A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis

Conditions

• Atopic Dermatitis (AD)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• BFB759 — BIOLOGICAL
  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 — DRUG
  Placebo for BFB759

Study Details

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.

Key Dates

Start date

Jul 15, 2025

Status verified

May 2026

Primary completion

Feb 28, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

225 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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)
• 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 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).
• Experimental: 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)

Primary Outcome Measure

Efficacy of BFB759 in AD [ Time Frame: week 16 and week 32 ]

Central Contacts

• Rob Eichelkraut
  +1-214-728-6505
  [email protected]

Locations (48)

Find similar trials in Phoenix, AZ

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