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

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BDB-001 Injection
Placebo
Placebo
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:

  • 18 years old≤Age≤65 years old, male or female;
  • Diagnosis of HS for at least 6 months;
  • HS lesions must be present in at least two distinct anatomical areas, one of which must be at least located in the apocrine sweat gland area and Hurley Stage II or Hurley Stage III;
  • Total abscess and inflammatory nodule (AN) count of ≥ 3.

Exclusion Criteria:

  • Subject was previously treated with adalimumab or another biologic product during the 3 months before the first administration;
  • Subject received any oral antibiotic treatment for HS within 2 weeks before the first administration;
  • Subject received any oral retinoids treatment for HS within 4 weeks before the first administration;
  • Subject received oral opioids analgesics within 1 week before the first administration;
  • Systematic treatment with glucocorticoid or intramural injection within 4 weeks before the first administration;
  • History of heart disease or malignancy.

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 First 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 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Treatment group 1

Treatment group 2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Safety and tolerability of BDB-001 injection after multiple administration in the treatment of HS patients.
Number of Participants developing anti-BDB-001 antibodies.
Safety and tolerability of BDB-001 injection after multiple administration in the treatment of HS patients.
Area under the plasma concentration versus time curve (AUC) of BDB-001 Assessment of pharmacokinetic parameters.
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.
Peak Plasma Concentration (Cmax) of BDB-001and time to reach Cmax Assessment of pharmacokinetic parameters.
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.
Minimal Plasma Concentration (Cmin) of BDB-001 Assessment of pharmacokinetic parameters.
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.
Terminal phase half-life Assessment of pharmacokinetic parameters.
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.

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.
Changes in Pain VAS score from Day 0 by time point
Pain VAS:This is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10) that best reflects the intensity of their pain. The scale title for the VAS is points. The minimum score is 0 points (No skin pain), and the maximum score is 10 points (Skin pain as bad as you can imagine). The higher the score the more severe is the disease/worse is the outcome.

Full Information

First Posted
June 23, 2021
Last Updated
June 26, 2023
Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05103423
Brief Title
Safety and Efficacy Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Official Title
A Multicenter, Randomized, Double-blind, Placebo Parallel-controlled, Phase I/II Study to Explore Safety and Efficacy of BDB-001 Injection in Subjects With Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
June 6, 2023 (Actual)
Study Completion Date
June 6, 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
A study to explore the safety and efficacy of treatment with BDB-001 Injection in adults with 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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group 1
Arm Type
Experimental
Arm Title
Treatment group 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BDB-001 Injection
Intervention Description
Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Multiple IV infusions of Placebo Injection diluted in sodium chloride
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Multiple IV infusions of Placebo Injection diluted in sodium chloride
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Description
Safety and tolerability of BDB-001 injection after multiple administration in the treatment of HS patients.
Time Frame
Week 8
Title
Number of Participants developing anti-BDB-001 antibodies.
Description
Safety and tolerability of BDB-001 injection after multiple administration in the treatment of HS patients.
Time Frame
Week 8
Title
Area under the plasma concentration versus time curve (AUC) of BDB-001 Assessment of pharmacokinetic parameters.
Description
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.
Time Frame
Week 8
Title
Peak Plasma Concentration (Cmax) of BDB-001and time to reach Cmax Assessment of pharmacokinetic parameters.
Description
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.
Time Frame
Week 8
Title
Minimal Plasma Concentration (Cmin) of BDB-001 Assessment of pharmacokinetic parameters.
Description
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.
Time Frame
Week 8
Title
Terminal phase half-life Assessment of pharmacokinetic parameters.
Description
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.
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
Changes in Pain VAS score from Day 0 by time point
Description
Pain VAS:This is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10) that best reflects the intensity of their pain. The scale title for the VAS is points. The minimum score is 0 points (No skin pain), and the maximum score is 10 points (Skin pain as bad as you can imagine). The higher the score the more severe is the disease/worse is the outcome.
Time Frame
From Day 0 until Day 56

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: 18 years old≤Age≤65 years old, male or female; Diagnosis of HS for at least 6 months; HS lesions must be present in at least two distinct anatomical areas, one of which must be at least located in the apocrine sweat gland area and Hurley Stage II or Hurley Stage III; Total abscess and inflammatory nodule (AN) count of ≥ 3. Exclusion Criteria: Subject was previously treated with adalimumab or another biologic product during the 3 months before the first administration; Subject received any oral antibiotic treatment for HS within 2 weeks before the first administration; Subject received any oral retinoids treatment for HS within 4 weeks before the first administration; Subject received oral opioids analgesics within 1 week before the first administration; Systematic treatment with glucocorticoid or intramural injection within 4 weeks before the first administration; History of heart disease or malignancy.
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
Chang chun
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 First 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
Xian
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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Safety and Efficacy Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

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