Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01375179
Recruitment Status : Terminated
First Posted : June 17, 2011
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: KRP203 Drug: Placebo matching KRP203 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2010
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: KRP203




Drug: KRP203
Placebo Comparator: Placebo
Drug: Placebo matching KRP203

Primary Outcome Measures :
  1. Change in clinical remission rate [ Time Frame: 8 weeks ]
    Difference between clinical remission rate of subjects on KRP203 versus placebo

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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

  2. Pharmacokinetic properties of KRP203 at steady-state using whole blood samples in patients with ulcerative colitis subjects [ Time Frame: 8 weeks ]
  3. Difference in pharmacokinetic levels [ Time Frame: 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

  4. Assessment of the pharmacodynamic effect of KRP203 on absolute lymphocyte count and leukocyte subsets in ulcerative colitis subjects [ Time Frame: 12 weeks ]
  5. Change in markers of inflammation [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01375179

Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Leuven, Belgium, 3000
Novartis Investigative Site
Frankfurt am Main, Germany, 60318
Novartis Investigative Site
Hamburg, Germany, 20148
Novartis Investigative Site
Köln, Germany, 51103
Novartis Investigative Site
Budapest, Hungary, 1083
Novartis Investigative Site
Debrecen, Hungary, 4032
Novartis Investigative Site
Stockholm, Sweden, 116 91
Novartis Investigative Site
Stockholm, Sweden, SE-141 86
Novartis Investigative Site
Uppsala, Sweden, 751 85
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01375179     History of Changes
Other Study ID Numbers: CKRP203A2201
2010-019970-33 ( EudraCT Number )
First Posted: June 17, 2011    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Inflammatory Bowel disease
Ulcerative colitis

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