Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
2026년 7월 7일 업데이트: AbbVie
A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC).
This study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
연구 개요
연구 유형
중재적
등록 (추정된)
2000
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: ABBVIE CALL CENTER
- 전화번호: 844-663-3742
- 이메일: abbvieclinicaltrials@abbvie.com
연구 장소
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Gauteng
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Johannesburg, Gauteng, 남아프리카, 1821
- Lenasia Clinical Trial Centre - Johannesburg /ID# 281415
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Johannesburg, Gauteng, 남아프리카, 1864
- Chris Hani Baragwanath Hospital /ID# 284122
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Western Cape
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George, Western Cape, 남아프리카, 6529
- Excellentis Clinical Trial Consultants /ID# 282430
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Baden-Wurttemberg
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Tübingen, Baden-Wurttemberg, 독일, 72076
- Universitaetsklinikum Tuebingen /ID# 282958
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Florida
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Lakeland, Florida, 미국, 33813
- Auzmer Research /ID# 280786
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Miami, Florida, 미국, 33176
- Gastro Health - Miami /ID# 282001
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Maine
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Portland, Maine, 미국, 04102
- Portland Gastroenterology Center - Portland - Congress Street /ID# 281970
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- Hackensack Meridian Health - Hackensack University Medical Center /ID# 281865
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New York
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New York, New York, 미국, 11428
- Queens Village Primary Medical Center /ID# 281857
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Ohio
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Brunswick, Ohio, 미국, 44212
- Digestive Disease Consultants - Brunswick /ID# 283935
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Tennessee
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Jackson, Tennessee, 미국, 38301
- Skyline Gastroenterology of West Tennessee /ID# 284146
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Texas
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Austin, Texas, 미국, 78731
- Texas Digestive Disease Consultants /ID# 284159
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San Marcos, Texas, 미국, 78666
- Gi Alliance - Texas Digestive Disease Consultants - San Marcos /ID# 283947
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Liège, 벨기에, 4000
- CHU de Liege /ID# 281182
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Antwerpen
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Edegem, Antwerpen, 벨기에, 2650
- Universitair Ziekenhuis Antwerpen /ID# 282218
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Hainaut
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Lodelinsart, Hainaut, 벨기에, 6042
- Chu De Charleroi - Hopital Civil Marie Curie /ID# 281632
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Namur
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Yvoir, Namur, 벨기에, 5530
- Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 281312
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West-Vlaanderen
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Roeselare, West-Vlaanderen, 벨기에, 8800
- AZ-Delta. /ID# 281031
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Canton of Zurich
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Zurich, Canton of Zurich, 스위스, 8091
- University Hospital Zurich /ID# 280548
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Córdoba, 스페인, 14004
- Hospital Universitario Reina Sofia /ID# 281446
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Valladolid, 스페인, 47012
- Hospital Rio Hortega /ID# 281426
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Vizcaya
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Galdakao, Vizcaya, 스페인, 48960
- Hospital Galdakao-Usansolo /ID# 280388
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Maribor, 슬로베니아, 2000
- University Medical Centre Maribor /ID# 281175
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Iwate
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Shiwa-gun, Iwate, 일본, 028-3695
- Iwate Medical University Hospital /ID# 282387
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Miyagi
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Sendai, Miyagi, 일본, 981-3213
- Takagi Clinic - Sendai /ID# 281805
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New South Wales
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Macquarie University, New South Wales, 호주, 02109
- Macquarie Hospital /ID# 281739
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Newcastle, New South Wales, 호주, 2305
- John Hunter Hospital /ID# 282537
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Queensland
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South Brisbane, Queensland, 호주, 4101
- Mater Hospital Brisbane /ID# 281738
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Southport, Queensland, 호주, 4215
- Gold Coast Hospital /ID# 282434
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Victoria
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Clayton, Victoria, 호주, 3168
- Monash Health - Monash Medical Centre - Clayton /ID# 281711
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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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
CD specific:
- Crohn's Disease Activity Index (CDAI) score of ≥ 220
- Confirmed diagnosis of CD at least 90 days prior to Baseline
- Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.
