Hidradenitis SuppurativaPhase 1/2NCT05103423
Safety and Efficacy Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
A Phase 1/2 study testing BDB-001 Injection in people with Hidradenitis Suppurativa, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 15 sites in China.
Trial summary
A study to explore the safety and efficacy of treatment with BDB-001 Injection in adults with 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?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 15 sitesChina
- Study dates
- 24 Jun 2021to 7 Jul 2023
- Phase
- Phase 1/2
- 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
- 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.
Who cannot join
- 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.
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 First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710004
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
About this study
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
A study to explore the safety and efficacy of treatment with BDB-001 Injection in adults with moderate to severe hidradenitis suppurativa (HS).
- Conditions
- Hidradenitis Suppurativa
- Being tested
- BDB-001 Injection, Placebo
- 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
PlaceboDrug
Multiple IV infusions of Placebo Injection diluted in sodium chloride
PlaceboDrug
Multiple IV infusions of Placebo Injection diluted in sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | Not described Receives: Drug: BDB-001 Injection; Drug: Placebo |
| Treatment group 2 | Experimental | Not described Receives: Drug: BDB-001 Injection; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Number of Participants developing anti-BDB-001 antibodies.
Safety and tolerability of BDB-001 injection after multiple administration in the treatment of HS patients.
Measured: Week 8
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.
Measured: Week 8
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.
Measured: Week 8
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.
Measured: Week 8
Terminal phase half-life Assessment of pharmacokinetic parameters.
To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.
Measured: Week 8
Secondary outcomes (7)
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
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
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
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
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
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
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.
Measured: From Day 0 until Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start24 Jun 2021
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baoxi Wang, Master, Principal investigator, Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103423
- Sponsor's protocol ID
- STS-BDB001-06
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2021
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05103423
- Acronym / sponsor ID
- STS-BDB001-06
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to explore the safety and efficacy of treatment with BDB-001 Injection in adults with moderate to severe hidradenitis suppurativa (HS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Drug: BDB-001 Injection, Drug: Placebo |
| Treatment group 2 | Experimental | Drug: BDB-001 Injection, Drug: Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BDB-001 InjectionMultiple IV infusions of BDB-001 Injection diluted in sodium chloride | Drug | Treatment group 1, Treatment group 2 |
| PlaceboMultiple IV infusions of Placebo Injection diluted in sodium chloride | Drug | Treatment group 1, Treatment group 2 |
| PlaceboMultiple IV infusions of Placebo Injection diluted in sodium chloride | Drug | Placebo |
Primary outcome
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.
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.
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.
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.
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.
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.
7 secondary outcomes
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
Time frame: 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
Change in Hidradenitis Suppurativa Clinical Response (HiSCR) from Day 0 by time point
Time frame: 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
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
Change in Dermatology Life Quality Index (DLQI) score from Day 0 by time point
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
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Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
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A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
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Acceptability of MBSR for People With HS
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Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baoxi Wang, Master principal investigator
Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 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 4 inclusion and 6 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 26 Mar 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. (time frame: Week 8). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2024.