Ulcerative Colitis
Conditions
Keywords
Inflammatory Bowel Disease
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.
Interventions
DRUGPF-07054894
Oral
DRUGPlacebo
Placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants are assigned to one of the two groups in parallel for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Proportion of participants achieving clinical remission at Week 12 in participants with moderate to severe UC. | 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 |
| Part B: Percent change from baseline in the mMS in participants with mild to moderate UC. | Week 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: 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) |
| Part A: 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 |
| Part B: Proportion of participants achieving clinical remission at Week 12 | Week 12 | Clinical Remission based on modified Mayo Score is defined as endoscopic subscore 0 or 1 (without friability), stool frequency subscore 0 or 1, and rectal bleeding subscore 0. |
Countries
Germany, Poland, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed