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AzTrials

Primary Biliary CholangitisPhase 3NCT04620733

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

A Phase 3 study testing Seladelpar 10 mg and Seladelpar 5 mg in people with Primary Biliary Cholangitis, run by Gilead Sciences at 134 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Biliary Cholangitis
What is being tested?
Seladelpar 10 mg and Seladelpar 5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
193 participants
Where
134 sitesin 26 countries
Study dates
21 Apr 2021to 11 Aug 2023
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

  • Must have given written informed consent (signed and dated) and any authorizations required by local law.
  • Male or female with a definitive diagnosis of primary biliary cholangitis (PBC).
  • Ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for >3 months prior to screening) or intolerant to UDCA (last dose of UDCA >3 months prior to screening).
  • Laboratory parameters measured by the Central Laboratory at screening:
  • Alkaline phosphatase (ALP) ≥1.67× ULN (upper limit of normal)
  • Aspartate aminotransferase (AST) ≤3× ULN
Show all 12Show fewer
  • Alanine aminotransferase (ALT) ≤3× ULN
  • Total bilirubin ≤2× ULN
  • Estimated glomerular filtration rate (eGFR) >45 mL/min/1.73 m^2 (calculated by the Modification of Diet in Renal Disease study equation).
  • International normalized ratio (INR) below 1.1× ULN (For individuals on anticoagulation therapy, INR must be maintained in the range required for prophylaxis for their specific disease).
  • Platelet count ≥100 ×10^3/µL.
  • Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose.

Who cannot join

  • Previous exposure to seladelpar (MBX-8025).
  • A medical condition other than PBC that, in the investigator's opinion, would preclude full participation in the study (e.g., cancer) or confound its results (e.g., Paget's disease, any active infection).
  • Advanced PBC as defined by the Rotterdam criteria (albumin below the lower limit of normal and total bilirubin above 1.0 × ULN).
  • Presence of clinically important hepatic decompensation, including the following:
  • History of liver transplantation, current placement on liver transplantation list, or current Model for End-Stage Liver Disease (MELD) score ≥12. For individuals on anticoagulation medication, evaluation of the baseline INR, in concert with their current dose adjustments of their anticoagulant medication, will be taken into account when calculating the MELD score. This will be done in consultation with the medical monitor.
  • Complications of portal hypertension, including known esophageal varices, history of variceal bleeds or related interventions (e.g., transjugular intrahepatic portosystemic shunt placement), ascites, and hepatic encephalopathy.
Show all 31Show fewer
  • Cirrhosis with complications, including history or presence of spontaneous bacterial peritonitis, hepatocellular carcinoma, or hepatorenal syndrome.
  • Other chronic liver diseases:
  • Current features of autoimmune hepatitis (AIH) as determined by the investigator based on immunoserology, liver biochemistry, or historic confirmed liver histology.
  • PSC determined by the presence of diagnostic cholangiographic findings.
  • History or clinical evidence of alcoholic liver disease.
  • History or clinical evidence of alpha-1-antitrypsin deficiency.
  • History of biopsy confirmed nonalcoholic steatohepatitis (NASH).
  • History or evidence of Gilbert's syndrome with elevated total bilirubin.
  • History or evidence of hemochromatosis.
  • Hepatitis B, defined as the presence of hepatitis B surface antigen.
  • Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid.
  • History, evidence, or high suspicion of hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms.
  • Known history of human immunodeficiency virus (HIV) or positive antibody test at screening
  • Clinically important alcohol consumption, defined as more than 2 drink units per day (equivalent to 20 g) in women and 3 drink units per day (equivalent to 30 g) in men, or inability to quantify alcohol intake reliably.
  • History of malignancy diagnosed or treated, actively or within 2 years, or ongoing evaluation for malignancy; localized treatment of squamous or noninvasive basal cell skin cancers and cervical carcinoma in situ is allowed if appropriately treated prior to screening.
  • Treatment with obeticholic acid (OCA) or fibrates (e.g., bezafibrate, fenofibrate, elafibranor, lanifibranor, pemafibrate, saroglitizar) 6 weeks prior to screening.
  • Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids (>2 weeks) during 2 months prior to screening
  • Treatment with anti-pruritic drugs (e.g., cholestyramine, naltrexone, rifampicin, sertraline, or any experimental approach) must be on a stable dose within 1 month prior to screening
  • Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening
  • For females, pregnancy or breastfeeding.
  • Any other condition(s) that would compromise the safety of the individual or compromise the quality of the clinical study, as judged by the investigator.
  • Immunosuppressant therapies.
  • Other medications that effect liver or gastrointestinal (GI) functions, such as absorption of medications or the roux-en-y gastric bypass procedure, may be prohibited and should be discussed with the medical monitor on a case-by-case basis.
  • Active Coronavirus Disease-2019 (COVID-19) infection during Screening.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

134 sites in 26 countries.

134 sites in 26 countries

United States40 sites

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • The Institute for Liver Health DBA Arizona Liver Health

    Chandler, Arizona, 85224

  • Galen Hepatology

    Chattanooga, Tennessee, 37421

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Hospitals

    Chicago, Illinois, 60637

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Texas Digestive Disease Consultants dba GI Alliance

    Fort Hood, Texas, 76104

  • Covenant Metabolic Specialists, LLC

    Fort Myers, Florida, 33912

  • Gastro One

    Germantown, Tennessee, 38138

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Southern Therapy and Advanced Research, LLC (STAR)

    Jackson, Mississippi, 39216

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Arkansas Diagnostic Center

    Little Rock, Arkansas, 72205

  • Care Access Research - Lumberton

    Lumberton, North Carolina, 28358

  • MNGI Digestive Health, P.A.

    Maplewood, Minnesota, 55117

  • Schiff Center for Liver Diseases/University of Miami

    Miami, Florida, 33136

  • Vanderbilt Digestive Disease Center

    Nashville, Tennessee, 37212

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • NYU Langone Health / NYU Grossman School of Medicine

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Henry Ford Health System

    Novi, Michigan, 48377

  • Stanford University School of Medicine

    Palo Alto, California, 94305

  • California Liver Research Institute

    Pasadena, California, 91105

  • UPMC Center for Liver Diseases

    Pittsburgh, Pennsylvania, 15213

  • Bon Secours Richmond Community Hospital LLC

    Richmond, Virginia, 23226

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research, PLLC

    San Antonio, Texas, 78229

  • California Pacific Medical Center - Sutter Pacific Medical Foundation

    San Francisco, California, 94109

  • Covenant Research and Clinics, LLC

    Sarasota, Florida, 34240

  • Liver Institute Northwest

    Seattle, Washington, 98105

  • Saint Louis University

    St Louis, Missouri, 63104

Other trials in United States

South Korea9 sites

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, Gyeonggido, 14584

  • Inje University Busan Paik Hospital

    Busan, Busan Gwangyeogsi, 47392

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, 41944

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Severance Hospital Yonsei University Health System - PPDS

    Soeul, 03722

Other trials in South Korea

United Kingdom8 sites

  • University Hospitals Birmingham NHS Foundation Trust, Heritage Building (Queen Elizabeth Hospital)

    Birmingham, B15 2TH

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

    London, London, City of, E1 1RF

  • Kings College Hospital

    London, SE5 9RS

  • Queen's Medical Centre

    Nottingham, Nottinghamshire, NG7 2UH

  • Gemini Clinical Trial Unit

    Oxford, Oxfordshire, OX4 2LL

  • University Hospitals Plymouth NHS Trust

    Plymouth, Devon, PL6 8DH

  • Portsmouth Hospitals NHS Trust

    Portsmouth, Hampshire, P06 3LY

Other trials in United Kingdom

Germany7 sites

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

  • Universitatsklinikum Erlangen, Medizinische Klinik I, Gastroenterologie

    Erlangen, 91054

  • Universitatsklinikum Frankfurt. Medizinische Klinik I

    Frankfurt am Main, 60590

  • Ifi-Medizin GmbH

    Hamburg, 20099

  • Gastroenterologische Gemeinschaftspraxis

    Herne, 44623

  • Universitätsklinikum des Saarlandes

    Homburg, Saarland, 66421

  • Universitatsklinikum Leipzig

    Leipzig, 04103

Other trials in Germany

Argentina6 sites

  • CINME (Centro de Investigaciones Metabolicas)

    Buenos Aires, C1056ABJ

  • Hospital Italiano de Buenos Aires

    Caba, C1199ABB

  • Centro Medico Dra. De Salvo

    CABA, Buenos Aires, C1426ABP

  • STAT Research S.A.

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1023AAB

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, B1900AX

  • DIM CliniaPrivada

    Ramos Mejía, Buenos Aires, B1704ETD

Other trials in Argentina

Italy6 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

    Ancona, 60020

  • Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara

    Bologna, 41126

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50139

  • ASST di Monza

    Monza, MB, 20900

  • Azienda Ospedaliera Universita Padova

    Padova, 35128

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

Other trials in Italy

Russia6 sites

  • State budget institution of healthcare of Moscow city "Moscow Clinical Scientific and Practical Centre n. a. A.S. Loginov" of Moscow City Healthcare, Department, Central Research Institute of Gastroenterology

    Moscow, 111123

  • Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia", Centre of Liver Studies

    Moscow, 117198

  • Clinic of High Medical Technologies n.a. N.I. Pirogov

    Saint Petersburg, 199034

  • LLC Medical Company "Hepatolog"

    Samara, 443045

  • Stavropol state medical university

    Stavropol, 355017

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, 432063

Other trials in Russia

Spain6 sites

  • Hospital Universitario German Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitario Vall D'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria

    Málaga, Malaga, 2910

  • Hospital Universitario Margues de Valdecilla

    Santander, Cantabria, 39008

Other trials in Spain

Belgium5 sites

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • AZ Maria Middelares

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000

  • Universitaire Ziekenhuizen Leuven

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liège

    Liège, Liège, 4000

Other trials in Belgium

Turkey (Türkiye)5 sites

  • Ankara Gazi University Faculty of Medicine Hospital

    Ankara, 06560

  • Ankara Sehir Hastanesi

    Ankara, 06800

  • Bezmi Alem University

    Istanbul, 34093

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34899

  • Ege University Medical Faculty

    Izmir, 35100

Other trials in Turkey (Türkiye)

Australia4 sites

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Mexico4 sites

  • Consultorio de la Doctora Maria Sarai Gonzalez Huezo

    Metepec, 52140

  • Campeche No. 280, Int. 601 y 602, Col. Hipodromo, Cuauhtemoc

    Mexico City, 06100

  • Consultorio Medico - Distrito Federal

    Mexico City, 06700

  • Hospital Universitario Dr. Jose Eleuterio González

    Monterrey, 64460

Other trials in Mexico

Canada3 sites

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • University Health Network

    Toronto, Ontario, M5G 2C4

  • Toronto Digestive Disease Associates Inc

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Chile3 sites

  • Centro Clinico Mediterraneo

    La Serena, Coquimbo Region, 1700000

  • Clinical Research Chile SpA

    Valdivia, Los Ríos Region, 5110683

  • Centro de Investigaciones Clínicas Vina del Mar

    Valparaíso, 2540364

Other trials in Chile

France3 sites

  • CHU de Grenoble

    Grenoble, 38043

  • Hopital de la Croix-Rousse

    Lyon, 69004

  • Hopital Saint-Antoine - Service d'Hepato-Gastro-Enterologie -184, rue du Faubourg Saint-Antoine

    Paris, 75012

Other trials in France

Israel3 sites

  • Liver Unit

    Jerusalem, 91120

  • Liver Disease Center, Sheba Medical Center

    Ramat Gan, 52621

  • Institute for Digestive Tract & Liver Disease

    Tel Aviv, 64239

Other trials in Israel

Denmark2 sites

  • Aalborg Universitetshospital, Ambulatoriet for Medicinske Mave-Tarm Sygdomme

    Aalborg, 9000

  • Hvidovre Hospital

    Hvidovre, 2650

Other trials in Denmark

Greece2 sites

  • Ippokrateio General Hospital of Athens

    Athens, Attica, 115 27

  • General University Hospital of Larissa Department of Medicine and Research Laboratory of internal rv1edicine, National Expertise Center of Greece in Autoimmune liver Diseases

    Larissa, 41110

Other trials in Greece

Hungary2 sites

  • Semmelweis Egyetem

    Budapest, 1082

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

Other trials in Hungary

New Zealand2 sites

  • Gastroenterology, Christchurch Hospital

    Christchurch, Canterbury, 8011

  • Gastroenterology Research Unit Dunedin Hospital

    Dunedin, Otago, 9016

Other trials in New Zealand

Poland2 sites

  • Uniwersyteckie Centrum Kliniczne Im.

    Katowice, 40-752

  • ID Clinic Akradiusz Pisula

    Mysłowice, 41-400

Other trials in Poland

Ukraine2 sites

  • Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council

    Kharkiv, 61124

  • Medical Center OK!Clinic+LLC International Institute of Clinical Research

    Kyiv, 0291

Other trials in Ukraine

Austria1 site

  • Klinikum Wels-Grieskirchen GmbH, Abteilung Fur Innere Medizin I - Gastroenterologie

    Wels, 4600

Other trials in Austria

Czechia1 site

  • Fakultni nemocnice Ostrava- Interni a Kardiologicka Klinika, Oddeleni gastroenterologie, hepatologie a pankreatologie

    Ostrava, 708 52

Other trials in Czechia

Romania1 site

  • Fundeni Clinical Institute

    Bucharest, 022328

Other trials in Romania

Switzerland1 site

  • University of Zurich, Gastroenterology and Hepatology

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo.

The study also checked the effect of treatment on the symptoms of PBC, including pruritus.

