A Phase 2 interventional study of Setanaxib and Placebo in Primary Biliary Cholangitis and Liver Stiffness, sponsored by Calliditas Therapeutics Suisse SA. Completed at 128 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Calliditas Therapeutics Suisse SA · Phase 2, Interventional, and Treatment
Among 83 studies in Liver Cirrhosis, Biliary with a site in United States — 11 open to participants now, 18 under way, 8 of them phase 3. Liver Cirrhosis, Biliary · United States.
Among the 83 studies in Liver Cirrhosis, Biliary with a site in United States, this one is the 22nd largest by enrollment of the 65 interventional ones, is one of 8 that started in 2022, is one of 34 in phase 2, and was the 56th registered.
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
This study's enrollment of 76 is above the median of 60 across 151 interventional studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →11 of the 83 studies in Liver Cirrhosis, Biliary with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 34 Liver Cirrhosis, Biliary studies recruiting now, 16 (47%) set no upper age limit and 11 (32%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →83 studies; the count open now beside each. This study's row is marked.
First in 1994; this study’s year is marked. 8 started in 2022.
Median enrollment 46 across the 65 interventional studies, 430 across the 17 observational. Of the 61 that completed or were terminated, 33 (54%) have results posted.
56 of 83 have an industry lead sponsor. The 10 most frequent:
Calliditas Therapeutics Suisse SA is the lead sponsor of 2 studies on the registry; none are open to participants now.
Calliditas Therapeutics Suisse SA has 1 study filed under Liver Cirrhosis, Biliary — fewer than ten, so there is no comparison to draw.
4 of the studies in Liver Cirrhosis, Biliary with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06427395Phase 3Zydus Therapeutics Inc.Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis | 2027-04-18 |
| NCT06825559Zydus Therapeutics Inc.Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease | 2026-12-31 |
| NCT05050136Mirum Pharmaceuticals, Inc.A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis | 2027-01 |
| NCT07631442Stanford UniversityUsing Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC) | 2027-10 |
Among the 83 studies in Liver Cirrhosis, Biliary with a site in United States, from their registry updates:
The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Definite or probable PBC diagnosis as demonstrated by the presence of ≥2 of the following 3 diagnostic factors:
Female participants of must use a highly effective method of to prevent pregnancy for ≥4 weeks before Randomization and must agree to continue strict contraception up to 90 days after the last dose of medicinal product (IMP).
Highly effective contraception is defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are:
Exclusion Criteria:
History of a within 5 years of Screening with the following exceptions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be administered setanaxib at a dose of 1200 mg/day for the 24-week double-blind treatment period.
Drug: Setanaxib
Participants will be administered setanaxib at a dose of 1600 mg/day for the 24-week double-blind treatment period.
Drug: Setanaxib
Participants will be administered a placebo for the 24-week double-blind treatment period.
Drug: Placebo
Oral tablets, 400mg per tablet
Oral tablets
Change in ALP at Week 24 Compared to Baseline
Change in ALP at Week 24 Compared to Baseline, ratio of week 24 value to baseline value.
Time frame: Baseline (Day 1) and Week 24
Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PROMIS Short Form-Fatigue 7b Daily
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).
Time frame: Baseline (Day 1) and Week 24
Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Severity (PGIS) Fatigue
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.
Time frame: Baseline (Day 1) and Week 24
Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Change (PGIC) Fatigue
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.
Time frame: Week 24
Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PBC-40 Questionnaire (PBC 40) Fatigue Domain
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.
Time frame: Baseline (Day 1) and Week 24
Change in Liver Stiffness at Week 24 Compared to Screening
Change in liver stiffness at Week 24 compared to Screening, as assessed by transient elastography (FibroScan®)
Time frame: Screening (Day -28) and Week 24
Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the Worst Itch Numerical Rating Scale (WI-NRS)
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.
Time frame: Baseline (Day 1) and Week 24
Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PBC-40 Itch Domain
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.
Time frame: Baseline (Day 1) and Week 24
Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PGIS Pruritus
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.
Time frame: Baseline (Day 1) and Week 24
Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PGIC Pruritus
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.
Time frame: Week 24
Changes in Markers of Cholestasis at Week 24
Changes in markers of cholestasis as assessed by proportion of patients at Week 24 with: * ALP reduction to \<1.67×ULN and total bilirubin ≤1×ULN and a ≥15% or ≥30% or ≥40% or ≥70% ALP reduction from Baseline, respectively * ALP reduction to \<1.5×ULN and total bilirubin ≤1×ULN and a ≥40% ALP reduction from Baseline * ALP \<1×ULN and total bilirubin ≤1×ULN * Total bilirubin \<0.6×ULN
Time frame: Baseline (Day 1) and Week 24
Change in ALP at Week 24 Compared to Baseline, Where Setanaxib Doses Are Combined
Change in ALP at Week 24 Compared to Baseline, ratio of week 24 value to baseline value. Setanaxib doses are combined and the change from baseline is estimated using a mixed model-repeated measures approach with fixed factors for treatment, visit, log(baseline), treatment\*visit, and log(baseline)\*visit, subject is included as a random effect. The variance-covariance matrix is therefore not the same as in the three arm analysis, which causes treatment effects estimated in the placebo to group differ from those estimated in the analysis with three treatment arms.
Time frame: Baseline (Day 1) and Week 24
Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PROMIS Short Form-Fatigue 7b Daily, Where Setanaxib Doses Are Combined
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). Setanaxib doses are combined and the change from baseline is estimated using a mixed model-repeated measures approach with fixed factors for treatment, visit, log(baseline), treatment\*visit, and log(baseline)\*visit, subject is included as a random effect. The variance-covariance matrix is therefore not the same as in the three arm analysis, which causes treatment effects estimated in the placebo to group differ from those estimated in the analysis with three treatment arms.
Time frame: Baseline (Day 1) and Week 24
Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PBC-40 Questionnaire (PBC 40) Fatigue Domain, Where Setanaxib Doses Are Combined
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. Setanaxib doses are combined and the change from baseline is estimated using a mixed model-repeated measures approach with fixed factors for treatment, visit, log(baseline), treatment\*visit, and log(baseline)\*visit, subject is included as a random effect. The variance-covariance matrix is therefore not the same as in the three arm analysis, which causes treatment effects estimated in the placebo to group differ from those estimated in the analysis with three treatment arms.
Time frame: Baseline (Day 1) and Week 24
Change in Liver Stiffness at Week 24 Compared to Screening, Where Setanaxib Doses Are Combined
Change in liver stiffness at Week 24 compared to Screening, as assessed by transient elastography (FibroScan®). Setanaxib doses are combined and the change from baseline is estimated using a mixed model-repeated measures approach with fixed factors for treatment, visit, log(baseline), treatment\*visit, and log(baseline)\*visit, subject is included as a random effect. The variance-covariance matrix is therefore not the same as in the three arm analysis, which causes treatment effects estimated in the placebo to group differ from those estimated in the analysis with three treatment arms.
Time frame: Screening (Day -28) and Week 24
| Milestone | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| Started | 24 | 25 | 27 |
| Completed | 17 | 20 | 23 |
| Not completed | 7 | 5 | 4 |
Change in ALP at Week 24 Compared to Baseline, ratio of week 24 value to baseline value.
| ratio | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| Change in ALP at Week 24 Compared to Baseline | 0.89 (0.802 to 0.988) | 0.84 (0.758 to 0.931) | 1.03 (0.936 to 1.141) |
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).
| T-scores | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PROMIS Short Form-Fatigue 7b Daily | -3.60 (-7.625 to 0.429) | -0.80 (-4.679 to 3.072) | -1.43 (-5.331 to 2.461) |
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.
| units on a scale | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Severity (PGIS) Fatigue | -0.07 ± 0.730 | 0.12 ± 0.857 | 0.22 ± 1.003 |
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.
| units on a scale | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Change (PGIC) Fatigue | 3.27 ± 1.534 | 3.62 ± 1.564 | 3.58 ± 1.427 |
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.
| units on a scale | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PBC-40 Questionnaire (PBC 40) Fatigue Domain | -1.44 (-4.919 to 2.048) | -1.83 (-5.361 to 1.699) | -1.85 (-5.217 to 1.515) |
Change in liver stiffness at Week 24 compared to Screening, as assessed by transient elastography (FibroScan®)
| ratio | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| Change in Liver Stiffness at Week 24 Compared to Screening | 0.78 (0.672 to 0.906) | 0.88 (0.764 to 1.012) | 0.92 (0.808 to 1.055) |
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.
| units on a scale | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the Worst Itch Numerical Rating Scale (WI-NRS) | -0.23 ± 2.280 | 0.61 ± 1.391 | -0.56 ± 2.268 |
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.
