Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis (CAMEO)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Shire Identifier:
First received: February 11, 2014
Last updated: September 21, 2015
Last verified: September 2015
The study is an open-label study in adults with primary sclerosing cholangitis to evaluate the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.

Condition Intervention Phase
Primary Sclerosing Cholangitis (PSC)
Drug: LUM001
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Primary Sclerosing Cholangitis

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    Adverse events, changes in vital signs, laboratory and other safety parameters from baseline to week 14

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    Changes in serum bile acids, pruritus, and other biochemical markers of cholestasis and liver disease from baseline to week 14

Estimated Enrollment: 20
Study Start Date: March 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LUM001
LUM001 administered orally once each day
Drug: LUM001


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of Primary Sclerosing Cholangitis
  2. Ability to understand and willingness to sign informed consent prior to initiation of any study procedures

Exclusion Criteria:

  1. History or presence of other concomitant significant liver disease
  2. Liver transplant
  3. Known HIV infection
  4. Women who are pregnant or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02061540

United States, California
Scripps Clinic
: La Jolla, California, United States, 92037
University of California at Davis
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Canada, Alberta
University of Calgary Liver Unit
Calgary, Alberta, Canada, T2N 4Z6
Canada, Ontario
University Health Network, Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
United Kingdom
University of Birmingham
Birmingham, England, United Kingdom, B15 2TT
Royal Free Hospital
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Shire Identifier: NCT02061540     History of Changes
Other Study ID Numbers: LUM001-401, 2014-005558-21
Study First Received: February 11, 2014
Last Updated: September 21, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases processed this record on November 25, 2015