Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
- Conditions
- Hidradenitis Suppurativa (HS)
- Interventions
- Biological: Tibulizumab Dose ABiological: Tibulizumab Dose BOther: Placebo
- Registration Number
- NCT06993610
- Lead Sponsor
- Zura Bio Inc
- Brief Summary
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 16 weeks (Period 1) in adults with hidradenitis suppurativa, followed by a 16-week open-label extension period in which all participants will receive tibulizumab (Period 2)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- Male or female, 18 to 70 years of age
- ≥6-month history of Hidradenitis suppurativa (HS)
- Total AN (abscesse and inflammatory nodule) count ≥5
- HS lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III
- Draining tunnel count >20
- Presence of another inflammatory condition or a skin condition that may interfere with study assessments
- Known to have immune deficiency or is immunocompromised
- Evidence or suspicion of active or latent tuberculosis
- History of opportunistic, chronic, or recurrent infection requiring chronic antibiotic use, serious or life-threatening infection within 2 months, or had an infection requiring systemic antibiotics within 2 weeks
- Has active systemic candidiasis
- Unable to tolerate subcutaneous drug administration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tibulizumab Dose A Tibulizumab Dose A Subcutaneous injection Tibulizumab Dose B Tibulizumab Dose B Subcutaneous injection Placebo Placebo Subcutaneous injection
- Primary Outcome Measures
Name Time Method [Period 1] Percent change from baseline in abscess and inflammatory nodule (AN) count at 16 weeks Week 16 AN count is calculated based on the sum of the abscesses and inflammatory nodules across 12 different anatomical areas
- Secondary Outcome Measures
Name Time Method [Period 1] Achieving HiSCR50 at Week 16 Week 16 HiSCRO50 is defined as at least a 50% decrease in total abscess and inflammatory nodule (AN) count with no increase from baseline in abscess and/or draining fistula count
[Period 1] Achieving HiSCR75 at Week 16 Week 16 HiSCR75 is defined as at least a 75% decreased in total abscess and inflammatory nodule (AN) count with no increase from baseline in abscess and/or draining fistula count
[Period 1] Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16 Week 16 The DLQI is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each item uses a scale from 0 (not at all) to 3 (very much), with a total score being the sum of each question. The higher the total score the more a patient's life is affected by their skin condition.
[Period 1] Absolute change from baseline in Patient's Global Assessment of Hidradenitis Suppurativa (HS-PtGA) score at Week 16 Week 16 The HS-PtGA is a single item measure that asks the individual to rate the overall impact of HS on their quality of life, capturing their comprehensive perception of disease severity and treatment response.
[Period 1] Absolute change from baseline in Skin Pain Numeric Rating Scale (NRS) at Week 16 Week 16 The Skin Pain NRS is a single-item measure in which the participant rates the worst level of skin pain in the previous 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable).
[Period 1] Safety and tolerability of tibulizumab Week 16 Assessed by the incidence of all treatment-emergent adverse events (TEAEs), as well as changes from baseline in vital signs, electrocardiogram (ECG) parameters, and laboratory results.
Trial Locations
- Locations (1)
DelRicht LLC
🇺🇸Baton Rouge, Louisiana, United States