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

크론병 환자에서 SAR441566의 효능과 안전성을 조사하기 위한 연구. (SPECIFI-CD)

2026년 10월 7일 업데이트: Sanofi

중등도 및 중증 크론병이 있는 성인을 대상으로 SAR441566의 유효성과 안전성을 평가하기 위한 2상, 다국적, 다기관, 무작위, 이중 맹검, 위약 대조, 용량 범위 연구.

This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD.

This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance.

Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

105

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 그루지야
      • Kutaisi, 그루지야, 4600
        • Investigational Site Number : 2680006
      • Tbilisi, 그루지야, 0160
        • Investigational Site Number : 2680002
      • Tbilisi, 그루지야, 0102
        • Investigational Site Number : 2680007
      • Tbilisi, 그루지야, 0144
        • Investigational Site Number : 2680001
      • Tbilisi, 그루지야, 0159
        • Investigational Site Number : 2680005
      • Tbilisi, 그루지야, 0172
        • Investigational Site Number : 2680003
      • Tbilisi, 그루지야, 0180
        • Investigational Site Number : 2680004
  • 네덜란드
      • Breda, 네덜란드, 4818 CK
        • Investigational Site Number : 5280004
      • Nijmegen, 네덜란드, 6525 GA
        • Investigational Site Number : 5280002
      • Tilburg, 네덜란드, 5022 GC
        • Investigational Site Number : 5280001
      • Utrecht, 네덜란드, 3584 CX
        • Investigational Site Number : 5280003
  • 대한민국
    • Busan
      • Haeundae-Gu, Busan, 대한민국, 48108
        • Investigational Site Number : 4100002
    • Daegu
      • Daegu, Daegu, 대한민국, 41944
        • Investigational Site Number : 4100001
    • Daejeon
      • Daejeon, Daejeon, 대한민국, 34943
        • Investigational Site Number : 4100003
    • Gangwon-do
      • Wŏnju, Gangwon-do, 대한민국, 26426
        • Investigational Site Number : 4100004
  • 독일
      • Berlin, 독일, 10318
        • Investigational Site Number : 2760004
      • Berlin, 독일, 12203
        • Investigational Site Number : 2760002
      • Fulda, 독일, 36043
        • Investigational Site Number : 2760001
      • Halle, 독일, 06108
        • Investigational Site Number : 2760005
      • Ludwigshafen, 독일, 67067
        • Investigational Site Number : 2760006
      • Magdeburg, 독일, 39104
        • Investigational Site Number : 2760008
      • Nordhausen, 독일, 99734
        • Investigational Site Number : 2760007
  • 루마니아
      • Bucharest, 루마니아, 011461
        • Investigational Site Number : 6420004
      • Cluj-Napoca, 루마니아, 400162
        • Investigational Site Number : 6420005
      • Constanța, 루마니아, 900673
        • Investigational Site Number : 6420003
      • Timișoara, 루마니아, 300002
        • Investigational Site Number : 6420001
  • 모리셔스
      • Vacoas, 모리셔스
        • Investigational Site Number : 4800001
  • 미국
    • Arizona
      • Sun City, Arizona, 미국, 85351
        • GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020
    • Connecticut
      • Bristol, Connecticut, 미국, 06010
        • Bristol Hospital- Site Number : 8400007
    • Florida
      • Clermont, Florida, 미국, 34711
        • Novum Research- Site Number : 8400021
      • Homestead, Florida, 미국, 33033
        • Homestead Associates in Research- Site Number : 8400012
      • Kissimmee, Florida, 미국, 34741
        • Clinical Research of Osceola- Site Number : 8400013
      • Miami Lakes, Florida, 미국, 33016
        • Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010
      • Tampa, Florida, 미국, 33609
        • GCP Clinical Research- Site Number : 8400004
    • Illinois
      • Glenview, Illinois, 미국, 60026
        • GI Alliance - Glenview- Site Number : 8400015
      • Gurnee, Illinois, 미국, 60031
        • Illinois Gastroenterology Group- Site Number : 8400011
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • University of Michigan Health System - Ann Arbor- Site Number : 8400017
    • Mississippi
      • Flowood, Mississippi, 미국, 39232
        • Gi Alliance - Flowood- Site Number : 8400019
    • Nevada
      • Las Vegas, Nevada, 미국, 89128
        • Vector Clinical Trials- Site Number : 8400001
    • New York
      • Queens Village, New York, 미국, 11428
        • Queens Village Primary Medical Center- Site Number : 8400005
    • North Carolina
      • Greenville, North Carolina, 미국, 27834
        • Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014
    • Pennsylvania
      • Uniontown, Pennsylvania, 미국, 15401
        • Frontier Clinical Research - Uniontown- Site Number : 8400009
    • South Carolina
      • Charleston, South Carolina, 미국, 29401
        • Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016
    • Texas
      • Katy, Texas, 미국, 77494
        • Gastro Health & Nutrition- Site Number : 8400003
      • Southlake, Texas, 미국, 76092
        • Texas Digestive Disease Consultants - Southlake- Site Number : 8400002
    • Washington
      • Tacoma, Washington, 미국, 98405
        • Washington Gastroenterology - Tacoma- Site Number : 8400008
  • 불가리아
      • Gorna Oryahovitsa, 불가리아, 5100
        • Investigational Site Number : 1000001
      • Sofia, 불가리아, 1680
        • Investigational Site Number : 1000005
      • Sofia, 불가리아, 1431
        • Investigational Site Number : 1000004
  • 브라질
    • Estado de Bahia
      • Salvador, Estado de Bahia, 브라질, 41820-020
        • Centro de Pesquisas da Clínica IBIS- Site Number : 0760001
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, 브라질, 90035-902
        • Hospital Moinhos de Vento- Site Number : 0760006
      • Porto Alegre, Rio Grande do Sul, 브라질, 90035903
        • Hospital de Clinicas de Porto Alegre- Site Number : 0760007
      • Porto Alegre, Rio Grande do Sul, 브라질, 90160-093
        • Hospital Ernesto Dornelles- Site Number : 0760002
    • São Paulo
      • Santo André, São Paulo, 브라질, 09080-110
        • Pesquisare Saude- Site Number : 0760004
  • 스페인
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, 스페인, 28046
        • Investigational Site Number : 7240001
    • Sevilla
      • Seville, Sevilla, 스페인, 41009
        • Investigational Site Number : 7240002
  • 아르헨티나
      • Buenos Aires, 아르헨티나, 1061
        • Investigational Site Number : 0320003
      • Buenos Aires, 아르헨티나, 1119
        • Investigational Site Number : 0320005
      • Buenos Aires, 아르헨티나, 1125
        • Investigational Site Number : 0320001
      • Buenos Aires, 아르헨티나, 1221
        • Investigational Site Number : 0320004
      • Buenos Aires, 아르헨티나, 1280
        • Investigational Site Number : 0320006
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, 아르헨티나, 4000
        • Investigational Site Number : 0320002
  • 이탈리아
      • Pisa, 이탈리아, 56124
        • Investigational Site Number : 3800005
    • Milano
      • Milan, Milano, 이탈리아, 20132
        • Investigational Site Number : 3800002
      • Milan, Milano, 이탈리아, 20097
        • Investigational Site Number : 3800009
      • Rozzano, Milano, 이탈리아, 20089
        • Investigational Site Number : 3800004
    • Padova
      • Padua, Padova, 이탈리아, 35128
        • Investigational Site Number : 3800001
    • Roma
      • Rome, Roma, 이탈리아, 00168
        • Investigational Site Number : 3800006
      • Rome, Roma, 이탈리아, 00128
        • Investigational Site Number : 3800008
  • 인도
      • Hyderabad, 인도, 500032
        • Investigational Site Number : 3560007
      • Hyderabad, 인도, 500048
        • Investigational Site Number : 3560003
      • Jaipur, 인도, 302001
        • Investigational Site Number : 3560009
      • Jaipur, 인도, 302007
        • Investigational Site Number : 3560001
      • Kolkata, 인도, 700020
        • Investigational Site Number : 3560005
      • Pune, 인도, 412201
        • Investigational Site Number : 3560006
      • Secunderabad, 인도, 500003
        • Investigational Site Number : 3560002
      • Surat, 인도, 395002
        • Investigational Site Number : 3560013
      • Surat, 인도, 395010
        • Investigational Site Number : 3560010
  • 일본
      • Hiroshima, 일본, 734-8530
        • Investigational Site Number : 3920013
      • Tokyo, 일본, 169-0073
        • Investigational Site Number : 3920011
      • Wakayama, 일본, 640-8558
        • Investigational Site Number : 3920012
      • Ōita, 일본, 870-0033
        • Investigational Site Number : 3920018
    • Chiba
      • Kashiwa, Chiba, 일본, 277-0871
        • Investigational Site Number : 3920004
      • Sakura, Chiba, 일본, 285-0841
        • Investigational Site Number : 3920001
    • Fukuoka
      • Kitakyushu, Fukuoka, 일본, 802-0077
        • Investigational Site Number : 3920005
    • Hokkaido
      • Sapporo, Hokkaido, 일본, 065-0033
        • Investigational Site Number : 3920007
      • Sapporo, Hokkaido, 일본, 004-0041
        • Investigational Site Number : 3920006
      • Sapporo, Hokkaido, 일본, 064-0919
        • Investigational Site Number : 3920010
    • Iwate
      • Yahaba, Iwate, 일본, 028-3695
        • Investigational Site Number : 3920008
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, 일본, 760-0017
        • Investigational Site Number : 3920019
    • Niigata
      • Nagaoka, Niigata, 일본, 940-2108
        • Investigational Site Number : 3920020
    • Tokyo
      • Bunkyo-Ku, Tokyo, 일본, 113-8510
        • Investigational Site Number : 3920003
  • 중국
      • Changzhou, 중국, 213003
        • Investigational Site Number : 1560008
      • Chongqing, 중국, 400013
        • Investigational Site Number : 1560009
      • Fuzhou, 중국, 350005
        • Investigational Site Number : 1560012
      • Guangzhou, 중국, 510080
        • Investigational Site Number : 1560001
      • Guangzhou, 중국, 510655
        • Investigational Site Number : 1560002
      • Hangzhou, 중국, 310009
        • Investigational Site Number : 1560004
      • Hangzhou, 중국, 310016
        • Investigational Site Number : 1560003
      • Hefei, 중국, 230022
        • Investigational Site Number : 1560007
      • Nanchang, 중국, 330006
        • Investigational Site Number : 1560011
      • Shanghai, 중국, 200025
        • Investigational Site Number : 1560006
      • Shanghai, 중국, 200127
        • Investigational Site Number : 1560005
      • Suzhou, 중국, 215004
        • Investigational Site Number : 1560010
  • 체코
      • Brno, 체코, 602 00
