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“Just managing” isn’t enough.

You can be part of the RESPONSE against Primary Biliary Cholangitis (PBC).

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Join the RESPONSE clinical research study and help us learn more about PBC treatment

RESPONSE is a clinical research study of seladelpar in primary biliary cholangitis (PBC).

Participants may be reimbursed for study-related travel expenses.

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Why Participate?

The purpose of this study is to test seladelpar to see if it can improve PBC-related laboratory blood results and symptoms of PBC, such as itching. The goal of the study is to find a new treatment for PBC patients. Click here if you are interested in potentially participating in the RESPONSE study.

Eligibility Requirements
Close Eligibility Requirements

To qualify for the RESPONSE study you must:

  • Be 18 to 75 years old (inclusive)
  • Be diagnosed with PBC (Note, PBC was once called primary biliary cirrhosis. The current name, primary biliary cholangitis, is more medically accurate and less likely to cause misunderstanding).
  • Have been on a stable and recommended dose of UDCA (Ursodeoxycholic Acid also known as Ursodiol, URSO Forte, URSO 250, and Actigall) or you were required to stop taking the medication
  • Have blood laboratory test results in the following range:
    • Alkaline phosphatase (ALP) at least 1.67 times the upper limit of normal (ULN)
    • Bilirubin test levels less than two times the ULN

Study doctors will check other requirements to confirm that you qualify for this study. If you are currently taking UDCA you will continue to take your UDCA at the same recommended dose during study participation. During the study, you will be reimbursed for your UDCA for 12 months. You will also begin to take seladelpar or placebo, orally (by mouth) once a day for 52 weeks. At the end of the study, you may be given the opportunity to participate and receive seladelpar in the open label ASSURE long-term study (CB8025-31731-RE).

There is no guarantee at this point in time that being treated with seladelpar will have any effect on your PBC. There is also a 1 in 3 chance you will receive placebo in this study. Placebo is an inactive substance that looks like seladelpar. During the study neither you nor your study doctor will know if you are receiving placebo or seladelpar.

How Does It Work?

The RESPONSE Study is enrolling people who have been using UDCA (Ursodeoxycholic Acid also known as Ursodiol, URSO Forte, URSO 250, and Actigall), but have not achieved the recommended treatment goal or who develop troublesome side effects from UDCA that prevent them from continuing to take this treatment. In this study, we want to find out if seladelpar can improve PBC-related blood laboratory tests and can improve symptoms of PBC, such as itching.

Read our FAQ
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  • What is the RESPONSE study?

    The RESPONSE clinical research study is a phase 3 clinical study (study number CB8025-32048) enrolling participants with primary biliary cholangitis (PBC) who have been taking UDCA (Ursodeoxycholic Acid also known as Ursodiol, URSO Forte, URSO 250, and Actigall) and don’t have adequate results or cannot tolerate UDCA. If you have PBC, you may qualify for this clinical research study.

    A clinical research study, or clinical study, is a pre-planned set of tests conducted over time to learn about a potential new drug, treatment, or clinical method. In this study, researchers are trying to learn more about an investigational drug called seladelpar and whether seladelpar can improve PBC-related blood laboratory tests and whether it can improve symptoms of PBC, as well as the safety of seladelpar (the side effect profile) in people with PBC.

  • How do I qualify for enrollment in the RESPONSE study?

    To qualify for the RESPONSE study you must:

    • Be 18 to 75 years old (inclusive)
    • Be diagnosed with PBC (Note, PBC was once called primary biliary cirrhosis. The current name, primary biliary cholangitis, is more medically accurate and less likely to cause misunderstanding.)
    • Have been on a stable and recommended dose of UDCA (Ursodeoxycholic Acid also known as Ursodiol, URSO Forte, URSO 250, and Actigall) or you were required to stop taking the medication
    • Have blood laboratory test results in the following range:
      • Alkaline phosphatase (ALP) at least 1.67 times the upper limit of normal (ULN)
      • Bilirubin test levels less than two times the ULN

    For other requirements and more trial or PBC information, please go to clinicaltrials.gov.

  • What else do I need to do to enroll in the study?

    After you volunteer for the study, the study doctor and staff will provide you with an informed consent document. If you consent to participate in the study, the study staff will give you some tests to make sure you qualify. This is called the “screening period,” and getting all of the results can take approximately 4 weeks.

    If you are currently taking UDCA, you will continue to take approximately the same  recommended dose during study participation. At the screening visit your UDCA will be reimbursed, and if you qualify for the study, you will continue to receive UDCA reimbursement for 12 months.

    You will also begin to take seladelpar or placebo orally (by mouth) once a day for 52 weeks. Seladelpar or placebo will be provided to you at no cost. You will not know whether you are receiving study drug or placebo. Participants already on URSO will continue that therapy for the duration of this study.

    The RESPONSE study will also ask participants who enter the study to consider a biopsy at baseline and end of study treatment. The biopsy is voluntary and performed only if it is considered safe by the study doctor. Participating in this aspect of the research study is important to help researchers and regulators better understand the changes in your liver health and the effect that seladelpar has on your liver health.

  • Will I receive the seladelpar (study drug) or a placebo?

    There is a 2 in 3 chance that you will receive seladelpar and a 1 in 3 chance you will receive placebo in this study. Placebo is an inactive substance that looks like seladelpar. During the study, neither you nor your study doctor will know if you are receiving placebo or seladelpar.

  • Where are the nearest clinical research sites to me?

    To find the study location nearest to you, please click here.

  • Will there be compensation for travel expenses?

    You may be reimbursed for study-related travel expenses you incur.

  • How long will the study take?

    The study will last for a total of about 60 weeks.

  • Is there a way to stay on seladelpar (study drug) after the study ends?

    Yes, after participation in the RESPONSE study, you may be eligible to participate in the ASSURE long-term study where all participants receive Seladelpar and there is no placebo (CB8025-31731-RE).

  • Do I have to pay for seladelpar (study drug) or UDCA on the study?

    You will receive seladelpar (study drug) and UDCA (Ursodeoxycholic Acid also known as Ursodiol, URSO Forte, URSO 250, and Actigall, if applicable) at no cost to you. At the screening visit your UDCA will be reimbursed, and if you qualify for the study, you will continue to receive UDCA reimbursement for 12 months.

  • Why should I participate in the study?

    By participating in the RESPONSE study, you will contribute to PBC research and you will be helping to develop possible future treatment options for people with PBC, including yourself.

  • Will seladelpar cause my itching to get worse?

    There is no guarantee that being treated with seladelpar will have any effect on your itching caused by liver disease (also referred to as pruritus). In a previous clinical study, seladelpar did not appear to be associated with pruritus, and preliminary data suggests that seladelpar may help improve PBC-related itch.

  • Is seladelpar a safe PBC treatment?

    The purpose of the RESPONSE study, which involves research, is to determine if seladelpar is safe and effective in treating patients with PBC compared to placebo (which looks like the study drug but is not active medication). Seladelpar is still an investigational drug that is not currently approved in any country or for any indication. Consequently, its safety profile has still not been fully determined. To date, 315 PBC patients have received seladelpar in clinical studies. In these studies, 106 received seladelpar treatment for ≥ 1 year, and 51 patients for ≥ 2 years. The most common adverse events are pruritus (itching), nausea (feeling sickness with the urge to vomit), urinary tract infection, diarrhea, and upper abdominal pain.

  • Is RESPONSE looking at other liver diseases?

    The RESPONSE study is only evaluating the effectiveness and safety of seladelpar in participants with primary biliary cholangitis (PBC).

  • What is a clinical research study?

    In a clinical research study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants’ behavior, such as diet. Clinical research studies may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical research studies compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases. Clinical research studies used in drug development are sometimes described by phases, from 1 to 3, depending on the stage of development.

  • What is informed consent?

    To make an informed decision about whether to participate or not in a clinical research study, people need to be informed about:

    • What will be done to them
    • How the protocol (plan of research) works
    • What risks or discomforts they may experience
    • Participation being a voluntary decision on their part

    As new investigational medical products are being developed, no one knows for sure how well they will work, or what risks they will find. Clinical research studies are used to answer questions such as:

    • Are new investigational medical products safe enough to outweigh the risks related to the underlying condition?
    • How should the product be used? For example, what are the best dose, frequency, or any special precautions necessary to avoid problems?
    • How effective is the investigational medication product at relieving symptoms, treating or curing a condition?

    This information is provided to potential participants through the informed consent process. Informed consent means that the purpose of the research is explained to them, including what their role would be and how the study will work.

    All this information is included in the informed consent document. Subjects participating in this study will have to sign this document before any study related procedure can be performed by the research staff.

  • Where can I go for more information and to view the RESPONSE study protocol?

    For additional information and to view the RESPONSE study protocol, please visit clinicaltrials.gov (study number CB8025-32048).

  • Why participate in RESPONSE?

    The purpose of this study is to test seladelpar to see if it can improve the results of your PBC-related lab results and symptoms of PBC, such as itching. The goal of the study is to find new treatments to help PBC patients.

What Can I Expect?

During the study (a total of 60 weeks), you will have approximately nine visits to the study doctor’s office. You may also have a follow-up visit after you leave the study. You may be reimbursed for study-related travel expenses you incur.

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Locations

The RESPONSE study is being conducted at more than 100 locations throughout the world. Find a location near you and see if you might be eligible to participate.

  • US & Canada

  • To find a RESPONSE location near you enter your postal (zip) code or browse the location list below.

    • Arkansas Diagnostic Center
      8908 Kanis Rd
      Little Rock, AR, 72205
      (501) 687-9300
    • Arizona Liver Health
      2201 W Fairview St , Suite 9
      Chandler, AZ, 85224
      (520) 485-4000
    • University of California Davis Medical Center
      2000 Stockton Boulevard, Suite 100B
      Sacramento, CA, 95817
      (916) 734-8696
    • California Pacific Medical Center
      2200 Webster Street, 4th Floor
      San Francisco, CA, 94115
      (415) 600-5708
    • Stanford University School of Medicine
      750 Welch Road, Medical Center, Division Of Gastroenterology And Hepatology, Pavilion C, 3rd Floor
      Palo Alto, CA, 94305
      (650) 497-4151
    • University of California San Francisco
      513 Parnassus Ave, UCSF, Ste 775
      San Francisco, CA, 94143
      (415) 476-6119
    • Pasadena Liver Center
      301 South Fair Oaks Avenue, Suite 405
      Pasadena, CA, 91105
      (626) 795-5769
    • Southern California Permanente Medical Group
      1505 North Edgemont Street, 2nd floor
      Los Angeles, CA, 90027
      (323) 783-2262
    • University of Colorado Denver - PPDS
      12631 East 17th Ave, Gastroenterology and Hepatology, Room 7409
      Aurora, CO, 80045
      (303) 724-1866
    • Yale University School of Medicine
      333 Cedar St, LMP 1080
      New Haven, CT, 06510
      (203) 737-6845
    • Florida Research Institute
      10910 Technology Terrace
      Lakewood Ranch, FL, 34211
      (941) 727-7772
    • Schiff Center for Liver Diseases/University of Miami
      1500 NW 12th Avenue, Jackson Medical Tower - E, Suite 1101
      Miami, FL, 33136
      (305) 243-1104
    • Covenant Research, LLC
      6230 University Pkwy, Ste 201 & 203
      Sarasota, FL, 34240
      (941) 500-3200
    • Digestive Healthcare of Georgia PC
      95 Collier Road Northwest, Suite 4085
      Atlanta, GA, 30309
      (678) 686-5085
    • University of Chicago Hospitals
      5841 South Maryland Avenue
      Chicago, IL, 60637
      (773) 702-4477
    • Rush University Medical Center
      1725 West Harrison Street, Suite 158
      Chicago, IL, 60612
      (312) 563-2140
    • Tulane University Health Sciences Center
      1430 Tulane Avenue, Room 7551
      New Orleans, LA, 70112
      (504) 988-1346
    • Beth Israel Deaconess Medical Center
      110 Francis Street, Suite 4A
      Boston, MA, 2215
      (617) 632-1129
    • Massachusetts General Hospital
      55 Fruit Street, GI Associates, Blake 4
