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Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients

NCT ID: NCT01375179

Last Updated: 2020-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KRP203

Experimental

Edit

Experimental

Group Type EXPERIMENTAL

KRP203

Intervention Type DRUG

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo matching KRP203

Intervention Type DRUG

Interventions

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KRP203

Intervention Type DRUG

Placebo matching KRP203

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Ghent, , Belgium

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Cologne, , Germany

Site Status

Novartis Investigative Site

Frankfurt am Main, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Debrecen, , Hungary

Site Status

Novartis Investigative Site

Stockholm, , Sweden

Site Status

Novartis Investigative Site

Stockholm, , Sweden

Site Status

Novartis Investigative Site

Uppsala, , Sweden

Site Status

Novartis Investigative Site

Bern, , Switzerland

Site Status

Novartis Investigative Site

Zurich, , Switzerland

Site Status

Novartis Investigative Site

Oxford, Oxfordshire, United Kingdom

Site Status

Novartis Investigative Site

Nottingham, , United Kingdom

Site Status

Countries

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Belgium Germany Hungary Sweden Switzerland United Kingdom

Other Identifiers

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2010-019970-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CKRP203A2201

Identifier Type: -

Identifier Source: org_study_id

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