Study Comparing the usefulness and safety of Etrolizumab Vs Placebo in patients with Ulcerative Colitis.
- Conditions
- Ulcerative colitis, unspecified,
- Registration Number
- CTRI/2017/04/008363
- Lead Sponsor
- F HoffmannLa Roche Ltd
- Brief Summary
Althoughthere are therapeutic options including anti-TNF agents, a significantproportion of patients with UC will not experience a durable clinical benefitwith those treatment options. Furthermore, adverse events associated withanti-TNFs include elevated rates of serious bacterial infection, including TB,and (more rarely) lymphoma and demyelination (Chang and Lichtenstein 2006). Nocurrently available therapy achieves sustained remission in more than 10%−30%of patients with IBD who have chronic disease(Hanauer et al. 2002; Sandborn et al. 2005). As noted above, etrolizumab distinguishesitself from other anti-integrins on the basis of gut selectivity combined with apotential dual mechanism of action. It binds αEβ7 in addition to α4β7 and soregulates retention as well as trafficking leukocyte/lymphocyte in theintestinal mucosa.
In summary, favorablesafety (see Section 1.2) and efficacy data were observed in the Phase IIEUCALYPTUS study and in the OLE study (SPRUCE). Overall, etrolizumab showedcompelling efficacy compared with placebo and there were no clinically significantsafety signals. Additionally, etrolizumab distinguishes itself from vedolizumabby blocking αEβ7 in addition to α4β7, which is involved in lymphocyte retentionand may contribute to its efficacy and/or safety profile. Etrolizumab is a gut-selective anti-traffickingagent and does not bind to α4β1 (target for natalizumab), which regulates traffickingto both mucosal and non-mucosal tissues, including the CNS. Although natalizumabhas been associated with an increased risk of PML, no events of PML to datehave been reported during 2-year PML extensive monitoring in the Phase IIstudy, EUCALYPTUS, and OLE SPRUCE study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 350
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission at Week 62 among randomized patients in remission at Week 10 Remission at Week 62 among randomized patients in remission at Week 10
- Secondary Outcome Measures
Name Time Method Clinical remission at Week 62 among randomized patients in clinical remission at Week 10
Trial Locations
- Locations (19)
 Shree Giriraj Multispeciality Hospital
🇮🇳Rajkot, GUJARAT, India
Deccan College of Medical Sciences
🇮🇳Hyderabad, ANDHRA PRADESH, India
Dispur Hospitals Pvt Ltd
🇮🇳Kamrup, ASSAM, India
G B Pant Hospital
🇮🇳Delhi, DELHI, India
Grant Medical Foundation
🇮🇳Pune, MAHARASHTRA, India
Kaizen Hospital institute of Gastroentrology & Research Center
🇮🇳Ahmadabad, GUJARAT, India
Kasturba Medical College Hospital
🇮🇳Kannada, KARNATAKA, India
King Edward Memorial Hospital and Seth G S Medical College,
🇮🇳Mumbai, MAHARASHTRA, India
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre
🇮🇳Belgaum, KARNATAKA, India
Midas Multispeciality Hospital Pvt. Ltd,
🇮🇳Nagpur, MAHARASHTRA, India
Scroll for more (9 remaining)Â Shree Giriraj Multispeciality Hospital🇮🇳Rajkot, GUJARAT, IndiaChetan MehtaPrincipal investigator9825077472mehtacn@hotmail.com