Colitis, UlcerativePhase 1NCT00928681
A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis
A Phase 1 study testing Single dose-group A, Multiple dose- Group B and Multiple dose-Group B in people with Colitis, Ulcerative, run by Pfizer at 18 sites in 7 countries.
Trial summary
study to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Single dose-group A, Multiple dose- Group B and Multiple dose-Group B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 18 sitesin 7 countries
- Study dates
- Sep 2005to Oct 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
Spain5 sites
Pfizer Investigational Site
Barcelona, BARCELONA, 08025
Pfizer Investigational Site
Barcelona, BARCELONA, 08035
Pfizer Investigational Site
L'hospitalet DEL Llobregat, BARCELONA, 08907
Pfizer Investigational Site
Madrid, Madrid, 28040
Pfizer Investigational Site
Majadahonda, Madrid, 28222
Germany4 sites
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Kiel, 24105
Pfizer Investigational Site
Münster, 48129
Pfizer Investigational Site
Regensburg, 93042
Belgium3 sites
Pfizer Investigational Site
Brussels, 1200
Pfizer Investigational Site
Brussels, B-1070
Pfizer Investigational Site
Leuven, 3000
Czechia3 sites
Pfizer Investigational Site
Brno, 625 00
Pfizer Investigational Site
Prague, 120 00
Pfizer Investigational Site
Prague, 128 01
About this study
Official 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.
study to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis
- Conditions
- Colitis, Ulcerative
- Being tested
- Single dose-group A, Multiple dose- Group B, Multiple dose-Group B
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose-group ABiological
PF-00547659, single iv dose
Single dose-group ABiological
PF-00547659, single iv dose
Multiple dose- Group BBiological
PF-00547659, multiple dose
Single dose-group ABiological
PF-00547659, single iv dose
Multiple dose- Group BBiological
PF-00547659, multiple dose
Single dose-group ABiological
PF-00547659, single dose
Single dose-group ABiological
PF-00547659, single dose
Single dose-group ABiological
PF-00547659, single dose
Single dose-group ABiological
PF-00547659, single dose
Multiple dose-Group BBiological
PF-00547659, multiple dose
Multiple dose- Group BBiological
PF-00547659, multiple dose
Multiple dose- Group BBiological
PF-00547659, multiple dose
Multiple dose- Group BBiological
PF-00547659, multiple dose
Multiple dose- Group BBiological
PF-00547659, multiple dose
Multiple dose-Group BBiological
PF-00547659, multiple dose
| Study group | Role | What they receive |
|---|---|---|
| 0.03 mg/kg or placebo iv | Other | Not described Receives: Biological: Single dose-group A |
| 0.1 mg/kg or placebo iv | Other | Not described Receives: Biological: Single dose-group A; Biological: Multiple dose- Group B |
| 0.3 mg/kg or placebo iv | Other | Not described Receives: Biological: Single dose-group A; Biological: Multiple dose- Group B |
| 1.0 mg/kg or placebo iv | Experimental | Not described Receives: Biological: Single dose-group A |
| 3.0 mg/kg or placebo sc | Other | Not described Receives: Biological: Single dose-group A |
| 10 mg/kg or placebo iv | Other | Not described Receives: Biological: Single dose-group A |
| 0.3 mg/kg or placebo sc | Other | Not described Receives: Biological: Single dose-group A; Biological: Multiple dose-Group B |
| 0.1 mg/kg or placebo iv (multiple dose) | Other | Not described Receives: Biological: Multiple dose- Group B |
| 0.3 mg/kg or placebo iv (multiple dose) | Other | Not described Receives: Biological: Multiple dose- Group B |
| 3.0 mg/kg or placebo iv | Other | Not described Receives: Biological: Multiple dose- Group B |
| 0.1 mg/kg or placebo sc | Other | Not described Receives: Biological: Multiple dose- Group B |
| 0.3 mg/kg or placebo sc (multiple dose) | Other | Not described Receives: Biological: Multiple dose-Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and toleration
Measured: up to 12 weeks
Endoscopic score changes as calculated using section 3 of the Mayo Score
Measured: up to 12 weeks
Disease activity score changes as calculated using the Mayo Score
Measured: up to 12 weeks
Secondary outcomes (3)
Plasma concentrations of PF-00547659
Measured: up to 12 weeks
Fecal concentrations of calprotectin
Measured: up to 12 weeks
Plasma concentrations of CRP
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startSep 2005
- Primary completionApr 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928681
- Sponsor's protocol ID
- A7281001
- Status last verified
- Jun 2009
- First submitted
- 22 Jun 2009
- Last updated
- 26 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Vermeire S, Ghosh S, Panes J, Dahlerup JF, Luegering A, Sirotiakova J, Strauch U, Burgess G, Spanton J, Martin SW, Niezychowski W. The mucosal addressin cell adhesion molecule antibody PF-00547,659 in ulcerative colitis: a randomised study. Gut. 2011 Aug;60(8):1068-75. doi: 10.1136/gut.2010.226548. Epub 2011 Feb 11.
