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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209556
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 1, 2019
First Posted Date  ICMJE December 24, 2019
Last Update Posted Date June 9, 2020
Estimated Study Start Date  ICMJE June 30, 2020
Estimated Primary Completion Date October 26, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
  • Percentage of participants achieving endoscopic response [ Time Frame: At Week 8 ]
    Endoscopic response is defined by Mayo endoscopic index < 2
  • Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs) [ Time Frame: At Week 60 ]
  • Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: At Week 60 ]
    Following parameters will be analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).
  • Percentage of participants with clinically significant changes in Electrocardiogram (ECG) [ Time Frame: At Week 60 ]
    Clinical significant changes in ECG
  • Number of Participants With Categorical changes from baseline in Vital Signs Data [ Time Frame: At Week 60 ]
    Number of participants with increase from baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 60.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
  • Percentage of participants achieving clinical remission [ Time Frame: At Week 8 and 60 ]
    Clinical remission is defined by total Mayo score of ≤ 2 with no individual subscore of > 1
  • Percentage of participants achieving endoscopic remission [ Time Frame: At Week 8 and 60 ]
    Endoscopic remission is defined as Mayo endoscopic index of 0
  • Percentage of participants achieving mucosal healing [ Time Frame: At Week 8 and 60 ]
    Mucosal healing is defined as both total Mayo score and histologic index of ≤ 1.
  • Percentage of participants achieving clinical response [ Time Frame: At Week 8 and 60 ]
    Clinical response is defined as 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.
  • Mean change from baseline in partial Mayo score over time [ Time Frame: Up to 60 weeks ]
  • Change from baseline in total Mayo score [ Time Frame: At Week 8 and 60 ]
  • Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs) [ Time Frame: At Week 8 ]
  • Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: At Week 8 ]
    Following parameters will be analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).
  • Percentage of participants with clinically significant changes in Electrocardiogram (ECG) [ Time Frame: At Week 8 ]
    Clinically significant changes from baseline in ECG (heart rate, QT, QTc, PR and QRS intervals)
  • Number of Participants With Categorical Vital Signs Data [ Time Frame: At Week 8 ]
    Number of participants with increase from baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 8.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/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 June 2020

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