      Boston, MA, 2114
      (617) 724-1316
    • Mercy Medical Center - McAuley Plaza
      301 St. Paul Place
      Baltimore, MD, 21202
      (410) 576-5389
    • Henry Ford Health System
      39450 West 12 Mile Road, Suite 2C
      Novi, MI, 48377
      (248) 344-2364
    • MNGI Digestive Health, P.A.
      1973 Sloan Pl
      Maplewood, MN, 55117
      (612) 870-5597
    • University of Minnesota Medical Center, Fairview
      420 Delaware Street Southeast
      Minneapolis, MN, 55455
      (612) 626-8658
    • Kansas City Research Institute
      6675 Holmes Road, Suite 430
      Kansas City, MO, 64131
      USA
      (816) 759-5274
    • Southern Therapy and Advanced Research LLC
      971 Lakeland Dr, STAR LLC, Suite 1159
      Jackson, MS, 39216
      (769) 251-5674
    • Duke University Medical Center
      40 Duke Medicine Circle, GI Suite 03107
      Durham, NC, 27710
      (919) 668-5499
    • Care Access Research - Lumberton
      4348 Fayetteville Rd
      Lumberton, NC, 28358
      (740) 441-3990
    • Atlantic Medical Group - Kinston - CAR
      2541 North Queen Street
      Kinston, NC, 28501
      (252) 527-3636
    • NYU Langone Medical Center
      530 First Ave, Gastroenterology and Hepatology, HCC Suite 4J
      New York, NY, 10016
      (646) 501-9624
    • University of Rochester Medical Center - PPDS
      601 Elmwood Avenue, Division of Gastroenterology & Hepatology, Room 3-8103
      Rochester, NY, 14642
      (585) 275-4763
    • Icahn School of Medicine at Mount Sinai
      One Gustave L. Levy Place, Box 1104
      New York, NY, 10029
      (212) 241-0255
    • Weill Cornell Medical College
      1305 York Ave, Floor 4
      New York, NY, 10021
      (646) 962-5302
    • Westchester Digestive Disease Group
      469 N Broadway
      Yonkers, NY, 10701
      (914) 969-1115
    • Toronto Digestive Disease Associates Inc
      4600 Highway 7, Suite 225
      Vaughan, ON, L4L 4Y7
      (416) 650-0017 X480
    • University Health Network
      200 Elizabeth Street, Toronto General Hospital, 9EN
      Toronto, ON, M5G 2C4
      (647) 466-7889
    • London Health Sciences Centre
      339 Windermere Road, Dept of Gastroenterology, Room 126
      London, ON, N6A 5A5
      (519) 685-8500 x32520
    • University of Pittsburgh Medical Center
      3471 Fifth Avenue, Kaufmann Building, Suite 201
      Pittsburgh, PA, 15213
      (412) 647-1461
    • Penn State Milton S Hershey Medical Center
      500 University Drive
      Hershey, PA, 17033
      (717) 531-5226
    • Gastro One
      1310 Wolf Park Drive
      Germantown, TN, 38138
      (901) 309-6270
    • Vanderbilt University Medical Center
      1211 21st Ave South, Med Ctr North, A4103
      Nashville, TN, 37232
      (615) 343-5683
    • Galen Medical Group
      4976 Alpha Lane
      Hixson, TN, 37343
      (423) 954-9015
    • Pinnacle Clinical Research, PLLC
      5109 Medical Dr, Suite 200
      San Antonio, TX, 78229
      (210) 982-0320
    • The Texas Liver Institute
      607 Camden St., Suite 101
      San Antonio, TX, 78215
      (210) 253-3426
    • Texas Digestive Disease Consultants - TDDC - PPDS
      900 West Magnolia Avenue, Suite 100
      Fort Worth, TX, 76104
      (817) 345-7463
    • Baylor College of Medicine
      6620 Main St., Advanced Liver Therapies, Suite 1505
      Houston, TX, 77030
      (713) 798-1966
    • University of Texas Southwestern Medical Center
      5959 Harry Hines Blvd, HP4.420
      Dallas, TX, 75390
      (214) 648-2725
    • Liver Institute at Methodist Dallas
      1411 N Beckley Ave , Suite 268
      Dallas, TX, 75203
      (214) 947-4681
    • Bon Secours Richmond Community Hospital
      5855 Bremo Road, Liver Institute of Richmond, Suite 509
      Richmond, VA, 23226
      (804) 977-8921
    • Liver Institute Northwest, PLLC
      3216 NE 45th Place, Liver Institute Northwest, Suite 212
      Seattle, WA, 98105
      (206) 536-3030
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