A Phase 2A, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06687234 as Add-On Therapy to Infliximab in Active Ulcerative Colitis Subjects Who Are Not in Remission

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

2

Condition

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

TX155002
  • Ages 18-75
  • All Genders

Study Summary

This is a phase 2a, randomized, double-blind, placebo-controlled, parallel group, multicenter study in subjects with active UC and a non-remission response to infliximab.

There will be up to 13 study visits, across the 12 weeks of treatment, along with 2 follow-up visits, at Weeks 16 and 22.

Ideal patients for this study will have a flexible schedule, as they will be required to come in for weekly study visits.

Eligibility Criteria

Inclusion

Inclusion:

• Male or Female, 18 to 75 years old

• Subject must be on a stable dose (5-10 mg/kg) of Remicade, Inflectra, or Remsima - for a minimum of 14 weeks and a maximum of 2 years

• Documented diagnosis of UC for at least 4 months, and with a minimum disease extent of at least 25 cm from the anal verge

• Subject must still have ACTIVE UC, and NOT be considered in remission, while on Remicade

• May be on the following meds: 5-ASA compounds (stable for 4 weeks prior to randomization), Corticosteroids (stable for 2 weeks prior to randomization), Azathioprine / 6-MP / MTX (stable for 8 weeks prior to randomization)

Exclusion:

• Subjects with known colonic stricture, or history of colonic or small bowel obstruction or resection, or total colectomy

• Subjects with pouchitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, or Crohn's disease

• Subjects who require Remicade dosing interval other than every 8 weeks

• Subjects with primary sclerosing cholangitis

• Subjects with significant cardiac issues: MI or unstable angina (within 24 weeks before Screening), current or history of QT prolongation, and Class III / IV heart failure

• History of malignancy within the last 5 years (other than resected cutaneous basal cell or squamous cell carcinoma)

Study Design

Study Start date:
Estimated Completion Date:

Study Description