Trial · NCT05014672
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
NCT05014672, Phase 2, Completed, Calliditas Therapeutics Suisse SA; results first posted 2025-04-24
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness. Trials, record NCT05014672. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05014672
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
- NCT number
- NCT05014672
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Calliditas Therapeutics Suisse SA
- Conditions
- Primary Biliary Cholangitis, Liver Stiffness
- Interventions
- Setanaxib, Placebo
- First posted
- 2021-08-20
- Last updated
- 2025-04-24
- Other registries' IDs
- eudract:2021-001810-13
- Results first posted
- 2025-04-24
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in ALP at Week 24 Compared to Baseline | Baseline (Day 1) and Week 24 | Change in ALP at Week 24 Compared to Baseline, ratio of week 24 value to baseline value. |
| Secondary | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PROMIS Short Form-Fatigue 7b Daily | Baseline (Day 1) and Week 24 | The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7b measures the severity of fatigue since waking. There are 7 questions, each scored between 1 and 5, with a total score between 7 to 35. A higher score indicates worse fatigue. This raw score is converted to a T score (a standardized score with a mean of 50 and a SD of 10). |
| Secondary | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Severity (PGIS) Fatigue | Baseline (Day 1) and Week 24 | The Patient's Global Impression of Severity (PGIS)-Fatigue is a global index where subjects are asked to rate the severity of fatigue on a 5-point scale within the past 7 days, with choices of 1=None, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. Higher scores indicate a worse assessment for fatigue. |
| Secondary | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Change (PGIC) Fatigue | Week 24 | The Patient's Global Impression of Change (PGIC)-Fatigue is a 7-point scale reflecting a subject's rating of overall improvement where subjects are asked to rate their overall improvement with fatigue with 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Worse, 6=Much worse, 7=Very much worse. Higher scores indicate a worse outcome for change in fatigue. |
| Secondary | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PBC-40 Questionnaire (PBC 40) Fatigue Domain | Baseline (Day 1) and Week 24 | PBC-40 fatigue domain includes 11 item questions, items scores range from 1 to 5. The individual item scores are summed to obtain a total domain score (Range for fatigue domain: 11 to 55), high scores represent high impact and low scores indicate low impact of PBC on the quality of life. |
| Secondary | Change in Liver Stiffness at Week 24 Compared to Screening | Screening (Day -28) and Week 24 | Change in liver stiffness at Week 24 compared to Screening, as assessed by transient elastography (FibroScan®) |
| Secondary | Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the Worst Itch Numerical Rating Scale (WI-NRS) | Baseline (Day 1) and Week 24 | WI-NRS is a daily patient-reported measure of itch intensity using an 11-point scale where 0=no itch and 10=worst itching imaginable. The WI-NRS score is calculated by averaging the daily WI-NRS scores before the visit date (inclusive). Higher scores indicate worse functioning for pruritus on the WI-NRS. |
| Secondary | Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PBC-40 Itch Domain | Baseline (Day 1) and Week 24 | Pruritus was assessed by answering 3 questions on the PBC-40 Itch domain from 1 to 5, which was also summed to obtain a total domain score (range 3 to 15). A high score represents a high impact, and a low score indicates low impact of pruritus on the quality of life. |
| Secondary | Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PGIS Pruritus | Baseline (Day 1) and Week 24 | PGIS-Pruritus is a global index where subjects are asked to rate the severity of pruritus on a 5-point scale within the past 7 days, with choices of 1=None, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. Higher scores indicate a worse assessment for pruritus. |
| Secondary | Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PGIC Pruritus | Week 24 | The PGIC-Pruritus is a 7-point scale reflecting a subject's rating of overall improvement where subjects are asked to rate their overall improvement with fatigue with 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Worse, 6=Much worse, 7=Very much worse. Higher scores indicate a worse outcome for change in pruritus. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in ALP at Week 24 Compared to Baseline | Baseline (Day 1) and Week 24 | Full Analysis Set | ratio | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PROMIS Short Form-Fatigue 7b Daily | Baseline (Day 1) and Week 24 | Full Analysis Set. This questionnaire was introduced after protocol version 1.0, so patients enrolled under protocol version 1.0 do not have a baseline value and are excluded from the number of participants analyzed. | T-scores | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Severity (PGIS) Fatigue | Baseline (Day 1) and Week 24 | Full Analysis Set subjects who have both non-missing baseline and Week 24 results | units on a scale | MEAN |
| SECONDARY | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Change (PGIC) Fatigue | Week 24 | Full Analysis Set | units on a scale | MEAN |
| SECONDARY | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PBC-40 Questionnaire (PBC 40) Fatigue Domain | Baseline (Day 1) and Week 24 | Full Analysis Set | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Liver Stiffness at Week 24 Compared to Screening | Screening (Day -28) and Week 24 | Full Analysis Set | ratio | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the Worst Itch Numerical Rating Scale (WI-NRS) | Baseline (Day 1) and Week 24 | Full Analysis Set subjects who have both non-missing baseline and Week 24 results | units on a scale | MEAN |
| SECONDARY | Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PBC-40 Itch Domain | Baseline (Day 1) and Week 24 | Full Analysis Set subjects who have both non-missing baseline and Week 24 results | units on a scale | MEAN |
| SECONDARY | Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PGIS Pruritus | Baseline (Day 1) and Week 24 | Full Analysis Set subjects who have both non-missing baseline and Week 24 results | units on a scale | MEAN |
| SECONDARY | Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PGIC Pruritus | Week 24 | Full Analysis Set | units on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group59
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in ALP at Week 24 Compared to Baseline | Setanaxib 1200 mg/Day | 0.89 | 95% Confidence Interval 0.802 to 0.988 | ratio | |
| Change in ALP at Week 24 Compared to Baseline | Setanaxib 1600 mg/Day | 0.84 | 95% Confidence Interval 0.758 to 0.931 | ratio | |
| Change in ALP at Week 24 Compared to Baseline | Placebo | 1.03 | 95% Confidence Interval 0.936 to 1.141 | ratio | |
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PROMIS Short Form-Fatigue 7b Daily | Setanaxib 1200 mg/Day | -3.60 | 95% Confidence Interval -7.625 to 0.429 | T-scores | |
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PROMIS Short Form-Fatigue 7b Daily | Setanaxib 1600 mg/Day | -0.80 | 95% Confidence Interval -4.679 to 3.072 | T-scores | |
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PROMIS Short Form-Fatigue 7b Daily | Placebo | -1.43 | 95% Confidence Interval -5.331 to 2.461 | T-scores | |
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Severity (PGIS) Fatigue | Setanaxib 1200 mg/Day | -0.07 | Standard Deviation 0.730 | units on a scale | |
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Severity (PGIS) Fatigue | Setanaxib 1600 mg/Day | 0.12 | Standard Deviation 0.857 | units on a scale | |
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Severity (PGIS) Fatigue | Placebo | 0.22 | Standard Deviation 1.003 | units on a scale | |
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Change (PGIC) Fatigue | Setanaxib 1200 mg/Day | 3.27 | Standard Deviation 1.534 | units on a scale |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Setanaxib 1200 mg/Day | 24 | |
| Overall Study | STARTED | Setanaxib 1600 mg/Day | 25 | |
| Overall Study | STARTED | Placebo | 27 | |
| Overall Study | COMPLETED | Setanaxib 1200 mg/Day | 17 | |
| Overall Study | COMPLETED | Setanaxib 1600 mg/Day | 20 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | NOT COMPLETED | Setanaxib 1200 mg/Day | 7 | |
| Overall Study | NOT COMPLETED | Setanaxib 1600 mg/Day | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
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 | Nasopharyngitis | Infections and infestations | Setanaxib 1200 mg/Day | 3 | 25 | |
| other | Nasopharyngitis | Infections and infestations | Setanaxib 1600 mg/Day | 4 | 25 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 0 | 26 | |
| other | COVID-19 | Infections and infestations | Setanaxib 1200 mg/Day | 3 | 25 | |
| other | COVID-19 | Infections and infestations | Setanaxib 1600 mg/Day | 3 | 25 | |
| other | COVID-19 | Infections and infestations | Placebo | 0 | 26 | |
| other | Influenza | Infections and infestations | Setanaxib 1200 mg/Day | 0 | 25 | |
| other | Influenza | Infections and infestations | Setanaxib 1600 mg/Day | 2 | 25 | |
| other | Influenza | Infections and infestations | Placebo | 0 | 26 | |
| other | Upper respiratory tract infection | Infections and infestations | Setanaxib 1200 mg/Day | 0 | 25 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Setanaxib 1200 mg/Day | 0 | 25 |
| Total, all-cause mortality | Setanaxib 1600 mg/Day | 0 | 25 |
| Total, all-cause mortality | Placebo | 0 | 26 |
| Total, other adverse events | Setanaxib 1200 mg/Day | 14 | 25 |
| Total, other adverse events | Setanaxib 1600 mg/Day | 18 | 25 |
| Total, other adverse events | Placebo | 17 | 26 |
| Total, serious adverse events | Setanaxib 1200 mg/Day | 4 | 25 |
| Total, serious adverse events | Setanaxib 1600 mg/Day | 2 | 25 |
| Total, serious adverse events | Placebo | 3 | 26 |
Source ClinicalTrials.gov
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05014672
GET https://conductscience.org/api/trials/v1/NCT05014672/results?page=2