A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis

NCT04209556

Last updated date
Study Location
Hope Clinical Research
Canoga Park, California, 91303, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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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

- Participants with moderate to severe UC as defined by a total Mayo score of ≥6, with a rectal bleeding subscore of ≥1 and an endoscopic subscore of ≥2;

- Participants must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC: Oral, intravascular, or intramuscular corticosteroids; Immunosuppressants (azathioprine [AZA], 6-MP, or methotrexate [MTX]); Anti-tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab, or golimumab); Anti-integrin inhibitors (eg, vedolizumab); JAK inhibitor (eg, tofacitinib); Anti-IL-12/IL-23 inhibitors (eg, ustekinumab).

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


- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, radiation colitis, and diverticular disease associated with colitis, or
Crohn's disease


- Participants displaying clinical signs of fulminant colitis or toxic megacolon;


- Participants with evidence of colonic dysplasia, adenomas or neoplasia.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
Official Title  ICMJE A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Brief Summary The purpose of this study is to evaluate efficacy and safety of PF-06826647 in moderate to severe ulcerative colitis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: PF-06826647 100 mg QD
    Investigational Product
  • Drug: PF-06826647 300 mg QD
    Investigational Product
  • Drug: PF-06826647 600 mg QD
    Investigational Product
  • Drug: Placebo
    Matched Placebo
  • Drug: PF-6826647 400 mg QD
    Investigational Product
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06826647 100 mg once a day (QD)
    PF-06826647 100 mg once a day (QD)
    Intervention: Drug: PF-06826647 100 mg QD
  • Experimental: PF-06826647 300 mg QD
    PF-06826647 300 mg QD
    Intervention: Drug: PF-06826647 300 mg QD
  • Experimental: PF-06826647 600 mg QD
    PF-06826647 600 mg QD
    Intervention: Drug: PF-06826647 600 mg QD
  • Experimental: Open Label Extension, PF-06826647 400 mg QD
    PF-06826647 400 mg QD
    Intervention: Drug: PF-6826647 400 mg QD
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: December 20, 2019)
202
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 26, 2023
Estimated Primary Completion Date October 26, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants with moderate to severe UC as defined by a total Mayo score of ?6, with a rectal bleeding subscore of ?1 and an endoscopic subscore of ?2;
  • Participants must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC: Oral, intravascular, or intramuscular corticosteroids; Immunosuppressants (azathioprine [AZA], 6-MP, or methotrexate [MTX]); Anti-tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab, or golimumab); Anti-integrin inhibitors (eg, vedolizumab); JAK inhibitor (eg, tofacitinib); Anti-IL-12/IL-23 inhibitors (eg, ustekinumab).

Exclusion Criteria:

  • Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, or Crohn's disease
  • Participants displaying clinical signs of fulminant colitis or toxic megacolon;
  • Participants with evidence of colonic dysplasia, adenomas or neoplasia.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04209556
Other Study ID Numbers  ICMJE C2501003
2019-003999-39 ( EudraCT 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