- Demonstrated failure of 1 or more therapy for CD
UC specific:
- Confirmed diagnosis of UC at least 90 days prior to Baseline
- Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3
- Demonstrated failure of 1 or more therapy for UC
Exclusion Criteria:
- Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)
- Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment
- Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame
- Participants with surgical bowel resection within the past 3 months prior to Baseline
CD specific:
- Participants with >3 prior bowel resections
- Participants with previous small bowel resection(s) of combined length >100 cm
UC specific:
- Participants with prior colectomy (total or subtotal)
- Participants with extent of disease limited to < 10 cm of rectum
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Substudy 1: UC Arm 1 Risankizumab monotherapy
Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
|
|
실험적: Substudy 1: CD Arm 1 Risankizumab monotherapy
Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
|
|
실험적: Substudy 1: UC Arm 2 Trosunilimab monotherapy
Ulcerative Colitis (UC) participants will receive Trosunilimab Dose A as induction treatment followed by Trosunilimab Dose C as maintenance treatment.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
|
|
실험적: Substudy 1: CD Arm 2 Trosunilimab monotherapy
Crohn's Disease (CD) participants will receive Trosunilimab Dose B as induction treatment followed by Trosunilimab Dose D as maintenance treatment.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
|
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실험적: Substudy 1: UC Arm 3 Trosunilimab monotherapy
Ulcerative Colitis (UC) participants will receive Trosunilimab Dose E as induction treatment followed by Trosunilimab Dose G as maintenance treatment.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
|
|
실험적: Substudy 1: CD Arm 3 Trosunilimab monotherapy
Crohn's Disease (CD) participants will receive Trosunilimab Dose F as induction treatment followed by Trosunilimab Dose H as maintenance treatment.
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Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
|
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실험적: Substudy 1: UC Arm 4 ABBV-466 (Risankizumab/Trosunilimab)
Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose A followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose C
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
|
|
실험적: Substudy 1: CD Arm 4 ABBV-466 (Risankizumab/Trosunilimab)
Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose B followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose D
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
|
|
실험적: Substudy 1: UC Arm 5 ABBV-466 (Risankizumab/Trosunilimab)
Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose E followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose G
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
|
|
실험적: Substudy 1: CD Arm 5 ABBV-466 (Risankizumab/Trosunilimab)
Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose F followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose H
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
|
|
실험적: Substudy 2: UC Arm 1 Risankizumab monotherapy
Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
|
|
실험적: Substudy 2: CD Arm 1 Risankizumab monotherapy
Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
|
|
실험적: Substudy 2: UC Arm 2 ABBV-701 monotherapy
Ulcerative Colitis (UC) participants will receive ABBV-701 Dose A as induction treatment and Dose C maintenance treatment.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
실험적: Substudy 2: CD Arm 2 ABBV-701 monotherapy
Crohn's Disease (CD) participants will receive ABBV-701 Dose B as induction treatment and Dose D maintenance treatment.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
실험적: Substudy 2: UC Arm 3 ABBV-701 monotherapy
Ulcerative Colitis (UC) participants will receive ABBV-701 Dose E as induction treatment and Dose G maintenance treatment.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
실험적: Substudy 2: CD Arm 3 ABBV-701 monotherapy
Crohn's Disease (CD) participants will receive ABBV-701 Dose F as induction treatment and Dose H maintenance treatment.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
실험적: Substudy 2: UC Arm 4 ABBV-7066 (Risankizumab/ABBV-701)
Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose A followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose C.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
실험적: Substudy 2: CD Arm 4 ABBV-7066 (Risankizumab/ABBV-701)
Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose B followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose D.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
실험적: Substudy 2: UC Arm 5 ABBV-7066 (Risankizumab/ABBV-701)
Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose E followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose G.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
실험적: Substudy 2: CD Arm 5 ABBV-7066 (Risankizumab/ABBV-701)
Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose F followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose H.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
실험적: Substudy 2: UC Arm 6 ABBV-7066 (Risankizumab/ABBV-701)
Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose I followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose J
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
실험적: Substudy 2: CD Arm 6 ABBV-7066 (Risankizumab/ABBV-701)
Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ ABBV-701) combination Dose K followed by maintenance treatment of ABBV-7066 (Risankizumab/ ABBV-701) combination Dose L
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
다른 이름들:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
기간: At Week 28
|
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
|
At Week 28
|
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Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission
기간: At Week 28
|
Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
|
At Week 28
|
|
Number of Participants with Adverse Events (AEs)
기간: Up to 98 Weeks
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
The investigator assesses the relationship of each event to the use of study.
|
Up to 98 Weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
기간: At Week 12
|
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
|
At Week 12
|
|
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response
기간: At Week 12
|
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation.
Endoscopic Response is defined as a decrease in SES-CD > 50% from Baseline, and/or endoscopic remission, as scored by central reader.
|
At Week 12
|
|
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response
기간: At Week 28
|
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation.
Endoscopic Response is defined as a decrease in SES-CD > 50% from Baseline, and/or endoscopic remission, as scored by central reader.
|
At Week 28
|
|
Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission
기간: At Week 12
|
Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
|
At Week 12
|
|
Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission
기간: At Week 28
|
Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
|
At Week 28
|
|
Crohn's Disease Specific: Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)
기간: At Week 12
|
SF/APS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.
|
At Week 12
|
|
Crohn's Disease Specific: Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)
기간: At Week 28
|
SF/APS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.
|
At Week 28
|
|
Ulcerative Colitis Specific: Percentage of Participants with Clinical Remission per modified Mayo Score (mMS)
기간: At Week 12
|
Clinical remission on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore <= 1, AND not greater than baseline.
The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]).
The overall mMS ranges from 0 to 9 with higher scores representing more severe disease.
The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
|
At Week 12
|
|
Ulcerative Colitis Specific: Percentage of Participants with Clinical Remission per mMS
기간: At Week 28
|
Clinical remission on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore <= 1, AND not greater than baseline.
The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]).
The overall mMS ranges from 0 to 9 with higher scores representing more severe disease.
The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
|
At Week 28
|
|
Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission
기간: At Week 12
|
Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
|
At Week 12
|
|
Ulcerative Colitis Specific: Percentage of Participants Achieving Endoscopic Improvement
기간: At Week 12
|
Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
|
At Week 12
|
|
Ulcerative Colitis Specific: Percentage of Participants Achieving Endoscopic Improvement
기간: At Week 28
|
Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
|
At Week 28
|
|
Ulcerative Colitis Specific: Percentage of Participants who Achieve Clinical Response Per mMS
기간: At Week 12
|
Clinical response per mMS is defined as decrease from baseline >=2 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1.
The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]).
The overall mMS ranges from 0 to 9 with higher scores representing more severe disease.
The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
|
At Week 12
|
|
Ulcerative Colitis Specific: Percentage of Participants who Achieve Clinical Response Per mMS
기간: At Week 28
|
Clinical response per mMS is defined as decrease from baseline >=2 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1.
The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]).
The overall mMS ranges from 0 to 9 with higher scores representing more severe disease.
The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
|
At Week 28
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: ABBVIE INC., AbbVie
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 (추정된)
2026년 7월 24일
기본 완료 (추정된)
2031년 10월 1일
연구 완료 (추정된)
2031년 10월 1일
연구 등록 날짜
최초 제출
2026년 7월 7일
QC 기준을 충족하는 최초 제출
2026년 7월 7일
처음 게시됨 (실제)
2026년 7월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 7일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- M26-266
- 2026-525960-16-00 (기타 식별자: EU CT)
- 2026-525959-86-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
AbbVie is committed to responsible clinical trial data sharing.
This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD 공유 기간
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 공유 액세스 기준
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
예
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. .
크론병에 대한 임상 시험
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L2 Bio, LLCFDAMap; Akan Biosciences, Inc.아직 모집하지 않음Crohn & amp;#39; s | Crohn & amp;#39; s Disease (CD)
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Kaohsiung Medical University아직 모집하지 않음폐 선암종 | 폐암(진단) | Condition/Disease
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Nandakumar NarayananNational Institute of Neurological Disorders and Stroke (NINDS)초대로 등록
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UNC Lineberger Comprehensive Cancer CenterFogarty International Center of the National Institute of Health모집하지 않고 적극적으로
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Novartis Pharmaceuticals모병류마티스 관절염 (RA) 및 Sjögren 's Disease (SJD)스페인, 프랑스, 독일, 싱가포르
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University of PennsylvaniaEUSA Pharma, Inc.; Castleman Disease Collaborative Network모병캐슬맨병 | 캐슬맨병 | 거대 림프절 과형성 | 혈관여포 림프 증식증 | 혈관여포 림프절 과형성 | 혈관여포성 림프종 과형성 | GLNH | 과형성, 거대 림프절 | 림프절 과형성, 거인미국
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Jiulongpo No.1 People's HospitalJiangxi Maternal and Child Health Hospital아직 모집하지 않음