A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
NCT04209556
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- 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).
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | The purpose of this study is to evaluate efficacy and safety of PF-06826647 in moderate to severe ulcerative colitis | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | 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 | Withdrawn | ||||||
Actual Enrollment ICMJE | 0 | ||||||
Original Estimated Enrollment ICMJE | 202 | ||||||
Estimated Study Completion Date ICMJE | October 26, 2023 | ||||||
Estimated Primary Completion Date | October 26, 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 | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04209556 | ||||||
Other Study ID Numbers ICMJE | C2501003 2019-003999-39 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
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 | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |