Trial · NCT07904806
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants in Remission at Week 24 | Week 24 | A participant is considered to be in remission at Week 24 if the Birmingham Vasculitis Activity Score version 3 (BVAS v3) is 0 at Week 24 and no rescue medication was required. BVAS v3 is a measure of vasculitis disease activity, with a score of 0 indicating no active disease. |
| Primary | Incidence of Treatment-Emergent Adverse Events (TEAEs) Through Week 24 | Baseline through Week 24 | TEAEs will be classified according to severity and seriousness and summarized through Week 24. Participants may experience more than one TEAE. |
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters Through Week 24 | Baseline through Week 24 | |
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs Through Week 24 | Baseline through Week 24 | |
| Secondary | Number of Participants With Clinically Significant Changes in Physical Examination Findings Through Week 24 | Baseline through Week 24 | |
| Secondary | Number of Participants With Clinically Significant Injection Site Reactions Through Week 24 | Baseline through Week 24 | |
| Secondary | Incidence of TEAEs Through Week 52 | Baseline through Week 52 | TEAEs will be classified according to severity and seriousness and summarized through Week 52. Participants may experience more than one TEAE. |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | Baseline through Week 24 | Change from baseline in estimated glomerular filtration rate through Week 24. |
| Secondary | Time to Remission | Up to Week 24 | Time to remission is defined as the time to achieve a BVAS v3 score of 0. BVAS v3 measures disease activity in systemic vasculitis, with higher scores indicating greater disease activity. A score of 0 indicates no active disease. |
| Secondary | Duration of Remission | Up to Week 24 | Duration of Remission is defined as the time from the first achievement of a BVAS v3 score of 0 on or before Week 24 to the first major relapse. Relapse is classified as major or minor based on recurrent disease activity following remission, as assessed using BVAS v3 criteria. |
| Secondary | Proportion of Participants Experiencing a Major or Minor Relapse After Achieving Remission | Up to Week 24 | Relapse is classified as major or minor based on recurrent disease activity following remission, as assessed using BVAS v3 criteria. |
| Secondary | Proportion of Participants in Glucocorticoid-Free Remission at Week 24 | Week 24 | Glucocorticoid-free remission is defined as a BVAS v3 score of 0 at Week 24 and no systemic glucocorticoid use after Week 20 through Week 24. |
| Secondary | Change From Baseline in Urine Protein-to-Creatinine Ratio | Baseline through Week 24 | |
| Secondary | Change From Baseline in Hematuria | Baseline through Week 24 | Assesses the change from baseline through Week 24 in the amount of blood present in the urine (hematuria), based on laboratory measurements. |
| Secondary | Proportion of Participants With Complete Resolution of Hematuria | Up to Week 24 | Percentage of participants with complete resolution of hematuria through Week 24. |
| Secondary | Cumulative Oral Glucocorticoid Dose | Week 24 | Cumulative oral glucocorticoid dose (in milligrams \[mg\]) at Week 24. |
| Secondary | Incidence of Infection-Related Treatment-Emergent Adverse Events through Week 52 | Baseline through Week 52 | Incidence of Infection-Related Treatment-Emergent Adverse Events will be summarized through Week 52. Participants may experience more than one infection-related TEAE. |
| Secondary | Serum Pharmacokinetic (PK) Concentrations Over Time | Baseline through Week 52 | Evaluation of serum PK concentrations over time. |
| Secondary | VIS954 Percentage Receptor Occupancy | Baseline through Week 52 | Pharmacodynamic parameter to characterize and evaluate VIS954 binding to target receptor. |
| Secondary | Number of Participants With Serum Anti-Drug Antibodies (ADA) Over Time | Baseline through Week 52 | The proportion of participants with treatment-emergent anti-drug antibodies (ADA) in serum will be assessed at scheduled time points throughout the study. |
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.
For software
Read this list from software.
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