A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis

Phase 1

• Conditions: lcerative colitis; MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis

• Registration Number: EUCTR2008-003169-19-GB
• Lead Sponsor: Sigmoid Pharma Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-17
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Male and female subjects aged >18 years.
2. Subjects with a mild to moderate diagnosis of UC involving at least the
rectum and sigmoid colon (i.e., ulcerative proctosigmoiditis, left-sided
ulcerative colitis or pancolitis), determined by historical (> 3 months prior to
Day 0) colonoscopy or, sigmoidoscopy, with biopsies.

3. Clinical severity assessed at screening using the Disease Activity Index (DAI, Table 1) of 4 to 10, inclusive, and must be restricted to either mild or moderate UC defined as:- Mild clinical disease — Subjects with mild clinical UC often present insidiously with intermittent rectal bleeding associated with the passage of mucus, and mild diarrhoea with fewer than 4 small loose stools per day. Mild crampy pain, tenesmus, and periods of constipation are also common, but severe abdominal pain, profuse bleeding, fever, and weight loss are not part of the spectrum of mild disease.
- Moderate clinical disease — Subjects with moderate clinical disease have frequent loose, bloody stools (up to 8 per day), mild anaemia not requiring blood transfusions, abdominal pain that is not severe, and low grade fever. Adequate nutrition is usually maintained.
4. Clinical severity must be documented and confirmed by flexible
sigmoidoscopy within 7 days of starting study treatment (i.e., Day 0)

5. Subjects must sign and date a written informed consent

6. Subjects must agree not to change the dosing regimen of any current UC medications (e.g. low dose steroids, e.g. < 10mg daily prednisolone, 5-ASA compounds, or immunomodulatory agents, namely purine analogues), starting at screening and continuining until the end of the 4-week treatment period of the study.
7. Subjects must agree to refrain from intake of St. Johns Wort or any other prescription, over-the-counter, or herbal preparation that is known to affect cytochrome P450 throughout the 4-week treatment period of the study.
8. Subjects must agree to refrain from intake of grapefruit or grapefruit juice or any other food or drink that is known to affect cytochrome P450 throughout the 4-week treatment period of the study.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects with severe or fulminant UC.
2. Subjects with UC limited to rectum only.
3. Subjects who have had any previous colonic surgery.
4. Subjects who have any histological evidence of dysplasia on colonoscopic biopsy.
5. Women of childbearing potential who are unable or unwilling to use an acceptable method of birth control to avoid pregnancy.
6. Subjects who have failed on previous ciclosporin therapy.
7. Subjects who have had any biologic therapy within the past 2 months prior to Day 0.
8. Subjects who have had methotrexate therapy within the past 6 months prior to Day 0.
9. Subjects who have had steroid treatment dose of greater than 10 mg/day prednisolone (or equivalent) within the past 2 months prior to Day 0.
10. Subjects who have had topical treatment (e.g. enemas) within 4 weeks of
Day 0 and must refrain from taking topical treatments for UC from the
screening visit until the end of the 4-week treatment period.
11. Subjects with renal impairment, hepatic impairment, uncontrolled hypertension, premalignant skin lesions or current malignancies or any other severe co-morbid condition.
12 Subjects with any known hypersensitivity to ciclosporin or any of its excipients.
13.Subjects with a positive screening stool assay for Clostridium difficile, hemorrhagic E.Coli 0157:H7, Salmonella or Shigella
14.Subjects with a diagnosis of Crohn’s colitis, ischemic colitis, NSAID-induced colitis, or radiation colitis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified