이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

중등도에서 중증 화농땀샘염이 있는 연구 참여자를 대상으로 비메키주맙의 장기 치료를 테스트하기 위한 연구 (BE HEARD EXT)

2026년 10월 1일 업데이트: UCB Biopharma SRL

중등도에서 중증 화농땀샘염이 있는 연구 참여자에서 비메키주맙의 장기 치료를 평가하는 3상, 공개, 병렬 그룹, 다기관, 확장 연구

The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

658

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 그리스
      • Athens, 그리스
        • Hs0005 40251
      • Efkarpia, 그리스
        • Hs0005 40252
  • 네덜란드
      • Breda, 네덜란드
        • Hs0005 40351
      • Groningen, 네덜란드
        • Hs0005 40292
      • Rotterdam, 네덜란드
        • Hs0005 40264
  • 독일
      • Berlin, 독일
        • Hs0005 40325
      • Berlin, 독일
        • Hs0005 40326
      • Bochum, 독일
        • Hs0005 40248
      • Bonn, 독일
        • Hs0005 40327
      • Darmstadt, 독일
        • Hs0005 40288
      • Dresden, 독일
        • Hs0005 40324
      • Dresden, 독일
        • Hs0005 40356
      • Frankfurt am Main, 독일
        • Hs0005 40287
      • Hamburg, 독일
        • Hs0005 40142
      • Hanover, 독일
        • Hs0005 40328
      • Kiel, 독일
        • Hs0005 40249
      • Lübeck, 독일
        • Hs0005 40250
      • Mainz, 독일
        • Hs0005 40174
      • München, 독일
        • Hs0005 40323
      • Münster, 독일
        • Hs0005 40177
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35249
        • Hs0005 50140
    • Arizona
      • Phoenix, Arizona, 미국, 85006
        • Hs0005 50175
    • California
      • Fountain Valley, California, 미국, 92708
        • Hs0005 50162
      • Los Angeles, California, 미국, 90045
        • Hs0005 50161
      • San Diego, California, 미국, 92123
        • Hs0005 50220
      • Thousand Oaks, California, 미국, 91320
        • Hs0005 50196
    • Florida
      • Miami, Florida, 미국, 33136
        • Hs0005 50199
      • North Miami Beach, Florida, 미국, 33162-4708
        • Hs0005 50205
      • Orange Park, Florida, 미국, 32073
        • Hs0005 50152
      • Pembroke Pines, Florida, 미국, 33028
        • Hs0005 50184
    • Georgia
      • Sandy Springs, Georgia, 미국, 30329
        • Hs0005 50193
      • Watkinsville, Georgia, 미국, 30677
        • Hs0005 50280
    • Indiana
      • Plainfield, Indiana, 미국, 46168
        • Hs0005 50234
    • Kentucky
      • Murray, Kentucky, 미국, 42071
        • Hs0005 50425
    • Massachusetts
      • Beverly, Massachusetts, 미국, 01915
        • Hs0005 50198
      • Boston, Massachusetts, 미국, 02215
        • Hs0005 50146
    • Michigan
      • Clarkston, Michigan, 미국, 48346
        • Hs0005 50178
    • Missouri
      • St Louis, Missouri, 미국, 63110
        • Hs0005 50105
    • Nebraska
      • Omaha, Nebraska, 미국, 68144
        • Hs0005 50194
    • Nevada
      • Las Vegas, Nevada, 미국, 89148
        • Hs0005 50208
    • New Hampshire
      • Newington, New Hampshire, 미국, 03801
        • Hs0005 50159
    • New Jersey
      • East Windsor, New Jersey, 미국, 08520
        • Hs0005 50137
      • Verona, New Jersey, 미국, 07044
        • Hs0005 50200
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87102
        • Hs0005 50237
    • New York
      • New York, New York, 미국, 10003
        • Hs0005 50235
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27516
        • Hs0005 50151
      • Durham, North Carolina, 미국, 27710
        • Hs0005 50211
      • Winston-Salem, North Carolina, 미국, 27157
        • Hs0005 50179
    • Ohio
      • Cincinnati, Ohio, 미국, 45219
        • Hs0005 50177
      • Columbus, Ohio, 미국, 43213
        • Hs0005 50138
      • Columbus, Ohio, 미국, 43230
        • Hs0005 50145
      • Fairborn, Ohio, 미국, 45324
        • Hs0005 50202
    • Oklahoma
      • Tulsa, Oklahoma, 미국, 74137
        • Hs0005 50204
    • Pennsylvania
      • Hershey, Pennsylvania, 미국, 17033
        • Hs0005 50147
    • Rhode Island
      • Johnston, Rhode Island, 미국, 02919
        • Hs0005 50008
      • Providence, Rhode Island, 미국, 02903
        • Hs0005 50180
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • Hs0005 50084
      • Greenville, South Carolina, 미국, 29615
        • Hs0005 50236
    • Tennessee
      • Nashville, Tennessee, 미국, 37215
        • Hs0005 50142
    • Texas
