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

This study has been completed.
Information provided by (Responsible Party):
Shire Identifier:
First received: July 17, 2013
Last updated: June 9, 2015
Last verified: June 2015

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
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 Shire:

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

Enrollment: 66
Study Start Date: August 2013
Study Completion Date: April 2015
Primary Completion Date: April 2015 (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


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

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 identifier: NCT01904058

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Sponsors and Collaborators
  More Information

Additional Information:
No publications provided

Responsible Party: Shire Identifier: NCT01904058     History of Changes
Other Study ID Numbers: LUM001-201, 2013-000482-36
Study First Received: July 17, 2013
Last Updated: June 9, 2015
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Shire:

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis, Intrahepatic
Digestive System Diseases
Liver Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 08, 2015