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

Phase 1

Completed

• Conditions: Colitis, Ulcerative
• Interventions: Biological: Single dose-group A; Biological: Multiple dose- Group B; Biological: Multiple dose-Group B

• Registration Number: NCT00928681
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2008-04
• Study Completion: 2008-10
• Status Verified: 2009-06
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-25
• Last Update Submitted: 2009-06-25
• Study First Posted: 2009-06-26
• Last Update Posted: 2009-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 mg/kg or placebo iv	Single dose-group A	-
0.3 mg/kg or placebo sc	Single dose-group A	-
0.3 mg/kg or placebo sc	Multiple dose-Group B	-
0.1 mg/kg or placebo iv (multiple dose)	Multiple dose- Group B	-
3.0 mg/kg or placebo iv	Multiple dose- Group B	-
0.03 mg/kg or placebo iv	Single dose-group A	-
0.1 mg/kg or placebo iv	Single dose-group A	-
0.1 mg/kg or placebo iv	Multiple dose- Group B	-
0.3 mg/kg or placebo iv	Single dose-group A	-
0.3 mg/kg or placebo iv	Multiple dose- Group B	-
1.0 mg/kg or placebo iv	Single dose-group A	-
3.0 mg/kg or placebo sc	Single dose-group A	-
0.3 mg/kg or placebo iv (multiple dose)	Multiple dose- Group B	-
0.1 mg/kg or placebo sc	Multiple dose- Group B	-
0.3 mg/kg or placebo sc (multiple dose)	Multiple dose-Group B	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Madrid, Spain