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

NCT03269695

Last updated date
Study Location
Keimyung University Dongsan Hospital
Daegu, , 42601, Korea, Republic of
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Subcutaneous injections
Intravenous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes addition
Duration
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)
Biopsy
Urine test
Blood test
Colonoscopy
Vital signs and measurements
X-rays

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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
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
  • Drug: PF-06687234
    SC QW
    Other Name: Investigational product
  • Drug: Placebo
    SC QW
    Other Name: PF-06687234 matched placebo
Study Arms  ICMJE
  • Experimental: PF-06687234
    PF-06687234 subcutaneous (SC) weekly (QW) x 12 doses
    Intervention: Drug: PF-06687234
  • Placebo Comparator: Placebo
    PF-06687234 matched Placebo SC QW x 12 doses
    Intervention: Drug: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2019)
76
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2017)
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:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Australia,   Belgium,   Germany,   Israel,   Italy,   Korea, Republic of,   Saudi Arabia,   Serbia,   Spain,   Turkey,   United States
Removed Location Countries  
 
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP