Clinical trial NCT05103423: Safety and Efficacy Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
timeFrame: Week 8
measure: Number of Participants developing anti-BDB-001 antibodies.
timeFrame: Week 8
measure: Area under the plasma concentration versus time curve (AUC) of BDB-001 Assessment of pharmacokinetic parameters.
timeFrame: Week 8
measure: Peak Plasma Concentration (Cmax) of BDB-001and time to reach Cmax Assessment of pharmacokinetic parameters.
timeFrame: Week 8
measure: Minimal Plasma Concentration (Cmin) of BDB-001 Assessment of pharmacokinetic parameters.
timeFrame: Week 8
measure: Terminal phase half-life Assessment of pharmacokinetic parameters.
timeFrame: Week 8
Secondary outcomes:
measure: Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
timeFrame: From Day 0 until Day 56
measure: Change in modified Sartorius Score (mSS) from Day 0 by time point
timeFrame: From Day 0 until Day 56
measure: Change in Hidradenitis Suppurativa Clinical Response (HiSCR) from Day 0 by time point
timeFrame: From Day 0 until Day 56
measure: Change in Hidradenitis suppurativa-Physician Global Assessment (HS-PGA) score from Day 0 by time point
timeFrame: From Day 0 until Day 56
measure: Changes of active lesions (number of inflammatory nodules, abscesses, fistulas, and abscess overflow score) from Day 0 by time point
timeFrame: From Day 0 until Day 56
measure: Change in Dermatology Life Quality Index (DLQI) score from Day 0 by time point
timeFrame: From Day 0 until Day 56
measure: Changes in Pain VAS score from Day 0 by time point
timeFrame: From Day 0 until Day 56
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Nanjing
country: China
facility: Chinese Academy of Medical Sciences and Peking Union Medical College
state: Jiangsu
city: Chang chun
country: China
facility: The First Hospital of Jilin Universitv
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Air Force Medical University
state: Shaanxi
city: Xian
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
name: Baoxi Wang, Master
role: PRINCIPAL_INVESTIGATOR
References: