A Phase 2 interventional study of Obinutuzumab beta and Glucocorticoids in ANCA-Associated Glomerulonephritis (AAGN) and ANCA-Associated Vasculitis (AAV), sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Chinese PLA General Hospital · Phase 2, Interventional, and Treatment
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Among 57 studies in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis with a site in China — 42 open to participants now, 46 under way, 1 of them phase 3. Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis · China.
Among the 57 studies in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis with a site in China, this one is the 23rd largest by planned enrollment of the 52 interventional ones that give a count, is one of 9 that started in 2026, is one of 4 in phase 2, reaches primary completion later than 40 of the 45 other live ones, and was the 56th registered.
158 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 76 are open to participants now.
Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →42 of the 57 studies in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis with a site in China are open now. Recruiting first, the newest first:
The Children's Hospital of Zhejiang University School of Medicine · Sites in China
Ages 3+
Shanghai Changzheng Hospital · Sites in China
Ages 18–65
Changhai Hospital · Sites in China
Ages 18–70
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18+
Peking University Third Hospital · Sites in China
Ages 18–80
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 56 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies recruiting now, 21 (38%) set no upper age limit and 28 (50%) stop at 75 or younger; 9 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
57 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 35 · Phase 2 8 · Phase 3 1 · Phase 4 3
First in 2014; this study’s year is marked. 9 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 36 across 117 interventional studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.
Median enrollment 18 across the 52 interventional studies, 80 across the 5 observational. Of the 5 that completed or were terminated, 1 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
19 of 57 have an industry lead sponsor. The 10 most frequent:
Chinese PLA General Hospital is the lead sponsor of 571 studies on the registry; 207 are open to participants now.
Chinese PLA General Hospital has 1 study filed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis — fewer than ten, so there is no comparison to draw.
20 of the studies in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07168161Phase 3Staidson (Beijing) Biopharmaceuticals Co., LtdBDB-001 Phase III Trial in ANCA-Associated Vasculitis | 2027-04-16 |
| NCT07236762China Immunotech (Beijing) Biotechnology Co., Ltd.An Exploratory Clinical Study of YTS109 Cell for R/R Autoimmune Diseases | 2026-11-24 |
| NCT06388941Novartis PharmaceuticalsIptacopan in Patients With ANCA Associated Vasculitis | 2026-12-30 |
| NCT07033299Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe Safety, Efficacy, and Cellular Metabolic Kinetics of CT1192 in Treating Patients With Anti Neutrophil Cytoplasmic Antibody Associated Vasculitis | 2026-12-31 |
| NCT06285279Nanjing University School of MedicineThe BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases | 2026-12-31 |
Add all 20 to your calendar (.ics) → With an account.
Among the 57 studies in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN).
This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN). The primary objective is to assess the complete remission rate at Week 24.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive Obinutuzumab beta intravenous infusion during induction phase, combined with oral glucocorticoids following a prespecified rapid tapering schedule aiming for complete discontinuation by Week 24.
Drug: Obinutuzumab beta · Drug: Glucocorticoids
Intravenous infusion of Obinutuzumab beta administered during the induction phase.
Also known as: MIL62
Oral glucocorticoid induction starting alongside Obinutuzumab beta, following a prespecified rapid tapering schedule aimed at complete discontinuation by Week 24.
Complete Remission (CR) rate
Proportion of participants achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and complete withdrawal of oral glucocorticoids
Time frame: Month 6 (Week 24)
Renal Remission (RR) rate
Proportion of participants achieving renal remission, defined by stabilization or improvement in renal function and resolution of active urinary sediment.
Time frame: Up to Month 12
Change in estimated Glomerular Filtration Rate (eGFR)
Dynamic change of eGFR from baseline.
Time frame: Up to Month 12
Change in proteinuria
Dynamic change of 24-hour urine protein or Urine Protein-to-Creatinine Ratio (UPCR) from baseline.
Time frame: Up to Month 12
Incidence of End-Stage Renal Disease (ESRD) or death
Proportion of participants reaching the composite endpoint of ESRD or all-cause mortality.
Time frame: Up to Month 12
Overall Remission rate
Proportion of participants achieving a BVAS of 0.
Time frame: Up to Month 12
Proportion of participants achieving peripheral B-cell depletion
Pharmacodynamic assessment of peripheral B-cell count changes from baseline.
Time frame: Up to Month 12
Change in ANCA serological status and titer levels
Proportion of participants achieving ANCA negativity and changes in ANCA titers from baseline.
Time frame: Up to Month 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Safety and tolerability evaluated by the number and severity of AEs graded according to CTCAE v6.0.
Time frame: Up to Month 12
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Oct 2028, 26 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Anti-CD20 Monoclonal Antibody MIL62
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis →
Chinese PLA General Hospital →