Being tested
Seladelpar 10 mg, Placebo, Seladelpar 5 mg
Keywords
Primary Biliary Cholangitis (PBC), PBC
Medical subject headings
Liver Cirrhosis, Biliary

What participants receive

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

  • Seladelpar 10 mgDrug

    Seladelpar 10 mg one capsule daily for double-blind period, for a duration of up to 12 months

  • PlaceboDrug

    One capsule daily for double-blind period, for a duration of up to 12 months

  • Seladelpar 5 mgDrug

    If down-titration needed, one capsule daily for double-blind period, for a duration of up to 12 months

Study groups in NCT04620733
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive placebo to match seladelpar, orally, once daily, for a duration of up to 12 months.
Receives: Drug: Placebo
SeladelparExperimentalParticipants will receive seladelpar 10 mg (or 5 mg down-titrated, for those participants who met specific safety monitoring criteria or had tolerability issues), orally, once daily, for a duration of up to 12 months.
Receives: Drug: Seladelpar 10 mg; Drug: Seladelpar 5 mg

What is being measured

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

  1. Percentage of Participants With Response Criteria for the Composite Endpoint of ALP <1.67 × Upper Limit of Normal (ULN), ≥15% Reduction in ALP, and Total Bilirubin ≤ 1.0× ULN at Month 12

    Percentages were rounded-off.

    Measured: Month 12

  2. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

    Percentages were rounded-off.

    Measured: First dose date up to last dose plus 30 days (up to 13.4 months)

  3. Percentage of Participants With Shift of ≥ 2 CTCAE Grades From Baseline in Treatment-emergent Laboratory Abnormalities Related to Hematology and Select Liver Biochemistry

    Treatment-emergent graded laboratory abnormalities were defined as values that increase at least 2 toxicity grade from baseline at any time post baseline. The laboratory abnormalities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening laboratory abnormality.

    The data is reported for shift of ≥ 2 grades from baseline in values for hematology and select liver biochemistry. Hematology includes parameters like RBCs, (erythrocytes), hemoglobin, hematocrit, platelets, WBC, WBC differentials (absolute and percentage) including basophils, neutrophils, lymphocytes, eosinophils, and monocytes, etc. Biochemistry included select liver function tests like blood bilirubin, gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Percentages were rounded-off.

    Measured: First dose date up to last dose (up to 13.4 months)

Secondary outcomes (2)

  1. Percentage of Participants With ALP ≤1.0× ULN at Month 12

    Percentages were rounded-off.

    Measured: Month 12

  2. Change From Baseline in Weekly Averaged Pruritus Numerical Rating Scale (NRS) in Participants With NRS ≥ 4 at Month 6

    Pruritus NRS is used to rate the intensity of the itching experienced by the participants in the past 24 hours from no itching to worst possible itching by selecting a number from 0 to 10 on Itch Scale. Zero means no itching and 10 means worst imaginable itching.

    Measured: Baseline, Month 6

Timeline

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

  1. First posted9 Nov 2020
  2. Study start21 Apr 2021
  3. Primary completion11 Aug 2023
  4. Study completion11 Aug 2023

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
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04620733
Sponsor's protocol ID
CB8025-32048
Other IDs
2020-004348-27
Status last verified
Aug 2024
First submitted
4 Nov 2020
Last updated
5 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Levy C, Jones DEJ, Mayo MJ, Bowlus CL, Kowdley KV, Hirschfield GM, Liu J, Burk C, Carroll S, Crittenden DB, Kremer AE. Seladelpar Improved Itch, Itch-Related Sleep Disturbance and Measures of Fatigue in Patients With Primary Biliary Cholangitis and Pruritus in the Phase 3 RESPONSE Trial. Aliment Pharmacol Ther. 2026 Jul;64(1):23-35. doi: 10.1111/apt.70630. Epub 2026 Apr 3.

    PubMed 41933275

  • Hirschfield GM, Bowlus CL, Mayo MJ, Kremer AE, Vierling JM, Kowdley KV, Levy C, Villamil A, Ladron de Guevara Cetina AL, Janczewska E, Zigmond E, Jeong SH, Yilmaz Y, Kallis Y, Corpechot C, Buggisch P, Invernizzi P, Londono Hurtado MC, Bergheanu S, Yang K, Choi YJ, Crittenden DB, McWherter CA; RESPONSE Study Group. A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis. N Engl J Med. 2024 Feb 29;390(9):783-794. doi: 10.1056/NEJMoa2312100. Epub 2024 Feb 21.

    PubMed 38381664

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Seladelpar 10 mg and Seladelpar 5 mg in people with Primary Biliary Cholangitis, run by Gilead Sciences at 134 sites in 26 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 12 inclusion and 31 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: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, South Korea, United Kingdom, Germany, Argentina and 21 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 25 Jul 2024). 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 Response Criteria for the Composite Endpoint of ALP <1.67 × Upper Limit of Normal (ULN), ≥15% Reduction in ALP, and Total Bilirubin ≤ 1.0× ULN at Month 12 (time frame: Month 12). The study lists 3 primary outcomes in all. 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 NCT04620733, which also lists 2 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 5 Sep 2024.

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