A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003824-36-SE

Enrollment

1250

Registered

2015-01-27

Start date

2015-08-12

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn`s Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Etrolizumab CAS Number: 1044758-60-2 Current Sponsor c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18-80 years of age (inclusive) - Moderately to severely active Crohn's disease as determined by the Crohn's Disease Activity Index (CDAI), patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon - Intolerance, loss of response or failure to respond to corticosteroids (CS) or, immunosuppressants (IS), or TNF inhibitors within the previous 5 years - Use of effective contraception as defined by the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: - A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminant colitis, abdominal or perianal abscess, adenomatous colonic polyps, colonic mucosal dysplasia, and short bowel syndrome - Sinus tract with evidence for infection (e.g., Fistula with purulent discharge) in the clinical judgment of the investigator. Fistulas related to Crohn's disease are not exclusionary - Planned surgery for CD - Ileostomy or colostomy - Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab, as stated in the protocol) - Chronic hepatitis B or C infection, HIV, active or latent tuberculosis (patients with prior history of BCG vaccination must pass protocol-defined screening criteria)

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy Objectives Induction Phase (IP) • To independently evaluate the efficacy of etrolizumab dose regimens compared with placebo in inducing clinical remission and endoscopic improvement at the end of the Induction Phase (Week 14) Maintenance Phase • To evaluate the efficacy of etrolizumab compared placebo in achieving clinical remission and endoscopic improvement at 1 year of maintenance treatment (Week 66), for patients who achieved a Crohn's Disease Activity Index (CDAI) 70 response (defined as a decrease of at least 70 points from baseline CDAI) at Week 14 Safety Objectives • To evaluate the overall safety and tolerability of etrolizumab compared with placebo during Induction and Maintenance Phases of therapy ;Secondary Objective: Evaluate in IP the efficacy of etrolizumab compared with placebo: • in achieving clinical remission at Week 6 • in achieving an SES-CD =4, with no segment having a subcategory score that is >1, at Week 14 • in achieving a reduction of CD signs and symptoms Evaluate in MP the efficacy of etrolizumab compared with placebo: • in maintaining clinical remission at W. 66 for patients who achieved clinical remission at W. 14 • in achieving corticosteroid-free clinical remission at Week 66 • in maintaining endoscopic improvement at Week 66 for patients who achieved endoscopic improvement at W. 14 • in achieving a SES CD =4, with no segment having a subcategory score that is >1, at W. 66 • in achieving durable clinical remission during 1 year of maintenance therapy • in change of CD signs and symptoms from baseline to W. 66 Evaluate in MP the efficacy of etrolizumab: • corticosteroid-free clinical remission at Week 66 in patients who were receiving corticosteroids at baseline;Primary end point(s): a, Induction Phase • Clinical remission at Week 14 • Endoscopic improvement at Week 14 b, Maintenance Phase • Clinical remission at Week 66 • Endoscopic improvement at Week 66;Timepoint(s) of evaluation of this end point: a, a	—

Measure

Time frame

Main Objective: Efficacy Objectives Induction Phase (IP) • To independently evaluate the efficacy of etrolizumab dose regimens compared with placebo in inducing clinical remission and endoscopic improvement at the end of the Induction Phase (Week 14) Maintenance Phase • To evaluate the efficacy of etrolizumab compared placebo in achieving clinical remission and endoscopic improvement at 1 year of maintenance treatment (Week 66), for patients who achieved a Crohn's Disease Activity Index (CDAI) 70 response (defined as a decrease of at least 70 points from baseline CDAI) at Week 14 Safety Objectives • To evaluate the overall safety and tolerability of etrolizumab compared with placebo during Induction and Maintenance Phases of therapy ;Secondary Objective: Evaluate in IP the efficacy of etrolizumab compared with placebo: • in achieving clinical remission at Week 6 • in achieving an SES-CD =4, with no segment having a subcategory score that is >1, at Week 14 • in achieving a reduction of CD signs and symptoms Evaluate in MP the efficacy of etrolizumab compared with placebo: • in maintaining clinical remission at W. 66 for patients who achieved clinical remission at W. 14 • in achieving corticosteroid-free clinical remission at Week 66 • in maintaining endoscopic improvement at Week 66 for patients who achieved endoscopic improvement at W. 14 • in achieving a SES CD =4, with no segment having a subcategory score that is >1, at W. 66 • in achieving durable clinical remission during 1 year of maintenance therapy • in change of CD signs and symptoms from baseline to W. 66 Evaluate in MP the efficacy of etrolizumab: • corticosteroid-free clinical remission at Week 66 in patients who were receiving corticosteroids at baseline;Primary end point(s): a, Induction Phase • Clinical remission at Week 14 • Endoscopic improvement at Week 14 b, Maintenance Phase • Clinical remission at Week 66 • Endoscopic improvement at Week 66;Timepoint(s) of evaluation of this end point: a, a

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Secondary

Measure	Time frame
Secondary end point(s): Induction Phase a, Clinical remission at Week 6 b, SES CD =4 (=2 for ileal patients), with no segment having a subcategory score that is >1, at Week 14 c, Change in CD signs and symptoms from baseline to Week 14 as assessed by the CD-PRO/SS measure Maintenance Phase a, Clinical remission at Week 66 among patients who achieved clinical remission at Week 14 b, Corticosteroid-free clinical remission at Week 66 c, Endoscopic improvement at Week 66 among patients who achieved endoscopic improvement at Week 14 d, SES CD =4 (=2 for ileal patients), with no segment having a subcategory score that is >1, at Week 66 e, Durable clinical remission f, Corticosteroid-free clinical remission for 24 weeks at Week 66 g, Change in CD signs and symptoms from baseline to Week 66 as assessed by the CD-PRO/SS measure;Timepoint(s) of evaluation of this end point: Induction Phase a, At Week 6 b, At Week 14 c, From baseline to Week 14 Maintenance Phase a To d. at Week 66 e. From baseline to Week 66 f. At Week 66 g. From baseline to Week 66	—

Measure

Time frame

Secondary end point(s): Induction Phase a, Clinical remission at Week 6 b, SES CD =4 (=2 for ileal patients), with no segment having a subcategory score that is >1, at Week 14 c, Change in CD signs and symptoms from baseline to Week 14 as assessed by the CD-PRO/SS measure Maintenance Phase a, Clinical remission at Week 66 among patients who achieved clinical remission at Week 14 b, Corticosteroid-free clinical remission at Week 66 c, Endoscopic improvement at Week 66 among patients who achieved endoscopic improvement at Week 14 d, SES CD =4 (=2 for ileal patients), with no segment having a subcategory score that is >1, at Week 66 e, Durable clinical remission f, Corticosteroid-free clinical remission for 24 weeks at Week 66 g, Change in CD signs and symptoms from baseline to Week 66 as assessed by the CD-PRO/SS measure;Timepoint(s) of evaluation of this end point: Induction Phase a, At Week 6 b, At Week 14 c, From baseline to Week 14 Maintenance Phase a To d. at Week 66 e. From baseline to Week 66 f. At Week 66 g. From baseline to Week 66

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Estonia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026