GA29144: 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 | NYU Langone Health

GA29144: 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

Are you eligible to participate in this study?

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

Conditions:
Crohns Disease
Age: Between 18 years - 80 years
Gender: Male or Female

Other Inclusion Criteria:
1. Subjects who are between the ages of 18 and 80 years old
2. Subjects able and willing to provide written informed consent
3. For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use a highly effective method of contraception
4. For men: agreement to remain abstinent or use a condom, as well as not donate sperm during the treatment period and for at least 24 weeks after the last dose of study drug
5. Subjects diagnosed with CD based on clinical, histopathological, and endoscopic evidence
6. Subjects diagnosed with moderately to severely active disease defined in the Screening Phase
7. Subjects who meets the surveillance colonoscopy requirements as per the protocol
8. Subjects have experienced intolerance, refractory disease, or no response (as defined below) to at least one of the following therapies such as CS therapy, IS therapy and Anti-TNF therapy

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

1. Subjects who have undergone subtotal colectomy with ileorectal anastomosis or have undergone total colectomy
2. Subjects with short-bowel syndrome
3. Subjects have had an ileostomy or colostomy
4. Subjects have evidence of fixed stenosis or small-bowel stenosis with prestenotic dilation that precludes adequate endoscopic assessment of the bowel
5. Subjects diagnosed of UC or indeterminate colitis
6. Subjects with suspicion of ischaemic colitis, radiation colitis, or microscopic colitis
7. Subjects with evidence of abdominal or perianal abscess
8. Subjects with sinus tract with evidence for infection in the clinical judgment of the investigator.
9. Subjects expected to require surgery to manage CD-related complications during the study
10. Subjects with history or evidence of adenomatous colonic polyps that have not been removed
11. Subjects who had past or present disease-related colonic mucosal dysplasia