Trial · NCT02943460
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
NCT02943460, Phase 2, Completed, Gilead Sciences; results first posted 2019-03-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis. Trials, record NCT02943460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02943460
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
- NCT number
- NCT02943460
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Primary Sclerosing Cholangitis
- Interventions
- Cilofexor, Placebo to match cilofexor
- First posted
- 2016-10-24
- Last updated
- 2021-06-07
- Other registries' IDs
- eudract:2016-002442-23
- Results first posted
- 2019-03-12
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 Experiencing Treatment-Emergent Adverse Events During the Blinded Phase | First dose date up to last dose date plus 30 days (Up to 17 weeks) | Treatment-emergent adverse events occurring during the Blinded Phase were defined as 1 or both of the following: 1) Any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug in the Blinded Phase (and before the first dosing date in the Open Label Extension (OLE) Phase), or 2) Any AEs leading to premature discontinuation of study drug in the Blinded Phase. |
| Primary | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events During the Blinded Phase | First dose date up to last dose date plus 30 days (Up to 17 weeks) | A serious adverse event was defined as an event that, at any dose, resulted in any of the following: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction. |
| Primary | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities During the Blinded Phase | First dose date up to last dose date plus 30 days (Up to 17 weeks) | Treatment-emergent laboratory abnormalities occurring during the Blinded Phase were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug in the Blinded Phase plus 30 days (and prior to or on the first dose date of the OLE phase). The Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 was used for assigning toxicity grades (0 to 4, with higher grades indicating more severity). |
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 Experiencing Treatment-Emergent Adverse Events During the Blinded Phase | First dose date up to last dose date plus 30 days (Up to 17 weeks) | Safety Analysis Set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events During the Blinded Phase | First dose date up to last dose date plus 30 days (Up to 17 weeks) | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities During the Blinded Phase | First dose date up to last dose date plus 30 days (Up to 17 weeks) | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events During the Blinded Phase | Cilofexor 100 mg | 81.8 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events During the Blinded Phase | Cilofexor 30 mg | 70.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events During the Blinded Phase | Placebo | 100.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events During the Blinded Phase | Cilofexor 100 mg | 13.6 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events During the Blinded Phase | Cilofexor 30 mg | 0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events During the Blinded Phase | Placebo | 0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities During the Blinded Phase | Cilofexor 100 mg | Any Grade 1 or Higher | 90.9 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities During the Blinded Phase | Cilofexor 30 mg | Any Grade 1 or Higher | 85.0 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities During the Blinded Phase | Placebo | Any Grade 1 or Higher | 100.0 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities During the Blinded Phase | Cilofexor 100 mg | Grade 1 | 22.7 | percentage of participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Blinded Study Phase | STARTED | Cilofexor 100 mg | 22 | |
| Blinded Study Phase | STARTED | Cilofexor 30 mg | 20 | |
| Blinded Study Phase | STARTED | Placebo | 10 | |
| Blinded Study Phase | COMPLETED | Cilofexor 100 mg | 19 | |
| Blinded Study Phase | COMPLETED | Cilofexor 30 mg | 19 | |
| Blinded Study Phase | COMPLETED | Placebo | 10 | |
| Blinded Study Phase | NOT COMPLETED | Cilofexor 100 mg | 3 | |
| Blinded Study Phase | NOT COMPLETED | Cilofexor 30 mg | 1 | |
| Blinded Study Phase | NOT COMPLETED | Placebo | 0 | |
| Open Label Extension (OLE) Phase | STARTED | Cilofexor 100 mg | 19 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events320
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 | Blepharitis | Eye disorders | Cilofexor 100 mg (Blinded Phase) | 0 | 22 | |
| other | Blepharitis | Eye disorders | Cilofexor 30 mg (Blinded Phase) | 1 | 20 | |
| other | Blepharitis | Eye disorders | Placebo (Blinded Phase) | 0 | 10 | |
| other | Blepharitis | Eye disorders | Cilofexor 100 mg (Open Label Extension Phase) | 0 | 47 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Cilofexor 100 mg (Blinded Phase) | 2 | 22 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Cilofexor 30 mg (Blinded Phase) | 0 | 20 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo (Blinded Phase) | 1 | 10 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Cilofexor 100 mg (Open Label Extension Phase) | 4 | 47 | |
| other | Abdominal distension | Gastrointestinal disorders | Cilofexor 100 mg (Blinded Phase) | 2 | 22 | |
| other | Abdominal distension | Gastrointestinal disorders | Cilofexor 30 mg (Blinded Phase) | 0 | 20 |
1 to 10 of 320Source ClinicalTrials.gov
See all 320 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cilofexor 100 mg (Blinded Phase) | 0 | 22 |
| Total, all-cause mortality | Cilofexor 30 mg (Blinded Phase) | 0 | 20 |
| Total, all-cause mortality | Placebo (Blinded Phase) | 0 | 10 |
| Total, all-cause mortality | Cilofexor 100 mg (Open Label Extension Phase) | 0 | 47 |
| Total, other adverse events | Cilofexor 100 mg (Blinded Phase) | 18 | 22 |
| Total, other adverse events | Cilofexor 30 mg (Blinded Phase) | 14 | 20 |
| Total, other adverse events | Placebo (Blinded Phase) | 10 | 10 |
| Total, other adverse events | Cilofexor 100 mg (Open Label Extension Phase) | 41 | 47 |
| Total, serious adverse events | Cilofexor 100 mg (Blinded Phase) | 3 | 22 |
| Total, serious adverse events | Cilofexor 30 mg (Blinded Phase) | 0 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30661255 | RESULT |
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.
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/NCT02943460
GET https://conductscience.org/api/trials/v1/NCT02943460/results?page=2