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一项评估BFB759治疗中重度化脓性汗腺炎的研究 (COMPASS 2-HS)

2026年10月12日 更新者：Bluefin Biomedicine, Inc.

一项评估BFB759在中度至重度化脓性汗腺炎患者中的疗效和安全性的2期、剂量范围、随机、双盲、安慰剂对照研究

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.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (估计的)

210

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 保加利亚
      • Burgas、保加利亚
        • Medical Center Medconsult Burgas EOOD
      • Lovech、保加利亚
        • Medical Center Medconsult Pleven-Lovech Branch
      • Pleven、保加利亚
        • Medical Center Medconsult Pleven OOD
      • Plovdiv、保加利亚
        • Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD
      • Rousse、保加利亚
        • Medical Center Rusemed
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、AB T5J 3S9
        • Laser Rejuvenation Clinics Edmonton D.T. Inc.
    • Ontario
      • Richmond Hill、Ontario、加拿大、L4B 1L1
        • York Dermatology Clinical and Research Centre
      • Toronto、Ontario、加拿大、M2N 3A6
        • North York Research Inc.
    • Quebec
      • Québec、Quebec、加拿大、QC G1W 4R4
        • Centre de Recherche Saint-Louis (Quebec)
  • 德国
      • Bochum、德国
        • St. Josef-Hospital Bochum
      • Frankfurt、德国
        • Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie
      • Heidelberg、德国
        • University Clinic Dermatology Heidelberg
      • Leipzig、德国
        • University Hospital, Leipzig
      • Lübeck、德国
        • University of Luebeck
      • Munich、德国
        • Klinik und Poliklinik fur Dermatologie und Allergologie
  • 捷克语
      • Ostrava、捷克语
        • CCR Ostrava s.r.o.
      • Pardubice、捷克语
        • Pratia Pardubice a.s.
      • Prague、捷克语
        • Sanatorium of Professor Arenbergera
  • 波兰
      • Bialystok、波兰
        • NZOZ Specjal. Osrodek Dermatologiczny DERMAL
      • Lublin、波兰
        • Luxderm Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
      • Wroclaw、波兰
        • Melita Medical
      • Wroclaw、波兰
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
      • Wroclaw、波兰
        • Wojewódzki Szpital Specjalistyczny we Wrocławi,Oddział Dermatologiczny
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85008
        • Saguaro Dermatology
    • California
      • Encino、California、美国、91436
        • Encino Research Center
      • Huntington Beach、California、美国、92647
        • Marvel Clinical Research LLC
      • Santa Monica、California、美国、90404
        • Clinical Science Institute
    • Florida
      • Boca Raton、Florida、美国、33021
        • Skin Care Research
      • Fort Lauderdale、Florida、美国、33308
        • Center for Skin Science and Innovation
      • Margate、Florida、美国、33063
        • Gsi Clinical Research
      • North Miami Beach、Florida、美国、33126
        • Ziaderm Research LLC
      • Tampa、Florida、美国、33607
        • Clinical Trials Management, LLC
    • Georgia
      • Atlanta、Georgia、美国、30329
        • DelRicht Research
      • Douglasville、Georgia、美国、30135
        • Southeast Research Specialist LLC
    • Indiana
      • Plainfield、Indiana、美国、46168
        • The Indiana Clinical Trials Center, PC
    • Kentucky
      • Louisville、Kentucky、美国、40241
        • DS Research of Kentucky
    • Louisiana
      • Mandeville、Louisiana、美国、70448
        • Martha Stewart
      • Metairie、Louisiana、美国、70006
        • Clinical Trials Management, LLC
      • New Orleans、Louisiana、美国、70115
        • DelRicht Research
    • Michigan
      • Auburn Hills、Michigan、美国、48326
        • Oakland Hills Dermatology
      • Northville、Michigan、美国、48167
        • MI Skin Innovations
    • Missouri
      • Wildwood、Missouri、美国、63040
        • DelRicht Research
    • Nevada
      • Las Vegas、Nevada、美国、89145
        • JDR Dermatology Research LLC
      • Reno、Nevada、美国、89509
        • Skin Cancer and Dermatology Institute
    • New Jersey
      • Hackensack、New Jersey、美国、07601
        • Schweiger Dermatology, PC
    • New York
      • The Bronx、New York、美国、10455
        • Equity Medical LLC
    • Ohio
      • Boardman、Ohio、美国、44512
        • Optima Research - Boardman
      • Canton、Ohio、美国、44718
        • Apex Clinical Research Center, LLC
      • Mayfield Heights、Ohio、美国、44124
        • Apex Clinical Research Center, LLC
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • UPMC Department of Dermatology
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Medical Univ of SC Department of Dermatology
      • Mt. Pleasant、South Carolina、美国、29464
        • DelRicht Research
    • Tennessee
      • Smyrna、Tennessee、美国、37167
        • DelRicht Research
    • Texas
      • Dallas、Texas、美国、75230
        • Dermatology Treatment & Research Center
      • Frisco、Texas、美国、75033
        • VAST Clinical Research LLC
      • Prosper、Texas、美国、75078
        • DelRicht Research
      • Southlake、Texas、美国、76092
        • Stryde Research-Epiphany Dermatology
    • Washington
      • Spokane、Washington、美国、99202
        • Dermatology Specialists of Spokane
  • 西班牙
      • Granada、西班牙
        • Hospital Universitario Virgen De Las Nieves
      • Granollers、西班牙
        • Hospital Asil de Granollers
      • Las Palmas de Gran Canaria、西班牙
        • Hospital Universitario de Gran Canaria Doctor Negrin
      • Madrid、西班牙
        • Hospital Gregorio Maranon
      • Pontevedra、西班牙
        • Complejo Hospitalario Universitario de Pontevedra
      • Valencia、西班牙
        • Hospital de Manises

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Active - high dose

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).
生物：BFB759

BFB759 is a human mAb that inhibits multiple pro-inflammatory cytokines that contribute to the pathogenesis of multiple disease processes characterized by aberrant inflammation, including hidradenitis suppurativa.
实验性的：Active - low dose

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

BFB759 is a human mAb that inhibits multiple pro-inflammatory cytokines that contribute to the pathogenesis of multiple disease processes characterized by aberrant inflammation, including hidradenitis suppurativa.
安慰剂比较：Placebo

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).
其他：Placebo for BFB759

Placebo for BFB759

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Efficacy of BFB759 in HS
大体时间：Baseline to Week 16 and baseline to Week 32

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 inflammatory nodules (AN count).
Baseline to Week 16 and baseline to Week 32

次要结果测量

结果测量
措施说明
大体时间
Evaluate the clinical activity of BFB759 using HiSCR50
大体时间：Baseline to Week 16 and baseline to Week 32

The HiSCR50 is defined as at least a 50% reduction in inflammatory lesion count [the sum of Abscesses and Inflammatory Nodules (AN)] and no increase in abscess count and no increase in draining fistula count relative to baseline. The threshold of 50% reduction in AN count is the defined level that is clinically appropriate and meaningful to the patient regarding improvement in quality of life and pain level.
Baseline to Week 16 and baseline to Week 32
Evaluate the safety/tolerability of BFB759
大体时间：routinely over 21 months (about 22 visits during the course of study)

Record how well participants tolerate the treatment over time by recording the incidence and severity of treatment-emergent adverse events (as described by CTCAE Version 5.0)
routinely over 21 months (about 22 visits during the course of study)
To evaluate the clinical activity of BFB759 using the International Hidradenitis Suppurativa Severity Score System (IHS4)
大体时间：Baseline to Week 16 and baseline to Week 32

The IHS4 is a validated tool to dynamically assess HS severity that can be used both in real-life and the clinical trials setting (Zouboulis, 2017). It is calculated by counting nodules, abscesses and dTs/sinus tracts, and calculating a total score. IHS4 = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of dTs multiplied by 4].
Baseline to Week 16 and baseline to Week 32
To evaluate the clinical activity of BFB759 using the Skin Pain Numerical Rating Scale (NRS)
大体时间：Baseline to Week 16 and baseline to Week 32

The Skin Pain NRS is a single self-reported item designed to measure skin pain severity over the previous 24 hours. The following question is asked, and the response is marked on an 11 point scale where 0 equals no pain and 10 equals the worst pain imaginable.
Baseline to Week 16 and baseline to Week 32
To evaluate the clinical activity of BFB759 using the Hidradenitis Suppurativa-Investigator Global Assessment (HS-IGA)
大体时间：Baseline to Week 16 and baseline to Week 32

The HS IGA is a HS-specific global assessment. It is a 6 point ordinal scale based on objective lesion counts (Garg, 2022). Scores are calculated by the sum of abscesses, nodules (inflammatory or noninflammatory) and tunnels (draining or nondraining) in either the upper body regions or the lower body regions, whichever is greater. Scores are assigned as follows: 0 (0 1 lesions), 1 (2 5 lesions), 2 (6 10 lesions), 3 (11 15 lesions), 4 (16 20 lesions), and 5 (>20 lesions).
Baseline to Week 16 and baseline to Week 32

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bluefin Biomedicine, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年11月3日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2025年11月13日

首先提交符合 QC 标准的

2025年12月12日

首次发布 (实际的)

2025年12月17日

研究记录更新

最后更新发布 (实际的)

2026年10月14日

上次提交的符合 QC 标准的更新

2026年10月12日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CL-BFB759-003
  • COMPASS 2-HS (其他标识符：Sponsor)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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