Study Design

Focusing on UC. Evaluating Outcomes.

Read an overview of the Etro Studies in Ulcerative Colitis (UC).¹

Hibiscus I¹ & II²

NCT02163759 & NCT02171429

Key Primary Endpoint

• Induction of remission, based on Mayo Clinic Score (MSC), at Week 10 compared with placebo

Key Secondary Endpoint

• Induction of remission compared with adalimumab at Week 10

Key Inclusion Criteria:

• Adult patients, ≥ 18 or ≤ 80 years of age, with moderate to severe UC, as determined by the MCS
• Naïve to treatment with any anti-TNF therapy
• An inadequate response to prior corticosteroid and/or immunosuppressant treatment
• Background regimen for UC may include oral 5-ASA, oral corticosteroids, budesonide MMX, probiotics, AZA, 6-MP or MTX if doses have been stable during the screening period
• Use of highly effective contraception as defined by the protocol

Key Exclusion Criteria:

• A history of or current conditions and diseases affecting the digestive tract (indeterminate colitis, ulcerative colitis, fistulas or abdominal abscesses, short-bowel syndrome, fixed stenosis or small-bowel stenosis, colonic mucosal dysplasia, 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, and efalizumab) as stated in the protocol
• Chronic hepatitis B or C infection, HIV or tuberculosis (active or latent)

Laurel³

NCT02165215

Key Primary Endpoint:

• Maintenance of remission, based on Mayo Clinic Score (MCS), at Week 62 (among randomized patients in remission at Week 10)

Key Secondary Endpoints:

• Maintenance of clinical remission, based on MCS, at Week 62 (among randomized patients in clinical remission at Week 10)
• Clinical remission at Week 62

Key Inclusion Criteria:

• Adult patients, between 18 and 80 years of age, with moderate to severe UC, as determined by the MCS
• Naïve to treatment with any anti-TNF therapy
• An inadequate response to prior corticosteroid and/or immunosuppressant treatment
• Background regimen for UC may include oral 5-ASA, oral corticosteroids, budenoside MMX, probiotics, AZA, 6-MP, or MTX if doses have been stable during the screening period
• Use of highly effective contraception as defined by the protocol

Key Exclusion Criteria:

• A history of or current conditions and diseases affecting the digestive tract (indeterminate colitis, ulcerative colitis, fistulas or abdominal abscesses, short-bowel syndrome, fixed stenosis or small-bowel stenosis, colonic mucosal dysplasia, 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, and efalizumab) as stated in the protocol
• Chronic hepatitis B or C infection, HIV or tuberculosis (active or latent)

Hickory⁴

NCT02100696

Co-Primary Endpoint:

• Remission, based on Mayo Clinic Score (MCS), at Week 14 and at Week 66 (among randomized patients in remission at Week 14)

Key Secondary Endpoints:

• Clinical remission, based on MCS , at Week 14
• Clinical remission at Week 66

Key Inclusion Criteria:

• Adult patients, ≥ 18 or ≤ 80 years of age, with moderate to severe UC, as determined by the MCS
• An intolerance, loss of response or failure to respond to treatment with at least one anti-TNF agent within the previous 5 years
• Background regimen for UC may include oral 5-ASA, oral corticosteroids, budesonide MMX, probiotics, AZA, 6-MP or MTX if doses have been stable during the screening period
• Use of highly effective contraception as defined by the protocol

Key Exclusion Criteria:

• A history of or current conditions and diseases affecting the digestive tract (indeterminate colitis, Crohn’s disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolonor 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, and efalizumab) as stated in the protocol
• Chronic hepatitis B or C infection, HIV or tuberculosis (active or latent)

Cottonwood⁵

NCT02165215

Primary Outcome:

• Long-term efficacy as determined by the partial Mayo Clinical Score (MCS)
• Incidence of adverse events

Key Inclusion Criteria:

Part 1 (Open-label Extension)
• Patients previously enrolled in Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab as described in
 the study protocols

Part 2 (Safety Monitoring)
• Patients who participated in one of the etrolizumab Phase III studies and are not eligible or chose not to enter Part 1 (OLE)
• Patients who transfer from Part 1 (OLE)
• Completion of the 12-week safety follow-up prior to entering

Key Exclusion Criteria:

Part 1 (Open-label Extension)
• Any new, significant, uncontrolled condition

Part 2 (Safety Monitoring)
• No exclusion criteria

Read an overview of the Etro Studies in Ulcerative Colitis (UC) available outside of the US.¹

Gardenia⁶

NCT02136069

Primary Outcome

• Sustained remission compared with infliximab

Key Inclusion Criteria

• Adult patients, ≥ 18 or ≤ 80 years of age, with moderate to severe UC, as determined by the MCS
• Naïve to treatment with any anti-TNF therapy
• An inadequate response to prior corticosteroid and/or immunosuppressant treatment
• Background regimen for UC may include oral 5-ASA, oral corticosteroids, budesonide MMX, probiotics, AZA, 6-MP or MTX if doses have been stable during the screening period
• Use of highly effective contraception as defined by the protocol

Key Exclusion Criteria

• A history of or current conditions and diseases affecting the digestive tract (indeterminate 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, and efalizumab) as stated in the protocol
• Chronic hepatitis B or C infection, HIV or tuberculosis (active or latent)

Interested in referring a patient to the Etro Studies? Learn how now.

1. http://clinicaltrials.gov/show/NCT02163759
2. http://clinicaltrials.gov/show/NCT02171429
3. http://clinicaltrials.gov/show/NCT02165215
4. http://clinicaltrials.gov/show/NCT02100696
5. http://clinicaltrials.gov/show/NCT02165215
6. http://clinicaltrials.gov/show/NCT02136069