Colitis, Ulcerative
Conditions
Brief summary
study to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis
Interventions
BIOLOGICALSingle dose-group A
PF-00547659, single iv dose
BIOLOGICALMultiple dose- Group B
PF-00547659, multiple dose
BIOLOGICALMultiple dose-Group B
PF-00547659, multiple dose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* A positive histological diagnosis of UC ≥3 months prior to entry into the study. If a histological diagnosis is not available but all signs and symptoms suggest UC, the subject's eligibility should be discussed with Pfizer. * Active UC as defined by a score of ≥6 on the Mayo score. * An endoscopic (by flexible sigmoidoscopy) sub-score of ≥2 on the Mayo score determined within 7 days of first dosing.
Exclusion criteria
* Subjects with UC, which is confined to a proctitis on a flexible sigmoidoscopy. * Subjects who have had surgery as a treatment for UC or are likely to require surgery within the duration of the study. * Subjects displaying clinical signs of ischemic colitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and toleration | up to 12 weeks |
| Endoscopic score changes as calculated using section 3 of the Mayo Score | up to 12 weeks |
| Disease activity score changes as calculated using the Mayo Score | up to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of PF-00547659 | up to 12 weeks |
| Fecal concentrations of calprotectin | up to 12 weeks |
| Plasma concentrations of CRP | up to 12 weeks |
Countries
Belgium, Czechia, Denmark, Germany, Norway, Slovakia, Spain
Outcome results
None listed