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

Staidson (Beijing) Biopharmaceuticals Co., Ltd50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (15)

Peking University First Hospital

Beijing, Beijing Municipality, China

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

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Week 8

Secondary Outcomes

Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point

Data from ClinicalTrials.gov

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

Beijing, Beijing Municipality, China

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Union Hospital Tongji Medical College Huazong University of Science and Technology

Wuhan, Hubei, China

Xiangya Hospital, Central South University

Changsha, Hunan, China

Chinese Academy of Medical Sciences and Peking Union Medical College

Nanjing, Jiangsu, China

The First Hospital of Jilin Universitv

Changchun, Jilin, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, China

...and 5 more locations

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.