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Clinical Trials/NCT03558152
NCT03558152
Completed
Phase 2

A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative Colitis

Genentech, Inc.72 sites in 13 countries195 target enrollmentStarted: October 26, 2018Last updated:
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ConditionsUlcerative Colitis
InterventionsUTTR1147AVedolizumab PlaceboUTTR1147A PlaceboVedolizumab

Overview

Phase
Phase 2
Status
Completed
Enrollment
195
Locations
72
Primary Endpoint
Percentage of Participants With Clinical Remission at Week 8
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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.

Study Design

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

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)

Experimental

Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.

Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Intervention: UTTR1147A (Drug)

Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)

Experimental

Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.

Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Intervention: Vedolizumab Placebo (Drug)

Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)

Experimental

Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Intervention: UTTR1147A (Drug)

Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)

Experimental

Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Intervention: UTTR1147A Placebo (Drug)

Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)

Experimental

Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Intervention: Vedolizumab Placebo (Drug)

Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)

Experimental

Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.

Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Intervention: UTTR1147A (Drug)

Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)

Experimental

Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.

Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Intervention: Vedolizumab Placebo (Drug)

Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)

Experimental

Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Intervention: UTTR1147A (Drug)

Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)

Experimental

Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Intervention: UTTR1147A Placebo (Drug)

Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)

Experimental

Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Intervention: Vedolizumab Placebo (Drug)

Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)

Experimental

Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.

Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Intervention: UTTR1147A (Drug)

Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)

Experimental

Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.

Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Intervention: Vedolizumab Placebo (Drug)

Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)

Experimental

Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Intervention: UTTR1147A (Drug)

Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)

Experimental

Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Intervention: UTTR1147A Placebo (Drug)

Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)

Experimental

Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Intervention: Vedolizumab Placebo (Drug)

Arm 4: Vedolizumab

Active Comparator

Parts A and B: Vedolizumab and UTTR1147A Placebo.

Intervention: UTTR1147A Placebo (Drug)

Arm 4: Vedolizumab

Active Comparator

Parts A and B: Vedolizumab and UTTR1147A Placebo.

Intervention: Vedolizumab (Drug)

Arm 5: Placebo

Placebo Comparator

Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.

Intervention: UTTR1147A Placebo (Drug)

Arm 5: Placebo

Placebo Comparator

Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.

Intervention: Vedolizumab Placebo (Drug)

Outcomes

Primary Outcomes

Percentage of Participants With Clinical Remission at Week 8

Time Frame: 8 weeks

Clinical remission is defined as modified Mayo Clinic Score (mMCS) \<= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore \<=1 and Centrally read endoscopic score \<= 1. Patients were classified as Non-Remitters if Week 8 assessments were missing or patient received permitted/ prohibited Rescue Therapy prior to assessment.

Secondary Outcomes

  • Percentage of Participants With Sustained Remission(At Weeks 8 and 30)
  • Maximum Serum Concentration (Cmax) of UTTR1147A(Days 1 - 29, Visit: Day 57)
  • Percentage of Participants With Endoscopic Remission at Week 30(At Week 30)
  • Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score(At Week 8)
  • Change From Baseline in UC Abdominal Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score(At Week 8)
  • Percentage of Participants With Clinical Response at Week 8(At Week 8)
  • Percentage of Participants With Clinical Response at Week 30(At Week 30)
  • Minimum Serum Concentration (Cmin) of UTTR1147A(Days 1 - 29, Visit: Day 57)
  • Percentage of Participants With Endoscopic Healing at Week 30(At Week 30)
  • Percentage of Participants With Endoscopic Healing at Week 8(At Week 8)
  • Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score(At Week 30)
  • Percentage of Participants With Endoscopic Remission at Week 8(At Week 8)
  • Change From Baseline in UC Abdominal Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score(At Week 30)
  • Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8(At Week 8)
  • Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 30(At Week 30)
  • Percentage of Participants With Adverse Events(Up to 30 weeks)
  • Percentage of Participants With Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration(Baseline up to 30)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (72)

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