Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01375179
First received: May 12, 2011
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Drug: KRP203
Drug: Placebo matching KRP203
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in clinical remission rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Difference between clinical remission rate of subjects on KRP203 versus placebo


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Difference in pharmacokinetic levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in markers of inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 35
Study Start Date: December 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KRP203 Drug: KRP203
Placebo Comparator: Placebo Drug: Placebo matching KRP203

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375179

Locations
Belgium
Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Leuven, Belgium, 3000
Germany
Novartis Investigative Site
Frankfurt am Main, Germany, 60318
Novartis Investigative Site
Hamburg, Germany, 20148
Novartis Investigative Site
Köln, Germany, 51103
Hungary
Novartis Investigative Site
Budapest, Hungary, 1083
Novartis Investigative Site
Debrecen, Hungary, 4032
Sweden
Novartis Investigative Site
Linkoping, Sweden, SE-581 85
Novartis Investigative Site
Lund, Sweden, 221 85
Novartis Investigative Site
Stockholm, Sweden, 116 91
Novartis Investigative Site
Stockholm, Sweden, SE-141 86
Novartis Investigative Site
Uppsala, Sweden, 751 85
Switzerland
Novartis Investigative Site
Bern, Switzerland, 3010
Novartis Investigative Site
Zurich, Switzerland, 8091
United Kingdom
Novartis Investigative Site
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Novartis Investigative Site
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01375179     History of Changes
Other Study ID Numbers: CKRP203A2201, 2010-019970-33
Study First Received: May 12, 2011
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute of Pharmacy
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Novartis:
Inflammatory Bowel disease
Ulcerative colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014