A Study Evaluating BFB759 in Atopic Dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bluefin Biomedicine Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]

Trial duration

8 Jan 2026 → ongoing

Decision date (initial)

2025-11-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the efficacy of BFB759 in adult male and female participants with AD as assessed by Eczema Area and Severity Index (EASI) score

Secondary objectives 1

1. To evaluate the efficacy of different dose regimens of BFB759 on various clinical endpoints and patient-reported outcomes (PROs) of AD and the respective safety profiles of the different dose regimens

Conditions and MedDRA coding

Atopic dermatitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Are adults (18 to 75 years) with a diagnosis of atopic dermatitis for at least one year.
2. Have moderate to severe disease not well controlled by topical treatments.
3. Are willing to follow study instructions, attend regular visits, and avoid certain other medications during the study.

Exclusion criteria 3

1. Have certain infections or other immune conditions.
2. Recently used medications that could interfere with the study.
3. Are pregnant or breastfeeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent change from baseline at Week 16 in EASI (Eczema Area and Severity Index) for Active 1 and Active 2 groups compared to Placebo

Secondary endpoints 10

1. Analysis (Active 1 and Active 2 compared to Placebo): Proportion of participants meeting criteria for EASI75 defined as at least a 75% decrease in EASI score at Week 16 relative to baseline
2. Proportion of participants meeting criteria for EASI50 defined as at least a 50% decrease in EASI score at Week 16 relative to baseline
3. Proportion of participants meeting criteria for EASI90 defined as at least a 90% decrease in EASI score at Week 16 relative to baseline
4. Changes from baseline in Body Surface Area (BSA) at Week 16
5. Changes from baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16
6. Changes from baseline in the validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) at Week 16
7. Proportion of participants meeting the criteria of a vIGA-AD response of 0 or 1 at Week 16 relative to baseline
8. Changes from baseline in the weekly average Itch Numerical Rating Scale (NRS) at Week 16
9. Proportion of participants with ≥ 4-point decrease in weekly average Itch NRS in participants with a weekly average Itch NRS ≥ 4 at baseline at Week 16 relative to baseline
10. Safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events (TEAEs) (described by Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bluefin Biomedicine Inc.

Sponsor organisation

Bluefin Biomedicine Inc.

Address

32 Tozer Road

City

Beverly

Postcode

01915-5510

Country

United States

Scientific contact point

Organisation

Bluefin Biomedicine Inc.

Contact name

Scott Lonning

Public contact point

Organisation

Bluefin Biomedicine Inc.

Contact name

Scott Lonning

Third parties 12

Locations

5 EU/EEA countries · 37 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 78 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications