A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
NCT ID: NCT02516605
Last Updated: 2021-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2015-09-09
2018-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LJN452
Part 1: LJN452
LJN452 capsules administered once daily for 28 days
Part 2: LJN452 Dose level 1
LJN452 capsules administered once a day for 12 weeks
Part 2: LJN452 Dose level 2
LJN452
Placebo
Part 1: Placebo
Matching placebo capsules administered once daily for 28 days
Part 2: Placebo
Matching placebo to LJN452 administered once a day for 12 weeks
Interventions
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Part 1: LJN452
LJN452 capsules administered once daily for 28 days
Part 1: Placebo
Matching placebo capsules administered once daily for 28 days
Part 2: LJN452 Dose level 1
LJN452 capsules administered once a day for 12 weeks
Part 2: Placebo
Matching placebo to LJN452 administered once a day for 12 weeks
Part 2: LJN452 Dose level 2
LJN452
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of PBC as demonstrated by the presence of at least 2 of the following 3 diagnostic criteria:
* History of alkaline phosphatase (ALP) elevated above upper limit of normal (ULN) for at least 6 months
* Positive antimitochondrial antibodies (AMA) titer or if AMA negative or in low titer (\<1:80) PBC specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components (PDC-E2, 2-oxo-glutaric acid dehydrogenase complex))
* Previous liver biopsy findings consistent with PBC
* At least 1 of the following markers of disease severity:
* ALP ≥ 1.67 × ULN
* Total bilirubin \> ULN but \< 1.5 × ULN
* In addition, patients must meet the following biochemical criteria at enrollment:
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 × ULN
* Total bilirubin ≤ 1.5 × ULN
* INR ≤ ULN
* Taking UDCA for at least 12 months, or for at least 6 months and has reached maximal response to UDCA with a plateau in alkaline phosphatase, with no changes in dose for ≥ 3 months prior to Day 1.
* Patients must weigh at least 40 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
Exclusion Criteria
* Presence of other concomitant liver diseases.
* Cirrhosis with complications, including history or presence of:
* Variceal bleed
* Uncontrolled ascites
* Encephalopathy
* Spontaneous bacterial peritonitis
* Significant hepatic impairment as defined by Child-Pugh classification of B or C, history of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score ≥15.
* History of conditions that may cause increases in ALP (e.g., Paget's disease).
* Use of investigational drugs, or immunosuppressive drugs at the time of enrollment, or within 5 half-lives, or 30 days of randomization, whichever is longer; or longer if required by local regulations. Use of high dose oral steroids to treat co-morbid conditions (e.g., airways disease) will be allowed but must be properly documented as such in concomitant medications.
* Currently taking obeticholic acid or have taken obeticholic acid within 30 days of randomization
* Previous participation in CLJN452X2201 and received study medication within three months of randomization (or longer if required by local regulations).
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Rialto, California, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Marietta, Georgia, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Manhasset, New York, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Seattle, Washington, United States
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Würzburg, , Germany
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Mysłowice, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Wroclaw, , Poland
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Samara, , Russia
Novartis Investigative Site
Birmingham, West Midlands, United Kingdom
Novartis Investigative Site
Cambridge, , United Kingdom
Novartis Investigative Site
Hull, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Schramm C, Wedemeyer H, Mason A, Hirschfield GM, Levy C, Kowdley KV, Milkiewicz P, Janczewska E, Malova ES, Sanni J, Koo P, Chen J, Choudhury S, Klickstein LB, Badman MK, Jones D. Farnesoid X receptor agonist tropifexor attenuates cholestasis in a randomised trial in patients with primary biliary cholangitis. JHEP Rep. 2022 Jul 21;4(11):100544. doi: 10.1016/j.jhepr.2022.100544. eCollection 2022 Nov.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novartisclinicatrials.com
Other Identifiers
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2015-001590-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLJN452X2201
Identifier Type: -
Identifier Source: org_study_id
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