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临床试验/LBCTR2024015424
LBCTR2024015424招募中3 期

A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum - cessa

Cristcot HCA LLC0 个研究点目标入组 189 人开始时间: 2024年3月7日最近更新:
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适应症

试验速览

阶段
3 期
状态
招募中
入组人数
189
研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled trial
主要目的
Other
盲法
Blinded (masking used)

入排标准

年龄范围
18 至 100（—）
性别
All

入选标准

  • •Males or non-pregnant, non-lactating females aged 18 years and older.
  • •2. Able to provide a signed informed consent.
  • •3. Confirmed diagnosis of UC with an endoscopic score of 2-3 no further than 15 cm (5.9 inches)
  • •from the anal verge as assessed by the endoscopy performed at Visit 2. For clarity, subjects
  • •with an endoscopic score of 2-3 up to 15 cm from the anal verge and deceleration of disease
  • •severity (endoscopic score 0-1) beyond 15 cm from the anal verge are inclusionary. Note:
  • •Subjects may have a history of more extensive UC (e.g., pancolitis), but must have an
  • •endoscopic score of 2-3 only in the rectum at the time of the screening endoscopy.
  • •4. Modified Mayo sub-score for stool frequency of 1-3 at Screening Visit (Visit 1) and Baseline
  • •Visit (Visit 3).
  • •5. Modified Mayo sub-score for rectal bleeding of 0-2 at Screening Visit (Visit 1) and Baseline
  • •Visit (Visit 3).
  • •6. Modified Mayo endoscopic sub-score of 2-3 at endoscopy (Visit 2) as determined by Central
  • •7. Modified Mayo Total Score (without physician global assessment) of 4-8.
  • •8. Females of childbearing potential must be either sexually inactive (abstinent) for 21 days prior
  • •to the first dose and willing to be sexually inactive throughout the study or must be using one
  • •of the following acceptable methods of birth control:
  • •a) Surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for a
  • •minimum period of 1 month prior to screening;
  • •b) Intrauterine device in place for at least 1 month prior to screening;
  • •c) Barrier methods (condom, diaphragm) with spermicide for at least 21 days prior to
  • •screening and willing to continue throughout the study; or
  • •d) Hormonal contraceptives for at least 6 weeks prior to screening.
  • •9. Postmenopausal females with amenorrhea for at least 12 months prior to screening.
  • •10. Subjects willing to abstain from receiving anal sex, anal bleaching, anal waxing, etc.
  • •11. Availability of all the screening assessment results, such as: serum pregnancy test (for females
  • •of childbearing potential), medical history, concomitant medication, AEs, vital signs, physical examination, electrocardiogram (ECG), documented endoscopy assessment, complete blood
  • •count, clinical chemistry and serology, urinalysis and stool test results.
  • •12. Subjects may be allowed to be re-screened for the study after consultation and approval from
  • •the Global Medical Monitor but may be enrolled (randomized) only once.

排除标准

  • •Subjects will be excluded from the study if they meet any of the following criteria:
  • •1. Endoscopic sub-score of 0 or 1 within 15 cm from the anal verge assessed by the Investigator
  • •during the endoscopy at Visit 2 (no video sent to Central Reading).
  • •2. Endoscopic sub-score of 2 or 3 beyond 15 cm from the anal verge assessed by the Investigator
  • •during the endoscopy at Visit 2 (no video sent to Central Reading).
  • •3. Endoscopic sub-score of 0 or 1 as assessed by the Central Reading using the using the video
  • •obtained during the endoscopic procedure at Visit 2.
  • •4. History or current diagnosis of bacterial or other infectious colitis, radiation-enteritis and
  • •radiation-proctitis, Crohn’s disease, collagenous colitis and indeterminate colitis.
  • •5. Prior gastrointestinal surgery except appendectomy, cholecystectomy, hiatal hernia repair,
  • •Nissen Fundoplication wrap around lower esophagus, Heller myotomy of lower esophageal
  • •sphincter, gastric sleeve, limited small bowel resection, partial gastrectomy/Billroth I or II, and
  • •6. Concomitant active gastrointestinal disease affecting the colon or rectum (except irritable
  • •bowel syndrome) or distortion of intestinal anatomy.
  • •7. Bleeding hemorrhoids at the time of screening.
  • •8. Acute diverticulitis at the time of screening.
  • •9. Acute pancreatitis at the time of screening.
  • •10. Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.
  • •11. Uncontrolled abnormal thyroid function.
  • •12. Mean value for triplicate sitting SBP >160 mm Hg and/or DBP >100 mm Hg after at least a 5-
  • •minute seated rest at the Screening visit. The Investigator or the treating physician is allowed
  • •to adjust background blood pressure medication(s) to lower blood pressure values in order for
  • •the subject to be re-assessed for randomization eligibility.
  • •13. Clinically significant ECG abnormality at screening that requires further diagnostic evaluation
  • •or intervention (e.g., new, clinically significant arrhythmia or a conduction disturbance).
  • •14. Serum hemoglobin levels <7.5 g/dL (<4.65 mmol/L).
  • •15. Indication of impaired liver function as shown by an abnormal liver function profile at
  • •Screening (e.g., repeated values of aspartate aminotransferase [AST], alkaline phosphatase
  • •[ALP], and alanine aminotransferase [ALT] = 2 × the upper limit of normal).
  • •16. History of sclerosing cholangitis, cirrhosis, or hepatic impairment.
  • •17. Renal disease manifested by serum creatinine >2.0 mg/dL (176.8 µmol/L).
  • •18. Positive test result at screening for cytomegalovirus, tuberculosis (confirmed as active with xray),
  • •human immunodeficiency virus, hepatitis B or C infection.
  • •19. History of ocular herpes simplex or ocular varicella zoster infection.
  • •20. History of unresolved malignant disease, with the exception of basal cell carcinoma and/or
  • •squamous cell carcinoma in situ of the skin.
  • •21. Diagnosis of Addison’s disease, congenital adrenal hyperplasia, or other form of adrenal
  • •insufficiency.
  • •22. Subjects with abnormal response to the ACTH stimulation test performed at the screening visit
  • •(Visit 1).
  • •23. Active systemic infection.
  • •24. Toxic megacolon, fistula, perforation, or abscess.
  • •25. Uncontrolled psychiatric disorders or seizure disorders.
  • •26. History of non-responsive UC to steroid treatment.
  • •27. History of medical condition requiring use of inhaled steroids during the study (for treatment
  • •of asthma, COPD, etc.).
  • •28. History of drug or alcohol abuse within the last 6 months. Alcohol abuse is defined as

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