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

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
BDB-001 Injection
Sponsored by
Staidson (Beijing) Biopharmaceuticals Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University First Hospital
  • Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  • The Third Affiliated Hospital of Sun Yat-sen University
  • Union Hospital Tongji Medical College Huazong University of Science and Technology
  • Xiangya Hospital, Central South University
  • Chinese Academy of Medical Sciences and Peking Union Medical College
  • The First Hospital of Jilin Universitv
  • The First Hospital of China Medical University
  • The Second Affiliated Hospital of Air Force Medical University
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Qilu Hospital of Shandong University
  • Huashan Hospital of Fudan University
  • Shanghai Skin Disease Hospital
  • West China Hospital of Sichuan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Outcomes

Primary Outcome Measures

Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
The International Hidradenitis Suppurativa Severity Score 4 (IHS4: developed by the European Hidradenitis Suppurativa Foundation Investigator Group)，IHS4 Score=(Nodule Count) + (Abscess Count*2) + (Draining Tunnel Count *4). IHS4 score uses a range grades: Mild=0-3; Moderate=4-10; Severe ≥11.

Secondary Outcome Measures

Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
The International Hidradenitis Suppurativa Severity Score 4 (IHS4: developed by the European Hidradenitis Suppurativa Foundation Investigator Group)，IHS4 Score=(Nodule Count) + (Abscess Count*2) + (Draining Tunnel Count *4). IHS4 score uses a range grades: Mild=0-3; Moderate=4-10; Severe ≥11.
Change in modified Sartorius Score (mSS) from Day 0 by time point
The mSS is a summation of HS lesions based on a number of factors including anatomical region, number and type of lesions, distance between relevant lesions and lesions clearly separated by normal skin in each region measured as HS clinical parameters. The scale title for mSS is points. The mSS has a minimum value of 0 and no upper limit. The higher the score the more severe is the disease/worse is the outcome.
Change in Hidradenitis Suppurativa Clinical Response (HiSCR) from Day 0 by time point
The definition for response to treatment based on HiSCR relative to Baseline was: at least 50% reduction in abscesses and inflammatory nodule (AN) count (over all anatomical regions) with no increase in number of abscesses and in number of draining fistulas.
Change in Hidradenitis suppurativa-Physician Global Assessment (HS-PGA) score from Day 0 by time point
Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA)classifies patients' severity into six categories:clear, minimal, mild, moderate, severe, and very severe, based on the number and quality of inflammatory lesions.
Changes of active lesions (number of inflammatory nodules, abscesses, fistulas, and abscess overflow score) from Day 0 by time point.
Change in Dermatology Life Quality Index (DLQI) score from Day 0 by time point
A score is documented for each of the 10 DLQI items, ranging from 0 to 3 for each item. The scale title for DLQI is points. The total score is the sum of the responses to all 10 DLQI items, ranging from the minimum of 0 points to the maximum of 30 points. A higher score corresponds to worse health related quality of life/outcome.
7. Change in Dermatology visual analog scale (VAS) score from Day 0 by time point.
Safety of BDB-001 injection in the treatment of patients with HS will be assessed
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Full Information

First Posted
June 23, 2021
Last Updated
August 28, 2023
Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05093855
Brief Title
Efficacy and Safety Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Official Title
A Multicenter, Open-label, Phase II Study to Explore Efficacy and Safety of BDB-001 Injection in Subjects With Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
August 22, 2023 (Actual)
Study Completion Date
August 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BDB-001 Injection
Intervention Description
Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
Primary Outcome Measure Information:
Title
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
Description
The International Hidradenitis Suppurativa Severity Score 4 (IHS4: developed by the European Hidradenitis Suppurativa Foundation Investigator Group)，IHS4 Score=(Nodule Count) + (Abscess Count*2) + (Draining Tunnel Count *4). IHS4 score uses a range grades: Mild=0-3; Moderate=4-10; Severe ≥11.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
Description
The International Hidradenitis Suppurativa Severity Score 4 (IHS4: developed by the European Hidradenitis Suppurativa Foundation Investigator Group)，IHS4 Score=(Nodule Count) + (Abscess Count*2) + (Draining Tunnel Count *4). IHS4 score uses a range grades: Mild=0-3; Moderate=4-10; Severe ≥11.
Time Frame
From Day 0 until Day 56
Title
Change in modified Sartorius Score (mSS) from Day 0 by time point
Description
The mSS is a summation of HS lesions based on a number of factors including anatomical region, number and type of lesions, distance between relevant lesions and lesions clearly separated by normal skin in each region measured as HS clinical parameters. The scale title for mSS is points. The mSS has a minimum value of 0 and no upper limit. The higher the score the more severe is the disease/worse is the outcome.
Time Frame
From Day 0 until Day 56
Title
Change in Hidradenitis Suppurativa Clinical Response (HiSCR) from Day 0 by time point
Description
The definition for response to treatment based on HiSCR relative to Baseline was: at least 50% reduction in abscesses and inflammatory nodule (AN) count (over all anatomical regions) with no increase in number of abscesses and in number of draining fistulas.
Time Frame
From Day 0 until Day 56
Title
Change in Hidradenitis suppurativa-Physician Global Assessment (HS-PGA) score from Day 0 by time point
Description
Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA)classifies patients' severity into six categories:clear, minimal, mild, moderate, severe, and very severe, based on the number and quality of inflammatory lesions.
Time Frame
From Day 0 until Day 56
Title
Changes of active lesions (number of inflammatory nodules, abscesses, fistulas, and abscess overflow score) from Day 0 by time point.
Time Frame
From Day 0 until Day 56
Title
Change in Dermatology Life Quality Index (DLQI) score from Day 0 by time point
Description
A score is documented for each of the 10 DLQI items, ranging from 0 to 3 for each item. The scale title for DLQI is points. The total score is the sum of the responses to all 10 DLQI items, ranging from the minimum of 0 points to the maximum of 30 points. A higher score corresponds to worse health related quality of life/outcome.
Time Frame
From Day 0 until Day 56
Title
7. Change in Dermatology visual analog scale (VAS) score from Day 0 by time point.
Time Frame
From Day 0 until Day 56]
Title
Safety of BDB-001 injection in the treatment of patients with HS will be assessed
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame
From Day 0 until Day 77

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baoxi Wang, Master
Organizational Affiliation
Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100144
Country
China
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
51063
Country
China
Facility Name
Union Hospital Tongji Medical College Huazong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
100005
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Chinese Academy of Medical Sciences and Peking Union Medical College
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210042
Country
China
Facility Name
The First Hospital of Jilin Universitv
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
The Second Affiliated Hospital of Air Force Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Huashan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Skin Disease Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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