A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis
NCT04090411
ABOUT THIS STUDY
FOR MORE INFORMATION
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-
- 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.
- 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
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Descriptive Information | |||||||
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Brief Title ICMJE | A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis | ||||||
Official Title ICMJE | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | ||||||
Brief Summary | 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | ||||||
Condition ICMJE | Moderate to Severe Ulcerative Colitis | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE | 240 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | September 22, 2023 | ||||||
Estimated Primary Completion Date | September 22, 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:-
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Australia, Belgium, Bulgaria, France, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Russian Federation, Slovakia, South Africa, Spain, Thailand, Turkey, Ukraine, United States | ||||||
Removed Location Countries | Canada, United Kingdom | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04090411 | ||||||
Other Study ID Numbers ICMJE | B7541007 TL1A ( Other Identifier: Alias Study Number ) Tuscany 2 ( Other Identifier: Alias Study Number ) 2019-002698-74 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |