Skip to main content
OpenTrials
Completed

NCT Number: NCT05093855

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BDB-001 injection

Drug

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

Primary outcomes

  1. Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point

    Time frame: Week 8

    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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 7. Change in Dermatology visual analog scale (VAS) score from Day 0 by time point.

    Time frame: From Day 0 until Day 56]

  8. Safety of BDB-001 injection in the treatment of patients with HS will be assessed

    Time frame: From Day 0 until Day 77

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Sponsors and collaborators

Lead sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2021
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.