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

Hidradenitis Suppurativa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05103423
• Other study ID #: STS-BDB001-06
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 24, 2021
• Est. completion date: July 7, 2023

Study information

• Verified date: June 2023
• Source: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• BDB-001 Injection
Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
• Placebo
Multiple IV infusions of Placebo Injection diluted in sodium chloride
• Placebo
Multiple IV infusions of Placebo Injection diluted in sodium chloride

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing
China	The First Hospital of Jilin Universitv	Chang chun	Jilin
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Chinese Academy of Medical Sciences and Peking Union Medical College	Nanjing	Jiangsu
China	Huashan Hospital of Fudan University	Shanghai	Shanghai
China	Shanghai Skin Disease Hospital	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Union Hospital Tongji Medical College Huazong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Air Force Medical University	Xi'an	Shaanxi
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xian	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Staidson (Beijing) Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 8
Primary	Number of Participants developing anti-BDB-001 antibodies.	Safety and tolerability of BDB-001 injection after multiple administration in the treatment of HS patients.	Week 8
Primary	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.	Week 8
Primary	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.	Week 8
Primary	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.	Week 8
Primary	Terminal phase half-life Assessment of pharmacokinetic parameters.	To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients.	Week 8
Secondary	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.	From Day 0 until Day 56
Secondary	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.	From Day 0 until Day 56
Secondary	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.	From Day 0 until Day 56
Secondary	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.	From Day 0 until Day 56
Secondary	Changes of active lesions (number of inflammatory nodules, abscesses, fistulas, and abscess overflow score) from Day 0 by time point		From Day 0 until Day 56
Secondary	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.	From Day 0 until Day 56
Secondary	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.	From Day 0 until Day 56