Clinical trial NCT01375179: Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Inflammatory Bowel disease
Ulcerative colitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in clinical remission rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 8 weeks
measure: Pharmacokinetic properties of KRP203 at steady-state using whole blood samples in patients with ulcerative colitis subjects
timeFrame: 8 weeks
measure: Difference in pharmacokinetic levels
timeFrame: 12 weeks
measure: Assessment of the pharmacodynamic effect of KRP203 on absolute lymphocyte count and leukocyte subsets in ulcerative colitis subjects
timeFrame: 12 weeks
measure: Change in markers of inflammation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Frankfurt am Main
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Köln
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
state: Oxfordshire
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: