A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: PF-06826647 300 mg QDDrug: PlaceboDrug: PF-06826647 100 mg QDDrug: PF-06826647 600 mg QDDrug: PF-6826647 400 mg QD
- Registration Number
- NCT04209556
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-06826647 300 mg QD PF-06826647 300 mg QD PF-06826647 300 mg QD Placebo Placebo Placebo PF-06826647 100 mg once a day (QD) PF-06826647 100 mg QD PF-06826647 100 mg once a day (QD) PF-06826647 600 mg QD PF-06826647 600 mg QD PF-06826647 600 mg QD Open Label Extension, PF-06826647 400 mg QD PF-6826647 400 mg QD PF-06826647 400 mg QD
- Primary Outcome Measures
Name Time Method Number of Participants With Clinical Laboratory Abnormalities 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 achieving endoscopic response 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) At Week 60 Percentage of participants with clinically significant changes in Electrocardiogram (ECG) At Week 60 Clinical significant changes in ECG
Number of Participants With Categorical changes from baseline in Vital Signs Data 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
Name Time Method Percentage of participants achieving endoscopic remission At Week 8 and 60 Endoscopic remission is defined as Mayo endoscopic index of 0
Number of Participants With Clinical Laboratory Abnormalities 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 achieving clinical remission At Week 8 and 60 Clinical remission is defined by total Mayo score of ≤ 2 with no individual subscore of \> 1
Change from baseline in total Mayo score At Week 8 and 60 Percentage of participants with clinically significant changes in Electrocardiogram (ECG) 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 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.
Percentage of participants achieving mucosal healing 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 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 Up to 60 weeks Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs) At Week 8
Trial Locations
- Locations (24)
ADVA Clinical Research
🇺🇸Inglewood, California, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Gastroenterology Consultants P.C.
🇺🇸Roswell, Georgia, United States
Centinela Valley Endoscopy Center
🇺🇸Inglewood, California, United States
Inglewood Imaging Center
🇺🇸Inglewood, California, United States
Renaissance Imaging Center (CT/Xray)
🇺🇸Northridge, California, United States
Valley Endoscopy Center (Colonoscopy/Flexible sigmoidoscopy)
🇺🇸Tarzana, California, United States
Gastroenterology Associates of New Jersey, LLC (c/o TrialSpark, Inc.)
🇺🇸Clifton, New Jersey, United States
Associates in Gastroenterology (c/o TrialSpark, inc)
🇺🇸Woodbridge, Virginia, United States
Surinder Saini, M.D., Inc.
🇺🇸Newport Beach, California, United States
Saludmax Medical Corp.
🇺🇸Miami, Florida, United States
Alliance Clinical Research of Tampa
🇺🇸Tampa, Florida, United States
Internal Medicine Associates (c/o TrialSpark, Inc.)
🇺🇸Merrillville, Indiana, United States
Physicians Ambulatory Surgery Center, LLC, dba Physicians Endoscopy Center
🇺🇸Houston, Texas, United States
Memorial Hermann SW Surgery Center
🇺🇸Houston, Texas, United States
Gastroenterology Associates of Northern Virginia
🇺🇸Fairfax, Virginia, United States
Verity Research, Inc.
🇺🇸Fairfax, Virginia, United States
Houston Digestive Diseases Consultants, P.A.
🇺🇸Houston, Texas, United States
Sugar Lakes Family Practice, PA
🇺🇸Sugar Land, Texas, United States
Gastroenterolgy Associates of Northern Virginia
🇺🇸Fairfax, Virginia, United States
Gastroenterology Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Victorium Clinical Research
🇺🇸San Antonio, Texas, United States
South Texas Radiology Imaging Center
🇺🇸San Antonio, Texas, United States
Fair Oaks Imaging Center- Reston Radiology Consultants
🇺🇸Fairfax, Virginia, United States