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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Colitis, Ulcerative

Treatments: Biological: Multiple dose-Group B; Biological: Single dose-group A; Biological: Multiple dose- Group B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928681

A7281001

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 12 patient groups

0.03 mg/kg or placebo iv

Other group

Treatment:

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

0.1 mg/kg or placebo iv

Other group

Treatment:

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Multiple dose- Group B

Biological: Multiple dose- Group B

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: Single dose-group A

Biological: Multiple dose- Group B

Biological: Single dose-group A

0.3 mg/kg or placebo iv

Other group

Treatment:

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Multiple dose- Group B

Biological: Multiple dose- Group B

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: Single dose-group A

Biological: Multiple dose- Group B

Biological: Single dose-group A

1.0 mg/kg or placebo iv

Experimental group

Treatment:

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

3.0 mg/kg or placebo sc

Other group

Treatment:

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

10 mg/kg or placebo iv

Other group

Treatment:

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

Biological: Single dose-group A

0.3 mg/kg or placebo sc

Other group

Treatment:

Biological: Single dose-group A

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: Single dose-group A

Biological: Single dose-group A

0.1 mg/kg or placebo iv (multiple dose)

Other group

Treatment:

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

0.3 mg/kg or placebo iv (multiple dose)

Other group

Treatment:

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

3.0 mg/kg or placebo iv

Other group

Treatment:

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

0.1 mg/kg or placebo sc

Other group

Treatment:

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

0.3 mg/kg or placebo sc (multiple dose)

Other group

Treatment:

Biological: Multiple dose-Group B

Biological: Multiple dose-Group B