Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis (CLARITY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Lumena Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Lumena Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01904058
First received: July 17, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Primary Biliary Cirrhosis
PBC
Drug: LUM001
Drug: Placebo
Drug: Ursodeoxycholic Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Lumena Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    Change from baseline in pruritus compared to placebo


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    Change from baseline in liver enzymes and other biochemical markers compared to placebo


Other Outcome Measures:
  • Safety and Tolerability [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
    Evaluation of adverse events, changes in vital signs, laboratory and other safety parameters


Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LUM001 and Ursodeoxycholic Acid (UDCA)
Administered orally once daily
Drug: LUM001 Drug: Ursodeoxycholic Acid
Other Name: UDCA
Placebo Comparator: Placebo and Ursodeoxycholic Acid (UDCA)
Administered orally once daily
Drug: Placebo Drug: Ursodeoxycholic Acid
Other Name: UDCA

  Eligibility

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

Inclusion Criteria:

  1. Diagnosis of Primary Biliary Cirrhosis
  2. Moderate to severe pruritus
  3. Taking ursodeoxycholic acid (UDCA) for at least 6 months, or unable to tolerate UDCA
  4. 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 ClinicalTrials.gov identifier: NCT01904058

Contacts
Contact: Patricia Novak, PhD 858-461-0694 info@lumenapharma.com

  Show 24 Study Locations
Sponsors and Collaborators
Lumena Pharmaceuticals, Inc.
Investigators
Study Director: Alejandro Dorenbaum, MD Lumena Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Lumena Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01904058     History of Changes
Other Study ID Numbers: LUM001-201, 2013-000482-36
Study First Received: July 17, 2013
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Lumena Pharmaceuticals, Inc.:
PBC

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
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014