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Ulcerative ColitisPhase 2NCT04209556

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

A Phase 2 study testing PF-06826647 100 mg QD, PF-06826647 300 mg QD and PF-06826647 600 mg QD in people with Ulcerative Colitis, run by Pfizer at 24 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
PF-06826647 100 mg QD, PF-06826647 300 mg QD and PF-06826647 600 mg QD
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
24 sitesUnited States
Study dates
30 Sep 2020to 26 Oct 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Hope Clinical Research

    Canoga Park, California, 91303

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

    Clifton, New Jersey, 07013

  • Gastroenterolgy Associates of Northern Virginia

    Fairfax, Virginia, 22031

  • Gastroenterology Associates of Northern Virginia

    Fairfax, Virginia, 22031

  • Verity Research, Inc.

    Fairfax, Virginia, 22031

  • Fair Oaks Imaging Center- Reston Radiology Consultants

    Fairfax, Virginia, 22033

  • Physicians Ambulatory Surgery Center, LLC, dba Physicians Endoscopy Center

    Houston, Texas, 77063

  • Houston Digestive Diseases Consultants, P.A.

    Houston, Texas, 77074

  • Memorial Hermann SW Surgery Center

    Houston, Texas, 77074

  • ADVA Clinical Research

    Inglewood, California, 90301

  • Centinela Valley Endoscopy Center

    Inglewood, California, 90301

  • Inglewood Imaging Center

    Inglewood, California, 90301

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

    Merrillville, Indiana, 46410

  • Saludmax Medical Corp.

    Miami, Florida, 33165

  • Surinder Saini, M.D., Inc.

    Newport Beach, California, 92660

  • Renaissance Imaging Center (CT/Xray)

    Northridge, California, 91325

  • Gastroenterology Consultants P.C.

    Roswell, Georgia, 30076

  • Gastroenterology Consultants of San Antonio

    San Antonio, Texas, 78230

  • Victorium Clinical Research

    San Antonio, Texas, 78230

  • South Texas Radiology Imaging Center

    San Antonio, Texas, 78258

  • Sugar Lakes Family Practice, PA

    Sugar Land, Texas, 77479

  • Alliance Clinical Research of Tampa

    Tampa, Florida, 33615

  • Valley Endoscopy Center (Colonoscopy/Flexible sigmoidoscopy)

    Tarzana, California, 91356

  • Associates in Gastroenterology (c/o TrialSpark, inc)

    Woodbridge, Virginia, 22192

Other trials in United States

About this study

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

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

Being tested
PF-06826647 100 mg QD, PF-06826647 300 mg QD, PF-06826647 600 mg QD, Placebo, PF-6826647 400 mg QD
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06826647 100 mg QDDrug

    Investigational Product

  • PF-06826647 300 mg QDDrug

    Investigational Product

  • PF-06826647 600 mg QDDrug

    Investigational Product

  • PlaceboDrug

    Matched Placebo

  • PF-6826647 400 mg QDDrug

    Investigational Product

Study groups in NCT04209556
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo
PF-06826647 100 mg once a day (QD)ExperimentalPF-06826647 100 mg once a day (QD)
Receives: Drug: PF-06826647 100 mg QD
PF-06826647 300 mg QDExperimentalPF-06826647 300 mg QD
Receives: Drug: PF-06826647 300 mg QD
PF-06826647 600 mg QDExperimentalPF-06826647 600 mg QD
Receives: Drug: PF-06826647 600 mg QD
Open Label Extension, PF-06826647 400 mg QDExperimentalPF-06826647 400 mg QD
Receives: Drug: PF-6826647 400 mg QD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants achieving endoscopic response

    Endoscopic response is defined by Mayo endoscopic index < 2

    Measured: At Week 8

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

    Measured: At Week 60

  3. 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]).

    Measured: At Week 60

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

    Clinical significant changes in ECG

    Measured: At Week 60

  5. 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.

    Measured: At Week 60

Secondary outcomes (10)

  1. Percentage of participants achieving clinical remission

    Clinical remission is defined by total Mayo score of ≤ 2 with no individual subscore of > 1

    Measured: At Week 8 and 60

  2. Percentage of participants achieving endoscopic remission

    Endoscopic remission is defined as Mayo endoscopic index of 0

    Measured: At Week 8 and 60

  3. Percentage of participants achieving mucosal healing

    Mucosal healing is defined as both total Mayo score and histologic index of ≤ 1.

    Measured: At Week 8 and 60

  4. 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.

    Measured: At Week 8 and 60

  5. Mean change from baseline in partial Mayo score over time

    Measured: Up to 60 weeks

  6. Change from baseline in total Mayo score

    Measured: 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)

    Measured: At Week 8

  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]).

    Measured: At Week 8

  9. 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)

    Measured: At Week 8

  10. 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.

    Measured: At Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2019
  2. Study start30 Sep 2020 (estimated)
  3. Primary completion26 Oct 2023 (estimated)
  4. Study completion26 Oct 2023 (estimated)

Why it stopped: The study was withdrawn following a strategic portfolio re-prioritization.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04209556
Sponsor's protocol ID
C2501003
Other IDs
2019-003999-39, 2019
Status last verified
Dec 2020
First submitted
1 Dec 2019
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06826647 100 mg QD, PF-06826647 300 mg QD and PF-06826647 600 mg QD in people with Ulcerative Colitis, run by Pfizer at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants achieving endoscopic response (time frame: At Week 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04209556.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.

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