Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01033305
• Date of registration: 15/12/2009
• Prospective Registration: Yes
• Primary sponsor: Sigmoid Pharma
• Public title: Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)
• Scientific title: A Phase II, Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapsule Formulation of Ciclosporin (CyCol™) in the Treatment of Mild to Moderate Ulcerative Colitis
• Date of first enrolment: March 2010
• Target sample size: 118
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01033305
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Ireland, United Kingdom

Contacts

• Name: Stuart Bloom, M.D.
• Affiliation: University College Hospital NHS Trust

• Name: Diarmuid O'Donoghue, Prof
• Affiliation: St. Vincent's University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female aged > 18 years

- Diagnosis of mild to moderate diagnosis of UC involving at least the rectum and
sigmoid colon

- Clinical severity assessed at screening using the Disease Activity Index (DAI)

- Clinical severity documented and confirmed by flexible sigmoidoscopy, within 7 days
of starting study treatment

- Signed and dated written informed consent.

- Willing to maintain current UC medication dosing regimen from screening until the end
of the 4-week treatment period.

- Able and willing 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 metabolism throughout the 4-week treatment period.

- Able and willing to refrain from intake of grapefruit or grapefruit juice or any
other food or drink that is known to affect cytochrome P450 metabolism throughout the
4 week treatment period of the study.

Exclusion Criteria:

- Severe or fulminant UC.

- UC limited to rectum only.

- Any previous colonic surgery.

- Any histological evidence of dysplasia on colonoscopic biopsy.

- Women of childbearing potential who are unable or unwilling to use adequate
contraceptive methods to avoid pregnancy.

- Previous unsuccessful ciclosporin therapy.

- Biologic therapy within the past 2 months prior to study treatment.

- Methotrexate therapy within 4 weeks of study treatment.

- A steroid treatment dose of greater than 10 mg/day prednisolone (or equivalent)
within 4 weeks of study treatment.

- Use of topical treatment (e.g. enemas) within 4 weeks of study treatment and
unwilling to refrain from use of topical treatments from the screening visit until
the end of the 4-week treatment period.

- Significant renal impairment, hepatic impairment, uncontrolled hypertension,
premalignant skin lesions or current malignancies, or any other severe co-morbid
condition.

- Known hypersensitivity to ciclosporin or any of its excipients.

- Positive screening stool assay for Clostridium difficile, hemorrhagic E.coli 0157:H7,
Salmonella or Shigella

- Diagnosis of Crohn's colitis, ischemic colitis, NSAID-induced colitis, or radiation
colitis.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Mild to Moderate Ulcerative Colitis

Intervention(s)

Drug: CyCol™

Drug: Placebo

Primary Outcome(s)

Efficacy of CyCol™ in inducing clinical remission of mild to moderate Ulcerative Colitis. [Time Frame: 4 weeks]

Secondary ID(s)

CYC-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors