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

Mirum Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: PBC; Primary Biliary Cirrhosis

Treatments: Drug: Ursodeoxycholic Acid; Drug: Placebo; Drug: LUM001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01904058

LUM001-201

2013-000482-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

LUM001 and Ursodeoxycholic Acid (UDCA)

Experimental group

Description:

Administered orally once daily

Treatment:

Drug: LUM001

Drug: Ursodeoxycholic Acid

Placebo and Ursodeoxycholic Acid (UDCA)

Placebo Comparator group

Description:

Administered orally once daily

Treatment:

Drug: Ursodeoxycholic Acid

Drug: Placebo