Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients

Novartis

Status and phase

Terminated

Phase 2

Conditions

Ulcerative Colitis

Treatments

Drug: Placebo matching KRP203

Drug: KRP203

Study type

Interventional

Funder types

Industry

Identifiers

NCT01375179

2010-019970-33 (EudraCT Number)

CKRP203A2201

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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