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Elafibranor

Phase 2

Primary Biliary Cholangitis (PBC) | Small molecule | Other |Genfit SA Sponsored ADR|Last Updated: Aug 13, 2020

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical trial landscape

Elafibranor · 5 trials · 10 indications

Phase 2 1Phase 1 4
NCT03124108Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic AcidPrimary Biliary Cholangitis (PBC)
COMPLETED45 Analytics
PHASE2COMPLETED
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cholangitis (PBC)
NCT0312410845
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Study Endpoints
Primary Endpoints
Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) Levels at Week 12 (Endpoint)
Baseline, Week 12 (Endpoint)

Relative change from baseline is in serum ALP levels at Week 12 (endpoint) were reported. Relative change from baseline is defined as percentage (%) change from baseline to endpoint.

Plasma pharmacokinetics: Area under curve from dosing time to infinity (AUC(0-∞)) of elafibranor and active metabolite
pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers

In Healthy Young Adults compared to Healthy Elderly

Plasma pharmacokinetics: Area under curve from dosing time to last measurement (AUC(0-t)) of elafibranor and active metabolite
pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers

In Healthy Young Adults compared to Healthy Elderly

Plasma pharmacokinetics: maximum plasma drug concentration (Cmax) of elafibranor and active metabolite
pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers

In Healthy Young Adults compared to Healthy Elderly

Plasma pharmacokinetics: Area under curve from dosing time to infinity (AUC(0-∞))
Pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose (336 and 384 hours post-dose added in sequence 2)

of elafibranor

Plasma pharmacokinetics: Maximum plasma drug concentration (Cmax)
Pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose (336 and 384 hours post-dose added in sequence 2)

of elafibranor

Area under curve from dosing time to last measurement (AUC(0-t)) of elafibranor and active metabolite
pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose

In participants with end stage renal disease compared to healthy volunteers

Area under curve from dosing time to infinity (AUC(0-∞)) of elafibranor and active metabolite
pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose

In participants with end stage renal disease compared to healthy volunteers

Secondary Endpoints
Percentage of Participants With Response Defined by Composite Risk Scores (ALP< 1.67 * Upper Limit of Normal [ULN] at Endpoint, Total Bilirubin [BIL] Within Normal Limits at Endpoint, and Greater Than [>] 15% ALP Reduction From Baseline to Endpoint)
Up to Week 12 (Endpoint)
Percentage of Participants With Response Defined by Composite Risk Scores (ALP < 2 * Upper Limit of Normal at Endpoint, Total Bilirubin Within Normal Limits at Endpoint, and > 40% ALP Reduction From Baseline to Endpoint)
Up to Week 12 (Endpoint)
Percentage of Participants With Response Based on PARIS I Risk Score at Endpoint
At Week 12 (Endpoint)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORStudy subjects will take two tablets per day orally before breakfast with a glass of water each morning
Elafibranor 80 mgACTIVE_COMPARATORStudy subjects will take two tablets per day orally before breakfast with a glass of water each morning
Elafibranor 120 mgACTIVE_COMPARATORStudy subjects will take two tablets per day orally before breakfast with a glass of water each morning
Young AdultsEXPERIMENTALSingle oral dose of elafibranor 120mg
ElderlyEXPERIMENTALSingle oral dose of elafibranor 120mg
DDIEXPERIMENTALPeriod 1: study of elafibranor's pharmacokinetics Period 2: study of elafibranor's pharmacokinetics under CHRONO-INDOCID® (indomethacin) at steady state
End Stage Renal DiseaseEXPERIMENTALSingle oral dose of elafibranor 120mg
HealthyEXPERIMENTALSingle oral dose of elafibranor 120mg
Mild Child-Pugh AEXPERIMENTALSingle oral dose of elafibranor 120mg
Moderate Child-Pugh BEXPERIMENTALSingle oral dose of elafibranor 120mg
Severe Child-Pugh CEXPERIMENTALSingle oral dose of elafibranor 120mg
Interventions
NameTypeDescription
Elafibranor 80 mgDRUGTwo coated tablets daily for 12 weeks
Elafibranor 120 mgDRUGTwo coated tablets daily for 12 weeks
PlaceboDRUGTwo coated tablets daily for 12 weeks
elafibranorDRUGelafibranor 120mg is a coated tablet for oral administration
CHRONO-INDOCIDDRUGCHRONO-INDOCID 75mg is a capsule for bis in die (bid) oral administration
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Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: 1. Must have provided written informed consent 2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors: * History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit) * Positive...

Countries:United StatesFranceGermanySpainUnited KingdomRomania
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