A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis

Study Purpose

This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

-
  • - A diagnosis of UC for ≥3 months.
  • - Participants with moderate to severe active UC as defined by a Total Mayo Score of ≥6, and an endoscopic subscore of ≥2.
  • - Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
  • - Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors.

Exclusion Criteria:

  • - Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.).
  • - Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study - Chest Radiograph showing abnormalities: The study will accept a Chest x-ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available.
  • - 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results - Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection.
- Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04090411
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Moderate to Severe Ulcerative Colitis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: 450 mg

PF-06480605

Experimental: 150 mg

PF-06480605

Experimental: 50 mg

PF-06480605

Placebo Comparator: 0 mg

Interventions

Drug: - 50 mg

PF-06480605

Drug: - 450 mg

PF-06480605

Drug: - 150 mg

PF-06480605

Other: - 0 mg

0 mg Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

ADVA Clinical Research, Inglewood, California

Status

Not yet recruiting

Address

ADVA Clinical Research

Inglewood, California, 90301

Centinela Valley Endoscopy Center, Inglewood, California

Status

Not yet recruiting

Address

Centinela Valley Endoscopy Center

Inglewood, California, 90301

Front Range Endoscopy Center, Colorado Springs, Colorado

Status

Not yet recruiting

Address

Front Range Endoscopy Center

Colorado Springs, Colorado, 80903

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Not yet recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Not yet recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80920

Gastro Florida, Clearwater, Florida

Status

Not yet recruiting

Address

Gastro Florida

Clearwater, Florida, 33761

Safety Harbor Surgery, Clearwater, Florida

Status

Not yet recruiting

Address

Safety Harbor Surgery

Clearwater, Florida, 33761

Gastro Florida, Clearwater, Florida

Status

Not yet recruiting

Address

Gastro Florida

Clearwater, Florida, 33762

Valley View Surgery Center (ENDOSCOPY), Las Vegas, Nevada

Status

Not yet recruiting

Address

Valley View Surgery Center (ENDOSCOPY)

Las Vegas, Nevada, 89102

Sierra Clinical Research, Las Vegas, Nevada

Status

Not yet recruiting

Address

Sierra Clinical Research

Las Vegas, Nevada, 89106

Dayton, Ohio

Status

Not yet recruiting

Address

Digestive Specialist, Inc. Digestive Endoscopy Center, LLC

Dayton, Ohio, 45414

META Medical Research Institute, Dayton, Ohio

Status

Not yet recruiting

Address

META Medical Research Institute

Dayton, Ohio, 45432

Digestive Specialists, Inc., Dayton, Ohio

Status

Not yet recruiting

Address

Digestive Specialists, Inc.

Dayton, Ohio, 45459

Huber Heights, Ohio

Status

Not yet recruiting

Address

Digestive Specialist, INC. Digestive Endoscopy Center, LLC

Huber Heights, Ohio, 45424

Springboro, Ohio

Status

Not yet recruiting

Address

Digestive Specialist, Inc Digestive Endoscopy Center, LLC

Springboro, Ohio, 45066

Greenville Endoscopy Center Patewood, Greenville, South Carolina

Status

Not yet recruiting

Address

Greenville Endoscopy Center Patewood

Greenville, South Carolina, 29515

Greenville, South Carolina

Status

Not yet recruiting

Address

Gastroenterology Associates, PA of Greenville

Greenville, South Carolina, 29615

PrimeCare Medical Group, Houston, Texas

Status

Recruiting

Address

PrimeCare Medical Group

Houston, Texas, 77024

Rio Grande Gastroenterology CNS, McAllen, Texas

Status

Not yet recruiting

Address

Rio Grande Gastroenterology CNS

McAllen, Texas, 78503

Victorium Clinical Research, San Antonio, Texas

Status

Recruiting

Address

Victorium Clinical Research

San Antonio, Texas, 78230

Fairfax, Virginia

Status

Not yet recruiting

Address

Gastroenterology Associates of Northern Virginia

Fairfax, Virginia, 22031

Verity Research, Inc., Fairfax, Virginia

Status

Not yet recruiting

Address

Verity Research, Inc.

Fairfax, Virginia, 22031

Medical Diagnostic Imaging, Wauwatosa, Wisconsin

Status

Recruiting

Address

Medical Diagnostic Imaging

Wauwatosa, Wisconsin, 53222

Wauwatosa, Wisconsin

Status

Recruiting

Address

Allegiance Internal Medicine and Allegiance Research Specialists

Wauwatosa, Wisconsin, 53226

GI Associates, Wauwatosa, Wisconsin

Status

Recruiting

Address

GI Associates

Wauwatosa, Wisconsin, 53226

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