PF-06687234 add on therapy in active UC subjects - BUILD UC
NCT03269695
ABOUT THIS STUDY

FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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 endoscopy.
- 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 visit
- 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
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
- Known history of hypersensitivity, intolerance, or allergic reaction to PF-06687234 or
any constituent of the IP.
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Descriptive Information | |||||||
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Brief Title ICMJE | Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission. | ||||||
Official Title ICMJE | 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 (BUILD UC) | ||||||
Brief Summary | The purpose of this study is to determine if PF-06687234 is effective and safe as add-on therapy to infliximab in subjects with active ulcerative colitis who are not in remission. | ||||||
Detailed Description | This is a Phase 2a, double-blind, placebo-controlled, parallel group study in subjects with active ulcerative colitis and a non-remission (partial) response to infliximab. All enrolled subjects must have been on infliximab for a minimum of 14 weeks with last dose 8 weeks prior to the date of randomization. Subjects will be randomly assigned to 1 of 2 treatment arms (PF-06687234 or placebo) administered subcutaneously every week for a total of 12 doses. Blood, stool and tissue samples will be collected at various time points throughout the study to evaluate efficacy, safety, tolerability, pharmacokinetics and immunogenicity. Duration of participation for subjects will be approximately 6 months. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | ||||||
Condition ICMJE | Ulcerative Colitis | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE | 20 | ||||||
Original Estimated Enrollment ICMJE | 98 | ||||||
Estimated Study Completion Date ICMJE | July 27, 2021 | ||||||
Estimated Primary Completion Date | July 27, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Belgium, Germany, Israel, Italy, Korea, Republic of, Saudi Arabia, Serbia, Turkey, United States | ||||||
Removed Location Countries | Spain | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03269695 | ||||||
Other Study ID Numbers ICMJE | B7581002 2017-002108-28 ( EudraCT Number ) BUILD UC ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |