Efficacy & Safety in Moderately Active Refractory Ulcerat... | NCT01375179

ID	Type	Description	Link
2010-019970-33	EudraCT Number

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

May 12, 2011

First Submission Date that Met QC Criteria

Jun 16, 2011

First Posted Date

Jun 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2020

Last Update Posted Date

Feb 11, 2020Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KRP203	Experimental	Experimental Edit Experimental	Drug: KRP203
Placebo	Placebo Comparator	Placebo	Drug: Placebo matching KRP203

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KRP203	Drug		KRP203
Placebo matching KRP203

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in clinical remission rate	Difference between clinical remission rate of subjects on KRP203 versus placebo	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	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	8 weeks
Pharmacokinetic properties of KRP203 at steady-state using whole blood samples in patients with ulcerative colitis subjects

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Ghent		9000	Belgium
Novartis Investigative Site

ID	Term
D003093	Colitis, Ulcerative
D015212	Inflammatory Bowel Diseases

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases