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Completed

NCT Number: NCT00928681

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

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

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single dose-group A

Biological

PF-00547659, single iv dose

Multiple dose- Group B

Biological

PF-00547659, multiple dose

Multiple dose-Group B

Biological

PF-00547659, multiple dose

Primary outcomes

  1. Safety and toleration

    Time frame: up to 12 weeks

  2. Endoscopic score changes as calculated using section 3 of the Mayo Score

    Time frame: up to 12 weeks

  3. Disease activity score changes as calculated using the Mayo Score

    Time frame: up to 12 weeks

Secondary outcomes

  1. Plasma concentrations of PF-00547659

    Time frame: up to 12 weeks

  2. Fecal concentrations of calprotectin

    Time frame: up to 12 weeks

  3. Plasma concentrations of CRP

    Time frame: up to 12 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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.

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jun 26, 2009
Registry last updated
Jun 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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