The purpose of this study is to evaluate efficacy and safety of PF-06826647 in moderate to severe ulcerative colitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Investigational Product
Investigational Product
Investigational Product
Percentage of participants achieving endoscopic response
Endoscopic response is defined by Mayo endoscopic index \< 2
Time frame: At Week 8
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
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 \[urine mucus and leucocytes\]).
Time frame: At Week 60
Percentage of participants with clinically significant changes in Electrocardiogram (ECG)
Clinical significant changes in ECG
Time frame: At Week 60
Number of Participants With Categorical changes from baseline in Vital Signs Data
Number of participants with increase from baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 60.
Time frame: At Week 60
Percentage of participants achieving clinical remission
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Matched Placebo
Investigational Product
Hope Clinical Research
Canoga Park, California, United States
ADVA Clinical Research
Inglewood, California, United States
Centinela Valley Endoscopy Center
Inglewood, California, United States
Inglewood Imaging Center
Inglewood, California, United States
Surinder Saini, M.D., Inc.
Newport Beach, California, United States
Renaissance Imaging Center (CT/Xray)
Northridge, California, United States
Valley Endoscopy Center (Colonoscopy/Flexible sigmoidoscopy)
Tarzana, California, United States
Saludmax Medical Corp.
Miami, Florida, United States
Alliance Clinical Research of Tampa
Tampa, Florida, United States
Gastroenterology Consultants P.C.
Roswell, Georgia, United States
...and 14 more locations
Clinical remission is defined by total Mayo score of ≤ 2 with no individual subscore of \> 1
Time frame: At Week 8 and 60
Percentage of participants achieving endoscopic remission
Endoscopic remission is defined as Mayo endoscopic index of 0
Time frame: At Week 8 and 60
Percentage of participants achieving mucosal healing
Mucosal healing is defined as both total Mayo score and histologic index of ≤ 1.
Time frame: At Week 8 and 60
Percentage of participants achieving clinical response
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.
Time frame: At Week 8 and 60
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
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 \[urine mucus and leucocytes\]).
Time frame: At Week 8
Percentage of participants with clinically significant changes in Electrocardiogram (ECG)
Clinically significant changes from baseline in ECG (heart rate, QT, QTc, PR and QRS intervals)
Time frame: At Week 8
Number of Participants With Categorical Vital Signs Data
Number of participants with increase from baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 8.
Time frame: At Week 8