protocolSection identificationModule nctId: NCT06383403, orgStudyIdInfo id: CLIN-60190-463, secondaryIdInfos id: 2024-510695-20-00, type: CTIS, briefTitle: A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid., acronym: ELSPIRE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-06-22, completionDateStruct date: 2026-12-21, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Ipsen, class: INDUSTRY, descriptionModule briefSummary: The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms.Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment).The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease.There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored.Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio).Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver).They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months)., conditionsModule conditions: Primary Biliary Cholangitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Elafibranor, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of participants with normalisation of Alkaline Phosphate (ALP) Levels, secondaryOutcomes measure: Percentage of participants with normalisation of ALP Levels, secondaryOutcomes measure: Change from baseline in ALP levels, secondaryOutcomes measure: Percentage of participants with normalisation of ALP Levels and ≥15% decrease from Baseline, secondaryOutcomes measure: Percentage of participants with ≥40% decrease from Baseline in ALP Levels, secondaryOutcomes measure: Percentage of participants with ALP <0.5 × Upper Limit of Normal (ULN), secondaryOutcomes measure: Changes from baseline in Total Bilirubin (TB) Levels, secondaryOutcomes measure: Percentage of participants with TB <0.7 × ULN, secondaryOutcomes measure: Percentage of participants with normalisation of ALP and TB <0.7 × ULN, secondaryOutcomes measure: Percentage of participants with normalisation of TB and ALP Levels, secondaryOutcomes measure: Percentage of participants with complete biochemical response, secondaryOutcomes measure: Change from baseline in PBC Worst Itch Numeric Rating Scale (NRS) score, secondaryOutcomes measure: Percentage of participants with moderate to severe pruritus at baseline (i.e. score ≥4) with a clinically meaningful response in PBC Worst Itch NRS, secondaryOutcomes measure: Change from baseline in 5-D itch score, secondaryOutcomes measure: Change from baseline in Patient Global Impression of Severity (PGI-S) scores, secondaryOutcomes measure: Patient Global Impression of Change (PGI-C) scores, secondaryOutcomes measure: Change from baseline in PBC-40 Quality of Life (QoL) scores, secondaryOutcomes measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a scores, secondaryOutcomes measure: Percentage of participants experiencing Treatment- Emergent Adverse Events (TEAEs), treatment- related TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)., secondaryOutcomes measure: Percentage of participants developing clinically significant changes in physical examination, secondaryOutcomes measure: Percentage of participants developing clinically significant changes in vital signs, secondaryOutcomes measure: Percentage of participants developing clinically significant changes in Electrocardiogram (ECG) Readings, secondaryOutcomes measure: Percentage of participants developing clinically significant changes in laboratory parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False