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

Launched by PFIZER · Sep 17, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called PF-07054894 to see if it's safe and effective for treating ulcerative colitis (UC), a condition where the lining of the colon becomes inflamed and develops ulcers. The study aims to learn how the body processes this medication in adults who have moderate to severe or mild to moderate UC. Researchers are currently looking for participants aged between 18 and 80 who have been diagnosed with UC for at least three months and have not responded well to standard treatments.

Eligible participants will need to have specific characteristics related to their UC severity and must weigh more than 88 pounds. Those with certain other medical conditions, recent surgeries, or severe complications related to UC won't be able to join the study. If you choose to participate, you'll have regular check-ups to monitor your health while taking the study medication. This trial is a chance to help advance treatment options for ulcerative colitis, potentially benefiting many people in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed diagnosis of moderate to severe (Part A) or mild to moderate (Part B) 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).
• • Part A (moderate to severe): Must have a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least 2. Part B (mild to moderate): Participants with mMS of 4 to 6, ES of ≥2 and RB score of ≥1
• • Must have 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