판상 건선의 조기 개입: Bimekizumab은 만성 염증을 지연시킬 수 있습니까? (EARLYPSO)
판상 건선의 조기 개입: Bimekizumab은 만성 염증을 지연시킬 수 있습니까? 전향적 다기관 중재 연구
Psoriasis is a chronic inflammatory condition driven by a complex interplay between heritable and microenvironmental factors. Genome-wide heritability for psoriasis (PsO) is estimated at up to 50%. Although bearing genetic susceptibility at birth, most patients will remain disease free for years until an exposomal trigger activates the immunological pathway that leads to the first disease flare. In rare patients, the first flare is an isolated event, but in most patients it will evolve into a chronically relapsing-remitting disease characterized by lasting lesions and recurrent flares. Primary objective is to compare efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by PGA, at week 16 and week 24.
Patients will be randomized 1:1 to receive either 320mg bimekizumab at weeks 0 (W0), W4, W8 and W12, or clobetasol ointment for 2 to 4 weeks until complete clearance of the lesion. After a maximum of 4 weeks topical clobetasol will be applied twice weekly on the site of lesion until week 16 then stopped. Patients will not receive active treatment between week 16-24. Between week 24-96 patients that flare can receive continuous topical clobetasol if needed. These patients will be considered non-responders at subsequent timepoints for the main analysis. If the patients worsen their psoriasis under the treatments given during the study and progress to moderate or severe psoriasis (PASI 10 and above) they will end their participation to the study to receive a treatment adapted to the new severity of their psoriasis. The patients will be referred to their dermatologist to receive the actual standard of care adapted to their new condition.
During the study, the following assessments will be performed and samples will be collected
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Thierry Passeron, PhD
- 전화번호: +33492036488
- 이메일: passeron.t@chu-nice.fr
연구 연락처 백업
- 이름: emmanuelle PRADELLI
- 전화번호: +33492036488
- 이메일: pradelli.e@chu-nice.fr
연구 장소
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-
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Lyon, 프랑스, 69003
- 모병
- Hôpital Edouard Herriot
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연락하다:
- Axel VILLANI, PHD
- 전화번호: +33472117211
- 이메일: axel.villani@chu-lyon.fr
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부수사관:
- axel VILLANI, PhD
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Marseille, 프랑스, 13005
- 모병
- Hôpital Saint-Joseph
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연락하다:
- Nathalie QUILES-TSIMARATOS, Ph
- 전화번호: +33491806625
- 이메일: nquiles@hopital-saint-joseph.fr
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부수사관:
- Nathalie QUILES
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Martigues, 프랑스, 13500
- 모병
- Cabinet Dermatologie Dr RUER
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연락하다:
- Mireille RUER, Ph
- 전화번호: +33661944503
- 이메일: ruerdoc@gmal.com
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부수사관:
- Mireille RUER
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Saint-Etienne, 프랑스, 42055
- 모병
- CHU Saint-Etienne
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연락하다:
- Jean-Luc PERROT, PhD
- 전화번호: +33477828508
- 이메일: j.luc.perrot@chu-st-etienne.fr
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부수사관:
- Jean-Luc Perrot, PhD
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Toulon, 프랑스, 83000
- 모병
- CHITS
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연락하다:
- Thierry BOYE
- 전화번호: +33483162569
- 이메일: thierry.boye@yahoo.fr
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부수사관:
- Thierry BOYE, Ph
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Villeurbanne, 프랑스, 69100
- 초대로 등록
- Médipole Villeurbanne
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Alpes-Maritimes
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Nice, Alpes-Maritimes, 프랑스, 06200
- 모병
- CHU de Nice - Hôpital de l'Archet
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연락하다:
- Thierry Passeron, PhD
- 전화번호: +33492036488
- 이메일: passeron.t@chu-nice.fr
-
수석 연구원:
- Thierry Passeron, PhD
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Men and women
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≥ 18 and <45 years
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Plaque psoriasis without psoriatic arthritis
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Patients with mild psoriasis PASI >2 and <6
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Patient with at least one lesion on the elbows, or the knees, or the lower back to be recorded as target lesion (additional lesions in other areas on top are allowed)
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Disease duration less than 6 months (short duration psoriasis) or >2 years (long duration psoriasis)
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The psoriasis lesions should not having being treated by any topical treatment for at least 2 weeks
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For women of childbearing potential, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed.
Thus, a woman who is permanently sterile and therefore unable to procreate should not be subjected to pregnancy tests.
Women who are sexually abstinent are not requested to use a contraception. However, they must agree to take one if they want to become sexually active.
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Affiliation to a social security system
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Signed informed consent
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Patient willing and able to attend all study visits
Exclusion Criteria:
- Pregnant or breast-feeding women. Or women who plan to get pregnant during the study duration.
- Concomitant use of topical or systemic immunosuppressive medication or steroids in the past 12 weeks
- Personal history of skin cancer
- Personal history of cancer of less than 5 years
- Patients with active infection
- Abnormal blood counts (neutrophils <1500/mm3 and platelets <150 000/mm3) and/or positive HIV, HVB and HVC testing at screening.
- Patients with personal history of keloid scars
- Patients with personal history of hypersentitivity to xylocaine and/or adrenalin
- Vulnerable people: minors, adult under guardianship or deprived of freedom
- Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Treatment Group Bimekizumab
Bimekizumab 320mg given at weeks wk0, wk4, wk8 and wk12 |
Bimekizumab 320mg given at weeks wk0, wk4, wk8 and wk12 |
|
활성 비교기: Comparator group Clobetasol
Once daily evening application of 0.05% of clobetasol ointment for up to 4 weeks. The randomization will take place at the end of V1, baseline visit, after verifying the selection criteria and written consent, by the investigator in charge of the patient in each center. |
Once daily evening application of 0.05% of clobetasol ointment for up to 4 weeks |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Efficacy of bimekizumab versus topical corticosteroids on psoriasis
기간: at 24 weeks
|
The Physician's global Assessment is a validated method to simply assess plaque psoriasis severity using a scale ranging from 0 to 5 (Low to severe) |
at 24 weeks
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To compare patient's quality of life between BKZ and topical corticosteroids
기간: at 24 weeks
|
The Dermatological Life Quality Index is the main score to assess the impact of dermatoses on the quality of life of affected individuals. The score ranges from 0 to 30, with quality of life varying from pleasant to not at all pleasant. |
at 24 weeks
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Thierry Passeron, PhD, CHU de Nice, Service de Dermatologie
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 24-PP-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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