Trial · NCT06733935
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Dose-limiting toxicities (DLTs) [Safety and Tolerability] | The first 28 days after the first NKX019 dose | Incidence of DLTs will be evaluated |
| Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | From the first administration of NKX019 until the last administration of any study treatment + 30 days | Incidence and severity of treatment-emergent adverse events will be evaluated |
| Secondary | For all participants with Interstitial Lung Disease (ILD) | Up to 2 years after NKX019 infusion | Change from baseline in % predicted forced vital capacity (FVC) over time |
| Secondary | For all participants with Interstitial Lung Disease (ILD) | Up to 2 years after NKX019 infusion | Change from baseline in FVC volume over time |
| Secondary | For all participants with Interstitial Lung Disease (ILD) | Up to 2 years after NKX019 infusion | Change from baseline % predicted diffusing capacity of the lung for carbon monoxide (DLCO) corrected for hemoglobin \[and as appropriate alveolar volume (AV)\] over time |
| Secondary | For all participants with Interstitial Lung Disease (ILD) | Up to 2 years after NKX019 infusion | Time to improvement in FVC by ≥5% or ≥10% |
| Secondary | For all participants with Interstitial Lung Disease (ILD) | Up to 2 years after NKX019 infusion | Proportion of participants with improvement in FVC by ≥5% or ≥10% |
| Secondary | For all participants with Interstitial Lung Disease (ILD) | Up to 2 years after NKX019 infusion | Time to ILD progression |
| Secondary | For all participants with Interstitial Lung Disease (ILD) | Up to 2 years after NKX019 infusion | Proportion of participants with ILD progression |
| Secondary | For all participants with Systemic Sclerosis (SSc) | Up to 2 years after NKX019 infusion | Change from baseline in modified Rodnan skin score (mRSS) |
| Secondary | For all participants with Systemic Sclerosis (SSc) | Up to 2 years after NKX019 infusion | Proportion of participants with ≥ 50% improvement in mRSS over time |
| Secondary | For all participants with Systemic Sclerosis (SSc) | Up to 2 years after NKX019 infusion | Proportion of participants achieving revised Composite Response Index (rCRISS) 25, 50 and 70 compared to baseline |
| Secondary | For all participants with Systemic Sclerosis (SSc) | Up to 2 years after NKX019 infusion | Change from baseline modified EULAR (European Alliance of Associations for Rheumatology) Scleroderma Trials and Research Activity Index (EUSTAR AI) over time |
| Secondary | For all participants with Systemic Sclerosis (SSc) | Up to 2 years after NKX019 infusion | Change from baseline University of California Los Angeles Gastrointestinal Tract (UCLA GIT) 2.0 assessments over time |
| Secondary | For all participants with Idiopathic Inflammatory Myopathies (IIM) | Up to 2 years after NKX019 infusion | Change from baseline in manual muscle testing (MMT) over time |
| Secondary | For all participants with Idiopathic Inflammatory Myopathies (IIM) | Up to 2 years after NKX019 infusion | Change from baseline and normalization of muscle enzymes over time |
| Secondary | For all participants with Idiopathic Inflammatory Myopathies (IIM) | Up to 2 years after NKX019 infusion | Change from baseline Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score over time for those with cutaneous manifestations |
| Secondary | For all participants with Idiopathic Inflammatory Myopathies (IIM) | Up to 2 years after NKX019 infusion | Proportion of participants achieving a mild, moderate, or major (20, 40, 60 points) clinical response by Total Improvement Score (TIS) over time (including assessment of change from baseline in TIS components) |
| Secondary | For all participants with ANCA-Associated Vasculitis (AAV) | Up to 2 years after NKX019 infusion | Proportion of participants achieving Birmingham Vasculitis Activity Score (BVAS) remission over time |
| Secondary | For all participants with ANCA-Associated Vasculitis (AAV) | Up to 2 years after NKX019 infusion | Change from baseline BVAS over time |
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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GET https://conductscience.org/api/trials/v1/NCT06733935/registered