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New treatment option for Primary Biliary Cholangitis
Official title A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA
ClinicalTrials.gov ID: NCT07282353
What this study is testing
What is 2mg CS0159?
2mg CS0159 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary biliary cholangitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients with Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (UDCA).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Must have given written informed consent (signed and dated) and any authorizations required by local law;
- When signing ICF age ≥18 years ≤75 years, male or female;
- Meets the diagnostic criteria of PBC, based on any two of the following criteria:
- History of ALP above 1.0× ULN for at least 6 months
- Positive antimitochondrial antibody (AMA) titer (\>1:40 on immunofluorescence or M2 positive by ELISA) or positive PBC- specific antinuclear antibody...
You likely can't join if
- Previous exposure to CS0159;
- History of allergy to the CS0159 or its excipients or drugs of similar chemical classes;
- Advanced PBC as defined by the Rotterdam criteria (albumin\ 1.0× ULN);
- Patients who have had clinically significant complications of hepatic cirrhosis with clinically significant portal hypertension (CSPH), including the...
- History of liver transplantation, current placement on a liver transplant list, current MELD -Na score ≥ 12;
- History of confirmed esophagogastric variceal bleeding;
See the full eligibility criteria
Who can join
- Must have given written informed consent (signed and dated) and any authorizations required by local law;
- When signing ICF age ≥18 years ≤75 years, male or female;
- Meets the diagnostic criteria of PBC, based on any two of the following criteria:
- History of ALP above 1.0× ULN for at least 6 months
- Positive antimitochondrial antibody (AMA) titer (\>1:40 on immunofluorescence or M2 positive by ELISA) or positive PBC- specific antinuclear antibody (ANA) (either SP100 or GP210 positive)
- Documented liver biopsy results consistent with PBC;
- UDCA≥6 months before randomization and a stable dose ≥3 months after the how well it works was poor [meeting (5)a], or UDCA was not tolerated, and stop taking UDCA (no UDCA use for ≥3 months before randomization);
- Laboratory parameters measured at screening period meet the following criteria:
- ALP ≥1.67× ULN
- ALT≤5× ULN
- AST ≤5× ULN
- TB \<2× ULN
- Estimated glomerular filtration rate (eGFR) \> 60mL/min/1.73m2 (calculated by CKD-EPI equation)
- Platelet count ≥ 1.0× LLN (No thrombocytopenia-related treatment within the past two weeks)
- Albumin\> 35g/L
- White blood cells count (WBC) \>3×109/L
- Absolute neutrophil count (ANC) \>1.5×109/L
- Hemoglobin A1c (HbA1c) ≤9.0%;
- INR ≤ 1.0× ULN. For participants on anticoagulation therapy, INR must be maintained in the range required for prophylaxis for their specific disease;
- Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male participants who are sexually...
What rules you out
- Previous exposure to CS0159;
- History of allergy to the CS0159 or its excipients or drugs of similar chemical classes;
- Advanced PBC as defined by the Rotterdam criteria (albumin\ 1.0× ULN);
- Patients who have had clinically significant complications of hepatic cirrhosis with clinically significant portal hypertension (CSPH), including the following:
- History of liver transplantation, current placement on a liver transplant list, current MELD -Na score ≥ 12;
- History of confirmed esophagogastric variceal bleeding;
- Clinically significant ascites requiring intervention, such as sodium restriction, diuretic therapy, or therapeutic paracentesis;
- Any secondary complications resulting from clinically significant ascites, such as spontaneous bacterial peritonitis, hepatorenal syndrome, or hepatic hydrothorax;
- Hepatic encephalopathy requiring drug therapy;
- Portopulmonary hypertension and/or hepatopulmonary syndrome;
- Hepatocellular carcinoma;
- Other concomitant liver disease including:
- Autoimmune hepatitis (AIH) (simplified AIH diagnostic score \>6), PBC-AIH overlap syndrome, or overlap with other autoimmune liver diseases
- Positive HBsAg or positive HCV RNA (tested for in case of known cured HCV infection or positive HCV Ab at screening)
- Primary sclerosing cholangitis (PSC)
- History or clinical evidence of Alcoholic liver disease (ALD)
- Biopsy confirmed Non-alcoholic steatohepatitis (NASH)
- Gilbert's Syndrome
- History or evidence of alpha-1 antitrypsin deficiency
- Liver stiffness measured by transient elastography (TE) \> 16.9 Kpa;
- Patient has a positive test for HIV at screening, or active syphilis [defined as positive Treponema pallidum antibody (TP Ab) and a rapid plasma reagin (RPR) card test titer ≥1:8; for low titers (e.g., 1:1 or 1:2)...
- Administration of the following medications are prohibited as specified below:
- Use of medications, food, and drinks (e.g., grapefruit juice) that are strong or moderate CYP3A4 inhibitors or inducers within 14 days before randomization;
- Use of P-glycoprotein (P-gp) substrate drugs within 14 days before randomization;
- 2 months prior to randomization: fibrates, glitazones, seladelpar and elafibranor.
- 3 months prior to randomization: obeticholic acid (OCA), azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, systemic corticosteroids and budesonide (˃2 weeks); potentially hepatotoxic...
- Patients with systemic treatment for pruritus (e.g., with bile acid sequestrants [BAS]) within 3 months prior to randomization.
- 12 months prior to randomization: antibodies or immunotherapy directed against ILs or other cytokines or chemokines;
- Medical conditions that may cause non-hepatic increases in ALP (e.g., paget's disease);
- Patients with severe arrhythmia, or a QTcF interval corrected by Fridericia's formula ≥450 ms (males) or ≥470 ms (females) at screening [Fridericia's formula: QTcF=QT/(RR\^0.33)];
- History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the large intestine, eg, inflammatory bowel...
- History of malignancy (except for those with a disease-free survival of ≥5 years) or currently under evaluation for malignancy. Except for cases with long-term stable disease and assessed by the investigator as having...
- Drug abuse or heavy alcohol use from 12 months prior to randomization throughout the entire clinical study period. Heavy alcohol use is defined as an average weekly alcohol consumption of more than approximately 7...
- Poor blood pressure control is indicated after treatment by a systolic pressure greater than 160 mmHg or diastolic pressure greater than 100 mmHg during screening;
- Pregnancy, planned pregnancy, lactation;
- Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening;
- Mental instability or incompetence that may compromise the validity of informed consent or ability to adhere to study requirements;
- Any other condition(s) that would compromise the safety of the patient or compromise the quality of the clinical study, as judged by the investigator. \-
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Shenzhen, Guangdong, China
- Zhanjiang, Guangdong, China
- Nanning, Guangxi, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Shiyan, Hubei, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Wuxi, Jiangsu, China
- Zhenjiang, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Xiamen, Fujian, China; Shenzhen, Guangdong, China and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.