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

A Multicenter, Open-label, Phase II Study to Explore Efficacy and Safety of BDB-001 Injection in Subjects With Moderate to Severe Hidradenitis Suppurativa

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).

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: BDB-001 Injection

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Du Zhouqi; Phone Number: +86 17600505723; Email: duzhouqi@staidson.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Beijing, Beijing, China, 100144
      • Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  • Guangdong
    • Guangzhou, Guangdong, China, 51063
      • The Third Affiliated Hospital of Sun Yat-Sen University
  • Hubei
    • Wuhan, Hubei, China, 100005
      • Union Hospital Tongji Medical College Huazong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital, Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210042
      • Chinese Academy of Medical Sciences and Peking Union Medical College
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin Universitv
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • The First Hospital of China Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shaanxi, China, 710004
      • The Second Affiliated Hospital of Air Force Medical University
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital of Fudan University
    • Shanghai, Shanghai, China, 200443
      • Shanghai Skin Disease Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group	Drug: BDB-001 Injection; Multiple IV infusions of BDB-001 Injection diluted in sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Day 0 until Day 56
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.	From Day 0 until Day 56
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.	From Day 0 until Day 56
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.	From Day 0 until Day 56
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.	From Day 0 until Day 56
Changes of active lesions (number of inflammatory nodules, abscesses, fistulas, and abscess overflow score) from Day 0 by time point.		From Day 0 until Day 56
7. Change in Dermatology visual analog scale (VAS) score from Day 0 by time point.		From Day 0 until Day 56]
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.	From Day 0 until Day 77

Collaborators and Investigators

• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Investigators: Principal Investigator: Baoxi Wang, Master, Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): August 22, 2023
• Study Completion (Actual): August 22, 2023

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: STS-BDB001-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No