Vanderbilt Clinical Trials

A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis

Purpose

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.

Condition

Moderate to Severe Ulcerative Colitis

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

- 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.

Exclusion Criteria

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Cohort 1	Induction - Placebo SC Q4W, (sub-cutaneous every 4 weeks) Chronic- PF-06480605 50 mg SC Q4W	Other: Induction- Placebo SC Q4W 0 mg Placebo Drug: Chronic- PF-06480605 50 mg SC Q4W PF-06480605
Experimental Cohort 2	Induction - Placebo SC Q4W, Chronic- PF-06480605 150 mg SC Q4W	Other: Induction- Placebo SC Q4W 0 mg Placebo Drug: Chronic- PF-06480605 150 mg SC Q4W PF-06480605
Experimental Cohort 3	Induction - Placebo SC Q4W, Chronic- PF-06480605 450 mg SC Q4W	Other: Induction- Placebo SC Q4W 0 mg Placebo Drug: Chronic- PF-06480605 450 mg SC Q4W PF-06480605
Placebo Comparator Cohort 4	Induction- PF-06480605 50 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W	Drug: Induction- PF-06480605 50 mg SC Q4W PF-06480605 Drug: Chronic- PF-06480605 50 mg SC Q4W PF-06480605
Experimental Cohort 5	Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W	Drug: Induction- PF-06480605 150 mg SC Q4W PF-06480605 Drug: Chronic- PF-06480605 50 mg SC Q4W PF-06480605
Experimental Cohort 6	Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W	Drug: Induction- PF-06480605 150 mg SC Q4W PF-06480605 Drug: Chronic- PF-06480605 150 mg SC Q4W PF-06480605
Experimental Cohort 7	Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W	Drug: Induction- PF-06480605 450 mg SC Q4W PF-06480605 Drug: Chronic- PF-06480605 50 mg SC Q4W PF-06480605
Experimental Cohort 8	Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W	Drug: Induction- PF-06480605 450 mg SC Q4W PF-06480605 Drug: Chronic- PF-06480605 150 mg SC Q4W PF-06480605
Experimental Cohort 9	Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 450 mg SC Q4W	Drug: Induction- PF-06480605 450 mg SC Q4W PF-06480605 Drug: Chronic- PF-06480605 450 mg SC Q4W PF-06480605

More Details

Status: Completed
Sponsor: Hoffmann-La Roche

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.