A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa (COMPASS 2-HS)

Bluefin Biomedicine, Inc.

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Hidradenitis Suppurativa (HS)

Treatments: Other: Placebo for BFB759; Biological: BFB759

Study type: Interventional

Funder types: Industry

Identifiers

NCT07287644

COMPASS 2-HS (Other Identifier)

CL-BFB759-003

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are adults (18 to 75 years) with a diagnosis of hidradenitis suppurativa for at least one year.
• Have moderate to severe disease not well controlled by systemic antibiotic treatment.
• Are willing to follow study instructions, attend regular visits, and avoid certain other medications during the study.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups, including a placebo group

Active - high dose

Experimental group

Description:

BFB759 loading dose followed by BFB759 maintenance high dose every 2 weeks (Q2W) through Week 14 (inclusive), which is followed by placebo Q2W at Weeks 16 through 30 (inclusive).

Treatment:

Biological: BFB759

Active - low dose

Experimental group

Description:

BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 14 (inclusive).

Treatment:

Biological: BFB759

Placebo

Placebo Comparator group

Description:

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 2 groups (Cross 1 and Cross 2) to receive BFB759 * Cross 1 will receive BFB759 loading dose followed by BFB759 maintenance low-dose Q2W through Week 30 (inclusive). * Cross 2 will receive BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 30 (inclusive).

Treatment:

Other: Placebo for BFB759