled air to the red blood cells in the blood. DLCO is adjusted for hemoglobin as small changes in hemoglobin concentration can affect the carbon monoxide transfer. |
| Secondary | Cohorts 1 and 2: Time to Disease Progression | From the start of study treatment until disease progression or death, whichever occurs first (up to Week 52 of DBT) | Time to disease progression is defined as time to first occurrence of ≥10% absolute decline in percentage of predicted FVC, ≥15% relative decline in 6MWT distance, lung transplantation, or death. FVC=pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function. 6MWT test is performed indoors on a flat, straight corridor with a hard surface at least 30 m in length. 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes. 6MWT measure will be calculated as the simple difference between baseline distance walked over 6 minutes and week 52 distance walked over 6 minutes as measured in meters. |
| Secondary | Cohorts 1 and 2: Time to First Acute Exacerbation of ILD, or Suspected Acute Exacerbation of ILD | From the start of study treatment until end of DBT (up to Week 52) | |
| Secondary | Cohorts 1 and 2: Change From Baseline in Quantitative Lung Fibrosis on High-Resolution Computed Tomography (HRCT) Scan of the Thorax | Baseline up to Week 52 | High-resolution computer tomography (HRCT) is a type of computed tomography (CT) with specific techniques to enhance image resolution. It is used in the diagnosis of various health problems, most commonly for lung disease. These images show cross sections (slices) through the lungs. |
| Secondary | Cohorts 1 and 2: Percentage of Participants with Deaths | Up to Week 52 | |
| Secondary | Cohort 2: Change From Baseline in Skin Sclerosis Assessed Using Modified Rodnan Skin Score (mRSS) | Baseline up to Week 52 | mRSS is a measure of skin thickness. Skin thickness will be assessed by the investigator by palpation across 17 different body sites and scored on a scale of 0 (normal) to 3 (severe skin thickening). The total score is the sum of the individual skin scores from all of these sites and ranges from 0 (normal) to 51 (severe thickening in all 17 areas) units. Higher scores indicate disease worsening. |
| Secondary | Cohorts 1 and 2: Change From Baseline in Health-Related Quality of Life (HRQoL) Measured Using King's Brief Interstitial Lung Disease (K-BILD) Questionnaire | Baseline up to Week 52 | K-BILD is a questionnaire that assesses HRQoL in ILDs. It consists of 15 items grouped into psychological, breathlessness and activity, and chest symptom domains, each scored individually on a 7-point scale, with domain-level and total scores transformed 0-100, with higher scores indicating better quality of life. It uses a 2-week recall period. |
| Secondary | Cohorts 1 and 2: Change From Baseline in Cough Measured Using Living with Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score | Baseline up to Week 52 | The L-PF symptoms module is a 23-item tool with domains capturing shortness of breath, cough, and energy symptoms using a 0-4 numeric response scale (NRS) response format and a 24-hour recall period. The cough scores ranges from 0 to 100 with higher scores indicating greater symptom burden/impairment. |
| Secondary | Cohorts 1 and 2: Change From Baseline in Dyspnea Measured Using L-PF Symptoms Dyspnea Domain Score | Baseline up to Week 52 | The L-PF symptoms module is a 23-item tool with domains capturing shortness of breath, cough, and energy symptoms using a 0-4 NRS response format and a 24-hour recall period. L-PF Symptoms Dyspnea Domain score (dyspnea score) ranges from 0 to 100, with higher score indicating greater impairment. |
| Secondary | Cohort 2: Change From Baseline in Pruritus Measured Using the Five-Dimension Itch Scale (5-D Itch) Total Score | Baseline up to Week 52 | The 5-D-Itch questionnaire that measures itch and its impact. It consists of 8 items organized into 5 domains (duration, degree, direction, disability, and distribution). Each domain is scored 1 to 5 with a total score ranging from 5 to 25 with higher scores indicating greater itch severity. |
| Secondary | Cohorts 1, 2 and OLE Period: Number of Participants With Adverse Events (AEs) | Up to Week 52 | |
| Secondary | Cohorts 1 and 2: Serum Concentration of Vixarelimab | Baseline up to Week 52 | |
| Secondary | Cohorts 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Vixarelimab | Baseline up to Week 52 |
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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