A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects with Active Crohn*s Disease (Serenity)

Phase 2

Recruiting

Conditions: Crohns disease
10017969

Registration Number: NL-OMON49704

Lead Sponsor: Eli Lilly

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Subjects will be eligible for the study only if they meet all of the following criteria within the screening period, which is <=28 days prior to the start of study treatment, unless specifically defined:
Type of Subject and Disease Characteristics
• have had a diagnosis of Crohn*s disease for >=3 months before baseline
• have active Crohn*s disease as defined absolute SF >=4 (loose and waterystools defined as Bristol Stool Scale Category 6 or 7) and/or AP >=2 at baseline
• have a SES-CD score >=7 (centrally read) for subjects with ileal-colonic or >=4 for subjects with isolated ileal disease within 14 days before the first dose ofstudy treatment
Prior IBD Treatment
• must have received prior treatment for Crohn*s disease (according to the criteria below):
have received treatment with >=1 biologic agents (such as TNF antagonists, vedolizumab, experimental biologic Crohn*s disease therapeutics) with or without documented history of failure to respond to or tolerate suchtreatment:
o The treatment must have been discontinued according to the followingtimeline:
* anti-TNF therapy at least 8 weeks before baseline
* vedolizumab treatment at least 12 weeks before baseline
* experimental biologic Crohn*s disease therapy at least 8 weeks beforebaseline.
• may be receiving a therapeutic dosage of the following drugs:
• Oral 5-aminosalicylic (ASA) compounds: if the prescribed dose has been stablefor at least 3 weeks before screening colonoscopy or stopped treatment at least 3 weeks prior to screening colonoscopy.
• Oral corticosteroids must be at a prednisone-equivalent dose of <=20 mg/day, or <=9 mg/day of budesonide, and have been at a stable dose for at least 3 weeks prior to the screening colonoscopy. If stopping oral corticosteroid treatment prior to baseline, they must be stopped at least 3 weeks prior to screening colonoscopy.
• AZA, 6-MP, or methotrexate (MTX): if the prescribed dose has been stable for at least 4 weeks before screening endoscopy. Subjects who have discontinued therapy with AZA, 6-MP, or MTX must have stopped the medication at least 4 weeks prior to screening endoscopy to be considered eligible for enrollment.
• Crohn*s disease-specific antibiotics: if the prescribed dose has been stable 4 weeks prior to baseline or stopped treatment at least 3 weeks prior to screening endoscopy.;A complete list of inclusion criteria can be found in the protocol (section 6.1)

Exclusion Criteria

Subjects will be excluded from study enrollment if they meet any of the following criteria within the screening period, which is <=28 days prior to the start of study treatment, unless specifically defined:
Study Disease Conditions or Treatments
• have complications of Crohn*s disease such as strictures, stenoses, or any other manifestation for which surgery might be indicated or could confoundthe evaluation of efficacy
• diagnosis of conditions affecting the digestive tract, such as UC, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowelsyndrome
• 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 toscreening
• have received any of the following for treatment of Crohn*s disease:
• 6-thioguanine (6-TG), cyclosporine, tacrolimus, sirolimus, pentoxifylline, or mycophenolate mofetil within 8 weeks prior to baseline
• corticosteroid enemas, IV corticosteroids, corticosteroid suppositories, or topical treatment within 3 weeks prior to screening colonoscopy
• rectal 5-ASA within 3 weeks prior to screening colonoscopy
• have used apheresis (for example, Adacolumn apheresis) <=2 weeks prior to screening.
• have previous exposure to any biologic therapy targeting IL-23 p19 eitherlicensed or investigational, or prior exposure to ustekinumab
• have received natalizumab or agents that deplete B or T cells (for example, rituximab, alemtuzumab, or visilizumab) within 12 months of screening, or, if after receiving these agents, evidence is available at screening of persistentdepletion of the targeted lymphocyte population
• have been treated with any investigational drug for Crohn*s disease within8 weeks prior to baseline or 5 half-lives of the drug (whichever is longer), OR
with interferon therapy within 8 weeks before baseline;A complete list of exclusion criteria can be found in the protocol (section 6.2)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of subjects achieving endoscopic response at Week 12</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• AEs and discontinuation rates; mean change vital signs; laboratory values<br /><br>• Proportion of subjects achieving endoscopic response at Week 52<br /><br>• Proportion of subjects achieving endoscopic remission at Week 12<br /><br>• Proportion of subjects achieving endoscopic remission at Week 52<br /><br>• Proportion of subjects achieving PRO remission at Week 12<br /><br>• Proportion of subjects achieving PRO remission at Week 52<br /><br>• The mean change from baseline for PGRS score, PGRC score, IBDQ score,<br /><br>FACIT-Fatigue, and SF-36 at Weeks 12 and 52<br /><br>• Clearance and volume of distribution</p><br>