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

March 25, 2024 updated by: Staidson (Beijing) Biopharmaceuticals Co., Ltd

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

A study to explore the safety and efficacy of treatment with BDB-001 Injection in adults with moderate to severe hidradenitis suppurativa (HS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing, China, 100144
        • Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College 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
      • Chang chun, 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 First Affiliated Hospital of Air Force Medical University
      • Xian, Shaanxi, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Multiple IV infusions of Placebo Injection diluted in sodium chloride
Experimental: Treatment group 1
Drug: BDB-001 Injection
Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
Drug: Placebo
Multiple IV infusions of Placebo Injection diluted in sodium chloride
Experimental: Treatment group 2
Drug: BDB-001 Injection
Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
Drug: Placebo
Multiple IV infusions of Placebo Injection diluted in sodium chloride

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame: Week 8
Safety and tolerability of BDB-001 injection after multiple administration in the treatment of HS patients.
Week 8
Number of Participants developing anti-BDB-001 antibodies.
Time Frame: Week 8
Safety and tolerability of BDB-001 injection after multiple administration in the treatment of HS patients.
Week 8
Area under the plasma concentration versus time curve (AUC) of BDB-001 Assessment of pharmacokinetic parameters.
Time Frame: Week 8
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.
Week 8
Peak Plasma Concentration (Cmax) of BDB-001and time to reach Cmax Assessment of pharmacokinetic parameters.
Time Frame: Week 8
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.
Week 8
Minimal Plasma Concentration (Cmin) of BDB-001 Assessment of pharmacokinetic parameters.
Time Frame: Week 8
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.
Week 8
Terminal phase half-life Assessment of pharmacokinetic parameters.
Time Frame: Week 8
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
Time Frame: From Day 0 until Day 56

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
Change in modified Sartorius Score (mSS) from Day 0 by time point
Time Frame: From Day 0 until Day 56
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
Time Frame: From Day 0 until Day 56
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
Time Frame: From Day 0 until Day 56
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
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
From Day 0 until Day 56
Change in Dermatology Life Quality Index (DLQI) score from Day 0 by time point
Time Frame: From Day 0 until Day 56
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
Changes in Pain VAS score from Day 0 by time point
Time Frame: From Day 0 until Day 56
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.
From Day 0 until Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Staidson (Beijing) Biopharmaceuticals Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Baoxi Wang, Master, Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STS-BDB001-06

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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