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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

Brief Summary:
The purpose of this study is to evaluate efficacy and safety of PF-06826647 in moderate to severe ulcerative colitis

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: PF-06826647 100 mg QD Drug: PF-06826647 300 mg QD Drug: PF-06826647 600 mg QD Drug: Placebo Drug: PF-6826647 400 mg QD Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : October 26, 2023
Estimated Study Completion Date : October 26, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Matched Placebo

Experimental: PF-06826647 100 mg once a day (QD)
PF-06826647 100 mg once a day (QD)
Drug: PF-06826647 100 mg QD
Investigational Product

Experimental: PF-06826647 300 mg QD
PF-06826647 300 mg QD
Drug: PF-06826647 300 mg QD
Investigational Product

Experimental: PF-06826647 600 mg QD
PF-06826647 600 mg QD
Drug: PF-06826647 600 mg QD
Investigational Product

Experimental: Open Label Extension, PF-06826647 400 mg QD
PF-06826647 400 mg QD
Drug: PF-6826647 400 mg QD
Investigational Product




Primary Outcome Measures :
  1. Percentage of participants achieving endoscopic response [ Time Frame: At Week 8 ]
    Endoscopic response is defined by Mayo endoscopic index < 2

  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 ]
  3. 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]).

  4. Percentage of participants with clinically significant changes in Electrocardiogram (ECG) [ Time Frame: At Week 60 ]
    Clinical significant changes in ECG

  5. 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.


Secondary Outcome Measures :
  1. 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

  2. Percentage of participants achieving endoscopic remission [ Time Frame: At Week 8 and 60 ]
    Endoscopic remission is defined as Mayo endoscopic index of 0

  3. 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.

  4. 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.

  5. Mean change from baseline in partial Mayo score over time [ Time Frame: Up to 60 weeks ]
  6. Change from baseline in total Mayo score [ Time Frame: At Week 8 and 60 ]
  7. Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs) [ Time Frame: At Week 8 ]
  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]).

  9. 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)

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209556


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 24 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04209556    
Other Study ID Numbers: C2501003
2019-003999-39 ( EudraCT Number )
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases