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PF-06687234 add on therapy in active UC subjects - BUILD UC

Last updated on March 19, 2019

Study Location
GastroIntestinal Specialists, AMC
Shreveport, Louisiana, 71103 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Females and Males
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 and weight > 40 kg 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
4 or more but 9 or less and an endoscopic subscore of 2.or more.

- UC extending at least 15 cm proximal to the anal verge at the time of the screening

- Must be on a stable dose 5-10 mg/kg of Remicade, Inflectra, or Remsima for a minimum
of 14 weeks with no anticipation of need for change in infliximab treatment regimen
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 methods of contraception (at least one
of which is considered as highly effective) throughout the study and until the Week 16

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 prior to baseline.

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

- Subjects who require infliximab dosing interval other than every 6 weeks or every 8

- 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

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

- 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

- Known history of hypersensitivity, intolerance, or allergic reaction to PF-06687234 or
any constituent of the IP.

Trial Details
The form in which the study drug will be delivered to the patient's body.
Intravenous injections
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes addition
The time commitment for participation in the study.
Follow up: Up to 10 weeks
Screening: Up to 4 weeks
Treatment: 12 weeks
Site Visits
Follow up: Up to 2 visits
Screening: Up to 2 visits
Treatment: 12 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Keeping a diary
Stool test
Physical examination
Electrocardiogram (ECG)
Urine test
Blood test
Vital signs and measurements
PF-06687234 add on therapy in active UC subjects - BUILD UC


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