Subjects with Ulcerative Colitis of the Rectum Ulcerative Colitis of the Rectum
Conditions
Interventions
Hydrocortisone Acetate 90 milligrams (mg) Suppository Formulation Administered with the Sephure? Suppository
Applicator
Hydrocortisone acetate 90 mg or placebo will be administered as a rectal suppository with a Sephure suppository applicator. Two arms of the study will receive different dosage regimens of hydrocortiso
Hydrocortisone acetate 90 mg
Sponsors
Cristcot HCA LLC
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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 Reading. 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.
Exclusion criteria
Exclusion criteria: 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 hernia. 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Name: The primary efficacy endpoint is the proportion of subjects with clinical remission at the End of Treatment Visit (Visit 7).;Timepoints: The primary efficacy endpoint is the proportion of subjects with clinical remission at the End of Treatment Visit (Visit 7). Clinical remission is defined as the Modified Mayo Score of 0 to 2, with stool frequency sub-score of 0 or 1 (minimum 1 point decrease from a Baseline score of 1 or 2), rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1.;Measure: Clinical remission is defined as the Modified Mayo Score of 0 to 2, with stool frequency sub-score of 0 or 1 (minimum 1 point decrease from a Baseline score of 1 or 2), rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Name: Rectal bleeding;Timepoints: Endpoints will be evaluated hierarchically with Baseline (Day 1/Visit 3) compared to End of Treatment (Day 29/Visit 7) and then Follow Up (Day 15/Visit 5);Measure: Rectal bleeding sub-score of 0 (MMDAI).;Name: Reduction of stool frequency;Timepoints: Endpoints will be evaluated hierarchically with Baseline (Day 1/Visit 3) compared to End of Treatment (Day 29/Visit 7) and then Follow Up (Day 15/Visit 5):;Measure: Reduction of stool frequency | — |
Countries
Bulgaria, Denmark, France, Georgia, India, Italy, Philippines, Poland, Republic of Moldova, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Turkey, Ukraine, United States of America, Viet Nam
Contacts
Public ContactEliane Nase
Country Manager
Outcome results
None listed