Long-term Safety Study of Brodalumab in Adults With Crohn's Disease

Stopped early · Phase 2

Conditions studied: Crohn's Disease

In brief

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

Key facts

Study ID: NCT01199302
Run by: Amgen
People needed: 67
Starts: 2011-02-02
Expected to finish: 2011-10-18
Last updated by the study team: 2021-12-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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)

Where it is running

Research Site — Birmingham, Alabama, United States
Research Site — Jacksonville, Florida, United States
Research Site — Hammond, Louisiana, United States
Research Site — Chevy Chase, Maryland, United States
Research Site — Rochester, Minnesota, United States
Research Site — Mexico, Missouri, United States
Research Site — Great Neck, New York, United States
Research Site — Charlotte, North Carolina, United States
Research Site — Nashville, Tennessee, United States
Research Site — San Antonio, Texas, United States
Research Site — Ogden, Utah, United States
Research Site — Kurralta Park, South Australia, Australia
Research Site — Box Hill, Victoria, Australia
Research Site — Fitzroy, Victoria, Australia
Research Site — Fremantle, Western Australia, Australia
Research Site — Bonheiden, Belgium
Research Site — Ghent, Belgium
Research Site — Leuven, Belgium
Research Site — Roeselare, Belgium
Research Site — Vancouver, British Columbia, Canada
Research Site — Winnipeg, Manitoba, Canada
Research Site — Hamilton, Ontario, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Lille, France
Research Site — Nice, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.