        • Investigational Site Number : 2030003
      • Brno, 체코, 636 00
        • Investigational Site Number : 2030002
      • Olomouc, 체코, 779 00
        • Investigational Site Number : 2030001
      • Prague, 체코, 100 34
        • Investigational Site Number : 2030006
  • 칠레
    • Biobio
      • Concepción, Biobio, 칠레, 4070038
        • Investigational Site Number : 1520006
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, 칠레, 8331143
        • Investigational Site Number : 1520001
      • Santiago, Reg Metropolitana de Santiago, 칠레, 8380456
        • Investigational Site Number : 1520003
    • Valparaiso
      • Viña del Mar, Valparaiso, 칠레, 2540364
        • Investigational Site Number : 1520002
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T2N 4Z6
        • Investigational Site Number : 1240001
    • Quebec
      • Montreal, Quebec, 캐나다, H3H 1E8
        • Investigational Site Number : 1240003
      • Québec, Quebec, 캐나다, G1N 4V3
        • Investigational Site Number : 1240005
  • 크로아티아
      • Osijek, 크로아티아, 31000
        • Investigational Site Number : 1910004
      • Zagreb, 크로아티아, 10000
        • Investigational Site Number : 1910003
  • 터키 (Türkiye)
      • Mersin, 터키 (Türkiye), 33070
        • Investigational Site Number : 7920001
      • Sanliurfa, 터키 (Türkiye), 63290
        • Investigational Site Number : 7920006
  • 폴란드
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, 폴란드, 87-100
        • Investigational Site Number : 6160005
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, 폴란드, 20-582
        • Investigational Site Number : 6160006
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, 폴란드, 02-507
        • Investigational Site Number : 6160001
      • Warsaw, Masovian Voivodeship, 폴란드, 00-332
        • Investigational Site Number : 6160004
    • Pomeranian Voivodeship
      • Sopot, Pomeranian Voivodeship, 폴란드, 81-756
        • Investigational Site Number : 6160002
  • 프랑스
      • Montpellier, 프랑스, 34090
        • Investigational Site Number : 2500005
      • Nice, 프랑스, 06202
        • Investigational Site Number : 2500002
      • Saint-Priest-en-Jarez, 프랑스, 42270
        • Investigational Site Number : 2500004
      • Toulouse, 프랑스, 31059
        • Investigational Site Number : 2500003
      • Vandœuvre-lès-Nancy, 프랑스, 54511
        • Investigational Site Number : 2500001
  • 헝가리
      • Budapest, 헝가리, 1085
        • Investigational Site Number : 3480002
      • Budapest, 헝가리, 1085
        • Investigational Site Number : 3480008
      • Békéscsaba, 헝가리, 5600
        • Investigational Site Number : 3480003
      • Eger, 헝가리, 3300
        • Investigational Site Number : 3480010
      • Gyöngyös, 헝가리, 3200
        • Investigational Site Number : 3480001
      • Gyöngyös, 헝가리, 3200
        • Investigational Site Number : 3480009
      • Szeged, 헝가리, 6720
        • Investigational Site Number : 3480005
      • Szekszárd, 헝가리, 7100
        • Investigational Site Number : 3480006
      • Tatabánya, 헝가리, 2800
        • Investigational Site Number : 3480004
  • 호주
    • New South Wales
      • Sydney, New South Wales, 호주, 2139
        • Investigational Site Number : 0360002
    • Queensland
      • South Brisbane, Queensland, 호주, 4101
        • Investigational Site Number : 0360001
    • Victoria
      • Parkville, Victoria, 호주, 3050
        • Investigational Site Number : 0360003

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Male or female participants aged 18 to 75 years at the time of signing the ICF

  2. Confirmed diagnosis of CD for at least 3 months prior to Baseline

  3. Confirmed diagnosis of moderate to severe CD as assessed by:

    • Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader
    • stool frequency (SF), abdominal pain (AP) score

  4. History of prior exposure to standard treatment (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies

  5. On stable doses of standard treatments prior to screening (oral 5-ASA compounds, oral corticosteroids, thiopurines (eg. AZA, 6-MP), or MTX)

  6. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  1. Participants with active UC, indeterminate colitis or short bowel syndrome
  2. Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement
  3. Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of > 3 bowel resections
  4. Participants with stool sample positive for infectious pathogens
  5. Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines
  6. Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit
  7. Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
  8. Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
  9. Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
  10. History of colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit
  11. Infection(s) requiring treatment with IV anti infectives within 30 days or oral/intramuscular anti-infectives within 14 days prior to the screening visit
  12. Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
  13. Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
  14. Participants who received fecal microbial transplantation within 30 days prior to screening
  15. Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
  16. Participants who received IV corticosteroids within 14 days prior to screening or during screening period
  17. Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening
  18. Screening laboratory and other analyses show abnormal results

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: SAR441566 dose 1

Participants will receive SAR441566 dose 1.
의약품: SAR441566

Pharmaceutical form: Tablet Route of administration: Oral
실험적: SAR441566 dose 2

Participants will receive SAR441566 dose 2.
의약품: SAR441566

Pharmaceutical form: Tablet Route of administration: Oral
실험적: SAR441566 dose 3

Participants will receive SAR441566 dose 3.
의약품: SAR441566

Pharmaceutical form: Tablet Route of administration: Oral
위약 비교기: Placebo

Participants will receive SAR441566 matching placebo.
의약품: SAR441566 matching Placebo

Pharmaceutical form: Tablet Route of administration: Oral

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of participants achieving endoscopic response
기간: Week 12

Endoscopic response is defined as ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD).

The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Week 12

2차 결과 측정

결과 측정
측정값 설명
기간
선택된 방문에서 SAR441566의 혈장 투여 전 농도
기간: 52주차까지
52주차까지
선택된 방문에서 SAR441566의 혈장 투여 후 농도
기간: 52주차까지
52주차까지
Proportion of participants achieving clinical remission based on Crohn's Disease Activity Index (CDAI)
기간: Week 12

CDAI clinical remission is defined as CDAI score <150. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.
Week 12
Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission
기간: Week 12

PRO 2 remission is defined as the unweighted CDAI component of daily abdominal pain (AP) score ≤1, and the unweighted CDAI component of daily average stool frequency (SF) score ≤3 (ie, AP ≤1 and SF ≤3 and no worsening from baseline).
Week 12
Proportion of participants achieving both clinical remission and endoscopic response
기간: Week 12

Clinical remission and endoscopic response based on CDAI <150 and ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD)
Week 12
Proportion of participants achieving endoscopic remission based on centrally read SES-CD
기간: From Baseline to Week 12

Endoscopic remission is defined as a centrally read SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease from baseline ≥2 points with no SES-CD sub score >1 point
From Baseline to Week 12
Proportion of participants achieving CDAI clinical response
기간: From Baseline to Week 12

CDAI clinical response is defined as a CDAI reduction from baseline ≥100 points.
From Baseline to Week 12
Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission
기간: Week 12

IBDQ remission is defined as IBDQ total score ≥170 points. The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life.
Week 12
Proportion of participants achieving IBDQ response
기간: From baseline to Week 12

IBDQ response defined as an improvement of IBDQ scores by 27 points or more at Week 12 compared with baseline
From baseline to Week 12
Change from baseline in the IBDQ scores
기간: From Baseline to week 12

The total IBDQ score ranges from 32 to 224 which indicates better quality of life. A positive change from Baseline indicates improvement.
From Baseline to week 12
Number of participants experiencing any TEAEs
기간: Up to week 52

Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during double-blind (DB) induction and maintenance treatment period
Up to week 52
Number of participants experiencing any TEAEs
기간: From week 12 to week 52

Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during open-label treatment period
From week 12 to week 52

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sanofi

간행물 및 유용한 링크

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

유용한 링크

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)

2024년 12월 10일

기본 완료 (실제)

2026년 7월 30일

연구 완료 (실제)

2026년 10월 2일

연구 등록 날짜

최초 제출

2024년 10월 10일

QC 기준을 충족하는 최초 제출

2024년 10월 10일

처음 게시됨 (실제)

2024년 10월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 7일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DRI18212
  • 2024-512633-32-00 (레지스트리 식별자: CTIS)
  • U1111-1301-3830 (기타 식별자: WHO ICTRP)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

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. .

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