EUCTR2019-002945-39-ES进行中（未招募）1 期
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis - The SPRING study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ChemomAb Ltd
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males and females, age 18 to 75 years, both inclusive.
- •2. Subjects with diagnosis of large duct PSC (intrahepatic and/or extrahepatic), of more than 24 weeks’ duration (defined as cholestatic serum liver tests with consistent magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP) showing sclerosing cholangitis once secondary causes of sclerosing cholangitis have been excluded).
- •3. Subjects that have had no significant clinical concern for cholangiocarcinoma based on clinical, laboratory or imaging findings in the 12 months preceding Randomization.
- •4. Subjects with serum ALP greater than 1.5 × upper limit of normal (ULN) in both Screening and Baseline blood tests (taken at least 5 days apart).
- •5. Subjects receiving Ursodeoxycholic Acid (UDCA), must recieve a stable dose for =12 weeks prior to, Randomization and must not exceed 23 mg/kg/day during this time.
- •6. Subjects with concomitant IBD:
- •a. Subjects with ulcerative colitis (UC) must have undergone colonoscopy with biopsy confirming no dysplasia or colorectal cancer within 18 months of Randomization;
- •b. Subjects with Crohn’s Disease (CD) must be in remission as defined by a Crohn’s Disease Activity Index (CDAI) <150;
- •c. Subjects with ulcerative colitis (UC) must either be in remission or have mild disease. Remission is defined as a Partial Mayo score of =2 with no individual sub-score exceeding 1 point. Mild disease is defined as a Partial Mayo score of =3 with no individual sub-score exceeding 1 point.
- •7. Subjects receiving concomitant medications must be on stable therapy for > 12 weeks prior to Randomization.
- •8. Female subjects of childbearing potential (defined as sexually mature women who have not undergone surgical sterilization or who have not been naturally post-menopausal for at least 24 consecutive months for women =55 years; for women >55 years 12 consecutive months) must have a negative serum pregnancy test prior to starting study treatment. Sexually active women of childbearing potential must agree to use a highly effective method of contraception from the Screening Visit throughout the study period including 18 weeks post last dose.
- •Highly effective methods of contraception are considered to be those listed below:
- •Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- •o intravaginal
- •o transdermal
- •Progestogen-only hormonal contraception associated with inhibition of ovulation:
- •o injectable
- •o implantable
- •Intrauterine device
- •Intrauterine hormone-releasing system
- •Bilateral tubal occlusion
- •Vasectomy (partner)
- •Abstinence, if in line with the preferred and usual lifestyle of the subject [where abstinence is defined as refraining from heterosexual
- •intercourse during the trial duration (from first administration of investigational product until 18 weeks post last dose)].
- •9. Male subjects, if not vasectomized, must agree to use barrier contraception (condom plus spermicide) during heterosexual intercourse from screening through to study completion and for 90 days from the last dose of study investigational medicinal product.
- •10. Subjects able to understand and sign a written informed consent form (ICF).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects with presence of documented secondary sclerosing cholangitis (such as ischemic cholangitis, recurrent pancreatitis, intraductal stone disease, severe bacterial cholangitis, surgical or blunt abdominal trauma, recurrent pyogenic cholangitis, choledocholithiasis, toxic sclerosing cholangitis due to chemical agents, or any other cause of secondary sclerosing cholangitis) on prior clinical investigations.
- •2. Subjects with presence of competing etiology of liver disease (including, but not limited to, viral hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis, (Ig) G4-associated cholangitis, primary biliary cholangitis etc.) are excluded from the study. Subjects with possible overlap syndrome with autoimmune hepatitis are excluded if the Investigator considers autoimmune hepatitis as the predominant liver injury.
- •3. Subjects with small duct PSC in the absence of large duct disease.
- •4. Subjects with percutaneous biliary drain or bile duct stent or subjects who had required biliary drainage within 12 weeks of screening.
- •5. Subjects that have undergone prior biliary surgery (laparoscopic or open surgery) other than those who at the time of screening are more than 6 weeks after cholecystectomy without surgical complications.
- •6. Subjects with evidence of cirrhosis, as determined by local transient elastography (TE, preferably FibroscanTM) values of >/= 14.4 kPa obtained during the screening period.
- •7. History of cirrhosis and/or hepatic impairment (Child-Pugh classes A, B and C), and/or hepatic decompensation including ascites, encephalopathy or variceal bleeding.
- •8. Subjects who have undergone or are planned for liver transplantation or with current model of end stage liver disease (MELD) score =12.
- •9. Subjects with Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values > 5 x ULN as determined at Screening and/or Randomization blood tests (taken at least 5 days apart).
- •10. Subjects who show ‘clinically significant changes’ (as judged by the investigator) in liver transaminase levels on repeated measure will be excluded.
- •11. Subjects with serum Total Bilirubin values > 2 x ULN at Screening and/or at Randomization (taken at least 5 days apart). Subjects who show evidence of ‘clinically significant worsening’ (as judged by the investigator) of bilirubin between screening and Randomization will be excluded.
- •12. Subjects with known Gilbert's syndrome or a history of elevations in unconjugated (indirect) bilirubin >ULN.
- •13. Subjects with International Normalized Ratio (INR) >1.3 which does not correct on vitamin k replacement, in the absence of anticoagulants.
- •14. Subjects with serum creatinine >1.4 mg/dL (123 µmol/L) and/or a platelet count <100 x 109/L
- •15. Subjects with history of cholangiocarcinoma or a high clinical suspicion of cholangiocarcinoma, as indicated by clinical presentation, laboratory tests or imaging of a functional dominant stricture.
- •16. Subjects with elevated Ca 19-9 value (>129 U/mL) within 12 months prior to at Screening, unless Ca 19-9 levels have been stable and clinical evaluation & repeated MRI imaging within the same time period has not provided evidence of cholangiocarcinoma.
- •17. Subjects with a prior biliary stricture necessitating intervention should be stable for =24 weeks prior to Randomization without intervention, or episode of cholangitis, and should show a low level of clinical suspicion of cholangiocarcinoma.
- •18. Subjects with current known portal hyper
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