Trial · NCT04663308
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
NCT04663308, Phase 2, Active not recruiting, Mirum Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC). Trials, record NCT04663308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04663308
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
- NCT number
- NCT04663308
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 182 participants, actual
- Lead sponsor
- Mirum Pharmaceuticals, Inc.
- Conditions
- Primary Sclerosing Cholangitis
- Interventions
- Volixibat, Placebo
- First posted
- 2020-12-11
- Last updated
- 2026-10-19
- Other registries' IDs
- eudract:2020-003027-41
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire | Baseline through to Week 28 | The Adult ItchRO is an 11-point NRS measurement of itch severity ranging from 0=no itch to 10=worst possible itch. |
| Secondary | Proportion of participants with itch response using the Adult ItchRO | Baseline through to Week 28 | |
| Secondary | The incidence of adverse events | Baseline through to Week 28 | |
| Secondary | Changes in serum bile acid levels | Baseline through to Week 28 | |
| Secondary | Changes in alkaline phosphatase | Baseline through to Week 28 | |
| Secondary | Changes in total bilirubin levels | Baseline through to Week 28 | |
| Secondary | Change in Primary Sclerosing Cholangitis-Specific Patient-Reported Outcome | Baseline through to Week 28 | |
| Secondary | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) fatigue questionnaire | Baseline through to Week 28 | The PROMIS® Fatigue questionnaire is a 5-point response scale. Respondents endorse each item using a 5-point response scale: Never, Rarely, Sometimes, Often, and Always. |
| Secondary | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) sleep disturbance questionnaire | Baseline through to Week 28 | The PROMIS® Sleep Disturbance in an 8-item measure that assesses quality of sleep, sleep depth, and restoration associated with sleep. It is a 5-point response scale, the specific response options vary by items. The first 4 items use response options that range from Not at all to Very much. The next 3 items use response options that range from Never to Always. The final item assesses sleep quality ranging from Very poor to Very good. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04663308
GET https://conductscience.org/api/trials/v1/NCT04663308/registered