Clinical trial NCT05197842: Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: ANCA-associated Vasculitis
Lead sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: The proportion of patients achieving disease complete remission assessed by Birmingham Vasculitis Activity Score (BVAS)
timeFrame: 12 weeks
measure: Change from baseline in the Birmingham Vasculitis Activity Score (BVAS)
timeFrame: 4 weeks、8 weeks、12 weeks
measure: Change from baseline in the Vasculitis Damage Index (VDI)
timeFrame: 12 weeks
measure: Change from baseline in Estimated glomerular filtration rate (eGFR)、Urinary albumin:creatinine ratio (UACR)、Urine erythrocyte
timeFrame: 4 weeks、8 weeks、12 weeks
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
timeFrame: 0-24weeks
measure: Number of Participants developing anti-BDB-001 antibodies.
timeFrame: 0-24weeks
measure: Area under the plasma concentration versus time curve (AUC) of BDB-001.
timeFrame: 0-12 weeks
measure: Peak Plasma Concentration (Cmax) of BDB-001 and time to reach Cmax.
timeFrame: 0-12 weeks
measure: Minimal Plasma Concentration (Cmin) of BDB-001.
timeFrame: 0-12 weeks
measure: Terminal phase half-life.
timeFrame: 0-12 weeks
measure: Change from baseline in C5a (mg/dL) concentration.
timeFrame: 0-12 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second hospital Of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University International Hospital
state: Beijing
city: Nanning
country: China
facility: Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi Zhuang Autonomous Region (gzar)
city: Shijiazhuang
country: China
facility: The Second hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Third hospital of Hebei Medical University
state: Hebei
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of science and Technology
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital,Tongji Medical college of Hust
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University (Nephrology Department)
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University(Rheumatism Immunity Branch)
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shengyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia Hui Autonomous Region(NHAR)
city: Shanghai
country: China
facility: Zhongshan hospital,Fudan University
state: Shanghai
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Peking University First Hospital
name: Minghui Zhao, Postdoc
role: PRINCIPAL_INVESTIGATOR
References: