Trial · NCT03602560

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

NCT03602560, Phase 3, Completed, Gilead Sciences; results first posted 2022-05-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA). Trials, record NCT03602560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03602560

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
NCT number: NCT03602560
Status: Completed
Phases: Phase 3
Enrollment: 265 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Primary Biliary Cholangitis
Interventions: seladelpar 5-10 mg, seladelpar 10 mg, Placebo
First posted: 2018-07-27
Last updated: 2022-08-02
Results first posted: 2022-05-31

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3	Month 3	Percentage of Participants with Response to Composite Endpoint of ALP \<1.67 × Upper Limit of Normal \[ULN\], ≥15% reduction in ALP, and total bilirubin ≤ ULN) at Month 3. The mITT analysis set included all randomized subjects who received at least one study drug dose. The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 2:350 U/L; pruritus NRS: \<4 and 2:4). The CMH tests were performed for the comparison of 10 mg versus placebo and 5 mg/10 mg versus placebo separately.
Secondary	Percentage of Participants With Response Defined by Normalized Alkaline Phosphatase Levels at Month 3	Month 3	The response was defined by normalized ALP levels (ALP ≤1.0 × ULN) at endpoint. The mITT analysis set included all randomized subjects who received at least one study drug dose.
Secondary	Change From Baseline in Pruritus NRS for Subjects With Baseline NRS ≥4 at Month 3	Month 3	Pruritus Numerical Rating Scale (NRS) used to rate the intensity of the worst itching you experienced in the past 24 hours from no itching to worst possible itching by selecting a number from 0 to 10 on Itch Scale. Zero means no itching and 10 means worst imaginable itching. The analysis will be limited to those subjects in the mITT analysis set with a baseline NRS ≥ 4.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3	Month 3	mITT Population. The Modified Intent-to-Treat (mITT) set includes any subject who is randomized into the study and receives at least one dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants With Response Defined by Normalized Alkaline Phosphatase Levels at Month 3	Month 3	mITT Population. The Modified Intent-to-Treat (mITT) set includes any subject who is randomized into the study and receives at least one dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Pruritus NRS for Subjects With Baseline NRS ≥4 at Month 3	Month 3	mITT Population. The Modified Intent-to-Treat (mITT) set includes any subject who is randomized into the study and receives at least one dose of study drug.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3	Seladelpar 5-10 mg	32		Participants
Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3	Seladelpar 10 mg	43		Participants
Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3	Placebo	7		Participants
Percentage of Participants With Response Defined by Normalized Alkaline Phosphatase Levels at Month 3	Seladelpar 5-10 mg	3		Participants
Percentage of Participants With Response Defined by Normalized Alkaline Phosphatase Levels at Month 3	Seladelpar 10 mg	15		Participants
Percentage of Participants With Response Defined by Normalized Alkaline Phosphatase Levels at Month 3	Placebo	0		Participants
Change From Baseline in Pruritus NRS for Subjects With Baseline NRS ≥4 at Month 3	Seladelpar 5-10 mg	-1.95	Standard Deviation 2.226	score on a scale
Change From Baseline in Pruritus NRS for Subjects With Baseline NRS ≥4 at Month 3	Seladelpar 10 mg	-3.01	Standard Deviation 1.952	score on a scale
Change From Baseline in Pruritus NRS for Subjects With Baseline NRS ≥4 at Month 3	Placebo	-1.44	Standard Deviation 1.831	score on a scale

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Seladelpar 5-10 mg	89
Overall Study	STARTED	Seladelpar 10 mg	89
Overall Study	STARTED	Placebo	87
Overall Study	COMPLETED	Seladelpar 5-10 mg	1
Overall Study	COMPLETED	Seladelpar 10 mg	1
Overall Study	COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	Seladelpar 5-10 mg	88
Overall Study	NOT COMPLETED	Seladelpar 10 mg	88
Overall Study	NOT COMPLETED	Placebo	86

Source ClinicalTrials.gov

Adverse events96

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dry eye	Eye disorders	Seladelpar 5/10 mg	3	89	3
other	Dry eye	Eye disorders	Seladelpar 10 mg	3	89	3
other	Dry eye	Eye disorders	Placebo	2	87	2
other	Abdominal distension	Gastrointestinal disorders	Seladelpar 5/10 mg	1	89	1
other	Abdominal distension	Gastrointestinal disorders	Seladelpar 10 mg	3	89	4
other	Abdominal distension	Gastrointestinal disorders	Placebo	3	87	3
other	Abdominal pain upper	Gastrointestinal disorders	Seladelpar 5/10 mg	8	89	9
other	Abdominal pain upper	Gastrointestinal disorders	Seladelpar 10 mg	6	89	6
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	3	87	3
other	Constipation	Gastrointestinal disorders	Seladelpar 5/10 mg	5	89	5

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Seladelpar 5/10 mg	0	89
Total, all-cause mortality	Seladelpar 10 mg	0	89
Total, all-cause mortality	Placebo	0	87
Total, other adverse events	Seladelpar 5/10 mg	55	89
Total, other adverse events	Seladelpar 10 mg	58	89
Total, other adverse events	Placebo	62	87
Total, serious adverse events	Seladelpar 5/10 mg	3	89
Total, serious adverse events	Seladelpar 10 mg	1	89
Total, serious adverse events	Placebo	3	87

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42798953	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03602560

GET https://conductscience.org/api/trials/v1/NCT03602560/events?page=2

API reference For AI assistants