A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa

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

27 Apr 2026 → ongoing

Decision date (initial)

2026-04-01

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 HS as assessed by the count of abscesses and inflammatory nodules (AN).

Secondary objectives 1

1. To evaluate the efficacy of different dose regimens of BFB759 on various endpoints of HS (AN, Hidradenitis Suppurativa Clinical Response [HiSCR]50, HiSCR75, HiSCR90, International Hidradenitis Suppurativa Severity Score System [IHS4], and Skin Pain numerical rating scale [NRS]) and their respective safety profiles.

Conditions and MedDRA coding

Hidradenitis Suppurativa

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Are adults (18 to 75 years) with a diagnosis of hidradenitis suppurativa for at least one year.
2. Have moderate to severe disease not well controlled by systemic antibiotic treatment.
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 (Week 0) at Week 16 in count of AN for Active 1 and Active 2 groups versus Placebo group

Secondary endpoints 8

1. Analysis (Active 1 and Active 2 compared to Placebo): Proportion of participants meeting criteria for HiSCR50 defined as at least a 50% decrease in AN count with no increase in the number of abscesses and no increase in the number of dTs at Week 16 relative to Baseline (Week 0) and over time relative to Baseline (Week 0).
2. Proportion of participants meeting criteria for HiSCR75 defined as at least a 75% decrease in AN count with no increase in the number of abscesses and no increase in the number of dTs at Week 16 relative to Baseline (Week 0) and over time relative to Baseline (Week 0).
3. Proportion of participants meeting criteria for HiSCR90 defined as at least a 90% decrease in AN count with no increase in the number of abscesses and no increase in the number of dTs at Week 16 relative to Baseline (Week 0) and over time relative to Baseline (Week 0).
4. Percent change from Baseline (Week 0) at Week 16 on the IHS4
5. Percent change from Baseline (Week 0) at Week 16 on the skin pain NRS
6. Proportion of participants meeting criteria for IHS4-55 defined as at least a 55% reduction in IHS4 score at Week 16 relative to Baseline (Week 0)
7. Proportion of participants meeting criteria for IHS4-90 defined as at least a 90% reduction in IHS4 score at Week 16 relative to Baseline (Week 0).
8. Safety and tolerability will be assessed by the incidence and severity of TEAEs (described by 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 · 31 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 75 files

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

Application history

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