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NCT Number: NCT05103423

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

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

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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 1 / Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

BDB-001 injection

Drug

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

Placebo

Drug

Multiple IV infusions of Placebo Injection diluted in sodium chloride

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

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. 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.

Sponsors and collaborators

Lead sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2021
Registry last updated
Mar 26, 2024

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.

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