Efficacy and Safety Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

NCT ID: NCT05093855

Last Updated: 2023-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-18

Study Completion Date

2023-08-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to explore whether BDB-001 Injection is effective and safe in the treatment of moderate to severe hidradenitis suppurativa(HS).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hidradenitis Suppurativa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group

Group Type EXPERIMENTAL

BDB-001 Injection

Intervention Type DRUG

Multiple IV infusions of BDB-001 Injection diluted in sodium chloride

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BDB-001 Injection

Multiple IV infusions of BDB-001 Injection diluted in sodium chloride

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects who signed the informed consent to participate in the STS-BDB001-06 clinical study and completed all follow-up of the study as required by the protocol, or who withdrew early due to treatment failure or other objective reasons and completed the early withdrawal visit (at least 4 weeks of treatment)

Exclusion Criteria

* Never participated in the clinical study of STS-BDB001-06;
* Subjects withdrew from the STS-BDB001-06 clinical study due to an intolerable adverse event related to the study drug.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Staidson (Beijing) Biopharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Baoxi Wang, Master

Role: PRINCIPAL_INVESTIGATOR

Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Union Hospital Tongji Medical College Huazong University of Science and Technology

Wuhan, Hubei, China

Site Status

Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status

Chinese Academy of Medical Sciences and Peking Union Medical College

Nanjing, Jiangsu, China

Site Status

The First Hospital of Jilin Universitv

Changchun, Jilin, China

Site Status

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

The Second Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, China

Site Status

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China

Site Status

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STS-BDB001-08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.