AzTrials
AzTrials

Primary Sclerosing CholangitisPhase 3PRIMISNCT03890120

Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

A Phase 3 study testing Cilofexor in people with Primary Sclerosing Cholangitis, run by Gilead Sciences at 201 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Sclerosing Cholangitis
What is being tested?
Cilofexor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
419 participants
Where
201 sitesin 16 countries
Study dates
27 Mar 2019to 23 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of large duct PSC
  • Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader
  • Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:
  • Platelet count ≥ 150,000/mm^3
  • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
  • Alanine transaminase (ALT) ≤ 8 x upper limit of the normal range (ULN)
Show all 9Show fewer
  • Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia
  • International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
  • Negative anti-mitochondrial antibody

Who cannot join

  • Current or prior history of any of the following:
  • Cirrhosis
  • Liver transplantation
  • Cholangiocarcinoma or hepatocellular carcinoma (HCC)
  • Ascending cholangitis within 30 days of screening
  • Presence of a percutaneous drain or biliary stent
Show all 10Show fewer
  • Other causes of liver disease
  • Current or prior history of unstable cardiovascular disease
  • Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

201 sites in 16 countries.

201 sites in 16 countries

United States82 sites

  • Michigan Medicine - University of Michigan

    Ann Arbor, Michigan, 48109

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

  • University of Colorado Denver and Hospital

    Aurora, Colorado, 80045

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 28204

  • Carolinas Medical Center - Center for Liver Disease

    Charlotte, North Carolina, 28204

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital; Clinical Research Unit

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Medical Center (outpatient clinic)

    Chicago, Illinois, 60637

  • Holmes Hospital

    Cincinnati, Ohio, 45267

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Southern California Research Center

    Coronado, California, 92118

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • Annette & Harold C. Simmons Transplant Institute @ Baylor University Medical Center at Dallas

    Dallas, Texas, 75246

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • South Denver Gastroenterology, PC

    Englewood, Colorado, 80113

  • NorthShore University Healthsystem

    Evanston, Illinois, 60201

  • Verity Research Inc.

    Fairfax, Virginia, 22031

  • NECCR PrimaCare Research, LLC

    Fall River, Massachusetts, 02721

  • Baylor Scott & White Medical Center at Fort Worth

    Fort Worth, Texas, 76104

  • Institute For Liver Health

    Glendale, Arizona, 85306

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine - Advanced Liver Therapies

    Houston, Texas, 77030

  • Spring Gastroenterology Associates

    Humble, Texas, 77338

  • IU Health University Hospital

    Indianapolis, Indiana, 46202

  • Southern Therapy and Advanced Research LLC

    Jackson, Mississippi, 39157

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Altman Clinical and Translational Research Institute (Clinic)

    La Jolla, California, 92037

  • Scripps Clinic/Green Hospital

    La Jolla, California, 92037

  • Ruane Clinical Research Group Inc.

    Los Angeles, California, 90036

  • Northwell Health Center for Liver Diseases and Transplantation

    Manhasset, New York, 11030

  • Minnesota Gastroenterology, PA

    Maplewood, Minnesota, 55117

  • Methodist University Hospital

    Memphis, Tennessee, 38104

  • Schiff Center for Liver Diseases/University of Miami

    Miami, Florida, 33136

  • Intermountain Medical Center - Transplant Services

    Murray, Utah, 84107

  • Vanderbilt University Medical Center - Digestive Disease Center

    Nashville, Tennessee, 37232

  • Yale School of Medicine

    New Haven, Connecticut, 48109

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Advanced Research Institute, Inc

    New Port Richey, Florida, 34653

  • NYU Langone Health

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai Beth Israel

    New York, New York, 10029

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Center for Liver Disease and Transplantation, Columbia University Medical Center

    New York, New York, 10032

  • Rutgers New Jersey Medical School - Doctors Office Center

    Newark, New Jersey, 07103

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68105

  • Stanford Hospital

    Palo Alto, California, 94025

  • California Liver Research Institute

    Pasadena, California, 91105

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • The Institute for Liver Heath

    Phoenix, Arizona, 85013

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Rapid City Medical Center, LLP

    Rapid City, South Dakota, 57701

  • Bon Secours Richmond Community Hospital

    Richmond, Virginia, 23226

  • Virginia Commonwealth University Clinical Research Services Unit

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California, Davis Medical Center (study visits)

    Sacramento, California, 95817

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

  • San Antonio Military Medical Center, Gastro/Hepatology

    San Antonio, Texas, 78234

  • Sutter Pacific Medical Foundation - California Pacific Medical Center

    San Francisco, California, 94107

  • University of California, San Francisco Liver Clinic

    San Francisco, California, 94143

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Liver Institute Northwest

    Seattle, Washington, 98105

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Saint Louis University, Gastroenterology & Hepatology

    St Louis, Missouri, 63104

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Cedars Sinai Medical Center

    West Hollywood, California, 90048

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

Australia13 sites

  • Coral Sea Clinical Research Institute - Mackay

    Auchenflower, Queensland, 4066

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Health

    Clayton, Victoria, 3168

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Nepean Hospital

    Penrith, New South Wales, 2751

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Mater Misericordiae Ltd

    South Brisbane, Queensland, 4101

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Canada13 sites

  • William Osler Health System - Brampton Civic Hospital

    Brampton, L6R 3J7

  • University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)

    Calgary, T2N 4Z6

  • University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)

    Edmonton, T6G 2X8

  • Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

    Halifax, B3L 1E4

  • St. Joseph's Healthcare Hamilton

    Hamilton, L8N 4A6

  • McMaster University Medical Center

    Hamilton, L8S 4L8

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

    Montreal, H2X 3J4

  • Chronic Viral Illness Service/McGill University Health Centre (MUHC)

    Montreal, H4A 3J1

  • Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)

    Toronto, M5G 2C4

  • Toronto Liver Centre

    Toronto, M6H 3M1

  • Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

    Vancouver, V5Z 1M9

  • (G.I.R.I.) GI Research Institute

    Vancouver, V6Z 2K5

  • University of Manitoba/Health Sciences Centre

    Winnipeg, R3E 3P4

Other trials in Canada

France13 sites

  • CHU Amiens-Picardie Hôpital Sud

    Amiens, 80054

  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

    CHRU Lille, 59000

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU Grenoble Alpes

    Grenoble, 38043

  • Hôpital Saint-Joseph

    Marseille, 13008

  • Hôpital Saint-Eloi

    Montpellier, Herault, 34295

  • Hopital Saint Antoine

    Paris, 75571

  • CHU Bordeaux-Hopital Haut-Leveque

    Pessac, 33604

  • Hopital Robert Debré - Centre Hospitalier Universitaire de Reims

    Reims, 4025

  • CHU de Strasbourg - Nouvel Hôpital Civil

    Strasbourg, 67091

  • CHU de Toulouse Hopital Ranguiel

    Toulouse, 31059

  • CHU de Toulouse - Hopital Rangueil

    Toulouse, 31300

  • Hopital Paul Brousse

    Villejuif, 94800

Other trials in France

United Kingdom12 sites

  • University Hospital Birmingham NHS Foundation Trust

    Birmingham, B15 2TT

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • NHS Greater Glasgow and Clyde

    Glasgow, G4 0SF

  • The Leeds Teaching Hospitals NHS Trust

    Leeds

  • Aintree University Hospitals NHS Foundation Trust

    Liverpool, L9 7AL

  • Barts Health NHS Trust

    London, E1 1BB

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • King's College Hospital NHS Foundation Trust

    London, SE5 9NT

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, SW10 9NH

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU

  • Portsmouth Hospitals NHS Trust

    Portsmouth, PO6 3LY

Other trials in United Kingdom

Italy11 sites

  • Dipartimento Gastroenterologico e dei Trapianti

    Ancona, 60126

  • Azienda Ospedaliero Universitaria di Moderna, Ospedale di Baggiovara

    Bologna, 40138

  • Ca'Granda Ospedale Maggiore Policlinico UOC Gastroenterologia ed Epatologia

    Milan, 20122

  • Medicina Interna 1

    Novara, 28100

  • Azienda Ospedale Universita Padova

    Padova, 35128

  • Azienda Ospedaliera Universitaria Policlinico P. Giaccone

    Palermo, 90127

  • Azienda Ospedaliero-Universitaria Pisana - Unità Operativa Epatologia

    Pisa, 56124

  • Fondazione Policlinico Universitario Agostino Gemelli

    Rome, 00168

  • U.O.C. Gatroenterologia

    Rozzano, 20089

  • Istituto Clinico Humanitas - Unita Operativa di Epatologia

    Rozzano (Milan), 20089

  • IRCCS Ospedale Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

Other trials in Italy

Spain11 sites

  • Hospital General Universitario de Alicante

    Alicante, 3010

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Universitario Ramon y cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28220

  • Complejo Hospitalario de Pontevedra

    Pontevedra, 36071

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital General Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany10 sites

  • GASTRO-Studien GbR

    Berlin, 10825

  • Universitätsklinikum Essen

    Essen, 45147

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Medizinische Hochscule Hannover

    Hanover, 30625

  • Universitätsklinik Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Hepatologie

    Homburg, 66421

  • Gastroenterologisch-Hepatologisches Zentrum Kiel

    Kiel, 24146

  • Universitätsklinikum Leipzig AöR

    Leipzig, 04103

  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

    Mainz, 55131

  • Universitätsmedizin Mannheim, II. Medizinische Klinik

    Mannheim, 68167

Other trials in Germany

Japan10 sites

  • Chiba University Hospital

    Chiba, 260-8670

  • Hiroshima University Hospital

    Hiroshima, 7348551

  • National Hospital Organization Nagasaki Medical Center

    Nagasaki, 856-8562

  • Okayama University Hospital

    Okayama, 7008558

  • National University Corporation Tohoku University Tohoku University Hospital

    Sendai, 980-8574

  • Osaka University Hospital

    Suita, 565-0871

  • Juntendo University Hospital

    Tokyo, 113-8431

  • Teikyo University Hospital

    Tokyo, 173-8606

  • Ehime University Hospital

    Toon-Shi, 791-0295

  • Yamagata University Hospital

    Yamagata, 9909585

Other trials in Japan

Israel8 sites

  • Emek Medical Center

    Afula, 1834111

  • Rambam Health Care Campus

    Haifa, 31096

  • Carmel Medical Center

    Haifa

  • Shaare Zedek Medical Center

    Jerusalem, 64239

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 62431

Other trials in Israel

Belgium6 sites

  • Hôpital Erasme - ULB

    Brussels, 10070

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Algemeen Ziekenhuis Maria Middelares

    Ghent, 9000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitair Ziekenhuis Leuven

    Leuven, B-3000

  • Centre Hospitalier Universitaire de Liège Site Sart Tilman

    Liège, 4000

Other trials in Belgium

New Zealand3 sites

  • Auckland City Hospital

    Auckland, 92103

  • Christchurch Hospital

    Christchurch, 8011

  • Waikato Hospital

    Hamilton, 2001

Other trials in New Zealand

Switzerland3 sites

  • Universitatsspital Bern

    Bern, 3010

  • Epatocentro Ticino SA

    Lugano, 6900

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

Austria2 sites

  • Landeskrankenanstalten-Betriebsgesellscaft - KABEG, Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020

  • Allgemeines Krankenhaus Wien

    Vienna, 1090

Other trials in Austria

Denmark2 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Copenhagen University Hospital - Hvidovre

    København Ø, DK-2100

Other trials in Denmark

Finland2 sites

  • Helsinki University Hospital, Endoscopy Unit, Gastroenterology Outpatient clinic, Meilahden tomisairaala

    Helsinki, 00290

  • Turku University Hospital, Gastroenterology Outpatient Clinic

    Turku, 20520

Other trials in Finland

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis

The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

Being tested
Cilofexor, Placebo
Medical subject headings
Cholangitis, Sclerosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CilofexorDrug

    Also called GS-9674

    100 mg tablet administered orally once daily

  • PlaceboDrug

    Tablet administered orally once daily

Study groups in NCT03890120
Study groupRoleWhat they receive
Cilofexor 100 mg (Blinded Phase)ExperimentalParticipants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
Receives: Drug: Cilofexor
Placebo (Blinded Phase)Placebo comparatorParticipants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
Receives: Drug: Placebo
Cilofexor From Cilofexor 100 mg (OLE Phase)ExperimentalParticipants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.
Receives: Drug: Cilofexor
Cilofexor From Placebo (OLE Phase)ExperimentalParticipants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.
Receives: Drug: Cilofexor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96

    Progression of liver fibrosis was defined as having a ≥ 1-stage increase from baseline in fibrosis according to the Ludwig classification at Blinded Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).

    Measured: Blinded Phase Week 96

Secondary outcomes (12)

  1. Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase

    An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.

    Measured: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days

  2. Percentage of Participants Who Experienced TEAEs in The OLE Phase

    An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.

    Measured: First dose date in the OLE Phase up to 45 weeks plus 30 days

  3. Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase

    An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.

    Measured: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days

  4. Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase

    An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.

