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

Sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05197842

Collaborator

Beijing Defengrei Biotechnology Co.,Ltd (Other)

Enrollment

Locations

Arms

18.3

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
ANCA-associated Vasculitis	Drug: BDB-001 injection Drug: Cyclophosphamide Drug: Glucocorticoids Drug: BDB-001 injection Drug: Cyclophosphamide Drug: Glucocorticoids Drug: Cyclophosphamide Drug: Glucocorticoids	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 22, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A BDB-001 injection low dose plus reduced dose glucocorticoids in combination with cyclophosphamide	Drug: BDB-001 injection Intravenously administered Drug: Cyclophosphamide Intravenously administered Drug: Glucocorticoids Orally administered Other Names: Prednisone
Experimental: Group B BDB-001 injection high dose plus reduced dose glucocorticoids in combination with cyclophosphamide	Drug: BDB-001 injection Intravenously administered Drug: Cyclophosphamide Intravenously administered Drug: Glucocorticoids Orally administered Other Names: Prednisone
Active Comparator: Group C Standard dose glucocorticoids in combination with cyclophosphamide	Drug: Cyclophosphamide Intravenously administered Drug: Glucocorticoids Orally administered Other Names: Prednisone

Arm

Intervention/Treatment

Experimental: Group A

BDB-001 injection low dose plus reduced dose glucocorticoids in combination with cyclophosphamide

Drug: BDB-001 injection

Intravenously administered

Drug: Cyclophosphamide

Intravenously administered

Drug: Glucocorticoids

Orally administered

Other Names:

Prednisone

Experimental: Group B

BDB-001 injection high dose plus reduced dose glucocorticoids in combination with cyclophosphamide

Drug: BDB-001 injection

Intravenously administered

Drug: Cyclophosphamide

Intravenously administered

Drug: Glucocorticoids

Orally administered

Other Names:

Prednisone

Active Comparator: Group C

Standard dose glucocorticoids in combination with cyclophosphamide

Drug: Cyclophosphamide

Intravenously administered

Drug: Glucocorticoids

Orally administered

Other Names:

Prednisone

Outcome Measures

Primary Outcome Measures

The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS) [12 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 ≥20 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 or latent 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 multi-system autoimmune disease；
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 treatment, biological therapy, intravenous immunoglobulin (Ig) or plasma exchange, antithymocyte globulin, required renal dialysis or kidney transplant within 12 weeks before the first administration；
Pregnant or lactating.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second hospital Of Anhui Medical University	Hefei	Anhui	China	230601
2	Peking Union Medical College Hospital	Beijing	Beijing	China	100005
3	Peking University First Hospital	Beijing	Beijing	China	100034
4	Peking University International Hospital	Beijing	Beijing	China	102206
5	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510075
6	Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi Zhuang Autonomous Region (gzar)	China	530016
7	The Second hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050004
8	The Third hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050051
9	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
10	Tongji Hospital,Tongji Medical college of Hust	Wuhan	Hubei	China	100005
11	Xiangya Hospital Central South University (Nephrology Department)	Changsha	Hunan	China	410008
12	Xiangya Hospital Central South University(Rheumatism Immunity Branch)	Changsha	Hunan	China	410008
13	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330006
14	Shengjing Hospital of China Medical University	Shengyang	Liaoning	China	110004
15	The First Hospital of China Medical University	Shenyang	Liaoning	China	110001
16	General Hospital of Ningxia Medical University	Yinchuan	Ningxia Hui Autonomous Region(NHAR)	China	750003
17	Zhongshan hospital,Fudan University	Shanghai	Shanghai	China	200032
18	Xijing Hospital	Xi'an	Shanxi	China	710032
19	The First Affiliated Hospital of Xi'an Jiao Tong University	Xi'an	Shanxi	China	710061
20	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

Staidson (Beijing) Biopharmaceuticals Co., Ltd
Beijing Defengrei Biotechnology Co.,Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Staidson (Beijing) Biopharmaceuticals Co., Ltd

ClinicalTrials.gov Identifier:

NCT05197842

Other Study ID Numbers:

STS-BDB001-07

First Posted:

Jan 20, 2022

Last Update Posted:

May 5, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vasculitis

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Prednisone

Cyclophosphamide

Glucocorticoids

Study Results

No Results Posted as of May 5, 2022