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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
225
Anti BAFF/IL-17 antibody. ZB-106
Anti BAFF/IL-17 antibody. ZB-106
ZB-106 Placebo
[Period 1] Percent change from baseline in abscess and inflammatory nodule (AN) count at 16 weeks
AN count is calculated based on the sum of the abscesses and inflammatory nodules across different anatomical areas
Time frame: Week 16
[Period 1] Achieving HiSCR50 at 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
Time frame: Week 16
[Period 1] Achieving HiSCR75 at 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
Time frame: Week 16
[Period 1] Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at 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.
Time frame: Week 16
[Period 1] Absolute change from baseline in Patient's Global Assessment of Hidradenitis Suppurativa (HS-PtGA) score at 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.
Time frame: Week 16
[Period 1] Absolute change from baseline in Skin Pain Numeric Rating Scale (NRS) at Week 16
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Medical Dermatology Specialists (Phoenix)
Phoenix, Arizona, United States
RECRUITINGFirst OC Dermatology Research, Inc.
Irvine, California, United States
RECRUITINGWallace Medical Group, Inc.
Los Angeles, California, United States
RECRUITINGNorthridge Clinical Trials
Northridge, California, United States
RECRUITINGNorCal Clinical Research
Rocklin, California, United States
RECRUITINGFlorida Academic Dermatology Center
Coral Gables, Florida, United States
RECRUITINGGeorgia Skin & Cancer Clinic
Savannah, Georgia, United States
RECRUITINGIndiana University School of Medicine
Indianapolis, Indiana, United States
RECRUITINGThe Indiana Clinical Trials Center
Plainfield, Indiana, United States
RECRUITINGEquity Medical LLC (Kentucky)
Bowling Green, Kentucky, United States
RECRUITING...and 46 more locations
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).
Time frame: Week 16
[Period 1] Safety and tolerability of tibulizumab
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.
Time frame: Week 16