Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis

• Status: Completed
• Trial end date: 2018-04-10
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore > 1 point.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• Diagnosis of ulcerative colitis (UC) established ≥ 3 months before baseline by clinical and endoscopic evidence and corroborated by a histopathology report.

• Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with a centrally read rectosigmoidoscopy score ≥2 prior to baseline

• Inadequate response to, loss of response to, or intolerance to at least one of the following treatments:

• Immunomodulators

• Anti-TNF agents

• Corticosteroids (non-US sites only).

• Neurological exam free of clinically significant, unexplained signs or symptoms during screening and no clinically significant change prior to randomization

Exclusion Criteria:

• Disease limited to the rectum (ie, within 10 cm of the anal verge)

• Toxic megacolon

• Crohn's Disease

• History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC

• Planned bowel surgery within 24 weeks from baseline

• Stool positive for C. Difficile toxin at screening

• History of gastrointestinal surgery within 8 weeks of baseline

• Primary Sclerosing Cholangitis

• Any uncontrolled or clinically significant systemic disease

• Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion.

• Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus antibody or human immunodeficiency virus (HIV)

• Underlying condition that predisposes subject to infections (eg, uncontrolled diabetes; history of splenectomy)

• Known history of drug or alcohol abuse within 1 year of screening

• Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease free state since treatment)

• Immunosuppressive therapy with either cyclosporine A, tacrolimus, or mycophenolate mofetil, within 1 month prior to baseline

• Prior exposure to anti tumor necrosis factor (TNF) agents, within 2 months, or 5 times the respective elimination half life (whichever is longer) prior to baseline

• Any prior exposure to vedolizumab, rituximab, efalizumab, natalizumab

• Use of topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids within 2 weeks prior to baseline

• Use of intravenous or intramuscular corticosteroids within 2 weeks prior to screening and during screening

• Previously treated with AMG 181

• Received any type of live attenuated vaccine < 1 month prior to baseline or is planning to receive any such live attenuated vaccine over the course of the study

• Treatment of infection with intravenous (within 30 days of baseline) or oral (within 14 days prior to baseline) antibiotics, antivirals, or antifungals

• Abnormal laboratory results at screening

• Any other laboratory abnormality, which, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results

• Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)