PubMed 21317177
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00928681
- Acronym / sponsor ID
- A7281001
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
study to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| 0.03 mg/kg or placebo iv | Other | Biological: Single dose-group A |
| 0.1 mg/kg or placebo iv | Other | Biological: Single dose-group A, Biological: Multiple dose- Group B |
| 0.3 mg/kg or placebo iv | Other | Biological: Single dose-group A, Biological: Multiple dose- Group B |
| 1.0 mg/kg or placebo iv | Experimental | Biological: Single dose-group A |
| 3.0 mg/kg or placebo sc | Other | Biological: Single dose-group A |
| 10 mg/kg or placebo iv | Other | Biological: Single dose-group A |
| 0.3 mg/kg or placebo sc | Other | Biological: Single dose-group A, Biological: Multiple dose-Group B |
| 0.1 mg/kg or placebo iv (multiple dose) | Other | Biological: Multiple dose- Group B |
| 0.3 mg/kg or placebo iv (multiple dose) | Other | Biological: Multiple dose- Group B |
| 3.0 mg/kg or placebo iv | Other | Biological: Multiple dose- Group B |
| 0.1 mg/kg or placebo sc | Other | Biological: Multiple dose- Group B |
| 0.3 mg/kg or placebo sc (multiple dose) | Other | Biological: Multiple dose-Group B |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single dose-group APF-00547659, single iv dose | Biological | 0.03 mg/kg or placebo iv |
| Single dose-group APF-00547659, single iv dose | Biological | 0.1 mg/kg or placebo iv |
| Multiple dose- Group BPF-00547659, multiple dose | Biological | 0.1 mg/kg or placebo iv (multiple dose) |
| Single dose-group APF-00547659, single iv dose | Biological | 0.3 mg/kg or placebo iv |
| Multiple dose- Group BPF-00547659, multiple dose | Biological | 0.3 mg/kg or placebo iv (multiple dose) |
| Single dose-group APF-00547659, single dose | Biological | 1.0 mg/kg or placebo iv |
| Single dose-group APF-00547659, single dose | Biological | 3.0 mg/kg or placebo sc |
| Single dose-group APF-00547659, single dose | Biological | 10 mg/kg or placebo iv |
| Single dose-group APF-00547659, single dose | Biological | 0.3 mg/kg or placebo sc |
| Multiple dose-Group BPF-00547659, multiple dose | Biological | 0.3 mg/kg or placebo sc |
| Multiple dose- Group BPF-00547659, multiple dose | Biological | 0.1 mg/kg or placebo iv |
| Multiple dose- Group BPF-00547659, multiple dose | Biological | 0.3 mg/kg or placebo iv |
| Multiple dose- Group BPF-00547659, multiple dose | Biological | 3.0 mg/kg or placebo iv |
| Multiple dose- Group BPF-00547659, multiple dose | Biological | 0.1 mg/kg or placebo sc |
| Multiple dose-Group BPF-00547659, multiple dose | Biological | 0.3 mg/kg or placebo sc (multiple dose) |
Primary outcome
Safety and toleration
Time frame: up to 12 weeks
Endoscopic score changes as calculated using section 3 of the Mayo Score
Time frame: up to 12 weeks
Disease activity score changes as calculated using the Mayo Score
Time frame: up to 12 weeks
3 secondary outcomes
Plasma concentrations of PF-00547659
Time frame: up to 12 weeks
Fecal concentrations of calprotectin
Time frame: up to 12 weeks
Plasma concentrations of CRP
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2009.
- Derived from this study: PubMed 21317177Vermeire S, Ghosh S, Panes J, Dahlerup JF, Luegering A, Sirotiakova J, Strauch U, Burgess G, Spanton J, Martin SW, Niezychowski W. The mucosal addressin cell adhesion molecule antibody PF-00547,659 in ulcerative colitis: a randomised study. Gut. 2011 Aug;60(8):1068-75. doi: 10.1136/gut.2010.226548. Epub 2011 Feb 11.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single dose-group A, Multiple dose- Group B and Multiple dose-Group B in people with Colitis, Ulcerative, run by Pfizer at 18 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain, Germany, Belgium, Czechia, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and toleration (time frame: up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00928681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2009.