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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 15
- Primary Endpoint
- Terminal phase half-life Assessment of pharmacokinetic parameters.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treatment group 1
Intervention: BDB-001 Injection (Drug)
Treatment group 1
Intervention: Placebo (Drug)
Treatment group 2
Intervention: BDB-001 Injection (Drug)
Treatment group 2
Intervention: Placebo (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
- Change in Hidradenitis Suppurativa Clinical Response (HiSCR) from Day 0 by time point(From Day 0 until Day 56)
- Change in Hidradenitis suppurativa-Physician Global Assessment (HS-PGA) score from Day 0 by time point(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(From Day 0 until Day 56)
- Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point(From Day 0 until Day 56)
- Change in modified Sartorius Score (mSS) from Day 0 by time point(From Day 0 until Day 56)
- Change in Dermatology Life Quality Index (DLQI) score from Day 0 by time point(From Day 0 until Day 56)
- Changes in Pain VAS score from Day 0 by time point(From Day 0 until Day 56)