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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 8 and 60
Summary
The purpose of this study is to evaluate efficacy and safety of PF-06826647 in moderate to severe ulcerative colitis
Eligible Conditions
- Colitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 8 and 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 8 and 60
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Categorical changes from baseline in Vital Signs Data
Percentage of participants achieving endoscopic response
Secondary study objectives
Number of Participants With Categorical Vital Signs Data
Number of Participants With Clinical Laboratory Abnormalities
Percentage of participants achieving clinical remission
+4 moreTrial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: PF-06826647 600 mg QDExperimental Treatment1 Intervention
PF-06826647 600 mg QD
Group II: PF-06826647 300 mg QDExperimental Treatment1 Intervention
PF-06826647 300 mg QD
Group III: PF-06826647 100 mg once a day (QD)Experimental Treatment1 Intervention
PF-06826647 100 mg once a day (QD)
Group IV: Open Label Extension, PF-06826647 400 mg QDExperimental Treatment1 Intervention
PF-06826647 400 mg QD
Group V: PlaceboPlacebo Group1 Intervention
Placebo
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Who is running the clinical trial?
PfizerLead Sponsor
4,661 Previous Clinical Trials
17,844,989 Total Patients Enrolled
40 Trials studying Colitis
10,431 Patients Enrolled for Colitis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,546 Previous Clinical Trials
14,886,145 Total Patients Enrolled
32 Trials studying Colitis
9,882 Patients Enrolled for Colitis
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