Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients
A Multi-centre, Double-blind, Placebo Controlled, Parallel Group, Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of KRP203 in Subjects With Moderately Active Refractory Ulcerative Colitis
This study is designed as a proof of concept of KRP203 for induction of remission in ulcerative colitis (UC). The purpose of this study is to evaluate clinical benefit of KRP203 in subjects with moderately active refractory ulcerative colitis.
The study will provide safety and tolerability data in this subject population up to eight weeks of treatment with KRP203. Additionally, this study will evaluate the duration of a clinical response to KRP203 by following up responding subjects for an additional 12 weeks.
연구 개요
상세 설명
This is a multi-centre, double-blind, placebo controlled, parallel group, proof of concept study to evaluate the efficacy, safety and tolerability of KRP203 in subjects with moderately active refractory ulcerative colitis subjects. In total, approximately 72 subjects will be randomized into the study.
After 30 patients have completed the 8 week treatment period with KRP203 or placebo, there will be an interim analysis to determine preliminary efficacy. The study will consist of up to 28 day screening period (day -35 to -8), baseline period (day -7 to day -1), treatment period (day 1 to day 56), follow-up period and study completion.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Frankfurt am Main, 독일, 60318
- Novartis Investigative Site
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Hamburg, 독일, 20148
- Novartis Investigative Site
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Köln, 독일, 51103
- Novartis Investigative Site
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Gent, 벨기에, 9000
- Novartis Investigative Site
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Leuven, 벨기에, 3000
- Novartis Investigative Site
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Stockholm, 스웨덴, 116 91
- Novartis Investigative Site
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Stockholm, 스웨덴, SE-141 86
- Novartis Investigative Site
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Uppsala, 스웨덴, 751 85
- Novartis Investigative Site
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Bern, 스위스, 3010
- Novartis Investigative Site
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Zurich, 스위스, 8091
- Novartis Investigative Site
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Nottingham, 영국, NG7 2UH
- Novartis Investigative Site
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Oxfordshire
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Oxford, Oxfordshire, 영국, OX3 9DU
- Novartis Investigative Site
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Budapest, 헝가리, 1083
- Novartis Investigative Site
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Debrecen, 헝가리, 4032
- Novartis Investigative Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Active disease defined by partial Mayo score and modified Baron score with disease extending at least 25 cm from the anal verge
- Subjects must have inadequately responded or intolerance to 5-ASA therapy
Exclusion Criteria:
- Subjects receiving treatment for UC (other than 5-ASAs and steroids) within the time frame mentioned in protocol
- Past or recent history of significant medical illness and/or clinically significant lab abnormalities including but not limited to hematology, clinical chemistry, urine analysis, ECG abnormalities, HIV, Hepatitis B/C
- Presence or history of underlying metabolic, endocrine, hematologic, pulmonary, ophthalmic, cardiac, blood, renal, hepatic, infectious, psychiatric or any medically unstable condition, as assessed by the primary treating physician which, in the opinion of the investigator, would immunocompromise the subject and/or place the subject at unacceptable risk for participation in a study of an immunomodulatory therapy Other protocol-defined inclusion/exclusion criteria apply
공부 계획
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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위약 비교기: 위약
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실험적: KRP203
Experimental Edit Experimental |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in clinical remission rate
기간: 8 weeks
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Difference between clinical remission rate of subjects on KRP203 versus placebo
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8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
기간: 8 weeks
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Safety and tolerability of KRP203 assessed by the number of subjects with adverse events where KRP203 is given as an oral drug for 8 weeks once a day in ulcerative colitis subjects
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8 weeks
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Pharmacokinetic properties of KRP203 at steady-state using whole blood samples in patients with ulcerative colitis subjects
기간: 8 weeks
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8 weeks
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Difference in pharmacokinetic levels
기간: 12 weeks
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To explore the relationship between KRP203 and KRP203-P pharmacokinetic levels and clinical efficacy outcomes such as the partial Mayo score and endoscopic modified Baron Score
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12 weeks
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Assessment of the pharmacodynamic effect of KRP203 on absolute lymphocyte count and leukocyte subsets in ulcerative colitis subjects
기간: 12 weeks
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12 weeks
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Change in markers of inflammation
기간: 12 weeks
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Measure of the effect of KRP203 on markers of inflammation, including but not limited to ESR, CRP and fecal calprotectin/ lactoferrin as well as histopathological markers of gut mucosa using biopsy samples in ulcerative colitis subjects
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12 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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