GA28949: Phase III Randomized Double-Blind Double-Dummy Placebo-Controlled Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared with Adalimumab and Placebo in Patients with Moderate to Severe Ulcera | NYU Langone Health

GA28949: Phase III Randomized Double-Blind Double-Dummy Placebo-Controlled Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared with Adalimumab and Placebo in Patients with Moderate to Severe Ulcera

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Ulcerative Colitis
Age: Between 18 years - 80 years
Gender: Male or Female

Other Inclusion Criteria:
1. Subjects able and willing to provide written informed consent
2. Subjects between the ages of 18-80 years old
3. Subject diagnosed with UC established at least 3 months prior to randomization (Day 1) by clinical and endoscopic evidence.
4. Subjects with moderately to severely active UC
5. Subjects with evidence of UC extending a minimum of 20 cm from the anal verge
6. Subjects who are naive to treatment with TNF inhibitor therapy
7. Subjects must have had an inadequate response, loss of response, or intolerance to prior immunosuppressant and/or corticosteroid treatment.
8. Subjects who has any ongoing UC therapy must be at stable doses
9. Female Subjects who are not postmenopausal or surgically sterile must agree to remain abstinent or use a highly effective method of contraception for the duration of the study
10. Male subjects must agree to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
11. Subjects must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

You may not be eligible for this study if the following are true:

1. Subjects with Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
2. Subjects who had past or present ileostomy or colostomy
3. Subjects who are diagnosed of indeterminate colitis
4. Subjects who has suspicion of ischemic colitis, radiation colitis, or microscopic colitis
5. Subjects who are diagnosed of toxic megacolon within 12 months of initial screening visit
6. Subjects with any diagnosis of Crohn’s disease
7. Subjects who has past or present fistula or abdominal abscess
8. Subjects with a history or current evidence of colonic mucosal dysplasia
9. Subjects with any stricture (stenosis) of the colon
10. Subjects with history or evidence of adenomatous colonic polyps that have not been removed
11. Prior treatment with TNF-a antagonists
12. Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab