Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
CLARITY
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primary Biliary Cirrhosis
2 other identifiers
interventional
66
3 countries
24
Brief Summary
The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with LUM001 or placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2013
24 active sites
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
First Submitted
Initial submission to the registry
July 17, 2013
CompletedFirst Posted
Study publicly available on registry
July 22, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
July 6, 2016
CompletedMarch 27, 2019
March 1, 2019
1.7 years
July 17, 2013
April 1, 2016
March 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Pruritus Using Adult Itch Reported Outcome (ItchRO) Weekly Sum Score at Week 13/ Early Termination (ET)
Pruritus was assessed using ItchRO measure, administered as an electronic diary (eDiary) which was completed by the participants twice daily (morning and evening). (ItchRO) scores ranged from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.
Baseline and Week 13/ET
Secondary Outcomes (6)
Change From Baseline in Pruritus Using Adult ItchRO Weekly Sum Scores at Weeks 4, 8 and 13
Baseline, Weeks 4, 8 and 13
Change From Baseline in Pruritus Using Adult ItchRO Average Daily Scores at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)
Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)
Change From Baseline in Alkaline Phosphatase (ALP) at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)
Baseline, Weeks 4, 8, 13 and Last Post-baseline (Week 13/ET)
Change From Baseline in 5-D Itch Score at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)
Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)
Change From Baseline in Fasting Serum Bile Acid Level at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)
Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)
- +1 more secondary outcomes
Other Outcomes (1)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
From the first dose of study drug until the 13 weeks of treatment period (or ET) + 14 days (approximately 15 weeks)
Study Arms (2)
LUM001 and Ursodeoxycholic Acid (UDCA)
EXPERIMENTALAdministered orally once daily
Placebo and Ursodeoxycholic Acid (UDCA)
PLACEBO COMPARATORAdministered orally once daily
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Primary Biliary Cirrhosis
- Moderate to severe pruritus
- Taking ursodeoxycholic acid (UDCA) for at least 6 months, or unable to tolerate UDCA
- Ability to understand and willingness to sign informed consent prior to initiation of any study procedures
You may not qualify if:
- History or presence of other concomitant significant liver disease
- Liver transplant
- Known HIV infection
- Women who are pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Scripps Clinic
La Jolla, California, 92037, United States
University of California at Davis
Sacramento, California, 95817, United States
University of Miami
Miami, Florida, 33136, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Minnesota Gastroenterology
Saint Paul, Minnesota, 55114, United States
St. Louis University
St Louis, Missouri, 63104, United States
Weill Cornell Medical College
New York, New York, 10021, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Advanced Liver Therapies at St. Lukes Episcopal Hospital
Houston, Texas, 77030, United States
University of Utah Health Science Center
Salt Lake City, Utah, 84132, United States
Liver Institute of Virginia
Newport News, Virginia, 23602, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
University of Washington Harborview Medical Center
Seattle, Washington, 98104, United States
University Health Network, Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
University of Birmingham
Birmingham, England, B15 2TT, United Kingdom
Royal Liverpool & Broadgreen University Hospital
Liverpool, England, L7 8XP, United Kingdom
Newcastle University
Newcastle upon Tyne, England, NE1 4LP, United Kingdom
Oxford University Hospitals (John Radcliffe)
Oxford, England, OX3 9DU, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Imperial College London St Mary's Hospital
London, W2 1NY, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Physician
- Organization
- Mirum
Study Officials
- STUDY DIRECTOR
Study Director
Mirum
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
July 17, 2013
First Posted
July 22, 2013
Study Start
August 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
March 27, 2019
Results First Posted
July 6, 2016
Record last verified: 2019-03