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Trial record 1 of 1 for:    NCT03269695
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Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.

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ClinicalTrials.gov Identifier: NCT03269695
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 30, 2017
First Posted Date  ICMJE September 1, 2017
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE December 20, 2017
Estimated Primary Completion Date July 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
Proportion of subjects in Clinical Remission [ Time Frame: Week 12 ]
Clinical remission defined by a modified Mayo Score with an endoscopic subscore less than or equal to 1, stool frequency subscore less than or equal to 1 and rectal bleeding subscore = 0
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03269695 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
  • Proportion of subjects with endoscopic improvement [ Time Frame: Week 12 ]
    Endoscopic improvement defined as decrease of 1 point in Mayo endoscopy score or an absolute endoscopy score of 1 or less.
  • Mean change from baseline at Week 12 in Geboes histology score [ Time Frame: Baseline, Week 12 ]
    Mean change from baseline at Week 12 in Geboes score.
  • Proportion of subjects with a clinical response [ Time Frame: Week 12 ]
    Clinical response defined with a decrease from baseline of at least 3 points in total Mayo score with at least 30% change, accompanied by at least one point decrease or absolute score of 0 or 1 in rectal bleeding subscore.
  • Proportion of subjects with change from baseline in partial Mayo Score of 2 or less with no individual subscore >1 [ Time Frame: Weeks 2, 4, 6, 8, 12 ]
    Proportion of subjects with partial Mayo score <=2 with no individual subscore of > 1 at Week 2, 4, 6, 8 and 12
  • Serum concentrations of PF 06687234 [ Time Frame: Baseline through Week 12 ]
    Measure serum concentration of PF-06687234 at baseline, Week 1, 3, 7, 11, 12, and 16
  • Incidence of the development of HAFAs and Nabs against PF 06687234. [ Time Frame: Baseline through Week 16 ]
    Measure HAFA and neutralizing antibody against IL10 at screen, baseline, Week 3, 7, 11, 12, and 16
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
  • Proportion of subjects with endoscopic improvement [ Time Frame: Week 12 ]
    Endoscopic improvement defined as decrease of 1 point in Mayo endoscopy score or an absolute endoscopy score of 1 or less.
  • Mean change from baseline at Week 12 in Geboes histology score [ Time Frame: Baseline, Week 12 ]
  • Proportion of subjects with a clinical response [ Time Frame: Week 12 ]
    Clinical response defined with a decrease from baseline of at least 3 points in total Mayo score with at least 30% change, accompanied by at least one point decrease or absolute score of 0 or 1 in rectal bleeding subscore.
  • Proportion of subjects with change from baseline in partial Mayo Score of 2 or less with no individual subscore >1 [ Time Frame: Weeks 2, 4, 6, 8, 12 ]
  • Plasma concentrations of PF 06687234 [ Time Frame: Baseline through Week 12 ]
  • Incidence of the development of HAFAs and Nabs against PF 06687234. [ Time Frame: Baseline through Week 16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Australia,   Belgium,   Germany,   Israel,   Italy,   Korea, Republic of,   Saudi Arabia,   Serbia,   Spain,   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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2019

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