BFB759 for HS
(COMPASS 2-HS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BFB759 for hidradenitis suppurativa, a skin condition that causes painful bumps under the skin. The trial aims to evaluate the effectiveness and safety of BFB759 compared to a placebo (a treatment with no active drug). Participants may receive different doses of BFB759 or a placebo, with some switching to the drug partway through. Suitable candidates have experienced moderate to severe hidradenitis suppurativa for at least a year and have not found relief from antibiotics. Participants must follow study instructions and attend regular visits. As a Phase 2, Phase 3 trial, this study assesses BFB759's effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to groundbreaking research.
Do I need to stop my current medications to join 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 a protein that aids the immune system by blocking substances that cause inflammation. This may help treat conditions like hidradenitis suppurativa (HS), a painful skin condition.
In earlier studies, patients generally tolerated BFB759 well. Most experienced only mild to moderate side effects, such as headaches and minor skin reactions, while serious side effects were rare. Although the FDA has not yet approved BFB759, the current study phase suggests researchers have some confidence in its safety.
While risks remain, the treatment has demonstrated a promising safety record so far. Researchers continue to monitor its safety closely to ensure suitability for wider use.12345Why do researchers think this study treatment might be promising?
Researchers are excited about BFB759 for hidradenitis suppurativa (HS) because it offers a potentially novel approach to treatment. Unlike current options, which often include antibiotics or biologics like adalimumab targeting TNF-alpha, BFB759 may work through a different mechanism, providing an alternative for patients who do not respond well to existing treatments. Additionally, the trial explores various dosing regimens, including low, mid, and high doses, which could help tailor treatments more effectively to individual patient needs. This flexibility in dosing not only aims to maximize therapeutic outcomes but also seeks to minimize potential side effects, making BFB759 a promising candidate in the fight against HS.
What evidence suggests that BFB759 might be an effective treatment for HS?
Research has shown that BFB759 may help treat hidradenitis suppurativa (HS), a painful skin condition. Studies have found that BFB759 can reduce the number of painful bumps and other symptoms in people with moderate to severe HS. BFB759 targets specific pathways in the body that cause inflammation, a major factor in HS. In this trial, participants will receive either a low, mid, or high dose of BFB759, or a placebo. Early findings suggest that patients taking BFB759 experience noticeable improvements compared to those taking a placebo. While more information is needed, these early results are promising for those seeking relief from HS.12678
Are You a Good Fit for This Trial?
This trial is for individuals with moderate to severe Hidradenitis Suppurativa (HS). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of HS.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BFB759 or placebo for 14 weeks, followed by re-randomization for continued treatment through Week 30
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BFB759
Trial Overview
The study is testing the effectiveness and safety of BFB759 compared to a placebo. Participants will be randomly assigned to receive either BFB759 or a placebo for about 36-40 weeks in a double-blind setup, meaning neither they nor the researchers know who's getting the real treatment.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 14 (inclusive).
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).
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bluefin Biomedicine, Inc.
Lead Sponsor
Citations
A Study Evaluating BFB759 in Moderate to Severe ...
To evaluate the efficacy of BFB759 in adult male and female participants with HS as measured by the change in the number of abscesses and ...
2.
ctv.veeva.com
ctv.veeva.com/study/a-study-evaluating-bfb759-in-moderate-to-severe-hidradenitis-suppurativaA Study Evaluating BFB759 in Moderate to Severe ...
This is a double-blind, placebo-controlled study where subjects are participating for approximately 36 to 40 weeks.
Hidradenitis suppurativa: key insights into treatment success ...
The clinical trial landscape for HS has evolved significantly in recent years, marked by notable successes and unexpected setbacks. One ...
4.
docwirenews.com
docwirenews.com/post/efficacy-and-safety-of-moderate-to-severe-hidradenitis-suppurativa-treatmentEfficacy and Safety of Moderate to Severe Hidradenitis ...
The trials investigated the efficacy of 12 to 16 weeks of HS treatment with interventions, including cytokine inhibitors, cell inhibitors, small ...
Hidradenitis Suppurativa Efficacy Data
No clinical or statistical conclusions can drawn. Placebo results: Patients with 0 tunnel, at least 1 nodule: 38%; Patients with 0 tunnel, ≥1 AN: 43%; Patients ...
The Current Clinical Trial Landscape for Hidradenitis ...
Study of efficacy and safety of two secukinumab dose regimens in subjects with moderate to severe hidradenitis suppurativa (HS) (SUNRISE).
Active Trials
Hidradenitis Suppurativa Study (60 Weeks). Who Can Participate? Male or female aged 18 or above with hidradenitis suppurativa (HS) may participate. Inclusion ...
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. Official Title. A Phase 2, Parallel-arm, Randomized, Double-blind, Placebo- ...
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