Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease

Amgen

Status and phase: Terminated; Phase 2

Conditions: Crohn's Disease

Treatments: Biological: Brodalumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01150890

2010-019544-39 (EudraCT Number)

20090072

Details and patient eligibility

About

The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.

Enrollment: 130 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to initiating study drug
• Moderately to severely active Crohn's disease, as defined by a CDAI score >250 and < 450 at baseline
• Evidence of active inflammation

Exclusion criteria

• Short bowel syndrome
• Stricture with obstructive symptoms within 3 months
• Bowel surgery within 3 months
• Ileostomy and/or colostomy
• Any gastric or intestinal pouch
• Ulcerative colitis
• Evidence of an infected abscess
• Bowel perforation or evidence of noninflammatory obstruction during the 6 months
• Stool positive for C. Difficile toxin at screening
• Presence of active infection requiring treatment
• Serious infection within 8 weeks
• Significant concurrent medical conditions
• Pregnant or breast feeding
• Significant Laboratory abnormalities
• Any anti-tumor necrosis factor (TNF) agent within 2 months
• Steroid enemas within 2 weeks
• Tysabri (natalizumab) within 1 year
• Biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 3 months
• Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus within 2 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo intravenously at baseline and week 4.

Treatment:

Drug: Placebo

Brodalumab 210 mg

Experimental group

Description:

Participants received 210 mg brodalumab intravenously at baseline and week 4.

Treatment:

Biological: Brodalumab

Brodalumab 350 mg

Experimental group

Description:

Participants received 350 mg brodalumab intravenously at baseline and week 4.

Treatment:

Biological: Brodalumab

Brodalumab 700 mg

Experimental group

Description:

Participants received 700 mg brodalumab intravenously at baseline and week 4.

Treatment:

Biological: Brodalumab