New drug aims to tame rare blood vessel disease
NCT ID NCT07168161
First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 5 times
Summary
This Phase 3 trial is testing whether adding BDB-001 to standard treatments (cyclophosphamide, azathioprine, rituximab, or prednisone) helps more people with ANCA-associated vasculitis achieve remission. The study plans to enroll 300 adults with active GPA or MPA. Participants will be randomly assigned to receive BDB-001 or a placebo, and doctors will track disease activity using a standard scoring system.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BDB-001 injection (given alongside cyclophosphamide, azathioprine, rituximab, or prednisone)
- What this could lead to
- If successful, BDB-001 could become a new add-on treatment to help more people with ANCA vasculitis reach remission and stay in remission longer.
- What could go wrong
- This is still an experimental drug in a Phase 3 trial. It may not work better than standard therapy alone, and there could be unknown side effects. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 18 years old≤Age≤75 years old, male or female; 2. Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA)； 3. Newly diagnosed or relapsed GPA or MPA that requires treatment with a full starting dose of prednisone plus cyclophosphamide/azathioprine or rituximab； 4. Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)； 5. Estimated glomerular filtration rate ≥15 mL/minute/1.73 m\^2； 6. At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS； Exclusion Criteria: 1. Active tuberculosis infection; 2. alveolar hemorrhage requiring pulmonary ventilation support； 3. History of any malignancy of any organ system within 5 years prior to the first dose, except for basal cell carcinoma of the skin or carcinoma in situ (e.g., cervical or breast carcinoma in situ) that has been completely resected and shows no evidence of local recurrence or metastasis. 4. Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus, IgA vasculitis (Henoch-Schönlein), rheumatoid vasculitis,anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis； 5. HBsAg positive,or HBcAb positive and HBV-DNA positive； 6. Received CYC within 3 months before the first administration or Received rituximab(RTX) or other B-cell antibody within 12 months before the first administration； 7. Received glucocorticoid shock therapy within 4 weeks before the first administration； 8. Received an oral daily dose of a GC of \> 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration； 9. Received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration； 10. Received Continuous dialysis treatment for 12 weeks or more before the first administration; Received Dialysis within 1 week before the first administration; 11. Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before the first administration; 12. Pregnant or lactating.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for ANCA-associated vasculitis (AAV) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
65 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITINGHohhot, Neimenggu, 010050, China
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Affiliated Hospital of Yanbian University (Yanbian Hospital)
NOT_YET_RECRUITINGYanbian, Jilin, 133000, China
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Beijing Tsinghua Changgung Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 102218, China
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Cangzhou City People's Hospital
NOT_YET_RECRUITINGCangzhou, Hebei, 061000, China
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General Hospital of Hunan University of Medicine
NOT_YET_RECRUITINGChangde, Hunan, 415000, China
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General Hospital of Hunan University of Medicine
NOT_YET_RECRUITINGHuaihua, Hunan, 418000, China
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Guangdong General Hospital
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510080, China
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Guangdong Provincial People's Hospital
NOT_YET_RECRUITINGShenzhen, Guangdong, 510080, China
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Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region
NOT_YET_RECRUITINGNanning, Guangxi Zhuang Autonomous Region (gzar), 530016, China
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Guizhou Provincial People's Hospital
NOT_YET_RECRUITINGGuiyang, Guizhou, 550002, China
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Hunan Provincial People's Hospital
RECRUITINGChangsha, Hunan, 410005, China
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Jiang Su Province Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210029, China
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Jiangxi Provincial People's Hospital
NOT_YET_RECRUITINGNanchang, Jiangxi, 330006, China
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Kailuan General Hospital
NOT_YET_RECRUITINGTangshan, Hebei, 063000, China
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Liuzhou People's Hospital
NOT_YET_RECRUITINGLiuzhou, Guangxi, 545006, China
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Meizhou People's Hospital
NOT_YET_RECRUITINGMeizhou, Guangdong, 514031, China
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Nanjing Gulou Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
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Nanjing University School of Medicine Affiliated Gulou Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
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Peking Union Medical College Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100005, China
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Peking University First Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 710000, China
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Peking University International Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 102206, China
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Peking University People's Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100044, China
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Peking University Third Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100191, China
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Peking university Shenzhen Hospital
NOT_YET_RECRUITINGShenzhen, Guangdong, 518036, China
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People's Hospital of Lishui
NOT_YET_RECRUITINGLishui, Zhejiang, 323000, China
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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200025, China
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Shandong Provincial Hospital
NOT_YET_RECRUITINGJinan, Shandong, 250021, China
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Shanxi Bethune Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030032, China
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Shengjing Hospital of China Medical University
NOT_YET_RECRUITINGShengyang, Liaoning, 110004, China
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Sichuan Provincial People's Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, 610072, China
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Sun Yat-sen Memorial Hospital of Sun Yat-sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510120, China
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The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITINGXuzhou, Jiangsu, 221002, China
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The Affiliated Hospital of the Medical School of Ningbo University
NOT_YET_RECRUITINGNingbo, Zhejiang, 315010, China
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The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, 400016, China
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The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITINGNanning, Guangxi, 530021, China
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The First Affiliated Hospital of Henan University of science and Technology
NOT_YET_RECRUITINGLuoyang, Henan, 471003, China
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The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITINGNanchang, Jiangxi, 330006, China
Contact Email: •••••@•••••
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The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITINGXi’an, Shanxi, 710061, China
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The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITINGXiamen, Fujian, 361003, China
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The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITINGÜrümqi, Xinjiang, 830054, China
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The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, 450052, China
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The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, 450052, China
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The First Affiliated Hospital, College of Medicine, Zhejiang University
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310003, China
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The First Hospital of Lanzhou University
NOT_YET_RECRUITINGLanzhou, Gansu, 730000, China
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The First People's Hospital of Yunnan Province
NOT_YET_RECRUITINGKunming, Yunnan, 650032, China
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The Second Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, 400010, China
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The Second Affiliated Hospital of Harbin
NOT_YET_RECRUITINGHarbin, Heilongjiang, 150086, China
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The Second Affiliated Hospital of Nanchang University
NOT_YET_RECRUITINGNanchang, Jiangxi, 330006, China
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The Second Affiliated Hospital of Soochow University
NOT_YET_RECRUITINGSuzhou, Jiangsu, 215004, China
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The Second Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310009, China
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The Second Hospital of Hebei Medical University City:Shijiazhuang
NOT_YET_RECRUITINGShijiazhuang, Hebei, 050004, China
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The Second Hospital of Jilin University
NOT_YET_RECRUITINGChangchun, Jilin, 130041, China
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The Second Hospital of Shanxi Medical University
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030032, China
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The Third People's Hospital of Chengdu
NOT_YET_RECRUITINGChengdu, Sichuan, 610031, China
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Tongji Hospital,Tongji Medical college of Hust
NOT_YET_RECRUITINGWuhan, Hubei, 100005, China
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Weifang People's Hospital
NOT_YET_RECRUITINGWeifang, Shandong, 261041, China
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West China Hospital of Sichuan University
NOT_YET_RECRUITINGChengdu, Sichuan, 610041, China
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Xiangya Hospital Central South University (Nephrology Department)
NOT_YET_RECRUITINGChangsha, Hunan, 410008, China
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Xiangya Hospital Central South University(Rheumatism Immunity Branch)
NOT_YET_RECRUITINGChangsha, Hunan, 410008, China
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Xijing Hospital
NOT_YET_RECRUITINGXi’an, Shanxi, 710032, China
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Yichang Central People's Hospital
NOT_YET_RECRUITINGYichang, Hubei, 443003, China
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Yuebei People's Hospital
NOT_YET_RECRUITINGShaoguan, Guangdong, 512026, China
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Zhejiang Provincial People's Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310014, China
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Zhongshan hospital,Fudan University
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200032, China
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Zhuzhou Central Hospital
NOT_YET_RECRUITINGZhuzhou, Hunan, 412007, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a single cell therapy calm multiple autoimmune diseases?
- Can a targeted antibody tame kidney inflammation without heavy steroids?
- Could a diabetes drug shield kidneys from autoimmune attack?
- Promising vasculitis drug trial halted early
- Experimental liquid drug tested in ventilator patients with rare lung bleeding disease
- Hydroxychloroquine trial for rare vasculitis halted early