A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis
NCT ID: NCT07105488
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
225 participants
INTERVENTIONAL
2025-07-15
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active - high dose
BFB759 high dose Day 1 followed by BFB759 every 2 weeks (Q2W) starting at Week 2 through Week 14 (inclusive), which is followed by placebo Q2W at Weeks 16 through 30 (inclusive)
BFB759
BFB759 is a human mAb that inhibits multiple pro-inflammatory cytokines that contribute to the pathogenesis of multiple disease processes characterized by aberrant inflammation, including atopic dermatitis
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 two groups (Cross-1 or Cross-2) to receive BFB759 intervention.
* Cross-1 will receive BFB759 at Week 16, and then BFB759 Q2W at Week 18 through Week 30 (inclusive).
* Cross-2 will receive BFB759 at Week 16, and then BFB759 Q2W at Week 18 through Week 30 (inclusive).
BFB759
BFB759 is a human mAb that inhibits multiple pro-inflammatory cytokines that contribute to the pathogenesis of multiple disease processes characterized by aberrant inflammation, including atopic dermatitis
Placebo
Placebo for BFB759
Active - low dose
BFB759 low dose on Day 1 followed by BFB759 every 2 weeks (Q2W) starting at Week 2 through Week 14 (inclusive), which is followed by placebo Q2W at Weeks 16 through 30 (inclusive)
BFB759
BFB759 is a human mAb that inhibits multiple pro-inflammatory cytokines that contribute to the pathogenesis of multiple disease processes characterized by aberrant inflammation, including atopic dermatitis
Interventions
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BFB759
BFB759 is a human mAb that inhibits multiple pro-inflammatory cytokines that contribute to the pathogenesis of multiple disease processes characterized by aberrant inflammation, including atopic dermatitis
Placebo
Placebo for BFB759
Eligibility Criteria
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Inclusion Criteria
* Have moderate to severe disease not adequately controlled by topical treatments.
* Are willing to follow study instructions, attend regular visits, and avoid certain other medications during the study.
Exclusion Criteria
* Recently used medications that could interfere with the study.
* Are pregnant or breastfeeding.
18 Years
75 Years
ALL
No
Sponsors
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Bluefin Biomedicine, Inc.
INDUSTRY
Responsible Party
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Locations
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Antelope Valley Clinical Trials
Lancaster, California, United States
Ziaderm Research LLC
North Miami Beach, Florida, United States
Conquest Research LLC
Winter Park, Florida, United States
Clinical Trials Management, LLC
Metairie, Louisiana, United States
Vitality Clinical Trials LLC
Woodbury, New York, United States
Apex Clinical Research Center, LLC
Mayfield Heights, Ohio, United States
Stryde Research-Epiphany Dermatology
Southlake, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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CL-BFB759-002
Identifier Type: -
Identifier Source: org_study_id
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