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A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)
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Duration of study participation:120 weeks. 
Primary Objective:
To test the hypothesis that treatment with XXX -XXX is superior to placebo in the proportion of subjects with endoscopic response at Week 12, defined as 50% reduction from baseline in SES-CD Score.

Secondary objectives:

  • · To evaluate the safety and tolerability of treatment with XXX-XXX

  • · To evaluate the effect of XXX-XXX on the proportion of subjects with endoscopic response at Week 52, defined as 50% reduction from baseline in SES-CD score

  • · To evaluate the efficacy of treatment with XXX-XXX as superior to placebo in endoscopic remission (defined as an SES-CD score of <4 ilealcolonic or <2 for isolated ileal disease, and no subscore >1) at Week 12

  • · To evaluate the effect of XXX-XXX on the proportion of subjects with endoscopic remission (defined as an SES-CD score of <4 ileal-colonic or <2 for isolated ileal disease, and no subscore >1) at Week 52

 

Inclusion Criteria:

  • Diagnosis of Crohn disease for ≥3 months before baseline.

  • Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported stool frequency and abdominal pain.

  • Inadequate response or failure to tolerate at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of CD.

  • Are male or female subjects ≥18 and ≤75 years of age at the time of initial screening.

 

Exclusion Criteria:

  • Have complications of CD such as strictures, stenoses, or any other manifestation for which surgery might be indicated, or that could confound the evaluation of efficacy.

  • Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.

  • Have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening.

  • Are unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation.

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