| units on a scale | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PBC-40 Itch Domain | -1.11 ± 2.111 | 0.32 ± 2.647 | -0.70 ± 3.114 |
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.
| units on a scale | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PGIS Pruritus | -0.50 ± 0.941 | 0.25 ± 0.775 | -0.11 ± 0.758 |
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.
| units on a scale | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PGIC Pruritus | 2.73 ± 1.751 | 3.38 ± 1.244 | 3.37 ± 1.535 |
Changes in markers of cholestasis as assessed by proportion of patients at Week 24 with: * ALP reduction to \<1.67×ULN and total bilirubin ≤1×ULN and a ≥15% or ≥30% or ≥40% or ≥70% ALP reduction from Baseline, respectively * ALP reduction to \<1.5×ULN and total bilirubin ≤1×ULN and a ≥40% ALP reduction from Baseline * ALP \<1×ULN and total bilirubin ≤1×ULN * Total bilirubin \<0.6×ULN
| participants | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| ALP <1.67×ULN and Total Bilirubin ≤1×ULN and ≥15% ALP Reduction from Baseline | 1 | 4 | 1 |
| ALP <1.67×ULN and Total Bilirubin ≤1×ULN and ≥30% ALP Reduction from Baseline | 1 | 2 | 0 |
| ALP <1.67×ULN and Total Bilirubin ≤1×ULN and ≥40% ALP Reduction from Baseline | 0 | 2 | 0 |
| ALP <1.67×ULN and Total Bilirubin ≤1×ULN and ≥70% ALP Reduction from Baseline | 0 | 0 | 0 |
| ALP <1.50×ULN and Total Bilirubin ≤1×ULN and ≥40% ALP Reduction from Baseline | 0 | 2 | 0 |
| ALP <1.00×ULN and Total Bilirubin ≤1×ULN | 0 | 1 | 0 |
| Total bilirubin <0.6×ULN | 19 | 18 | 19 |
Change in ALP at Week 24 Compared to Baseline, ratio of week 24 value to baseline value. Setanaxib doses are combined and the change from baseline is estimated using a mixed model-repeated measures approach with fixed factors for treatment, visit, log(baseline), treatment\*visit, and log(baseline)\*visit, subject is included as a random effect. The variance-covariance matrix is therefore not the same as in the three arm analysis, which causes treatment effects estimated in the placebo to group differ from those estimated in the analysis with three treatment arms.
| ratio | Setanaxib Doses Combined | Placebo |
|---|---|---|
| Change in ALP at Week 24 Compared to Baseline, Where Setanaxib Doses Are Combined | 0.87 (0.804 to 0.931) | 1.03 (0.930 to 1.135) |
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). Setanaxib doses are combined and the change from baseline is estimated using a mixed model-repeated measures approach with fixed factors for treatment, visit, log(baseline), treatment\*visit, and log(baseline)\*visit, subject is included as a random effect. The variance-covariance matrix is therefore not the same as in the three arm analysis, which causes treatment effects estimated in the placebo to group differ from those estimated in the analysis with three treatment arms.
| T-scores | Setanaxib Doses Combined | Placebo |
|---|---|---|
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PROMIS Short Form-Fatigue 7b Daily, Where Setanaxib Doses Are Combined | -2.12 (-4.925 to 0.678) | -1.45 (-5.372 to 2.467) |
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. Setanaxib doses are combined and the change from baseline is estimated using a mixed model-repeated measures approach with fixed factors for treatment, visit, log(baseline), treatment\*visit, and log(baseline)\*visit, subject is included as a random effect. The variance-covariance matrix is therefore not the same as in the three arm analysis, which causes treatment effects estimated in the placebo to group differ from those estimated in the analysis with three treatment arms.
| units on a scale | Setanaxib Doses Combined | Placebo |
|---|---|---|
| Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PBC-40 Questionnaire (PBC 40) Fatigue Domain, Where Setanaxib Doses Are Combined | -1.64 (-4.096 to 0.826) | -1.84 (-5.176 to 1.492) |
Change in liver stiffness at Week 24 compared to Screening, as assessed by transient elastography (FibroScan®). Setanaxib doses are combined and the change from baseline is estimated using a mixed model-repeated measures approach with fixed factors for treatment, visit, log(baseline), treatment\*visit, and log(baseline)\*visit, subject is included as a random effect. The variance-covariance matrix is therefore not the same as in the three arm analysis, which causes treatment effects estimated in the placebo to group differ from those estimated in the analysis with three treatment arms.
