Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients
- Registration Number
- NCT01375179
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 27
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KRP203 KRP203 Experimental Edit Experimental Placebo Placebo matching KRP203 Placebo
- Primary Outcome Measures
Name Time Method Change in clinical remission rate 8 weeks Difference between clinical remission rate of subjects on KRP203 versus placebo
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability 8 weeks 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
Pharmacokinetic properties of KRP203 at steady-state using whole blood samples in patients with ulcerative colitis subjects 8 weeks Difference in pharmacokinetic levels 12 weeks 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
Assessment of the pharmacodynamic effect of KRP203 on absolute lymphocyte count and leukocyte subsets in ulcerative colitis subjects 12 weeks Change in markers of inflammation 12 weeks 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
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Nottingham, United Kingdom