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

NCT01199302 | Terminated Phase 2 Results

• 2 other identifiers: 201000082010-020881-53
• Study Type: interventional
• Target: 67
• Locations: 8 countries
• Sites: 34

Brief 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.

Conditions

Crohn's Disease

Keywords

Amgen; Crohn's; Inflammatory Bowel Disease; IBD; Irritable Bowel Syndrome; IBS; Inflammation; bowel; colon; gastrointestinal

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject including worsening of a pre-existing medical condition, and not necessarily having a causal relationship with study treatment. A treatment-emergent AE is an event that occurred after the initiation of study drug or was already present prior to the initiation of study drug but worsened in either intensity or frequency after the initiation of study drug. The investigator assessed whether each AE was possibly related to the study drug. A serious adverse event is defined as an AE that met at least 1 of the following serious criteria: * fatal, * life threatening, * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other significant medical hazard.

  From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)

• Percentage of Participants Who Achieved a CDAI Response

  CDAI response is defined as a reduction from baseline in CDAI score of ≥ 100 points. The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.

  Baseline of the parent study and weeks 2, 4, 6, 8, 10, 12, 16, and 20

• Percentage of Participants Who Achieved Clinical Remission

  Clinical remission is defined by a CDAI score of ≤ 150 points. The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.

  Weeks 2, 4, 6, 8, 10, 12, 16, and 20

Secondary Outcomes (4)

• CDAI Score Over Time

  Weeks 2, 4, 6, 8, 10, 12, 16, and 20

• Change From Baseline in CDAI Score Over Time

  Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20

• Number of Participants Who Developed Anti-brodalumab Binding Antibodies

  Blood samples were collected at study entry, week 4, 24 and at last visit (maximum time on study was 32 weeks).

• Change From Baseline in C-reactive Protein (CRP) Levels Over Time

  Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20

Study Arms (1)

Brodalumab 350 mg

EXPERIMENTAL

Participants received brodalumab 350 mg intravenously (IV) on day 1, week 4 and every 4 weeks thereafter for up to 132 weeks.

Biological: Brodalumab

Interventions

Brodalumab BIOLOGICAL

Administered intravenously once every 4 weeks

Also known as: AMG 827

Brodalumab 350 mg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Amgen: lead

Study Sites (34)

Research Site

Birmingham, Alabama, 35294, United States

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Jacksonville, Florida, 32256, United States

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Hammond, Louisiana, 70403, United States

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Chevy Chase, Maryland, 20815, United States

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Rochester, Minnesota, 55905, United States

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Mexico, Missouri, 65265, United States

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Great Neck, New York, 11021, United States

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Charlotte, North Carolina, 28207, United States

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Nashville, Tennessee, 37203, United States

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San Antonio, Texas, 78229, United States

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Ogden, Utah, 84405, United States

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Kurralta Park, South Australia, 5037, Australia

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Box Hill, Victoria, 3128, Australia

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Fitzroy, Victoria, 3065, Australia

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Fremantle, Western Australia, 6160, Australia

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Bonheiden, 2820, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Roeselare, 8800, Belgium

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Vancouver, British Columbia, V6Z 2K5, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Hamilton, Ontario, L8S 4J9, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Lille, 59037, France

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Nice, 06202, France

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Paris, 75010, France

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Paris, 75571, France

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Toulouse, 31059, France

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Vandœuvre-lès-Nancy, 54511, France

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Amsterdam, 1081 HV, Netherlands

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Bydgoszcz, 85-021, Poland

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Sopot, 81-757, Poland

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Barcelona, Catalonia, 08036, Spain

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Pontevedra, Galicia, 36164, Spain

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Inflammation

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: February 2, 2011
• Primary Completion: October 18, 2011
• Study Completion: October 18, 2011
• Last Updated: December 28, 2021
• Results First Posted: December 28, 2021

Record last verified: 2021-11

Locations

PL (2); US (11); ES (2); FR (6); NL (1); BE (4); CA (4); AU (4)