A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis

Study Overview
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Brief Summary
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study to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis

Official Title
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A Randomized, Double-Blind (Sponsor Open), Placebo Controlled, Dose Escalating, Parallel Group, Multi-Centre Study To Investigate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous/Sub-Cutaneous Doses Of PF-00547659 In Patients With Active Ulcerative Colitis.

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Biological: Single dose-group A
* Biological: Single dose-group A
* Biological: Multiple dose- Group B
* Biological: Single dose-group A
* Biological: Multiple dose- Group B
* Biological: Single dose-group A
* Biological: Single dose-group A
* Biological: Single dose-group A
* Biological: Single dose-group A
* Biological: Multiple dose-Group B
* Biological: Multiple dose- Group B
* Biological: Multiple dose- Group B
* Biological: Multiple dose- Group B
* Biological: Multiple dose- Group B
* Biological: Multiple dose-Group B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 0.03 mg/kg or placebo iv<br> | Biological: Single dose-group A<br>* PF-00547659, single iv dose<br>|
| Other: 0.1 mg/kg or placebo iv<br> | Biological: Single dose-group A<br>* PF-00547659, single iv dose<br>Biological: Multiple dose- Group B<br>* PF-00547659, multiple dose<br>|
| Other: 0.3 mg/kg or placebo iv<br> | Biological: Single dose-group A<br>* PF-00547659, single iv dose<br>Biological: Multiple dose- Group B<br>* PF-00547659, multiple dose<br>|
| Experimental: 1.0 mg/kg or placebo iv<br> | Biological: Single dose-group A<br>* PF-00547659, single dose<br>|
| Other: 3.0 mg/kg or placebo sc<br> | Biological: Single dose-group A<br>* PF-00547659, single dose<br>|
| Other: 10 mg/kg or placebo iv<br> | Biological: Single dose-group A<br>* PF-00547659, single dose<br>|
| Other: 0.3 mg/kg or placebo sc<br> | Biological: Single dose-group A<br>* PF-00547659, single dose<br>Biological: Multiple dose-Group B<br>* PF-00547659, multiple dose<br>|
| Other: 0.1 mg/kg or placebo iv (multiple dose)<br> | Biological: Multiple dose- Group B<br>* PF-00547659, multiple dose<br>|
| Other: 0.3 mg/kg or placebo iv (multiple dose)<br> | Biological: Multiple dose- Group B<br>* PF-00547659, multiple dose<br>|
| Other: 3.0 mg/kg or placebo iv<br> | Biological: Multiple dose- Group B<br>* PF-00547659, multiple dose<br>|
| Other: 0.1 mg/kg or placebo sc<br> | Biological: Multiple dose- Group B<br>* PF-00547659, multiple dose<br>|
| Other: 0.3 mg/kg or placebo sc (multiple dose)<br> | Biological: Multiple dose-Group B<br>* PF-00547659, multiple dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |