Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
Purpose
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)
Condition
- Hidradenitis Suppurativa (HS)
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tibulizumab Dose A |
Subcutaneous injection |
|
|
Experimental Tibulizumab Dose B |
Subcutaneous injection |
|
|
Placebo Comparator Placebo |
Subcutaneous injection |
|
Recruiting Locations
Medical Dermatology Specialists (Phoenix)
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85006
First OC Dermatology Research, Inc.
Irvine 5359777, California 5332921 92614
Irvine 5359777, California 5332921 92614
Wallace Medical Group, Inc.
Los Angeles 5368361, California 5332921 90056
Los Angeles 5368361, California 5332921 90056
NorCal Clinical Research
Rocklin 5388319, California 5332921 95765
Rocklin 5388319, California 5332921 95765
Florida Academic Dermatology Center
Coral Gables 4151871, Florida 4155751 33134
Coral Gables 4151871, Florida 4155751 33134
Georgia Skin & Cancer Clinic
Savannah 4221552, Georgia 4197000 31419
Savannah 4221552, Georgia 4197000 31419
The Indiana Clinical Trials Center
Plainfield 4263108, Indiana 4921868 46168
Plainfield 4263108, Indiana 4921868 46168
Equity Medical LLC (Kentucky)
Bowling Green 4285268, Kentucky 6254925 42104
Bowling Green 4285268, Kentucky 6254925 42104
DS Research of Kentucky, LLC
Louisville 4299276, Kentucky 6254925 40241
Louisville 4299276, Kentucky 6254925 40241
DelRicht LLC
Baton Rouge 4315588, Louisiana 4331987 70809
Baton Rouge 4315588, Louisiana 4331987 70809
Clinical Trials Management, LLC
Metairie 4333177, Louisiana 4331987 70006
Metairie 4333177, Louisiana 4331987 70006
MediSearch Clinical Trials
Saint Joseph 4407010, Missouri 4398678 64506
Saint Joseph 4407010, Missouri 4398678 64506
Skin Cancer and Dermatology Institute
Sparks 5512862, Nevada 5509151 89436
Sparks 5512862, Nevada 5509151 89436
Equity Medical
New York 5128581, New York 5128638 10023
New York 5128581, New York 5128638 10023
OptiSkin Medical
New York 5128581, New York 5128638 10128
New York 5128581, New York 5128638 10128
Optima Research
Boardman 5147784, Ohio 5165418 44512
Boardman 5147784, Ohio 5165418 44512
ClinOhio Research Services
Columbus 4509177, Ohio 5165418 43213
Columbus 4509177, Ohio 5165418 43213
Apex Clinical Research Center
Mayfield Heights 5162188, Ohio 5165418 44124
Mayfield Heights 5162188, Ohio 5165418 44124
Palmetto Clinical Trial Services
Anderson 4569298, South Carolina 4597040 29625
Anderson 4569298, South Carolina 4597040 29625
DelRicht Research
Mt. Pleasant 4588165, South Carolina 4597040 29464
Mt. Pleasant 4588165, South Carolina 4597040 29464
International Clinical Research - Tennessee LLC
Murfreesboro 4644312, Tennessee 4662168 37130
Murfreesboro 4644312, Tennessee 4662168 37130
BRCR Global Texas
Katy 4702732, Texas 4736286 77450
Katy 4702732, Texas 4736286 77450
DelRicht Research
Prosper 4720833, Texas 4736286 75078
Prosper 4720833, Texas 4736286 75078
Progressive Clinical Research
San Antonio 4726206, Texas 4736286 78213
San Antonio 4726206, Texas 4736286 78213
University of Washington Medical Center
Seattle 5809844, Washington 5815135 98164
Seattle 5809844, Washington 5815135 98164
Dermatology Specialists of Spokane
Spokane 5811696, Washington 5815135 99202
Spokane 5811696, Washington 5815135 99202
More Details
- Status
- Recruiting
- Sponsor
- Zura Bio Inc