Purpose

The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of ulcerative colitis for greater than/equal to 3 months.
  • Moderate to severe active ulcerative colitis
  • Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.

Exclusion Criteria

  • Pregnant or breastfeeding
  • Clinical findings suggestive of Crohn's Disease
  • History of bowel surgery within 6 months

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PF-06651600 Drug Dose Level 1
Delivered orally for 8 weeks
  • Drug: PF-06651600 or Placebo
    Delivered orally for 8 weeks.
Experimental
PF-06651600 Drug Dose Level 2
Delivered orally for 8 weeks
  • Drug: PF-06651600 or Placebo
    Delivered orally for 8 weeks.
Experimental
PF-06651600 Drug Dose Level 3
Delivered orally for 8 weeks.
  • Drug: PF-06651600 or Placebo
    Delivered orally for 8 weeks.
Placebo Comparator
PF-06651600 Placebo
Delivered orally for 8 weeks.
  • Drug: PF-06651600 or Placebo
    Delivered orally for 8 weeks.
Experimental
PF-06700841 Drug Dose Level 1
Delivered orally for 8 weeks
  • Drug: PF-06700841 or Placebo
    Delivered orally for 8 weeks.
Experimental
PF-06700841 Drug Dose Level 2
Delivered orally for 8 weeks.
  • Drug: PF-06700841 or Placebo
    Delivered orally for 8 weeks.
Experimental
PF-06700841 Drug Dose Level 3
Delivered orally for 8 weeks.
  • Drug: PF-06700841 or Placebo
    Delivered orally for 8 weeks.
Placebo Comparator
PF-06700841 Placebo
Delivered orally for 8 weeks.
  • Drug: PF-06700841 or Placebo
    Delivered orally for 8 weeks.
Experimental
PF-06651600 Drug Dose Level 4
Delivered orally for 24 weeks.
  • Drug: PF-06651600
    Delivered orally for 24 weeks.
Experimental
PF-06700841 Drug Dose Level 4
Delivered orally for 24 weeks.
  • Drug: PF-06700841
    Delivered orally for 24 weeks.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232-7610

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Vanderbilt University Medical Center
Nashville, Tennessee 37232-5543

Vanderbilt university medical Center
Nashville, Tennessee 37212-1610

Vanderbilt University Medical Center-IBD Clinic
Nashville, Tennessee 37212-1375

More Details

NCT ID
NCT02958865
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.