A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)
Who is this study for? Patients with Pruritus
What treatments are being studied? Linerixibat
Status: Completed
Location: See all (111) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Male and female participants must be between 18 to 80 years of age inclusive, at the time of signing the informed consent.
• Participants who have documented PBC.
• Participants who have moderate to severe itch.
Locations
United States
California
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Davis
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Los Angeles
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San Francisco
Colorado
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Colorado Springs
Florida
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Hialeah
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Miami
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Miami
Michigan
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Detroit
Mississippi
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Jackson
North Carolina
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Durham
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Morrisville
Nebraska
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Omaha
New York
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New York
Ohio
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Columbus
Pennsylvania
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Philadelphia
Texas
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Dallas
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Dallas
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Houston
Other Locations
Argentina
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Buenos Aires
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Capital Federal
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Ciudad Autonoma De Bueno
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Ciudad Autonoma De Buenos Aire
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Rosario
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San Nicolás
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Santa Fe
Belgium
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Ghent
Brazil
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Botucatu
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Brasília
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Porto Alegre
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Salvador
Bulgaria
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Plovdiv
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Sofia
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Sofia
Canada
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Edmonton
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Toronto
China
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Beijing
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Beijing
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Changchun
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Chongqing
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Guangzhou
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Nanchang
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Nanjing
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Shanghai
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Tianjin
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Zhanjiang
France
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Créteil
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Grenoble
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Lille
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Paris
Germany
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Erlangen
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Essen
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Münster
Greece
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Athens
Israel
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Beersheba
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Haifa
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Holon
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Jerusalem
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Nahariya
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Rehovot
Italy
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Milan
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Modena
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Monza
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Napoli
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Negrar Verona
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Palermo
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Roma
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Rozzano Mi
Japan
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Ehime
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Fukui
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Hiroshima
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Hiroshima
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Hokkaido
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Ibaraki
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Kagawa
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Kanagawa
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Nagano
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Nagasaki
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Nara
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Shizuoka
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Tokyo
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Tokyo
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Tokyo
Mexico
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Mexico City
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Mexico City
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Monterrey
Poland
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Częstochowa
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Katowice
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Mysłowice
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Warsaw
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Wroclaw
Russian Federation
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Kemerovo
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Moscow
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Moscow
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Novosibirsk
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Samara
Spain
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Barcelona
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Madrid
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Madrid
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Seville
United Kingdom
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Basingstoke
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Cambridge
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Durham
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Hull
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Liverpool
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London
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London
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Newcastle Upon Tyne
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Plymouth
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Reading Berkshire
GSK Investigational Site
Southampton
GSK Investigational Site
Surrey
Time Frame
Start Date: 2021-08-27
Completion Date: 2024-12-20
Participants
Target number of participants: 238
Treatments
Experimental: Part A: Linerixibat 40 milligrams (mg)
Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).
Experimental: Part A: Placebo
Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Placebo_comparator: Part B: Placebo in Part A and Part B
Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, continued to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.
Experimental: Part B: Placebo in Part A and Linerixibat 40 mg in Part B
Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, switched to receive linerixibat 40 mg tablet orally twice a day (BID) (from Week 24 to Week 32) in Part B.
Experimental: Part B: Linerixibat 40 mg in Part A and Placebo in Part B
Participants who were randomized to receive linerixibat 40 mg tablet orally BID (up to Week 24) in Part A, switched to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.
Experimental: Part B: Linerixibat 40 mg in Part A and Part B
Participants who were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) (up to Week 24) in Part A, continued to receive linerixibat 40 mg twice a day (BID) (from Week 24 to Week 32) in Part B.
Authors
Svetlana Smakotina, Walid S Ayoub, Agustin Martinez, Roberto Fernandez, Andrew J Muir, Brian Borg, Ramses Vega, Alexandre Louvet, David Harman, John Ramage, Sonja Staender, Lynsey Corless, Marcel Vetter, Dominique Larrey, Christophe Corpechot, Margaret Corrigan, Vincent Leroy, Janisha Patel, Fedja A Rochling, Christopher Bowlus, Maria Margarita Anders, Paolo Bocus, Maria S. Zharkova, Luis Alejandro Gaite, Kazuo Notsumata, Michio Imamura, Elena V. Vinnitskaya, Atsumasa Komori, Masanori Atsukawa, Linda Elsa Muñoz-Espinosa, Atsushi Tanaka, Ewa Janczewska, Takeji Umemura, Mikio Yanase, Marina F Osipenko, Pietro Invernizzi, Charlotte Costentin, Bingliang Lin, Yandan Zhong, Pietro Andreone, Qinglong Jin, Xavier Verhelst, Gideon Hirschfield, Masanori Abe, Christophe Moreno, Tadashi Namisaki, Koichi Takaguchi, Angela Cheung, Kazuhito Kawata, Olivier Roux, Tatehiro Kagawa, Jidong Jia
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline