Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

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

  • Ulcerative Colitis

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

Montefiore Medical Center
Bronx, New York 10467

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