2024-518714-31-00招募中3 期
A randomized, phase 3, double-blind, double-dummy, active comparator-controlled multicenter study to evaluate the efficacy and safety of 2 doses of linaprazan glurate compared to lansoprazole in 4 or 8 weeks healing in participants with erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D
Cinclus Pharma Holding AB (publ)56 个研究点 分布在 6 个国家目标入组 382 人开始时间: 2025年8月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 382
- 试验地点
- 56
- 主要终点
- Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.
研究概览
简要总结
To confirm superiority of linaprazan glurate 50 mg BID compared to lansoprazole in the healing of EE due to GERD of LA grades C/D after 4 weeks of double-blind treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any study-related assessments/procedures.
- •Male or female participants aged 18 to 80 years, inclusive, at the time of signing the ICF.
- •The participant is willing and able to comply with all aspects of the protocol (including endoscopies, PK sampling, tablet and capsule swallowing, electronic device [e-device] completion, etc.).
- •The participant has endoscopically confirmed EE due to GERD of LA grades A to D during the Screening Period as assessed in Central Review by an Independent Review Committee (IRC).
排除标准
- •Ongoing infection with HP or diagnosis and treatment of HP infection within 6 weeks of randomization OR any treatment with antibiotics or bismuth containing drugs within 6 weeks of randomization.
- •Body mass index (BMI) ≤ 18 and ≥ 40 kg/m2 at Screening.
- •Requiring concomitant therapy with any of the prohibited medications as defined in the protocol.
- •Any planned major surgery within 16 weeks of Screening.
- •Any clinically significant laboratory parameter outside reference value that, in the opinion of the Investigator, may suggest a new or insufficiently understood disease, may present an unreasonable risk to the participant as a result of his/her participation in the study, or may interfere with study assessments. Any of these Screening laboratory test results are exclusionary, but re-test is allowed: a. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × the upper limit of normal (ULN) for the central laboratory conducting the test. b. Serum total bilirubin (TBL) >1.5 × ULN for the central laboratory conducting the test (individuals with Gilbert’s syndrome can be included). c. Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 (as calculated by the central laboratory using the Modification of Diet in Renal Disease [MDRD] equation).
- •Known human immunodeficiency virus (HIV) infection/acquired immune deficiency syndrome (AIDS) or test positive for HIV antibodies at Screening.
- •Known chronic/active viral hepatitis or test positive at Screening for hepatitis B virus (HBV: hepatitis B surface antigen [HBsAg] and/or hepatitis B core antigen [anti-HBc], with detectable HBV DNA) or hepatitis C virus (HCV: positive hepatitis C antibody [anti-HCV], with detectable HCV ribonucleic acid [RNA]). Participants with positive screening HBV or HCV serology, but with undetectable/negative HBV DNA or HCV RNA viral load are permitted to participate.
- •History of long QTc syndrome (e.g., QTc ≥ 450 ms for males and ≥ 470 ms for females) or discovery of long QTc syndrome at Screening, as calculated by the Fridericia formula (QTc = QT / RR1/3) as reviewed and interpreted by a central reader.
- •Cardiac arrhythmias or any clinically significant abnormalities in the resting 12-lead ECG at the time of Screening, as reviewed and interpreted on site by the Investigator and by a central reader.
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity to any component of the relevant study treatments, including excipients, as judged by the Investigator.
- •Treatment with any investigational drug within 3 months prior to the first dose of the study treatment in this study or is currently enrolled in another interventional clinical study.
- •History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, neurological disease or disorder, or psychiatric diagnosis which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the study results or the participant’s ability to participate in the study. The following examples are conditions that would exclude the patient from participating: a. History of myocardial infarction/acute coronary syndrome within 3 months prior to Screening. b. History of ventricular arrhythmia or implanted cardioverter defibrillator. c. Symptomatic congestive heart failure (New York Heart Association class 3-4). d. Family history of/diagnosis of hereditary arrhythmia syndrome. e. History of adult asthma that required intensive treatment in an emergency room.
- •Positive screen for drugs of abuse at Screening (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates). Eligibility in study participation will be assessed by the Investigator.
- •Current or history of alcohol, drug abuse, and/or use of androgens/anabolic steroids (testosterone and testosterone esters [enanthate, undecanoate, cypionate], methyltestosterone, oxandrolone, stanozolol, fluoxymesterone, danazol, tetrahydrogestrinone, 7α-methyl-19-nortestosterone) within 2 years prior to Screening. Stable androgen substitution treatment for male hypogonadism is allowed.
- •Women who are pregnant or breast feeding.
- •Individual is an employee of the Investigator, study site, Sponsor, or Contract Research Organization (CRO) with direct involvement in the proposed study or other studies under the direction of that Investigator, study site, Sponsor, or CRO, as well as family members of the employee of the Investigator, study site, Sponsor, or CRO.
- •Individuals who have previously participated (completed or withdrawn) in this study. Note: rescreening is permitted under circumstances specified in the protocol, but never for participants who have undergone randomization.
- •A female participant of childbearing potential who is or may be sexually active with a non-sterilized male partner and who is unwilling to routinely use highly effective contraception from the signing of informed consent until 7 days after the last dose of study medication.
- •A male participant with a partner of childbearing potential who is unwilling to routinely use highly effective contraception and is unwilling to remain abstinent from the signing of informed consent until at least 7 days after the last dose of study medication.
- •History of malignancy of any organ system (other than completely treated localized basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or in situ cervical carcinoma), within the past 5 years.
- •Solitary esophageal ulcer in the proximal two-thirds of the esophagus, untreated Barrett’s esophagus or any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture*; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma. *Note: Patients with diagnosis of Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate, unless history of dilatation within 3 months of Screening.
- •History of any surgical or medical condition which might significantly alter the GERD status or the absorption, distribution, metabolism, or excretion of drugs. The Investigator is to be guided by evidence of any of the following: history of major GI surgery such as gastrectomy, any bariatric surgery, gastroenterostomy, bowel resection, or transjugular intrahepatic portosystemic shunt. Nissen fundoplication is not exclusionary as long as the patient is eligible according to other criteria.
- •Known severe atrophic gastritis as assessed from medical history or upper endoscopy during Screening.
- •Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
- •History of treatment course with lansoprazole within 2 months prior to Screening.
- •Current peptic ulcer.
结局指标
主要结局
Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.
Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.
次要结局
- 1. Cumulative healing of EE at Week 8 as assessed by endoscopy at 4 and 8 weeks.
- 2. Healing of EE at Week 4 as assessed by endoscopy.
- 3. Percentage of 24-hour heartburn-free days from Baseline to Week 8 based on the electronic Diary.
- 4. Percentage of 24-hour heartburn-free days from Baseline to Week 4 based on the electronic Diary.
- 5. Cumulative healing of EE at Week 8 as assessed by endoscopy at 4 and 8 weeks in participants with Baseline EE LA grades C/D.
- 6. Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.
- 7. Change in weekly mean 24-hour heartburn severity from Baseline to Week 1, Week 4, and Week 8 based on electronic Diary.
- 8. Safety analysis based on frequency and severity of adverse events (AEs) and any other safety signals detected.
研究者
Rikard Reneland
Scientific
Cinclus Pharma Holding AB (publ)
研究点 (56)
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