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

Site Contact

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