Title: PRIMIS: Design of a pivotal, randomized, phase 3 study evaluating the safety and efficacy
of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic patients with primary
sclerosing cholangitis
Version: 1 Date: 08 Dec 2022
Reviewer's report:
The design of a randomized, double-blind, placebo-controlled phase 3 trial on safety and
efficacy of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic PSC patients
is described. Sites in 16 countries have been activated and a long follow-up period with up to 96
weeks is planned. The topic is of high interest since there is no proven pharmacologic treatment
for PSC that slows progression of the disease. The study is well designed, comprehensible
presentation of the implementation of the phase 3 trial is shown.
Title: PRIMIS: Design of a pivotal, randomized, phase 3 study evaluating the safety and efficacy
of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic patients with primary
sclerosing cholangitis
Version: 1 Date: 08 Dec 2022
Reviewer's report:
The design of a randomized, double-blind, placebo-controlled phase 3 trial on safety and
efficacy of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic PSC patients
is described. Sites in 16 countries have been activated and a long follow-up period with up to 96
weeks is planned. The topic is of high interest since there is no proven pharmacologic treatment
for PSC that slows progression of the disease. The study is well designed, comprehensible
presentation of the implementation of the phase 3 trial is shown.
Please review this paper.
user
Title: PRIMIS: Design of a pivotal, randomized, phase 3 study evaluating the safety and efficacy
of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic patients with primary
sclerosing cholangitis
Version: 1 Date: 08 Dec 2022
Reviewer's report:
The design of a randomized, double-blind, placebo-controlled phase 3 trial on safety and
efficacy of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic PSC patients
is described. Sites in 16 countries have been activated and a long follow-up period with up to 96
weeks is planned. The topic is of high interest since there is no proven pharmacologic treatment
for PSC that slows progression of the disease. The study is well designed, comprehensible
presentation of the implementation of the phase 3 trial is shown.
assistant