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Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.

Last updated on September 9, 2019

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Study Location
Gastro Florida
Clearwater, Florida, 33756 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male and/or female subjects 18 years to 75 years of age at the time of informed
consent.

- A diagnosis of active UC (histologic) for 4 months.

- Subjects with active UC as defined by (via screening endoscopy) a total Mayo Score of
5 or more but 8 or less and an endoscopic subscore of 2.or more.

- UC extending at least 25 cm proximal to the anal verge at the time of the screening
endoscopy.

- Must be on a stable dose 5-10 mg/kg of infliximab (biosimilar versions are acceptable)
for a minimum of 14 weeks (4 doses) and a maximum of 2 years prior to study entry with
no anticipation of dose adjustment throughout the study.

- Male subjects able to father children and female subjects of childbearing potential
and at risk for pregnancy must agree to use two highly effective methods of
contraception throughout the study and until the Week 16 visit

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects with a diagnosis or documented history of total colectomy and/or pouchitis,
indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis,
radiation colitis, and diverticular disease associated with colitis, or clinical
findings suggestive of Crohn's disease.

- Subjects need for surgery or with major elective surgery scheduled during the study.

- Subjects with extensive colitis for at least 8 years who have not had a colonoscopy
with surveillance biopsies within 2 years.

- Subjects with history of or at screening endoscopy, biopsy documented colonic
dysplasia or neoplasia.

- Subjects who require infliximab dosing interval other than every 8 weeks.

- Subjects displaying clinical signs of fulminant colitis or toxic megacolon, with
primary sclerosing cholangitis, known colonic stricture, history of colonic, small
bowel obstruction or resection, with history of or current colonic or small bowel
stoma.

- Cyclic neutropenia, thrombocytopenia, lymphopenia, leukopenia or history of chronic
anemia.

- Presence of active enteric infection.

- Known history of human immunodeficiency virus (HIV) based on documented history with
positive serological test, or positive HIV serologic test.

- Presence of transplanted organ.

- Anticipated need for any live vaccine.

- Class III or Class IV heart failure.

- Acute coronary syndrome and any history of cerebrovascular disease.

- Subjects with current, or a history of QT prolongation.

- Subjects receiving the following therapies within the designated time period:

- >9 mg/day of oral budesonide or >20 mg/day of prednisone or equivalent within 2
weeks prior to baseline.

- IV, IM or topical (rectal) treatment of 5-ASA or corticosteroid enemas within 2
weeks prior to baseline.

- Anti integrin inhibitors within 14 weeks prior to baseline.

- Any use of natalizumab.

- Interferon therapy within 8 weeks prior to baseline.

- Prior treatment with lymphocyte depleting therapies and alkylating agents.

- Received selective B lymphocyte depleting agents within 1 year prior to baseline.

- Receiving leukocyte apheresis, granulocyte apheresis, or plasma exchange within 6
months of baseline.

- JAK inhibitors within 3 months prior to baseline.

- Any investigational procedures(s) or product(s)30 days prior to baseline.

- History of sensitivity to heparin or heparin induced thrombocytopenia.

NCT03269695
Pfizer
Not yet recruiting
Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.

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[email protected]

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1-800-718-1021

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