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A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis
EU CTIS ID: 2024-511753-22-00
What this study is testing
To evaluate the long-term safety and tolerability of seladelpar
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Must have given informed consent (signed and dated)
- Participated in a prior PBC study with seladelpar (e.g., including CB8025-21629, CB8025-31735, or CB8025-31731), current PBC studies (CB8025-32048 or CB8025-21838), or completed a future PBC study with seladelpar that allows rollover into CB8025-31731-RE, and meet eligibility criteria for the current study.
- Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects 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
You likely can't join if
- Exclusion criteria are only applicable for subjects with a study drug interruption greater than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838 irrespective of seladelpar interruption 1. Treatment-related AE leading to study drug discontinuation in a previous PBC study with seladelpar
- Known history of alpha-1-antitrypsin deficiency
- Known history of chronic viral hepatitis
- For females, pregnancy or breast-feeding
- Use of colchicine, methotrexate, azathioprine or long-term use of systemic steroids (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening. See the concomitant medication section for additional medications that may be excluded.
- Current use of fibrates or use of fibrates within 3 months prior to Screening
See the full eligibility criteria
Who can join
- Must have given informed consent (signed and dated)
- Participated in a prior PBC study with seladelpar (e.g., including CB8025-21629, CB8025-31735, or CB8025-31731), current PBC studies (CB8025-32048 or CB8025-21838), or completed a future PBC study with seladelpar that allows rollover into CB8025-31731-RE, and meet eligibility criteria for the current study.
- Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects 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
What rules you out
- Exclusion criteria are only applicable for subjects with a study drug interruption greater than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838 irrespective of seladelpar interruption 1. Treatment-related AE leading to study drug discontinuation in a previous PBC study with seladelpar
- Known history of alpha-1-antitrypsin deficiency
- Known history of chronic viral hepatitis
- For females, pregnancy or breast-feeding
- Use of colchicine, methotrexate, azathioprine or long-term use of systemic steroids (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening. See the concomitant medication section for additional medications that may be excluded.
- Current use of fibrates or use of fibrates within 3 months prior to Screening
- Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
- Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
- History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
- Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
- Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study as judged by the Investigator
- A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer, any active infection)
- Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, antiTNF or other immunosuppressive biologics)
- Other medications that effect liver or GI functions such as absorption of medications may be prohibited and should be discussed with the medical monitor on a case-by-case basis
- Positive for: a. Hepatitis B, defined as the presence of hepatitis B surface antigen b. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid c. Human immunodeficiency virus (HIV) antibody
- Active COVID-19 infection during Screening.
- AST or ALT above 3 × the upper limit of normal (ULN)
- Total bilirubin above 2 × ULN
- MELD score ≥ 12. For subjects on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor.
- Evidence of advanced PBC as defined by the Rotterdam criteria (albumin below 1 × lower limit of normal AND total bilirubin above 1 × ULN)
- Estimated glomerular filtration rate ≤ 45 mL/min/1.73 m2 (calculated by Modification of Diet in Renal Disease formula)
- Auto-immune hepatitis
- Primary sclerosing cholangitis
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- United Kingdom
- United States
- Russian Federation
- Turkey
- Korea, Republic of
- Australia
- Canada
- Israel
- New Zealand
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; United Kingdom; United States; Russian Federation; Turkey; Korea, Republic of and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.