IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)

Gilead Sciences

Status and phase: Enrolling; Phase 3

Conditions: Primary Biliary Cholangitis

Treatments: Drug: Placebo; Drug: Seladelpar 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06060665

CB8025-32251

2024-517409-10-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must meet the following criteria to be eligible for study participation:

  1. 18 to 75 years old (inclusive)
  2. Male or female with a diagnosis of PBC based on history
  3. UDCA for the 12 months prior to screening (with stable dose for >3 months prior to screening) OR intolerant to UDCA (last dose of UDCA >3 months prior to screening)
  4. ALP >1×ULN and <1.67×ULN
  5. 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 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.

Exclusion criteria

• Subjects must not meet any of the following criteria to be eligible for study participation:

  1. Previous exposure to seladelpar (MBX-8025)
  2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study (eg, cancer) or confound its results
  3. Advanced PBC as defined by the Rotterdam criteria
  4. Laboratory parameters measured by the Central Laboratory at screening
  5. Clinically important hepatic decompensation
  6. Other chronic liver diseases
  7. Known history of human immunodeficiency virus (HIV) or positive antibody test at screening
  8. Clinically important alcohol consumption, defined as more than 2 drink units per day in women and 3 drink units per day in men, or inability to quantify alcohol intake reliably
  9. History of malignancy diagnosed or treated, active 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
  10. History of drug abuse
  11. Treatment with obeticholic acid or fibrates 6 weeks prior to screening
  12. Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids within 2 months prior to screening
  13. Initiation or dose adjustment of anti-pruritic drugs within 1 month prior to screening
  14. Immunosuppressant therapies within 6 months prior to screening
  15. Other medications that affect liver or GI functions, as well as the roux-en-y gastric bypass procedure, may be prohibited and should be discussed with the medical monitor on a case-by-case basis
  16. Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening
  17. Pregnancy or plans to become pregnant, or breastfeeding
  18. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Seladelpar 10 mg

Experimental group

Treatment:

Drug: Seladelpar 10 mg

Placebo

Experimental group

Treatment:

Drug: Placebo