Trial · NCT04620733
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
NCT04620733, Phase 3, Completed, Gilead Sciences; results first posted 2024-07-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA). Trials, record NCT04620733. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04620733
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
- NCT number
- NCT04620733
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 193 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Primary Biliary Cholangitis
- Interventions
- Seladelpar 10 mg, Placebo, Seladelpar 5 mg
- First posted
- 2020-11-09
- Last updated
- 2024-09-05
- Other registries' IDs
- eudract:2020-004348-27
- Results first posted
- 2024-07-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Response Criteria for the Composite Endpoint of ALP <1.67 × Upper Limit of Normal (ULN), ≥15% Reduction in ALP, and Total Bilirubin ≤ 1.0× ULN at Month 12 | Month 12 | Percentages were rounded-off. |
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | First dose date up to last dose plus 30 days (up to 13.4 months) | Percentages were rounded-off. |
| Primary | Percentage of Participants With Shift of ≥ 2 CTCAE Grades From Baseline in Treatment-emergent Laboratory Abnormalities Related to Hematology and Select Liver Biochemistry | First dose date up to last dose (up to 13.4 months) | Treatment-emergent graded laboratory abnormalities were defined as values that increase at least 2 toxicity grade from baseline at any time post baseline. The laboratory abnormalities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening laboratory abnormality. The data is reported for shift of ≥ 2 grades from baseline in values for hematology and select liver biochemistry. Hematology includes parameters like RBCs, (erythrocytes), hemoglobin, hematocrit, platelets, WBC, WBC differentials (absolute and percentage) including basophils, neutrophils, lymphocytes, eosinophils, and monocytes, etc. Biochemistry included select liver function tests like blood bilirubin, gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Percentages were rounded-off. |
| Secondary | Percentage of Participants With ALP ≤1.0× ULN at Month 12 | Month 12 | Percentages were rounded-off. |
| Secondary | Change From Baseline in Weekly Averaged Pruritus Numerical Rating Scale (NRS) in Participants With NRS ≥ 4 at Month 6 | Baseline, Month 6 | Pruritus NRS is used to rate the intensity of the itching experienced by the participants 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. |
Source ClinicalTrials.gov
Outcomes5
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 Criteria for the Composite Endpoint of ALP <1.67 × Upper Limit of Normal (ULN), ≥15% Reduction in ALP, and Total Bilirubin ≤ 1.0× ULN at Month 12 | Month 12 | The Intend-to-treat Analysis Set was defined as any participant who was randomized into the study and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | First dose date up to last dose plus 30 days (up to 13.4 months) | The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Shift of ≥ 2 CTCAE Grades From Baseline in Treatment-emergent Laboratory Abnormalities Related to Hematology and Select Liver Biochemistry | First dose date up to last dose (up to 13.4 months) | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ALP ≤1.0× ULN at Month 12 | Month 12 | Participants in Intent-to-treat Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Weekly Averaged Pruritus Numerical Rating Scale (NRS) in Participants With NRS ≥ 4 at Month 6 | Baseline, Month 6 | The Moderate to Severe Pruritus NRS Analysis Set included participants in the Intent-to-treat Analysis Set who had a baseline NRS value ≥ 4. Participants with available data were analyzed. | score on scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Response Criteria for the Composite Endpoint of ALP <1.67 × Upper Limit of Normal (ULN), ≥15% Reduction in ALP, and Total Bilirubin ≤ 1.0× ULN at Month 12 | Placebo | 20.0 | 95% Confidence Interval 10.3 to 29.7 | percentage of participants | |
| Percentage of Participants With Response Criteria for the Composite Endpoint of ALP <1.67 × Upper Limit of Normal (ULN), ≥15% Reduction in ALP, and Total Bilirubin ≤ 1.0× ULN at Month 12 | Seladelpar | 61.7 | 95% Confidence Interval 53.3 to 70.1 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Placebo | TEAEs | 84.6 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Seladelpar | TEAEs | 86.7 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Placebo | Serious TEAEs | 6.2 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Seladelpar | Serious TEAEs | 7.0 | percentage of participants | |
| Percentage of Participants With Shift of ≥ 2 CTCAE Grades From Baseline in Treatment-emergent Laboratory Abnormalities Related to Hematology and Select Liver Biochemistry | Placebo | Shift ≥ 2 CTCAE grades in haematology | 12.3 | percentage of participants | |
| Percentage of Participants With Shift of ≥ 2 CTCAE Grades From Baseline in Treatment-emergent Laboratory Abnormalities Related to Hematology and Select Liver Biochemistry | Seladelpar | Shift ≥ 2 CTCAE grades in haematology | 14.1 | percentage of participants | |
| Percentage of Participants With Shift of ≥ 2 CTCAE Grades From Baseline in Treatment-emergent Laboratory Abnormalities Related to Hematology and Select Liver Biochemistry | Placebo | Shift ≥ 2 CTCAE grades in biochemistry | 6.2 | percentage of participants | |
| Percentage of Participants With Shift of ≥ 2 CTCAE Grades From Baseline in Treatment-emergent Laboratory Abnormalities Related to Hematology and Select Liver Biochemistry | Seladelpar | Shift ≥ 2 CTCAE grades in biochemistry | 7.0 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 65 | |
| Overall Study | STARTED | Seladelpar | 128 | |
| Overall Study | COMPLETED | Placebo | 57 | |
| Overall Study | COMPLETED | Seladelpar | 117 | |
| Overall Study | NOT COMPLETED | Placebo | 8 | |
| Overall Study | NOT COMPLETED | Seladelpar | 11 |
Source ClinicalTrials.gov
Adverse events64
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 | Vertigo positional | Ear and labyrinth disorders | Placebo | 4 | 65 | |
| other | Vertigo positional | Ear and labyrinth disorders | Seladelpar | 1 | 128 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 2 | 65 | |
| other | Abdominal distension | Gastrointestinal disorders | Seladelpar | 8 | 128 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 65 | |
| other | Abdominal pain | Gastrointestinal disorders | Seladelpar | 9 | 128 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 65 | |
| other | Nausea | Gastrointestinal disorders | Seladelpar | 8 | 128 | |
| other | Asthenia | General disorders | Placebo | 4 | 65 | |
| other | Asthenia | General disorders | Seladelpar | 5 | 128 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 65 |
| Total, all-cause mortality | Seladelpar | 0 | 128 |
| Total, other adverse events | Placebo | 40 | 65 |
| Total, other adverse events | Seladelpar | 66 | 128 |
| Total, serious adverse events | Placebo | 4 | 65 |
| Total, serious adverse events | Seladelpar | 9 | 128 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Seladelpar vs Placebo: deaths from any cause | Trial comparisons |
| Seladelpar vs Placebo: serious adverse events | Trial comparisons |
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.
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/NCT04620733
GET https://conductscience.org/api/trials/v1/NCT04620733/events?page=2