NCT01375179

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_2

Geographic Reach
6 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

February 11, 2020

Status Verified

May 1, 2015

Enrollment Period

1.4 years

First QC Date

May 12, 2011

Last Update Submit

February 8, 2020

Conditions

Ulcerative Colitis

Keywords

Inflammatory Bowel diseaseUlcerative colitis

Outcome Measures

Primary Outcomes (1)

  • Change in clinical remission rate

    Difference between clinical remission rate of subjects on KRP203 versus placebo

    8 weeks

Secondary Outcomes (5)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    8 weeks

  • 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

  • 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

Study Arms (2)

KRP203

EXPERIMENTAL

Experimental Edit Experimental

Drug: KRP203

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo matching KRP203

Interventions

KRP203DRUG
KRP203
Placebo matching KRP203DRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Cologne, 51103, Germany

Location

Novartis Investigative Site

Frankfurt am Main, 60318, Germany

Location

Novartis Investigative Site

Hamburg, 20148, Germany

Location

Novartis Investigative Site

Budapest, 1083, Hungary

Location

Novartis Investigative Site

Debrecen, 4032, Hungary

Location

Novartis Investigative Site

Stockholm, 116 91, Sweden

Location

Novartis Investigative Site

Stockholm, SE-141 86, Sweden

Location

Novartis Investigative Site

Uppsala, 751 85, Sweden

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Novartis Investigative Site

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Novartis Investigative Site

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Interventions

KRP-203

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2011

First Posted

June 17, 2011

Study Start

December 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

February 11, 2020

Record last verified: 2015-05

Locations

HU(2)GB(2)BE(2)SE(3)DE(3)CH(2)