Clinical trial NCT04209556: A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Percentage of participants achieving endoscopic response
timeFrame: At Week 8
measure: Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)
timeFrame: At Week 60
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: At Week 60
measure: Percentage of participants with clinically significant changes in Electrocardiogram (ECG)
timeFrame: At Week 60
measure: Number of Participants With Categorical changes from baseline in Vital Signs Data
timeFrame: At Week 60
Secondary outcomes:
measure: Percentage of participants achieving clinical remission
timeFrame: At Week 8 and 60
measure: Percentage of participants achieving endoscopic remission
timeFrame: At Week 8 and 60
measure: Percentage of participants achieving mucosal healing
timeFrame: At Week 8 and 60
measure: Percentage of participants achieving clinical response
timeFrame: At Week 8 and 60
measure: Mean change from baseline in partial Mayo score over time
timeFrame: Up to 60 weeks
measure: Change from baseline in total Mayo score
timeFrame: At Week 8 and 60
measure: Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)
timeFrame: At Week 8
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: At Week 8
measure: Percentage of participants with clinically significant changes in Electrocardiogram (ECG)
timeFrame: At Week 8
measure: Number of Participants With Categorical Vital Signs Data
timeFrame: At Week 8
Other outcomes:
Locations:
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Inglewood
country: United States
facility: ADVA Clinical Research
state: California
city: Inglewood
country: United States
facility: Centinela Valley Endoscopy Center
state: California
city: Inglewood
country: United States
facility: Inglewood Imaging Center
state: California
city: Newport Beach
country: United States
facility: Surinder Saini, M.D., Inc.
state: California
city: Northridge
country: United States
facility: Renaissance Imaging Center (CT/Xray)
state: California
city: Tarzana
country: United States
facility: Valley Endoscopy Center (Colonoscopy/Flexible sigmoidoscopy)
state: California
city: Miami
country: United States
facility: Saludmax Medical Corp.
state: Florida
city: Tampa
country: United States
facility: Alliance Clinical Research of Tampa
state: Florida
city: Roswell
country: United States
facility: Gastroenterology Consultants P.C.
state: Georgia
city: Merrillville
country: United States
facility: Internal Medicine Associates (c/o TrialSpark, Inc.)
state: Indiana
city: Clifton
country: United States
facility: Gastroenterology Associates of New Jersey, LLC (c/o TrialSpark, Inc.)
state: New Jersey
city: Houston
country: United States
facility: Physicians Ambulatory Surgery Center, LLC, dba Physicians Endoscopy Center
state: Texas
city: Houston
country: United States
facility: Houston Digestive Diseases Consultants, P.A.
state: Texas
city: Houston
country: United States
facility: Memorial Hermann SW Surgery Center
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Consultants of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Victorium Clinical Research
state: Texas
city: San Antonio
country: United States
facility: South Texas Radiology Imaging Center
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice, PA
state: Texas
city: Fairfax
country: United States
facility: Gastroenterolgy Associates of Northern Virginia
state: Virginia
city: Fairfax
country: United States
facility: Gastroenterology Associates of Northern Virginia
state: Virginia
city: Fairfax
country: United States
facility: Verity Research, Inc.
state: Virginia
city: Fairfax
country: United States
facility: Fair Oaks Imaging Center- Reston Radiology Consultants
state: Virginia
city: Woodbridge
country: United States
facility: Associates in Gastroenterology (c/o TrialSpark, inc)
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: