A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
This study is currently recruiting participants.
Verified May 2013 by Janssen Research & Development, LLC
Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01389973
First received: July 7, 2011
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Biliary Cirrhosis |
Drug: ustekinumab (double-blind) Drug: ustekinumab (open-label) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
progressive familial intrahepatic cholestasis
MedlinePlus related topics:
Cirrhosis
U.S. FDA Resources
Further study details as provided by Janssen Research & Development, LLC:
Primary Outcome Measures:
- Greater than 40% decrease from baseline in alkaline phosphatase [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Modified Corpechot Response [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
- Change from baseline in Enhanced Liver Fibrosis (ELF) score [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
- Change form baseline in the modified histologic activity index (HAI), in patients with biopsies [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
- Change from baseline in the total serum bile acid concentrations [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 128 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 003
ustekinumab (double-blind) Type=exact unit=mg number=45 form=solution for injection route=subcutaneous use. At Weeks 0 and 4 and every 8 weeks until the dose for the extension has been selected then every 8 weeks through Week 196 with the selected dose.
|
Drug: ustekinumab (double-blind)
Type=exact, unit=mg, number=90, form=solution for injection, route=subcutaneous use. At Weeks 0 and 4 and every 8 weeks until the dose for the extension has been selected
|
|
Experimental: 004
ustekinumab (double-blind) Type=exact unit=mg number=180 form=solution for injection route=subcutaneous use. At Weeks 0 and 4 and every 8 weeks until the dose for the extension has been selected then every 8 weeks through Week 196 with the selected dose.
|
Drug: ustekinumab (double-blind)
then every 8 weeks through Week 196 with the selected dose.
|
|
Placebo Comparator: 005
Placebo Form=solution for injection route=subcutaneous use At Weeks 0 and 4 and every 8 weeks until the dose for the extension has been selected then every 8 weeks through Week 196 with the selected dose.
|
Drug: Placebo
Type=exact, unit=mg, number=45, form=solution for injection, route=subcutaneous use. At Weeks 0 and 4 and every 8 weeks until the dose for the extension has been selected
|
|
Experimental: 001
ustekinumab (open-label) Type=exact unit=mg number=90 form=solution for injection route=subcutaneous use. At Weeks 0 and 4 and every 8 weeks until the dose for the extension has been selected then every 8 weeks through Week 196 with the selected dose.
|
Drug: ustekinumab (open-label)
Type=exact, unit=mg, number=90, form=solution for injection, route=subcutaneous use. At Weeks 0 and 4 and every 8 weeks until the dose for the extension has been selected
|
|
Experimental: 002
ustekinumab (double-blind) Type=exact unit=mg number=90 form=solution for injection route=subcutaneous use. At Weeks 0 and 4 and every 8 weeks until the dose for the extension has been selected then every 8 weeks through Week 196 with the selected dose.
|
Drug: ustekinumab (double-blind)
then every 8 weeks through Week 196 with the selected dose.
|
Detailed Description:
This is a multi-center, randomized (treatment will be assigned by chance), placebo-controlled (an inactive substance will be compared with the test drug to see whether the drug has a real effect), parallel-group (two or more groups of patients will receive different treatments) study that will consist of two parts. Part 1 will be an open-label (all participants will know the identity of the treatment) proof-of-concept study. Part 2 will be contingent on the results of Part 1 and will be double-blind (investigators and patients will not know what treatment is being given) and will evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis (PBC) who had an inadequate response to ursodeoxycholic acid. The duration of participation in the study for an individual participant may be up to 216 weeks. Patient safety will be monitored. Part 1: ustekinumab, 90mg subcutaneous (SC) at Weeks 0 and 4 and every 8 weeks through Week 20; Part 2: Depending on Part 1 results, either (ustekinumab 90mg or 45mg or placebo) or (ustekinumab 90mg or 180mg or placebo) SC at Weeks 0 and 4 and every 8 weeks through Week 20; Long-term Extension (including Part 1 and Part 2): beginning at Week 28, every 8 weeks with initially assigned dose until the extension dose has been selected; then every 8 weeks through Week 196 with the selected dose.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have proven or are likely to have Primary Biliary Cirrhosis (PBC)
- Be on a stable dose of ursodeoxycholic acid for at least 6 months prior to Week 0
- Have screening alkaline phosphatase (ALP) level > 1.67 ULN (the upper limit of normal)
- Have screening laboratory test results within protocol-specified limits
- Have no history of latent or active tuberculosis (TB) prior to screening and no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389973
Contacts
| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
Locations
| United States, California | |
| Withdrawn | |
| San Diego, California, United States | |
| United States, Florida | |
| Recruiting | |
| Jacksonville, Florida, United States | |
| Not yet recruiting | |
| Miami, Florida, United States | |
| Recruiting | |
| Naples, Florida, United States | |
| United States, Massachusetts | |
| Not yet recruiting | |
| Boston, Massachusetts, United States | |
| United States, Minnesota | |
| Withdrawn | |
| Rochester, Minnesota, United States | |
| United States, Mississippi | |
| Not yet recruiting | |
| Tupelo, Mississippi, United States | |
| United States, New York | |
| Not yet recruiting | |
| New York, New York, United States | |
| United States, Tennessee | |
| Not yet recruiting | |
| Chattanooga, Tennessee, United States | |
| Not yet recruiting | |
| Germantown, Tennessee, United States | |
| United States, Texas | |
| Not yet recruiting | |
| Houston, Texas, United States | |
| United States, Utah | |
| Recruiting | |
| Salt Lake City, Utah, United States | |
| Canada, Alberta | |
| Withdrawn | |
| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
| Not yet recruiting | |
| Vancouver, British Columbia, Canada | |
| Canada, Nova Scotia | |
| Not yet recruiting | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Not yet recruiting | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Not yet recruiting | |
| Montreal, Quebec, Canada | |
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
More Information
Additional Information:
No publications provided
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT01389973 History of Changes |
| Other Study ID Numbers: | CR018748, CNTO1275PBC2001, 2011-000554-31 |
| Study First Received: | July 7, 2011 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Janssen Research & Development, LLC:
|
Diseases [C] - Digestive System Diseases [C06] primary biliary cirrhosis ursodeoxycholic acid (UDCA) STELARA ustekinumab |
Additional relevant MeSH terms:
|
Liver Cirrhosis, Biliary Liver Cirrhosis Fibrosis Cholestasis, Intrahepatic Cholestasis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Liver Diseases |
Pathologic Processes Ursodeoxycholic Acid Antibodies, Monoclonal Cholagogues and Choleretics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013