Vanderbilt Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Purpose

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.

Condition

Ulcerative Colitis

Eligibility

Eligible Ages: Between 18 Years and 80 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Diagnosis of UC - Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score - Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid treatment - Use of highly effective contraception as defined by the protocol

Exclusion Criteria

History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis - History of cancer as defined by the protocol - Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC) - Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC - Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening - Suspicion of ischemic colitis, radiation colitis, or microscopic colitis - Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon - History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia - Prior treatment with UTTR1147A - Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents - Prior treatment with rituximab - Use of prohibited therapies, as defined by the protocol, prior to randomization - Congenital or acquired immune deficiency - Evidence or treatment of infections or history of infections, as defined by the protocol

Study Design

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

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)	Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.	Drug: UTTR1147A UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions. Other names: Efmarodocokin alfa RO7021610 RG7880 IL-22Fc Drug: Vedolizumab Placebo The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.
Experimental Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)	Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.	Drug: UTTR1147A UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions. Other names: Efmarodocokin alfa RO7021610 RG7880 IL-22Fc Drug: UTTR1147A Placebo The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV. Drug: Vedolizumab Placebo The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.
Experimental Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)	Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.	Drug: UTTR1147A UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions. Other names: Efmarodocokin alfa RO7021610 RG7880 IL-22Fc Drug: Vedolizumab Placebo The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.
Experimental Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)	Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.	Drug: UTTR1147A UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions. Other names: Efmarodocokin alfa RO7021610 RG7880 IL-22Fc Drug: UTTR1147A Placebo The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV. Drug: Vedolizumab Placebo The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.
Experimental Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)	Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.	Drug: UTTR1147A UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions. Other names: Efmarodocokin alfa RO7021610 RG7880 IL-22Fc Drug: Vedolizumab Placebo The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.
Experimental Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)	Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.	Drug: UTTR1147A UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions. Other names: Efmarodocokin alfa RO7021610 RG7880 IL-22Fc Drug: UTTR1147A Placebo The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV. Drug: Vedolizumab Placebo The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.
Active Comparator Arm 4: Vedolizumab	Parts A and B: Vedolizumab and UTTR1147A Placebo.	Drug: UTTR1147A Placebo The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV. Drug: Vedolizumab Vedolizumab will be administered IV, as specified in the prescribing information. Other names: Entyvio
Placebo Comparator Arm 5: Placebo	Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.	Drug: UTTR1147A Placebo The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV. Drug: Vedolizumab Placebo The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

More Details

Status: Completed
Sponsor: Genentech, Inc.

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.