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Hidradenitis SuppurativaPhase 2NCT05093855

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

A Phase 2 study testing BDB-001 Injection in people with Hidradenitis Suppurativa, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
BDB-001 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
15 sitesChina
Study dates
18 Aug 2021to 22 Aug 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100144

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin Universitv

    Changchun, Jilin, 130021

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 51063

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Chinese Academy of Medical Sciences and Peking Union Medical College

    Nanjing, Jiangsu, 210042

  • Huashan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality, 200443

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110000

  • Union Hospital Tongji Medical College Huazong University of Science and Technology

    Wuhan, Hubei, 100005

  • The Second Affiliated Hospital of Air Force Medical University

    Xi'an, Shaanxi, 710004

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

Other trials in China

About this study

Official 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

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).

Being tested
BDB-001 Injection
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BDB-001 InjectionDrug

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

Study groups in NCT05093855
Study groupRoleWhat they receive
Treatment groupExperimentalNot described
Receives: Drug: BDB-001 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 8

Secondary outcomes (8)

  1. 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.

    Measured: From Day 0 until Day 56

  2. 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.

    Measured: From Day 0 until Day 56

  3. 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.

    Measured: From Day 0 until Day 56

  4. 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.

    Measured: From Day 0 until Day 56

  5. Changes of active lesions (number of inflammatory nodules, abscesses, fistulas, and abscess overflow score) from Day 0 by time point.

    Measured: From Day 0 until Day 56

  6. 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.

    Measured: From Day 0 until Day 56

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

    Measured: From Day 0 until Day 56]

  8. 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.

    Measured: From Day 0 until Day 77

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2021
  2. Study start18 Aug 2021
  3. Primary completion22 Aug 2023
  4. Study completion22 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05093855
Sponsor's protocol ID
STS-BDB001-08
Status last verified
Aug 2023
First submitted
23 Jun 2021
Last updated
29 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BDB-001 Injection in people with Hidradenitis Suppurativa, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05093855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.

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