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

NCT04209556 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: C25010032019-003999-39
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (5)

• Percentage of participants achieving endoscopic response

  Endoscopic response is defined by Mayo endoscopic index \< 2

  At Week 8

• Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)

  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 \[urine mucus and leucocytes\]).

  At Week 60

• Percentage of participants with clinically significant changes in Electrocardiogram (ECG)

  Clinical significant changes in ECG

  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.

  At Week 60

Secondary Outcomes (10)

• Percentage of participants achieving clinical remission

  At Week 8 and 60

• Percentage of participants achieving endoscopic remission

  At Week 8 and 60

• Percentage of participants achieving mucosal healing

  At Week 8 and 60

• Percentage of participants achieving clinical response

  At Week 8 and 60

• Mean change from baseline in partial Mayo score over time

  Up to 60 weeks

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

PF-06826647 100 mg once a day (QD)

EXPERIMENTAL

PF-06826647 100 mg once a day (QD)

Drug: PF-06826647 100 mg QD

PF-06826647 300 mg QD

EXPERIMENTAL

PF-06826647 300 mg QD

Drug: PF-06826647 300 mg QD

PF-06826647 600 mg QD

EXPERIMENTAL

PF-06826647 600 mg QD

Drug: PF-06826647 600 mg QD

Open Label Extension, PF-06826647 400 mg QD

EXPERIMENTAL

PF-06826647 400 mg QD

Drug: PF-6826647 400 mg QD

Interventions

PF-06826647 100 mg QD DRUG

Investigational Product

PF-06826647 100 mg once a day (QD)

PF-06826647 300 mg QD DRUG

Investigational Product

PF-06826647 300 mg QD

PF-06826647 600 mg QD DRUG

Investigational Product

PF-06826647 600 mg QD

Placebo DRUG

Matched Placebo

Placebo

PF-6826647 400 mg QD DRUG

Investigational Product

Open Label Extension, PF-06826647 400 mg QD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (24)

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

ADVA Clinical Research

Inglewood, California, 90301, United States

Location

Centinela Valley Endoscopy Center

Inglewood, California, 90301, United States

Location

Inglewood Imaging Center

Inglewood, California, 90301, United States

Location

Surinder Saini, M.D., Inc.

Newport Beach, California, 92660, United States

Location

Renaissance Imaging Center (CT/Xray)

Northridge, California, 91325, United States

Location

Valley Endoscopy Center (Colonoscopy/Flexible sigmoidoscopy)

Tarzana, California, 91356, United States

Location

Saludmax Medical Corp.

Miami, Florida, 33165, United States

Location

Alliance Clinical Research of Tampa

Tampa, Florida, 33615, United States

Location

Gastroenterology Consultants P.C.

Roswell, Georgia, 30076, United States

Location

Internal Medicine Associates (c/o TrialSpark, Inc.)

Merrillville, Indiana, 46410, United States

Location

Gastroenterology Associates of New Jersey, LLC (c/o TrialSpark, Inc.)

Clifton, New Jersey, 07013, United States

Location

Physicians Ambulatory Surgery Center, LLC, dba Physicians Endoscopy Center

Houston, Texas, 77063, United States

Location

Houston Digestive Diseases Consultants, P.A.

Houston, Texas, 77074, United States

Location

Memorial Hermann SW Surgery Center

Houston, Texas, 77074, United States

Location

Gastroenterology Consultants of San Antonio

San Antonio, Texas, 78230, United States

Location

Victorium Clinical Research

San Antonio, Texas, 78230, United States

Location

South Texas Radiology Imaging Center

San Antonio, Texas, 78258, United States

Location

Sugar Lakes Family Practice, PA

Sugar Land, Texas, 77479, United States

Location

Gastroenterolgy Associates of Northern Virginia

Fairfax, Virginia, 22031, United States

Location

Gastroenterology Associates of Northern Virginia

Fairfax, Virginia, 22031, United States

Location

Verity Research, Inc.

Fairfax, Virginia, 22031, United States

Location

Fair Oaks Imaging Center- Reston Radiology Consultants

Fairfax, Virginia, 22033, United States

Location

Associates in Gastroenterology (c/o TrialSpark, inc)

Woodbridge, Virginia, 22192, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ropsacitinib

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 24, 2019
• Study Start: September 30, 2020
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

US (24)