Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 75 Years|
- - A diagnosis of UC for ≥3 months.
- - Participants with moderate to severe active UC as defined by a Total Mayo Score of.
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Austria, Belgium, Bulgaria, Colombia, France, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Moderate to Severe Ulcerative Colitis|
|Study Website:||View Trial Website|
Experimental: 450 mg
Experimental: 150 mg
Experimental: 50 mg
Placebo Comparator: 0 mg
Drug: - 50 mg
Drug: - 450 mg
Drug: - 150 mg
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.