Trial · NCT07168161
BDB-001 Phase III Trial in ANCA-Associated Vasculitis
NCT07168161, Phase 3, Recruiting, Staidson (Beijing) Biopharmaceuticals Co., Ltd
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BDB-001 Phase III Trial in ANCA-Associated Vasculitis. Trials, record NCT07168161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07168161
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BDB-001 Phase III Trial in ANCA-Associated Vasculitis
- NCT number
- NCT07168161
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Conditions
- ANCA Associated Vasculitis (AAV)
- Interventions
- BDB-001 injection, Cyclophosphamide, Rituximab, Azathioprine, Prednisone
- First posted
- 2025-09-11
- Last updated
- 2026-08-13
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS) | Week 24 | |
| Secondary | The proportion of patients achieving disease sustained remission assessed by Birmingham Vasculitis Activity Score (BVAS) | Week 48 | |
| Secondary | Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission in the Study | Week 48 | |
| Secondary | Percentage of Participants With BVAS of 0 at Week 4 | Week 4 | |
| Secondary | In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Estimated glomerular filtration rate (eGFR) | Baseline, Week 24 and Week 48 | |
| Secondary | In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Urinary albumin:creatinine ratio (UACR) | Baseline, Week 4, 24 and 48 | |
| Secondary | Glucocorticoid-induced Toxicity as Measured by Change From Baseline in the GTI | Baseline, Week 24 and 48 | |
| Secondary | Cumulative dose of glucocorticoids | Week 24 and 48 | |
| Secondary | Change from baseline in the Vasculitis Damage Index (VDI) | Baseline, Week 24 and 48 | |
| Secondary | Change From Baseline in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36 | Baseline, Week 24 and 48 |
Source ClinicalTrials.gov
Outcomes0
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/NCT07168161
GET https://conductscience.org/api/trials/v1/NCT07168161/registered