A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa
Purpose
This is a double-blind, placebo-controlled study where subjects are participating for approximately 36 to 40 weeks. The study compares how well BFB759 works and how safe it is compared with a placebo.
Condition
- Hidradenitis Suppurativa (HS)
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Are adults (18 to 75 years) with a diagnosis of hidradenitis suppurativa for at least one year. - Have moderate to severe disease not well controlled by systemic antibiotic treatment. - Are willing to follow study instructions, attend regular visits, and avoid certain other medications during the study.
Exclusion Criteria
- Have certain infections or other immune conditions. - Recently used medications that could interfere with the study. - Are pregnant or breastfeeding.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Placebo
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Active - high dose |
BFB759 loading dose followed by BFB759 maintenance high dose every 2 weeks (Q2W) through Week 14 (inclusive), which is followed by placebo Q2W at Weeks 16 through 30 (inclusive). |
|
|
Experimental Active - low dose |
BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 14 (inclusive). |
|
|
Placebo Comparator Placebo |
Placebo Q2W for 14 weeks. At Week 16, participants in Placebo group who are still enrolled in the study and receiving treatment will be re-randomized (1:1) into 2 groups (Cross 1 and Cross 2) to receive BFB759 - Cross 1 will receive BFB759 loading dose followed by BFB759 maintenance low-dose Q2W through Week 30 (inclusive). - Cross 2 will receive BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 30 (inclusive). |
|
Recruiting Locations
Saguaro Dermatology
Phoenix, Arizona 85008
Phoenix, Arizona 85008
Encino Research Center
Encino, California 91436
Encino, California 91436
Clinical Science Institute
Santa Monica, California 90404
Santa Monica, California 90404
Skin Care Research
Boca Raton, Florida 33021
Boca Raton, Florida 33021
Center for Skin Science and Innovation
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
Ziaderm Research LLC
North Miami Beach, Florida 33126
North Miami Beach, Florida 33126
Clinical Trials Management, LLC
Tampa, Florida 33607
Tampa, Florida 33607
DelRicht Research
Atlanta, Georgia 30329
Atlanta, Georgia 30329
Southeast Research Specialist LLC
Douglasville, Georgia 30135
Douglasville, Georgia 30135
The Indiana Clinical Trials Center, PC
Plainfield, Indiana 46168
Plainfield, Indiana 46168
DS Research of Kentucky
Louisville, Kentucky 40241
Louisville, Kentucky 40241
Martha Stewart
Mandeville, Louisiana 70448
Mandeville, Louisiana 70448
Clinical Trials Management, LLC
Metairie, Louisiana 70006
Metairie, Louisiana 70006
DelRicht Research
New Orleans, Louisiana 70115
New Orleans, Louisiana 70115
Oakland Hills Dermatology
Auburn Hills, Michigan 48326
Auburn Hills, Michigan 48326
MI Skin Innovations
Northville, Michigan 48167
Northville, Michigan 48167
DelRicht Research
Wildwood, Missouri 63040
Wildwood, Missouri 63040
JDR Dermatology Research LLC
Las Vegas, Nevada 89145
Las Vegas, Nevada 89145
Skin Cancer and Dermatology Institute
Reno, Nevada 89509
Reno, Nevada 89509
Schweiger Dermatology, PC
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Equity Medical LLC
The Bronx, New York 10455
The Bronx, New York 10455
Optima Research - Boardman
Boardman, Ohio 44512
Boardman, Ohio 44512
Apex Clinical Research Center, LLC
Canton, Ohio 44718
Canton, Ohio 44718
Apex Clinical Research Center, LLC
Mayfield Heights, Ohio 44124
Mayfield Heights, Ohio 44124
UPMC Department of Dermatology
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Medical Univ of SC Department of Dermatology
Charleston, South Carolina 29425
Charleston, South Carolina 29425
DelRicht Research
Mt. Pleasant, South Carolina 29464
Mt. Pleasant, South Carolina 29464
DelRicht Research
Smyrna, Tennessee 37167
Smyrna, Tennessee 37167
DelRicht Research
Prosper, Texas 75078
Prosper, Texas 75078
Stryde Research-Epiphany Dermatology
Southlake, Texas 76092
Southlake, Texas 76092
Dermatology Specialists of Spokane
Spokane, Washington 99202
Spokane, Washington 99202
More Details
- Status
- Recruiting
- Sponsor
- Bluefin Biomedicine, Inc.