Long-term Safety Study of Brodalumab in Adults With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Brodalumab
Intervention description: Administered intravenously once every 4 weeks
Intervention MeSH terms: Brodalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Healthy volunteers: No
Keywords: Amgen; Crohn's; Inflammatory Bowel Disease; IBD; Irritable Bowel Syndrome; IBS; Inflammation; bowel; colon; gastrointestinal

Summary:

      The purpose of this study is to evaluate the safety and efficacy of long-term treatment with
      brodalumab in adults with Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was randomized into study 20090072 (NCT01150890) and completed the week 12
             evaluation.

          -  Subject completed the week 12 evaluation in study 20090072 no more than 1 year prior
             to the planned first visit of AMG 827 in 20100008.

          -  Subject or subject's legally acceptable representative has provided informed consent.

          -  Subject meets regional recommendations for immunizations, eg, United States Centers
             for Disease Control and Prevention recommendations for subjects enrolled in the United
             States.

          -  For subjects with ≥ 3 months between the week 12 visit of 20090072 and the planned
             first dose of AMG 827 in 20100008: If testing is clinically indicated in the opinion
             of the investigator (eg, because of known recent exposure), then subject has negative
             test for hepatitis B, hepatitis C, and/or human immunodeficiency virus (HIV).

          -  For female subjects with ≤ 4 weeks between the week 12 visit of 20090072 and the
             planned first dose of AMG 827 in 20100008: Subject has a negative urine pregnancy test
             at baseline prior to the first dose of AMG 827 in the open-label extension (except
             those at least 2 years post menopausal or surgically sterile).

          -  For female subjects with > 4 weeks between the week 12 visit of 20090072 and the
             planned first dose of AMG 827 in 20100008: Subject has a negative serum pregnancy test
             within 28 days before initiating AMG 827 and a negative urine pregnancy test at
             baseline prior to the first dose of AMG 827 in the open-label extension (except those
             at least 2 years post menopausal or surgically sterile).

          -  For subjects with ≥ 3 months between the week 12 visit of 20090072 and the planned
             first dose of AMG 827 in 20100008, if clinically indicated in the opinion of the
             investigator (eg, because of known recent exposure) please assess the following:

          -  If the subject entered 20090072 with a negative purified protein derivative (PPD)
             test: Subject must have a negative PPD test within 30 days prior to the planned first
             dose of AMG 827. Tuberculin skin tests should be considered positive when they have
             greater than or equal to 5 mm of induration at 48-72 hours after test is placed.

          -  If the subject entered 20090072 with a positive PPD: Subject must have a negative
             Quantiferon test within 30 days prior to the planned first dose of AMG 827.

        Exclusion Criteria:

          -  Subject had any serious adverse event reported during study 20090072 and considered to
             be related to investigational product.

          -  Subject experienced an adverse event or laboratory abnormality in study 20090072 that,
             in the opinion of the investigator, could cause extension of treatment to be
             detrimental to the subject, prevent the subject from completing the study, or
             interfere with the interpretation of the study results.

          -  Subject has known sensitivity to any of the products to be administered during dosing.

        Other medical conditions

          -  Subject is currently experiencing an infection of Common Terminology Criteria for
             Adverse Events grade 2 (if requiring oral medication) or higher. Subject is ineligible
             until the infection resolves.

          -  Subject has a serious infection, defined as requiring hospitalization or intravenous
             antibiotics, within 8 weeks before the first dose of AMG 827 in 20100008.

          -  For subjects with ≥ 3 months between the week 12 visit of 20090072 and the planned
             first dose of AMG 827 in 20100008: Subject has recurrent or chronic infections,
             defined as ≥ 3 infections requiring anti-microbials over the past 12 months prior to
             screening.

          -  Subject has a significant concurrent medical condition, including

          -  Type 1 diabetes

          -  Uncontrolled type 2 diabetes

          -  Moderate to severe heart failure (New York Heart Association class III or IV)

          -  Myocardial infarction within the last year

          -  Current or history of unstable angina pectoris within the last year

          -  Uncontrolled hypertension as defined by resting blood pressure ≥ 150/90 mmHg prior to
             first investigational product dose (confirmed by a repeat assessment)

          -  Severe chronic pulmonary disease (eg, requiring oxygen therapy)

          -  Major chronic inflammatory disease or connective tissue disease other than Crohn's
             disease (eg, systemic lupus erythematosus, rheumatoid arthritis, psoriasis)

          -  Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or
             melanoma

          -  History of cancer (except successfully treated in situ cervical cancer or squamous or
             basal cell carcinoma of the skin).

          -  Any condition that, in the opinion of the investigator, might cause this study to be
             detrimental to the subject

          -  Laboratory abnormalities

          -  For subjects with > 4 weeks between the week 12 visit of 20090072 and the planned
             first dose of AMG 827 in 20100008, subject has laboratory abnormalities at screening,
             including

          -  Elevated aspartate aminotransferase or alanine aminotransferase (> 2x upper limit of
             normal)

          -  Serum direct bilirubin ≥ 1.5x upper limit of normal

          -  Hemoglobin < 10 g/dL

          -  Hemoglobin A1c > 8.0 (for subjects with type 2 diabetes)

          -  Platelet count < 125,000 /mm^3

          -  White blood cell count < 3,000 cells/mm^3

          -  Absolute neutrophil count < 2,000/mm^3

          -  Creatinine clearance < 50 mL/min (Cockroft-Gault formula, central lab will calculate
             value and provide to sites)

          -  Any other laboratory abnormality, which, in the opinion of the investigator, could
             cause extension of treatment to be detrimental to the subject, prevent the subject
             from completing the study, or interfere with the interpretation of the study results

          -  Washouts and non-permitted drugs

          -  Subject has used Tysabri (natalizumab) subsequent to study 20090072.

          -  Subject received an anti-tumor necrosis factor agent within 8 weeks prior to the first
             dose of AMG 827 in 20100008.

          -  Subject received other commercially available biologic agent (eg, ustekinumab) within
             12 weeks prior to the first dose of AMG 827 in 20100008.

          -  Subject received an investigational agent (other than AMG 827), investigational
             procedure, or participated in an investigational device study subsequent to study
             20090072.

          -  Subject received live vaccines within 12 weeks prior to the first dose of AMG 827 in
             20100008.

          -  Subject received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),
             thalidomide, or tacrolimus within 4 weeks prior to the first dose of AMG 827 in
             20100008.

          -  General or other

          -  Female subject is not willing to use highly effective contraception during treatment
             with AMG 827 (except if at least 2 years postmenopausal or surgically sterile).

          -  Subject is pregnant or breast feeding, or planning to become pregnant while enrolled
             in the study.

          -  Subject has any kind of disorder that, in the opinion of the investigator, may
             compromise the ability of the subject to give written informed consent and/or to
             comply with all required study procedures.

          -  Subject will not be available for protocol required study visits, to the best of the
             subject and investigator's knowledge.