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

NCT01033305 | Completed Phase 2 DMC

• 1 other identifier: CYC-201
• Study Type: interventional
• Target: 118
• Locations: 2 countries
• Sites: 22

Brief Summary

This is a multi-center study in Ireland and United Kingdom to determine the effects, safety and tolerability of a drug called CyCol™ in improving mild to moderate ulcerative colitis (UC). Informed consent will be obtained and following confirmation of eligibility and disease assessment, study participants will be randomised (allocated by chance) to take either CyCol™, or placebo, orally once every day for four weeks. Study visit assessments will include blood and stool tests, physical examinations and flexible sigmoidoscopies (inspection of the bowel wall using a flexible camera). Half the participants will receive CyCol™ and half will receive placebo. At the end of treatment (4 weeks) study participants will be reassessed again and the findings in those who received CyCol™ will be compared with those who received placebo. Any side effects experienced during the study and the safety of treatment with CyCol™ will also be evaluated.

Conditions

Mild to Moderate Ulcerative Colitis

Keywords

UC

Outcome Measures

Primary Outcomes (1)

• Efficacy of CyCol™ in inducing clinical remission of mild to moderate Ulcerative Colitis.

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

CyCol™

EXPERIMENTAL

Drug: CyCol™

Interventions

CyCol™ DRUG

Orally, once per day for 4 weeks

Also known as: Ciclosporin

CyCol™

Placebo DRUG

Orally, once per day for 4 weeks

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sigmoid Pharma: lead

Study Sites (22)

Cork University Hospital

Cork, Co. Cork, Ireland

Location

Mater Misercordiae University Hospital

Dublin, Co. Dublin, Ireland

Location

St. James's Hospital

Dublin, Co. Dublin, Ireland

Location

Clinical Science Institute

Galway, Co. Galway, Ireland

Location

The Adelaide and The Meath Hospital (Tallaght)

Tallaght, Dublin, Dublin 24, Ireland

Location

Beaumont Hospital

Dublin, Ireland

Location

St. Vincent's University Hospital

Dublin, Ireland

Location

MidWestern Regional Hospital

Limerick, Ireland

Location

University College Hospital London

London, London, NW1 2BU, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Sandwell and West MidlandsHospitals NHS Trust

Birmingham, B71 4HJ, United Kingdom

Location

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

Location

Conventry university Hospital

Coventry, CV2 2DX, United Kingdom

Location

Leeds General infirmary

Leeds, United Kingdom

Location

Royal Liverpool and Broadgreen University Hospitals NHS Trust

Liverpool, L7 8XP, United Kingdom

Location

Kings College London

London, SE5 9RS, United Kingdom

Location

St. Mark's Hospital

London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

George Elliot hospital

Nuneaton, CV10 7DJ, United Kingdom

Location

John Radcliff Hospital

Oxford, OX3 9DU, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, SY3 8XQ, United Kingdom

Location

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Links

• company website

MeSH Terms

Interventions

Cyclosporine; Sugars

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Carbohydrates

Study Officials

• Diarmuid O'Donoghue, Prof

  St Vincent's University Hospital, Ireland

  PRINCIPAL INVESTIGATOR

• Stuart Bloom, M.D.

  University College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: March 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 19, 2012

Record last verified: 2012-04

Locations

GB (14); IE (8)