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A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05549323
Collaborator
(none)
27
Enrollment
2
Arms
24.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a study to learn if the experimental medicine (called PF-07054894) is safe, effective, and how it is processed in adult people with ulcers in the colon.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are assigned to one of the two groups in parallel for the duration of the study.Participants are assigned to one of the two groups in parallel for the duration of the study.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A PHASE 1B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ORAL PF-07054894 IN ADULT PARTICIPANTS AGED 18-75 YEARS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Anticipated Study Start Date :
Oct 18, 2022
Anticipated Primary Completion Date :
Nov 8, 2024
Anticipated Study Completion Date :
Nov 8, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group 1

Oral PF-07054894

Drug: PF-07054894
Oral
Placebo Comparator: Treatment Group 2

Matched Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants achieving clinical remission at Week 12 [Week 12]

    Clinical remission based on modified Mayo Score is defined as endoscopic subscore equal 0 or 1 (without friability), stool frequency subscore equal 0 or 1, and rectal bleeding subscore equal 0

Secondary Outcome Measures

  1. Proportion of participants achieving improvement in endoscopic appearance at Week 12 [Week 12]

    Endoscopic improvement is defined as a Mayo endoscopic subscore of ≤1 (without friability)

  2. Proportion of participants with clinical remission at Week 12 [Week 12]

    Clinical Remission defined by Total Mayo Score ≤2 and no individual subscore >1 and rectal bleeding subscore of 0

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Confirmed diagnosis of moderate to severe UC for ≥3 months prior to baseline.

  • Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).

  • Must have a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least 2.

  • Must inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.

  • Total body weight >40 kg (88.2 lb).

Exclusion Criteria:

  • Presence of indeterminate; microscopic; ischemic; infectious; radiation colitis; diverticular disease; Crohn's disease; colonic stricture; colonic obstruction/ resection; presence of cancer.

  • History of bowel surgery within 6 months prior to baseline.

  • History of significant trauma or major surgery within 4 weeks of screening or considered in imminent need of surgery or with elective surgery scheduled to occur during the study.

  • Presence of clinical signs of fulminant colitis or toxic megacolon, primary sclerosing cholangitis and evidence of colonic dysplasia, adenomas or neoplasia.

  • Clinically significant infections within 6 months of baseline

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT05549323
Other Study ID Numbers:
  • C4151002
  • 2022-501047-32-00
First Posted:
Sep 22, 2022
Last Update Posted:
Sep 22, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Pfizer
Inflammatory Bowel Disease
Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer

Study Results

No Results Posted as of Sep 22, 2022