Study Comparing the usefulness and safety of Etrolizumab Vs Placebo in patients with Ulcerative Colitis.

Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy (Maintenance Of Remission) And Safety Of Etrolizumab Compared With Placebo In Patients With Moderate To Severe Active Ulcerative Colitis Who Are Naive To TNF Inhibitors.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/04/008363

Enrollment

350

Registered

2017-04-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patients with moderate to severe active Ulcerative Colitis who wre naive to TNF Inhibitors Health Condition 2: K519- Ulcerative colitis, unspecified

Interventions

Intervention1: ETROLIZUMAB: IMP, 105 mg given as 0.7 mL of a 150-mg/mL solution will be administered by SC injection Q4W. Control Intervention1: Placebo: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Able and willing to provide written informed consent Diagnosis of UC established at least 6 months prior Moderately to severely active UC as determined by an MCS Evidence of UC extending a minimum of 20 cm from the anal verge Naive to treatment with any anti-TNF therapy

Exclusion criteria

Exclusion criteria: Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC Past or present ileostomy or colostomy Diagnosis of indeterminate colitis Any prior treatment with etrolizumab or other anti-integrin agents Pregnant or lactating Infection Risk Abnormal Laboratory Values

Design outcomes

Primary

Measure	Time frame
Remission at Week 62 among randomized patients in remission at Week 10Timepoint: Remission at Week 62 among randomized patients in remission at Week 10	—

Secondary

Measure	Time frame
Clinical remission at Week 62 among randomized patients in clinical remission at Week 10 Clinical remission at Week 62 Clinical response at Week 62 Improvement in endoscopic appearance of the mucosa at Week 62 Endoscopic remission at Week 62Timepoint: Specified above	—

Countries

Argentina, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, France, Germany, India, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Ukraine, United Kingdom, United States of America

Contacts

Public ContactPriyanka Bhattacharya

Roche Products (India) Pvt. Ltd.

priyanka.bhattacharya@roche.com022-50457300

Outcome results

None listed

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