A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Part of paid clinical trials in Coronado, California.
- Sponsor
- Mirum Pharmaceuticals, Inc.
- Study ID
- NCT05050136
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- PBC
- Primary Biliary Cholangitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Volixibat — DRUGOral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.
- Placebo — DRUGCapsules matched to study drug without the active pharmaceutical ingredient
Study Details
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.
Key Dates
- Start date
- Sep 22, 2021
- Status verified
- May 2026
- Primary completion
- Apr 30, 2027
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 260 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part 1 Arm 1: Volixibat 20mgParticipants randomized to this arm will receive volixibat 20mg twice daily.
- Experimental: Part 1 Arm 2: Volixibat 80mgParticipants randomized to this arm will receive volixibat 80mg twice daily.
- Placebo Comparator: Part 1 Arm 3: PlaceboParticipants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
- Experimental: Part 2 Arm 1: Volixibat Selected Dose 20mgParticipants randomized to this arm will receive volixibat 20mg twice daily.
- Placebo Comparator: Part 2 Arm 2: PlaceboParticipants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Primary Outcome Measure
Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire [ Time Frame: Baseline to week 28 ]
Locations (44)
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