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: 15 Dec 2022
Reviewer:  Debjyoti Kundu
Reviewer's report:
The manuscript by Trauner et al describes a double -blind  placebo controlled phase 3 clinical
trial  study of an FXR agonist on non-cirrhotic PSC patients.
The manuscript  has been revised adequately addressing all the comments from the previous
review. It would have been indeed insightful to have preliminary data included, but the
manuscript contributes as an effective study design for a clinical trial of a drug that targets an
incredibly complex and heterogenous  biliary pathology per se. No further concern exists  for
this manuscript.
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: 15 Dec 2022
Reviewer:  Debjyoti Kundu
Reviewer's report:
The manuscript by Trauner et al describes a double -blind  placebo controlled phase 3 clinical
trial  study of an FXR agonist on non-cirrhotic PSC patients.
The manuscript  has been revised adequately addressing all the comments from the previous
review. It would have been indeed insightful to have preliminary data included, but the
manuscript contributes as an effective study design for a clinical trial of a drug that targets an
incredibly complex and heterogenous  biliary pathology per se. No further concern exists  for
this manuscript.
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: 15 Dec 2022
Reviewer:  Debjyoti Kundu
Reviewer's report:
The manuscript by Trauner et al describes a double -blind  placebo controlled phase 3 clinical
trial  study of an FXR agonist on non-cirrhotic PSC patients.
The manuscript  has been revised adequately addressing all the comments from the previous
review. It would have been indeed insightful to have preliminary data included, but the
manuscript contributes as an effective study design for a clinical trial of a drug that targets an
incredibly complex and heterogenous  biliary pathology per se. No further concern exists  for
this manuscript.
assistant