A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors

Part of paid clinical trials in Lakewood, Colorado.

Sponsor
Hoffmann-La Roche
Study ID
NCT02163759
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Adalimumab 160 milligrams (mg) will be administered subcutaneously (SC) at Week 0; 80 mg SC at Week 2; 40 mg SC at Weeks 4, 6, and 8.
  • Adalimumab Placebo — OTHER
    Placebo matching to adalimumab will be administered SC at Weeks 0, 2, 4, 6, and 8.
  • Etrolizumab — DRUG
    Etrolizumab 105 mg will be administered SC every 4 weeks (Q4W) up to Week 12 (at Weeks 0 \[Day 1\], 4, 8, and 12 \[clinical remitters only\]).
  • Etrolizumab Placebo — OTHER
    Placebo matching to etrolizumab will be administered SC once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 \[Day 1\], 4, 8, and 12 \[clinical remitters only\]).

Study Details

This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted.

Key Dates

Start date
Nov 4, 2014
Status verified
Jul 2021
Primary completion
Feb 19, 2020
Completion
Mar 19, 2020

Study Design

Enrollment
358 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants will receive placebo matching to etrolizumab up to Week 12 and placebo matching to adalimumab up to Week 8.
  • Active Comparator: Adalimumab
    Participants will receive adalimumab up to Week 8 and placebo matching to etrolizumab up to Week 12.
  • Experimental: Etrolizumab
    Participants will receive etrolizumab up to Week 12 and placebo matching to adalimumab up to Week 8.

Primary Outcome Measure

Percentage of Participants in Remission at Week 10 With Etrolizumab as Compared With Placebo, as Determined by the Mayo Clinic Score (MCS), GA28948 Population [ Time Frame: Week 10 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Rocky Mountain Gastroenterology Associates, P.L.L.C.; GastroenterologyLakewoodColorado80215-
Center for Advanced GastroenterologyMaitlandFlorida32751-
Gastroenterology Group of NaplesNaplesFlorida34102-
Gastroenterology Associates of Central GeorgiaMaconGeorgia31201-
University of Chicago Medical CenterChicagoIllinois60637-
Center for Digestive HealthTroyMichigan48098-
Huron Gastroenterology AssociatesYpsilantiMichigan48197-
Wellness Clinical Research CenterSan AntonioTexas78232-
Tyler Research Institute, LLCTylerTexas75701-

Find similar trials in Lakewood, CO

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology· Lakewood, COCenter for Advanced Gastroenterology· Maitland, FLGastroenterology Group of Naples· Naples, FLGastroenterology Associates of Central Georgia· Macon, GAUniversity of Chicago Medical Center· Chicago, ILCenter for Digestive Health· Troy, MI

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