Other: Placebo / Placebo
the presence of any of the following will exclude a subject from enrollment
exclusions related to general health
1. subject has any clinically relevant hepatic, neurological, pulmonary,
ophthalmological, endocrine, psychiatric, or other major systemic disease making
implementation of the protocol or interpretation of the study difficult or that would
put the subject at risk by participating in the study.
2. subject is pregnant, lactating, or has a positive urine beta human chorionic
gonadotropin (β-hcg) measured prior to randomization.
3. subject has suspected or diagnosed intra-abdominal or perianal abscess that has not
been appropriately treated.
4. subject has a history of uveitis (within the last year) or clinically confirmed
diagnosis of macular edema.
5. subject has undergone a colectomy (partial or total), small bowel resection, or an
ostomy (ie, temporary colostomy, permanent colostomy, ileostomy, or other enterostomy)
since day 1 of the induction studies or has developed symptomatic fistula
(enterocutaneous or entero-enteral).
6. subject has had active cancer within 5 years including solid tumors and hematological
malignancies (except basal cell and in situ squamous cell carcinomas of the skin or
cervical dysplasia/cancer that have been excised and resolved) or colonic dysplasia
that has not been completely removed.
exclusions related to medications
7. subject has received any of the following therapies during the induction study
1. rectal steroid therapy (ie, steroids administered to the rectum or sigmoid via
foam or enema)
2. rectal 5-asa (ie, 5-asa steroids administered to the rectum)
3. parenteral corticosteroids
4. total parenteral nutrition therapy
5. antibiotics for the treatment of cd
6. immunomodulatory agents (6-mp, azathioprine, including but not limited to
cyclosporine, mycophenolate mofetil, tacrolimus, and sirolimus)
7. immunomodulatory biologic agents
8. investigational agents
8. subject has current or planned treatment with immunomodulatory agents (eg,
azathioprine, 6-mp, or methotrexate) during the maintenance study.
9. subject has chronic nonsteroidal anti-inflammatory drug (nsaid) use (note occasional
use of nsaids and acetaminophen [eg, headache, arthritis, myalgias, or menstrual
cramps] and aspirin up to 325 mg/day is permitted).
10. subject has received treatment with class ia or class iii anti-arrhythmic drugs or
treatment with 2 or more agents in combination known to prolong pr interval.
11. subject has received a live vaccine within 4 weeks prior to first dose of ip.
12. subject has received previous treatment with lymphocyte-depleting therapies (eg,
campath™, anti-cd4, cladribine, rituximab, ocrelizumab, cyclophosphamide,
mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, or
13. subject has received previous treatment with d-penicillamine, leflunomide or
14. subject has received previous treatment with natalizumab or fingolimod.
15. subject has received previous treatment with cyclosporine, tacrolimus, sirolimus, or
mycophenolate mofetil within 16 weeks of first dose of ip.
16. subject has a history of treatment with iv immune globulin (ivig), or plasmapheresis,
within 3 months prior to first dose of ip.
exclusions related to laboratory results
17. subject has ecg results showing any clinically significant abnormality at week 12 of
the induction study.
18. subject has confirmed aspartate aminotransferase (ast) or alanine aminotransferase
(alt) > 5 times the uln
19. subject has a forced expiratory volume at 1 second (fev1) or forced vital capacity
(fvc) < 50% of predicted values prior to randomization.
20. subject has confirmed absolute lymphocyte count (alc) < 200 cells/μl
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