Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients

Phase 2TerminatedNCT01375179

Novartis Pharmaceuticals27 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ulcerative Colitis

Interventions

KRP203DRUG

Placebo matching KRP203DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (14)

Novartis Investigative Site

Ghent, Belgium

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Cologne, Germany

Outcomes

Primary Outcomes

Change in clinical remission rate

Difference between clinical remission rate of subjects on KRP203 versus placebo

Time frame: 8 weeks

Secondary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

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

Time frame: 8 weeks

Pharmacokinetic properties of KRP203 at steady-state using whole blood samples in patients with ulcerative colitis subjects

Time frame: 8 weeks

Difference in pharmacokinetic levels

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

Time frame: 12 weeks

Assessment of the pharmacodynamic effect of KRP203 on absolute lymphocyte count and leukocyte subsets in ulcerative colitis subjects

Time frame: 12 weeks

Change in markers of inflammation

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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