A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors

• Register: ClinicalTrials.gov
• Last refreshed on: 13 December 2021
• Main ID: NCT02136069
• Date of registration: 15/04/2014
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors GARDENIA
• Scientific title: Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
• Date of first enrolment: December 24, 2014
• Target sample size: 397
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02136069
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Canada, Czech Republic, Czechia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Norway, Philippines, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, United Kingdom, Vietnam

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Moderately to severely active UC as determined by the Mayo Clinic Score assessment
(MCS)

- Naive to treatment with any anti-TNF inhibitor therapy (including TNF inhibitor
biosimilars)

- An inadequate response to or intolerance of prior corticosteroid and/or
immunosuppressant treatment

- Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral
corticosteroids, budenoside multi-matrix system (MMX), probiotics, azathioprine (AZA),
6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the
screening period

- Use of highly effective contraception during and at least 24 weeks after the last dose
of study drug

Exclusion Criteria:

- A history of or current conditions and diseases affecting the digestive tract, such as
indeterminate colitis, suspicion of ischemic, radiation or microscopic colitis,
Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia,
intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps

- Prior or planned surgery for UC

- Past or present ileostomy or colostomy

- Have received non-permitted inflammatory bowel disease (IBD) therapies (including
natalizumab, vedolizumab, efalizumab, and tofactinib)

- History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to
chimeric, human, or humanized antibodies; fusion proteins, or murine proteins;
hypersensitivity to etrolizumab or any of its excipients

- Chronic hepatitis B or C infection, Human deficiency virus (HIV) or tuberculosis
(active or latent)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Infliximab

Other: Placebo (IV)

Drug: Etrolizumab

Other: Placebo (Injection)

Primary Outcome(s)

Percentage of Participants With Both Clinical Response at Week 10 and Clinical Remission at Week 54, as Determined by the Mayo Clinic Score (MCS) [Time Frame: Week 10, Week 54]

Secondary Outcome(s)

Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [Time Frame: Weeks 0, 4, 10, 12, 30, and 54]

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Overall Score at Weeks 10, 30, and 54 [Time Frame: Weeks 10, 30, and 54]

Number of Participants With Malignancies [Time Frame: Baseline until the end of study (up to 66 weeks)]

Percentage of Participants Achieving Clinical Remission at Week 54 Among Those With a Clinical Response at Week 10, as Determined by the MCS [Time Frame: Week 10 and Week 54]

Percentage of Participants Achieving Clinical Remission at Week 10, Defined as MCS =2 With Individual Subscores =1 [Time Frame: Week 10]

Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Both Week 10 and Week 54, as Determined by the MCS [Time Frame: Baseline to Week 10, Week 54]

Percentage of Participants Achieving Clinical Response at Both Weeks 10 and 54, as Determined by the MCS [Time Frame: Week 10, Week 54]

Number of Participants With Adverse Events, Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) [Time Frame: Baseline until the end of study (up to 66 weeks)]

Number of Participants With Infection-Related Adverse Events, Severity Determined According to the NCI CTCAE v4.0 [Time Frame: Baseline until the end of study (up to 66 weeks)]

Percentage of Participants Achieving Clinical Remission at Week 54, as Determined by the MCS [Time Frame: Week 54]

Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 54, as Determined by the MCS [Time Frame: Baseline to Week 54]

Number of Participants With Injection-Site Reactions, Severity Determined According to the NCI CTCAE v4.0 [Time Frame: Baseline until the end of study (up to 66 weeks)]

Percentage of Participants With Endoscopic Remission at Week 54, as Determined by the MCS [Time Frame: Week 54]

Number of Participants With Hypersensitivity Reaction Events, Severity Determined According to the NCI CTCAE v4.0 [Time Frame: Baseline until the end of study (up to 66 weeks)]

Percentage of Participants Achieving Clinical Remission at Both Week 10 and Week 54, as Determined by the MCS [Time Frame: Week 10 and Week 54]

Percentage of Participants Achieving Clinical Response at Week 10, as Determined by the MCS [Time Frame: Week 10]

Percentage of Participants That Achieve Clinical Remission Corticosteroid-Free at Week 54 (Off Corticosteroid for at Least 24 Weeks Prior to Week 54) Among Those Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS [Time Frame: Week 54]

Number of Participants With Adverse Events Leading to Study Drug Discontinuation [Time Frame: Baseline until the end of study (up to 66 weeks)]

Number of Participants With Serious Infection-Related Adverse Events [Time Frame: Baseline until the end of study (up to 66 weeks)]

Pharmacokinetics: Etrolizumab Serum Concentration [Time Frame: Weeks 2, 10, 12, 30, and 54]

Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 10, Determined by the MCS [Time Frame: Baseline to Week 10]

Secondary ID(s)

GA29103

2013-004282-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/08/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02136069