      • Arlington, Texas, 미국, 76011
        • Hs0005 50201
      • Pflugerville, Texas, 미국, 78660
        • Hs0005 50148
    • Utah
      • Salt Lake City, Utah, 미국, 84107
        • Hs0005 50141
    • Washington
      • Seattle, Washington, 미국, 98101
        • Hs0005 50270
  • 벨기에
      • Leuven, 벨기에
        • Hs0005 40002
      • Woluwe-Saint-Lambert, 벨기에
        • Hs0005 40121
  • 불가리아
      • Pleven, 불가리아
        • Hs0005 40313
      • Sofia, 불가리아
        • Hs0005 40284
      • Sofia, 불가리아
        • Hs0005 40311
      • Sofia, 불가리아
        • Hs0005 40314
      • Sofia, 불가리아
        • Hs0005 40315
      • Stara Zagora, 불가리아
        • Hs0005 40353
  • 스위스
      • Geneva, 스위스
        • Hs0005 40406
  • 스페인
      • Badalona, 스페인
        • Hs0005 40266
      • Barcelona, 스페인
        • Hs0005 40159
      • Barcelona, 스페인
        • Hs0005 40267
      • Granada, 스페인
        • Hs0005 40298
      • Las Palmas de Gran Canaria, 스페인
        • Hs0005 40294
      • Madrid, 스페인
        • Hs0005 40268
      • Manises, 스페인
        • Hs0005 40297
      • Pontevedra, 스페인
        • Hs0005 40295
      • Seville, 스페인
        • Hs0005 40049
      • Valencia, 스페인
        • Hs0005 40230
  • 아일랜드
      • Dublin, 아일랜드
        • Hs0005 40344
  • 영국
      • Leeds, 영국
        • Hs0005 40339
  • 이탈리아
      • Catania, 이탈리아
        • Hs0005 40261
      • Roma, 이탈리아
        • Hs0005 40263
      • Rozzano, 이탈리아
        • Hs0005 40258
      • Torino, 이탈리아
        • Hs0005 40330
  • 일본
      • Bunkyō City, 일본
        • Hs0005 20196
      • Fukuoka, 일본
        • Hs0005 20144
      • Kagoshima, 일본
        • Hs0005 20195
      • Kurume, 일본
        • Hs0005 20170
      • Kyoto, 일본
        • Hs0005 20190
      • Nagoya, 일본
        • Hs0005 20033
      • Nakagami-gun, 일본
        • Hs0005 20152
      • Nishinomiya, 일본
        • Hs0005 20178
      • Obihiro, 일본
        • Hs0005 20153
      • Osaka, 일본
        • Hs0005 20037
      • Sapporo, 일본
        • Hs0005 20154
      • Sendai, 일본
        • Hs0005 20171
      • tabashi City, 일본
        • Hs0005 20043
  • 체코
      • Prague, 체코
        • Hs0005 40063
      • Prague, 체코
        • Hs0005 40194
  • 캐나다
      • Barrie, 캐나다
        • Hs0005 50233
      • Cobourg, 캐나다
        • Hs0005 50172
      • Edmonton, 캐나다
        • Hs0005 50135
      • London, 캐나다
        • Hs0005 50174
      • Richmond Hill, 캐나다
        • Hs0005 50190
      • Saskatoon, 캐나다
        • Hs0005 50192
      • Surrey, 캐나다
        • Hs0005 50133
      • Waterloo, 캐나다
        • Hs0005 50134
      • Winnipeg, 캐나다
        • Hs0005 50136
  • 터키 (Türkiye)
      • Antalya, 터키 (Türkiye)
        • Hs0005 40270
      • Gaziantep, 터키 (Türkiye)
        • Hs0005 40273
      • Istanbul, 터키 (Türkiye)
        • Hs0005 40272
      • Izmir, 터키 (Türkiye)
        • Hs0005 40271
  • 폴란드
      • Lodz, 폴란드
        • Hs0005 40347
      • Rzeszów, 폴란드
        • Hs0005 40293
      • Warsaw, 폴란드
        • Hs0005 40335
      • Wroclaw, 폴란드
        • Hs0005 40095
      • Wroclaw, 폴란드
        • Hs0005 40333
      • Wroclaw, 폴란드
        • Hs0005 40334
  • 프랑스
      • Amiens, 프랑스
        • Hs0005 40197
      • Antony, 프랑스
        • Hs0005 40245
      • Auxerre, 프랑스
        • Hs0005 40321
      • La Rochelle, 프랑스
        • Hs0005 40320
      • Le Mans, 프랑스
        • Hs0005 40355
      • Lyon, 프랑스
        • Hs0005 40247
      • Marseille, 프랑스
        • Hs0005 40130
      • Nice, 프랑스
        • Hs0005 40132
      • Reims, 프랑스
        • Hs0005 40404
      • Rouen, 프랑스
        • Hs0005 40318
      • Saint-Etienne, 프랑스
        • Hs0005 40403
      • Saint-Mandé, 프랑스
        • Hs0005 40246
      • Toulon, 프랑스
        • Hs0005 40285
      • Toulouse, 프랑스
        • Hs0005 40286
  • 헝가리
      • Debrecen, 헝가리
        • Hs0005 40254
  • 호주
      • Campbelltown, 호주
        • Hs0005 30015
      • Carlton, 호주
        • Hs0005 30016
      • East Melbourne, 호주
        • Hs0005 30011
      • Kogarah, 호주
        • Hs0005 30017
      • Parkville, 호주
        • Hs0005 30018
      • St Leonards, 호주
        • Hs0005 30014
      • Westmead, 호주
        • Hs0005 30009
      • Woolloongabba, 호주
        • Hs0005 30012

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Study participant has completed the Maintenance Treatment Period through Week 48 in HS0003 (NCT04242446) or HS0004 (NCT04242498), was eligible to receive bimekizumab at the time of completing the feeder study, and did not meet any withdrawal criteria of the feeder study

  • Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator

  • A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

    1. Not a woman of childbearing potential (WOCBP) OR
    2. A WOCBP who agrees to follow the contraceptive guidance during the open-label extension period and for at least 20 weeks after the final dose of investigational medicinal product (IMP)

Exclusion Criteria:

  • Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP)
  • Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments Note: For any study participant with an ongoing serious adverse event (SAE) from HS0003 (NCT04242446) or HS0004 (NCT04242498), or any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry or a history of serious infections in HS0003 or HS0004, the Medical Monitor must be consulted prior to the study participant's entry into HS0005, although the decision on whether to enroll the participant remains with the Investigator.
  • Study participant has a positive or indeterminate interferon-gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
  • Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment
  • Study participant plans to participate in another study of a medicinal product or device under investigation during this study

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Bimekizumab dosing regimen 1

Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period.
의약품: Bimekizumab

Subjects will receive bimekizumab at pre-specified time-points.

다른 이름들:
  • UCB4940
실험적: Bimekizumab dosing regimen 2

Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.
의약품: Bimekizumab

Subjects will receive bimekizumab at pre-specified time-points.

다른 이름들:
  • UCB4940

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
기간: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of participants with treatment-emergent serious adverse events (SAEs) during the study
기간: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)

A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:

  • Results in death
  • Is life-threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization
  • Results in persistent disability/incapacity
  • Is a congenital anomaly/birth defect
  • Important medical events
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
기간: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to discontinuation of the study are reported.
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
기간: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180

HiSCR50 is defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count.

Results will be presented individually per week listed under time points.
Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
기간: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180

HiSCR75 is defined as at least a 75 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count.

Results will be presented individually per week listed under time points.
Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Percentage of participants with Flare
기간: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180

Flare is defined as a ≥25 % increase in abscess and inflammatory nodule (AN) count with an absolute increase in AN count of ≥2 relative to Baseline.

Results will be presented individually per week listed under time points.
Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain
기간: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180

The 4 items on the HSSQ assess the study participant's perception of the core symptoms of HS experienced in the past 7 days - pain, smell or odor, drainage or oozing from HS lesions, and itch on an 11-point numeric rating scale with higher scores indicating higher symptom level.

Results will be presented individually per week listed under time points.
Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
기간: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180

The DLQI is a skin disease specific questionnaire aimed at the evaluation of how the disease affects participants health related quality of life (QOL). The DLQI total score ranges from 0 to 30 with higher scores indicating higher skin disease impact on QOL.

Results will be presented individually per week listed under time points.
Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

UCB Biopharma SRL

수사관

  • 연구 책임자: UCB Cares, 001 844 599 2273

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 5월 27일

기본 완료 (실제)

2026년 7월 22일

연구 완료 (실제)

2026년 7월 22일

연구 등록 날짜

최초 제출

2021년 5월 20일

QC 기준을 충족하는 최초 제출

2021년 5월 20일

처음 게시됨 (실제)

2021년 5월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 1일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HS0005
  • 2020-004179-42 (EudraCT 번호)
  • U1111-1307-6132 (기타 식별자: World Health Organization (WHO))
  • 2024-511035-10 (레지스트리 식별자: EU Clinical Trials)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

IPD 공유 기간

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.

IPD 공유 액세스 기준

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다