Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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25 November 2019 |
Main ID: |
EUCTR2011-000554-31-GB |
Date of registration:
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12/07/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of Efficacy and Safety of Ustekinumab in Patients with Primary Biliary Cirrhosis (PBC) Who had an Inadequate Response to Ursodeoxycholic Acid
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Scientific title:
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A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects with Primary Biliary Cirrhosis Who had an Inadequate Response to Ursodeoxycholic Acid (UDCA) - PURIFI |
Date of first enrolment:
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21/09/2011 |
Target sample size:
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128 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000554-31 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Canada
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France
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Germany
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Italy
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+31715242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International N.V. |
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+31715242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International N.V. |
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Key inclusion & exclusion criteria
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Inclusion criteria: Have proven or are likely to have PBC; Be on a stable dose of ursodeoxycholic acid for at least 6 months prior to Week 0;Have screening ALP level > 1.67 ULN; Have screening laboratory test results within protocol-specified limits; Have no history of latent or active TB prior to screening and no signs or symptoms suggestive of active TB upon medical history and/or physical examination. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 96 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria: Has history of gastrointestinal bleeding, secondary to portal hypertension, hepatic encephalopathy, or ascites requiring treatment with diuretics; Has a screening direct bilirubin > 1.0 mg/dL; Has a previous liver histology with a diagnosis of steatohepatitis or has a high risk of nonalcoholic steatohepatitis; Has a previous liver histology with a diagnosis of chronic autoimmune hepatitis or has a high risk of autoimmune hepatitis overlap syndrome; Testing positive for surface antigen (HBsAg+), regardless of the results of other hepatitis B tests; Have used colchicine, methotrexate (MTX), azathioprine (AZA), or systemic corticosteroids within 3 months prior to the first administration of study drug.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Primary Biliary Cirrhosis MedDRA version: 14.1
Level: LLT
Classification code 10036680
Term: Primary biliary cirrhosis
System Organ Class: 100000004871
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Intervention(s)
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Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: N/A Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Primary end point(s): The primary endpoint is ALP response at Week 28 as defined by a decrease from baseline of > 40% in ALP.
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Secondary Objective: PART 2: Double-blind Secondary Objectives: • To evaluate the efficacy of ustekinumab in reducing ALP, ALT, AST, and total bilirubin. • To evaluate improvement in liver fibrosis as measured by the Enhanced Liver Fibrosis (ELF) test. • To evaluate improvement in liver histology as measured by the modified Hepatic Activity Index (HAI). • To evaluate the efficacy of ustekinumab in reducing cholestasis as measured by serum bile acid concentrations. • To evaluate pharmacokinetics, immune response (IR), and pharmacodynamics of ustekinumab. • To evaluate ustekinumab in improving fatigue, pruritus, and quality of life. • To evaluate the effect ustekinumab has on long-term disease progression (death, transplant, cirrhosis, doubling of bilirubin).
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Main Objective: This is a Phase 2 study that is divided into 2 parts. Part 1 is an open-label, proof-of-concept study. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety of ustekinumab in subjects with PBC who had an inadequate response to UDCA.
PART 1: Open Label Primary Objectives: • To evaluate the efficacy of ustekinumab in reducing alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin in subjects with PBC. • To determine the ustekinumab regimen(s), based on safety and efficacy, for development in Part 2.
PART 2: Double-blind Primary Objectives: • To evaluate the efficacy of ustekinumab in achieving ALP response (a decrease from baseline of > 40% in ALP) in subjects with PBC who had an inadequate response to UCDA. • To evaluate the safety of ustekinumab in subjects with PBC.
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Timepoint(s) of evaluation of this end point: Week 28
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Secondary Outcome(s)
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Secondary end point(s): The major secondary endpoints by order of importance are:
1. Modified Corpechot Response at Week 28 as defined by ALP = 3 x ULN, AST = 2 x ULN, total bilirubin = 1 mg/dL for subjects with a total bilirubin = 1 mg/dL at baseline, and > 40% decrease from baseline in ALP. Subjects with total bilirubin >1 mg/dL at baseline will only be considered responders provided that the direct bilirubin value does not increase;
2. Change from baseline in ELF score at Week 28;
3. Change from baseline in the modified HAI at Week 28, in subjects with biopsies;
4. Change from baseline in the total serum bile acid concentrations at Week 28.
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Timepoint(s) of evaluation of this end point: Week 28
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Secondary ID(s)
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CNTO1275PBC2001
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Source(s) of Monetary Support
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Janssen Research & development, a division of JJPRD, LLC
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Ethics review
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Status: Approved
Approval date:
Contact:
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