Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis

ANCA-associated Vasculitis Clinical Trial

Official title:

A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase I/II Trial to Study Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With ANCA-associated Vasculitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05197842
• Other study ID #: STS-BDB001-07
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 22, 2022
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Contact: Zheng Xiaohong
• Phone: +86 13811686425
• Email: zhengxiaohong[@]staidson.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the trial is to study the efficacy and safety of treatment with BDB-001 Injection substitution of glucocorticoid in patients with ANCA-associated vasculitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 years old=Age=75 years old, male or female;

• Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA);

• Newly diagnosed or relapsed GPA or MPA that requires treatment with cyclophosphamide(CYC) and glucocorticoids(GCs);

• Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO);

• Estimated glomerular filtration rate =15 mL/minute/1.73 m^2;

• At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS;

Exclusion Criteria:

• Active tuberculosis infection;

• Severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage requiring pulmonary ventilation support, rapid-onset mononeuritis multiplex or central nervous system involvement;

• 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;

• HBsAg positive,or HBcAb positive and HBV-DNA positive;

• Received CYC within 3 months before the first administration or Received rituximab(RTX) within 12 months before the first administration;

• Received glucocorticoid shock therapy within 4 weeks before the first administration;

• Received an oral daily dose of a GC of > 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration;

• Received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration;

• Received Continuous dialysis treatment for 12 weeks or more before the first administration; Received Dialysis within 1 week before the first administration;

• Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before the first administration;

• Pregnant or lactating.

Related Conditions & MeSH terms

• ANCA-associated Vasculitis
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Vasculitis

Intervention

Drug:
• BDB-001 injection
Intravenously administered
• Cyclophosphamide
Intravenously administered
• Glucocorticoids
Orally administered

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University International Hospital	Beijing	Beijing
China	Xiangya Hospital Central South University (Nephrology Department)	Changsha	Hunan
China	Xiangya Hospital Central South University(Rheumatism Immunity Branch)	Changsha	Hunan
China	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The Second hospital Of Anhui Medical University	Hefei	Anhui
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi Zhuang Autonomous Region (gzar)
China	Zhongshan hospital,Fudan University	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shengyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The Second hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Third hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tongji Hospital,Tongji Medical college of Hust	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiao Tong University	Xi'an	Shanxi
China	Xijing Hospital	Xi'an	Shanxi
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia Hui Autonomous Region(NHAR)
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Staidson (Beijing) Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS)		12 weeks
Secondary	The proportion of patients achieving disease complete remission assessed by Birmingham Vasculitis Activity Score (BVAS)		12 weeks
Secondary	Change from baseline in the Birmingham Vasculitis Activity Score (BVAS)		4 weeks?8 weeks?12 weeks
Secondary	Change from baseline in the Vasculitis Damage Index (VDI)		12 weeks
Secondary	Change from baseline in Estimated glomerular filtration rate (eGFR)?Urinary albumin:creatinine ratio (UACR)?Urine erythrocyte		4 weeks?8 weeks?12 weeks
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.	Safety and tolerability indexes of BDB-001 injection for multiple administration of ANCA-associated vasculitis(AAV) patients	0-24weeks
Secondary	Number of Participants developing anti-BDB-001 antibodies.	Safety and tolerability indexes of BDB-001 injection for multiple administration of ANCA-associated vasculitis(AAV) patients	0-24weeks
Secondary	Area under the plasma concentration versus time curve (AUC) of BDB-001.	Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.	0-12 weeks
Secondary	Peak Plasma Concentration (Cmax) of BDB-001 and time to reach Cmax.	Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.	0-12 weeks
Secondary	Minimal Plasma Concentration (Cmin) of BDB-001.	Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.	0-12 weeks
Secondary	Terminal phase half-life.	Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.	0-12 weeks
Secondary	Change from baseline in C5a (mg/dL) concentration.		0-12 weeks