A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 14.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856

• Registration Number: EUCTR2009-017044-13-BE
• Lead Sponsor: Shire Development LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-06
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Subjects meeting all of the criteria listed below at screening may be included in the study:

1. Adults aged 18 years or older.

2. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.

3. Diagnosis of active mild to moderate UC (acute flare or suspected newly diagnosed with a total score of 4-10 inclusive on the modified UCDAI with an endoscopy score of ³1 and a PGA of =2).* The original diagnosis of UC must be established by sigmoidoscopy or colonoscopy and have compatible histology (performed prior to screening). An endoscopy with biopsies taken for confirmatory histology will be performed during the screening period for suspected newly diagnosed subjects only.

4. Stable maintenance therapy of 5-ASA =3.2g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare. Stable maintenance therapy is defined as no change in dose, or no initiation of 5-ASA, from the onset of the acute flare through baseline (Visit 0).
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

Subjects are excluded from the study if any of the following criteria are met at screening:

1. Severe UC (assessed by PGA =3).*

2. Acute flare with onset >6 weeks prior to Baseline (Visit 0) while on maintenance
therapy. There is no limit to the onset of flare prior to Baseline (Visit 0) if the flare is
untreated.

3. Acute flare while on maintenance MMX mesalamine/mesalazine (LIALDA®, MEZAVANT®, MEZAVANT® XL,MEZAVANT® LP).

4. Unsuccessfully treated current acute flare using steroids or 5-ASA doses >3.2g/day.

5. Acute flare on a 5-ASA maintenance therapy of >3.2g/day.

6. Systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening.

7. History of biologic (anti-TNF agent) use.

8. Antibiotic use or repeated use (>3 consecutive days of use at doses above the prescribed over-the-counter dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to screening. However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted.

9. Current or recurrent disease, other than UC, that could affect the colon, the action, absorption, or disposition of the investigational medicinal product, or clinical or laboratory assessments.

* The symptom parameters of the modified UC-DAI (rectal bleeding and stool frequency) will be assessed at screening and Baseline (Visit 0). Endoscopy scores will be obtained at Baseline (Visit 0) to confirm eligibility, except in the case of suspected newly diagnosed subjects only, where endoscopy with biopsies taken for both confirmatory histology and for central laboratory assessment will be performed during the screening period. For all subjects (including suspected newly diagnosed subjects), the PGA, assessment of subject's symptoms, and calculation of total UC-DAI score will be performed at Baseline (Visit 0)

Study & Design

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