| ratio | Setanaxib Doses Combined | Placebo |
|---|---|---|
| Change in Liver Stiffness at Week 24 Compared to Screening, Where Setanaxib Doses Are Combined | 0.83 (0.750 to 0.921) | 0.92 (0.809 to 1.056) |
Collected over Reporting of adverse events began when the participant had provided informed consent and continued up to 30 days after the last IMP administration, which is in total a period of up to 32 weeks. AEs that occur, having been absent before the date and time of the first dose of the IMP, or have worsened in severity or seriousness after initiating the IMP until 30 days after the date and time of last dose of IMP will be classified as treatment-emergent AEs (TEAEs).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Setanaxib 1200 mg/Day | 0/25 (0%) | 4/25 (16%) | 14/25 (56%) |
| Setanaxib 1600 mg/Day | 0/25 (0%) | 2/25 (8%) | 18/25 (72%) |
| Placebo | 0/26 (0%) | 3/26 (11.5%) | 17/26 (65.4%) |
| Event | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| Drug-induced liver injuryHepatobiliary disorders | 0/25 | 1/25 | 1/26 |
| Pancreatitis acuteGastrointestinal disorders | 1/25 | 0/25 | 0/26 |
| Electrocardiogram QT prolongedInvestigations | 0/25 | 1/25 | 0/26 |
| Folate deficiencyMetabolism and nutrition disorders | 1/25 | 0/25 | 0/26 |
| Iron deficiencyMetabolism and nutrition disorders | 1/25 | 0/25 | 0/26 |
| OligoarthritisMusculoskeletal and connective tissue disorders | 1/25 | 0/25 | 0/26 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 1/25 | 0/25 | 0/26 |
| MyocarditisCardiac disorders | 0/25 | 0/25 | 1/26 |
| Hypertensive urgencyVascular disorders | 0/25 | 0/25 | 1/26 |
| Event | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo |
|---|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 0/25 | 0/25 | 6/26 |
| HeadacheNervous system disorders | 3/25 | 0/25 | 5/26 |
| NasopharyngitisInfections and infestations | 3/25 | 4/25 | 0/26 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/25 | 4/25 | 3/26 |
| COVID-19Infections and infestations | 3/25 | 3/25 | 0/26 |
| FatigueGeneral disorders | 3/25 | 3/25 | 3/26 |
| Drug-induced liver injuryHepatobiliary disorders | 0/25 | 3/25 | 0/26 |
| InfluenzaInfections and infestations | 0/25 | 2/25 | 0/26 |
| Upper respiratory tract infectionInfections and infestations | 0/25 | 2/25 | 0/26 |
| Gastroenteritis viralInfections and infestations | 0/25 | 2/25 | 0/26 |
| Age, Categorical(Participants) | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 18 | 25 | 61 |
| >=65 years | 6 | 7 | 2 | 15 |
| Sex: Female, Male(Participants) | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo | Total |
|---|---|---|---|---|
| Female | 22 | 24 | 25 | 71 |
| Male | 2 | 1 | 2 | 5 |
| Race/Ethnicity, Customized(Participants) | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo | Total |
|---|---|---|---|---|
| Race — Asian | 0 | 2 | 0 | 2 |
| Race — White | 22 | 20 | 23 | 65 |
| Race — Other | 0 | 3 | 2 | 5 |
| Race — Not reported | 1 | 0 | 2 | 3 |
| Race — Unknown | 1 | 0 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo | Total |
|---|---|---|---|---|
| Ethnicity — Hispanic or Latino | 2 | 2 | 6 | 10 |
| Ethnicity — Not Hispanic or Latino | 21 | 23 | 19 | 63 |
| Ethnicity — Not Reported | 1 | 0 | 2 | 3 |
| Randomised Screening serum ALP strata(Participants) | Setanaxib 1200 mg/Day | Setanaxib 1600 mg/Day | Placebo | Total |
|---|---|---|---|---|
| < 3.0 × ULN | 18 | 18 | 18 | 54 |
| ≥ 3.0 × ULN | 6 | 7 | 9 | 22 |
Showing the first 100 of 128 sites across 18 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2022 to primary completion in May 2024, 27 months.
Results were first posted in Apr 2025, 10 months after primary completion.
Of 21 phase 2 interventional studies under Liver Cirrhosis, Biliary, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 34. This study's 27 months is above that.
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Studies of the drug tested here: Setanaxib
Calliditas Therapeutics Suisse SA