Hidradenitis Suppurativa (HS)
Conditions
Keywords
Hidradenitis Suppurativa, HS, Tibulizumab, Hidradenitis Suppurativa clinical response, HiSCR, Skin Diseases, Inflammatory Skin Disease, Chronic Skin Condition, Sweat Gland Disease, Skin Diseases Bacterial, Suppurative Hidradenitis, Hidradenitis, Acne, Acne inversa, Inversa
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)
Interventions
BIOLOGICALTibulizumab Dose A
Anti BAFF/IL-17 antibody. ZB-106
BIOLOGICALTibulizumab Dose B
Anti BAFF/IL-17 antibody. ZB-106
OTHERPlacebo
ZB-106 Placebo
Sponsors
Zura Bio Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 18 to 70 years of age * ≥6-month history of Hidradenitis suppurativa (HS) * Total AN (abscess and inflammatory nodule) count ≥5 * HS lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [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 different anatomical areas |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| [Period 1] Achieving HiSCR50 at Week 16 | Week 16 | HiSCR50 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% decrease 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. |
Countries
Canada, Germany, Hungary, Poland, Spain, United States
Outcome results
None listed