BFB759 for Atopic Dermatitis

(COMPASS 2-AD Trial)

Recruiting at 6 trial locations

Overseen By Rob Eichelkraut

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bluefin Biomedicine, Inc.

Disqualifiers: Infections, Immune conditions, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 30 weeks

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BFB759, for individuals with atopic dermatitis (a type of eczema). The goal is to evaluate the effectiveness and safety of BFB759 compared to a placebo (a substance with no active medicine). Participants will receive either high or low doses of BFB759 or a placebo, with some eventually switching to BFB759. Suitable candidates for this trial are those who have experienced moderate to severe atopic dermatitis for at least a year and have not found relief with topical treatments. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop taking my current medications for the trial?

The trial requires participants to avoid certain other medications during the study, but it doesn't specify which ones. It's best to discuss your current medications with the study team to see if any need to be stopped.

Is there any evidence suggesting that BFB759 is likely to be safe for humans?

Research shows that BFB759 is undergoing safety testing in people with atopic dermatitis, a type of eczema. This treatment is compared to a placebo, a substance with no active ingredients. While specific safety data from past studies is not available, the trial's current phase suggests BFB759 demonstrated some safety in earlier research. Treatments reaching this stage typically have undergone basic safety testing in humans. Ongoing studies will provide more data on tolerance and potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for atopic dermatitis?

Researchers are excited about BFB759 for atopic dermatitis because it offers a new approach compared to standard treatments like topical corticosteroids and calcineurin inhibitors. Unlike these treatments, which generally suppress the immune system broadly, BFB759 targets specific pathways involved in inflammation, potentially reducing side effects. Additionally, BFB759 is administered every two weeks, which could be more convenient for patients compared to daily topical applications. This targeted and less frequent treatment approach could lead to better management of symptoms with improved patient compliance.

What evidence suggests that BFB759 might be an effective treatment for atopic dermatitis?

This trial will evaluate BFB759 for treating atopic dermatitis, a skin condition that causes itchy and inflamed patches. Participants will receive either a high dose or low dose of BFB759, or a placebo. Research has suggested that BFB759 could help treat atopic dermatitis, with previous patients showing improvements and many experiencing at least a 50% reduction in symptoms. The treatment aims to lower the Eczema Area and Severity Index (EASI) score, which measures the extent and severity of the affected skin. Although detailed human data remains limited, these early results suggest that BFB759 might reduce the discomfort and appearance of eczema. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to severe atopic dermatitis, commonly known as eczema. Participants will be involved in the study for about 36 to 40 weeks.

Inclusion Criteria

Willing to follow study instructions, attend regular visits, and avoid certain other medications during the study

I am between 18 and 75 years old and have had atopic dermatitis for at least a year.

My skin condition is not improving with creams or ointments.

Exclusion Criteria

Pregnant or breastfeeding

I am not taking any medications that could affect the study.

I have an infection or immune condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BFB759 or placebo every 2 weeks from Week 2 through Week 14, followed by placebo or BFB759 from Week 16 through Week 30

30 weeks

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6-10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BFB759

Trial Overview The study is testing BFB759 against a placebo. It's double-blind and placebo-controlled, meaning neither the participants nor the researchers know who receives the actual medication or the placebo.

How Is the Trial Designed?

Group I: Active - low dose Experimental Treatment 1 Intervention

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)

Group II: Active - high dose Experimental Treatment 1 Intervention

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)

Group III: Placebo Placebo Group 2 Interventions

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).

Who Is Running the Clinical Trial?

Bluefin Biomedicine, Inc.

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07105488

A Study Evaluating BFB759 in Moderate to Severe Atopic ... To evaluate the efficacy of BFB759 in adult male and female participants with AD as assessed by Eczema Area and Severity Index (EASI) score. Measure ...

2. trialx.com trialx.com/clinical-trials/listings/306207/a-study-evaluating-bfb759-in-moderate-to-severe-atopic-dermatitis/

A Study Evaluating BFB759 in Moderate to Severe Atopic ... Overview. This is a double-blind, placebo-controlled study where subjects are participating for approximately 36 to 40 weeks.

3. clinicaltrial.be clinicaltrial.be/en/details/556900?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

A Study Evaluating BFB759 in Moderate to Severe Atopic ... How well the treatment works at Week 16. * How many participants had at least a 50%, 75%, or 90% improvement in their eczema signs. * How much ...

4. withpower.com withpower.com/trial/phase-2-eczema-6-2025-1f136

BFB759 for Atopic Dermatitis (COMPASS 2-AD Trial) 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40900410/

Phase 3 Randomized Clinical Trial Results Through 140 ... Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Atopic Dermatitis: Phase 3 Randomized Clinical Trial Results Through 140 ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-evaluating-bfb759-in-moderate-to-severe-atopic-dermatitis

A Study Evaluating BFB759 in Moderate to Severe Atopic ... The study compares how well BFB759 works and how safe it is compared with a placebo. Enrollment. 225 estimated patients. Sex. All.

7. policylab.us policylab.us/clinical-trials/l/florida/condition/atopic-dermatitis

Atopic Dermatitis Paid Clinical Trials in Florida - Policy Lab The study compares how well BFB759 works and how safe it is compared with a placebo. This is a double-blind, placebo-controlled study where subjects are ...