Gender
All
Age Group
18 Years to 65 Years
Accepting Healthy Volunteers
No
Inclusion Criteria:
Part A:
1. Has a confirmed diagnosis of CD at least 3 months before baseline, based on
endoscopy results.
2. Has moderately to severely active CD at Screening, defined as a CDAI score ≥220 and
a SES-CD ≥6 (≥4 if isolated ileal disease).
3. Has demonstrated at least 1 of the following (a, b, or c) to at least 1 IL
antagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approved
for the treatment of CD:
1. Inadequate response after completing the full induction regimen;
2. Loss of response (recurrence of symptoms during scheduled maintenance dosing
after prior clinical benefit); or
3. Intolerance (a significant adverse event that precluded further use, including
but not limited to serious infection including opportunistic infections,
malignancy, infusion-related and hypersensitivity reactions including
anaphylaxis, and liver injury).
Note: Participants with primary nonresponse to ≥2 agents are not eligible.
Participants with intolerance to 2 agents may be eligible at the investigator's
discretion.
Part B:
4. Participant is in clinical remission at Week 26. Note: Participants exhibiting a
clinical response (defined as a ≥ 100-point decrease in CDAI) at Week 26 may enter
Part B at the investigator's discretion.
Exclusion Criteria:
1. A current diagnosis of ulcerative colitis or indeterminate colitis.
2. Clinical evidence of a current abdominal abscess or a history of prior abdominal
abscess.
3. Known fistula (other than perianal fistula) or phlegmon.
4. Known perianal fistula with abscess.
5. Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine.
6. Previous extensive colon resection with ≥2 colonic segments remaining, performed ≥ 6
months prior to screening.
7. Short bowel syndrome.
8. Any planned surgical intervention for CD, except for seton placement for perianal
fistula without abscess.
9. History or evidence of adenomatous colonic polyps that have not been removed.
10. History or evidence of colonic mucosal dysplasia.
11. Intolerance or contraindication to ileocolonoscopy.
12. Any identified congenital or acquired immunodeficiency (eg, common variable
immunodeficiency, human immunodeficiency virus [HIV] infection).
13. Active or latent tuberculosis (TB), regardless of treatment history.
14. A positive test for hepatitis B virus (HBV) as defined by the presence of hepatitis
B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test.
15. A positive test for hepatitis C virus (HCV), as defined by a positive hepatitis C
virus antibody (HCVAb) test and detectable HCV ribonucleic acid (RNA).
16. Primary nonresponse to ≥2 IL antagonists (Cohort 1) or ≥2 TNF antagonists (Cohort 2)
for the treatment of CD.
17. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab,
natalizumab, efalizumab, etrolizumab, abrilumab [AMG 181], anti- mucosal addressin
cell adhesion molecule-1 [MAdCAM-1] antibodies, or rituximab).
18. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the
investigator's opinion. If a participant has symptoms consistent with PML, a PML
checklist must be completed and submitted to the PML independent adjudication
committee (IAC). If the PML IAC deems the participant to have PML, the participant
is ineligible.