BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity

Inclusion criteria:

- Males and females aged >=18 and =<80 years at Screening who have a diagnosis of
moderate to severely active Crohn's Disease (CD), confirmed by endoscopy or radiologic
evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must
have all of the following:

- Crohn's Disease Activity Index (CDAI) score of >=220 and =<450

- A diagnosis of Crohn's Disease (CD) confirmed by ileocolonoscopy during Screening

- Presence of mucosal ulcers in at least one segment of the ileum or colon and a
SES-CD score ≥7 (for patients with isolated ileal disease SES-CD score ≥4), as
assessed by ileocolonoscopy and confirmed by central independent reviewer(s)
before randomization

- Anti-tumor necrosis factor (TNF) patients or patients previously treated with
infliximab who had initially responded and who meet one of the following criteria:

- Responded and developed secondary resistance due confirmed anti-infliximab
anti-drug antibody formation, which caused infliximab depletion

- Responded and became intolerant

- Further inclusion criteria apply

Exclusion criteria:

- Patients with ulcerative colitis or indeterminate colitis

- Patients with symptomatic known obstructive strictures

- Surgical bowel resection performed within 6 months prior to Screening or planned
resection at any time while enrolled in the trial

- Patients with an ostomy or ileoanal pouch

- Patients with short bowel syndrome

- Patients who have previously used infliximab and have never clinically responded

- Patients who have previously received treatment with adalimumab, or who have
participated in an adalimumab or adalimumab biosimilar clinical trial

- Further exclusion criteria apply