    Measured: First dose date in the OLE Phase up to 45 weeks plus 30 days

  5. Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96

    Measured: Baseline, Blinded Phase Week 96

  6. Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96

    Measured: Baseline, Blinded Phase Week 96

  7. Change From Baseline in Serum Concentrations of Fasting Total Bile Acids at Blinded Phase Week 96

    Measured: Baseline, Blinded Phase Week 96

  8. Percentage of Participants With ≥ 25% Relative Reduction in Serum ALP Concentration From Baseline and No Worsening of Fibrosis According to the Ludwig Classification at Blinded Phase Week 96

    The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).The percentage of participants with ≥ 25% reduction in serum ALP Concentration from baseline and no increase in fibrosis according to the Ludwig Classification at Blinded Phase Week 96 was analyzed.

    Measured: Baseline, Blinded Phase Week 96

  9. Percentage of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96

    Fibrosis improvement was defined as having ≥ 1-stage decrease from baseline in fibrosis according to the Ludwig classification score at Blinded Study Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).

    Measured: Blinded Phase Week 96

  10. Change From Baseline in Primary Sclerosing Cholangitis (PSC) Symptoms - Module 1 Based on Disease-specific Patient Reported Outcome (PSC-PRO) at Blinded Phase Week 96

    The PSC-PRO addressed the severity of common everyday symptoms of PSC (eg, pruritus, fatigue, and right upper quadrant abdominal discomfort); and their functional impact (eg, on physical function, activities of daily living, and work productivity, etc). PSC-PRO module 1 - PSC symptoms contains a total of 12 questions asking about the severity of specific PSC symptoms on a scale of 0 (no symptoms) to 10 (symptoms as bad as you could imagine) with a 24-hour recall period. The total score, which is computed as 12 times the average of nonmissing scores of the 12 questions, can potentially range between 0 and 120, with higher scores indicating more severe symptoms. A positive change from baseline indicates worsening of symptoms.

    Measured: Baseline, Blinded Phase Week 96

  11. Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Blinded Phase Week 96

    The Enhanced Liver Fibrosis (ELF™) test is a composite of three serum biomarkers of hepatobiliary fibrosis: hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase. A typical range for ELF™ test scores in PSC is between 6 and 14. Higher ELF™ test scores are associated with more severe liver disease. A positive change from baseline indicated worsening of fibrosis.

    Measured: Baseline, Blinded Phase Week 96

  12. Change From Baseline in Liver Stiffness by FibroScan® at Blinded Phase Week 96

    Change in liver stiffness was measured by FibroScan® scores. FibroScan measures liver scarring by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. Higher scores indicate increased scarring of the liver. A positive change from baseline indicates severe liver disease(s).

    Measured: Baseline, Blinded Phase Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2019
  2. Study start27 Mar 2019
  3. Primary completion10 Nov 2022
  4. Study completion23 Dec 2022

Why it stopped: Following recommendation of the external Data Monitoring Committee, after it reviewed the results of a planned interim futility analysis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03890120
Sponsor's protocol ID
GS-US-428-4194
Other IDs
2019-000204-14, jRCT2080224728, 2019
Acronym
PRIMIS
Status last verified
Nov 2023
First submitted
25 Mar 2019
Last updated
29 Nov 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Trauner M, Chung C, Sterling K, Liu X, Lu X, Xu J, Tempany-Afdhal C, Goodman ZD, Farkkila M, Tanaka A, Trivedi P, Kowdley KV, Bowlus CL, Levy C, Myers RP. 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. BMC Gastroenterol. 2023 Mar 15;23(1):75. doi: 10.1186/s12876-023-02653-2.

    PubMed 36922785

  • Trauner M, Levy C, Tanaka A, Goodman Z, Thorburn D, et al. A Phase 3 Randomized, Double-blind, Placebo-controlled Study Evaluation the Efficacy and Safety of Cilofexor in Patients With Non-cirrhotic Patients With Primary Sclerosing Cholangitis. J Hepatol. 2023 June;78(S1):S12-S13.

  • Trauner M, Levy C, Tanaka A, Goodman Z, Thorburn D, Joshi D, Salminen K, Yimam K, Isayama H, Montano-Loza AJ, Caldwell S, Danta M, Farkkila M, Gallegos-Orozco JF, Gordon SC, Hinrichsen H, Invernizzi P, Vuppalanchi R, Zhu K, Xu J, Liu X, Lu X, Crans G, Bolbolan S, Boyette L, Alani M, Barchuk WT, Watkins TR, Genovese MC, Bowlus CL. Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2026 Jan;11(1):46-58. doi: 10.1016/S2468-1253(25)00208-0. Epub 2025 Oct 28.

    PubMed 41173015

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cilofexor in people with Primary Sclerosing Cholangitis, run by Gilead Sciences at 201 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 201 sites in United States, Australia, Canada, France, United Kingdom and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96 (time frame: Blinded Phase Week 96). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03890120, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in