Crohn's DiseasePhase 2NCT01199302
Long-term Safety Study of Brodalumab in Adults With Crohn's Disease
A Phase 2 study testing Brodalumab in people with Crohn's Disease, run by Amgen at 34 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Brodalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 34 sitesin 8 countries
- Study dates
- 2 Feb 2011to 18 Oct 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
34 sites in 8 countries.
34 sites in 8 countries
United States11 sites
Research Site
Birmingham, Alabama, 35294
Research Site
Charlotte, North Carolina, 28207
Research Site
Chevy Chase, Maryland, 20815
Research Site
Great Neck, New York, 11021
Research Site
Hammond, Louisiana, 70403
Research Site
Jacksonville, Florida, 32256
Research Site
Mexico, Missouri, 65265
Research Site
Nashville, Tennessee, 37203
Research Site
Ogden, Utah, 84405
Research Site
Rochester, Minnesota, 55905
Research Site
San Antonio, Texas, 78229
France6 sites
Research Site
Lille, 59037
Research Site
Nice, 06202
Research Site
Paris, 75010
Research Site
Paris, 75571
Research Site
Toulouse, 31059
Research Site
Vandœuvre-lès-Nancy, 54511
Australia4 sites
Research Site
Box Hill, Victoria, 3128
Research Site
Fitzroy, Victoria, 3065
Research Site
Fremantle, Western Australia, 6160
Research Site
Kurralta Park, South Australia, 5037
Belgium4 sites
Research Site
Bonheiden, 2820
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
Roeselare, 8800
Canada4 sites
Research Site
Hamilton, Ontario, L8S 4J9
Research Site
Montreal, Quebec, H3A 1A1
Research Site
Vancouver, British Columbia, V6Z 2K5
Research Site
Winnipeg, Manitoba, R3A 1R9
Spain2 sites
Research Site
Barcelona, Catalonia, 08036
Research Site
Pontevedra, Galicia, 36164
About this study
Official title: A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohn's disease.
Read the detailed description
This study is an open-label extension of study 20090072 (NCT01150890) in adults with Crohn's disease.
- Conditions
- Crohn's Disease
- Being tested
- Brodalumab
- Keywords
- Amgen, Crohn's, Inflammatory Bowel Disease, IBD, Irritable Bowel Syndrome, IBS, Inflammation, bowel, colon, gastrointestinal
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrodalumabBiological
Also called AMG 827
Administered intravenously once every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Brodalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Secondary outcomes (4)
CDAI Score Over Time
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.
Measured: Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Change From Baseline in CDAI Score Over Time
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.
Measured: 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
Binding antibodies to brodalumab were detected using an anti-brodalumab immunoassay.
Measured: 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
Measured: Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study start2 Feb 2011
- Primary completion18 Oct 2011
- Study completion18 Oct 2011
Why it stopped: The study was terminated early based on an imbalance in worsening Crohn's disease in active treatment groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199302
- Sponsor's protocol ID
- 20100008
- Other IDs
- 2010-020881-53
- Status last verified
- Nov 2021
- First submitted
- 9 Sep 2010
- Last updated
- 28 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease
- ClinicalTrials.gov ID
- NCT01199302
- Acronym / sponsor ID
- 20100008
- Conditions
- Crohn's Disease
- Keywords
- Amgen, Crohn's, Inflammatory Bowel Disease, IBD, Irritable Bowel Syndrome, IBS, Inflammation, bowel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early based on an imbalance in worsening Crohn's disease in active treatment groups.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2011 (actual)
- Primary completion
- 18 Oct 2011 (actual)
- Study completion
- 18 Oct 2011 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Posted 28 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohn's disease.
Detailed description
This study is an open-label extension of study 20090072 (NCT01150890) in adults with Crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brodalumab 350 mg | Experimental | Biological: BrodalumabParticipants received brodalumab 350 mg intravenously (IV) on day 1, week 4 and every 4 weeks thereafter for up to 132 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (42 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrodalumabAlso: AMG 827Administered intravenously once every 4 weeks | Biological | Brodalumab 350 mg |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
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.
Percentage of Participants Who Achieved a CDAI Response
Time frame: Baseline of the parent study and weeks 2, 4, 6, 8, 10, 12, 16, and 20
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.
Percentage of Participants Who Achieved Clinical Remission
Time frame: Weeks 2, 4, 6, 8, 10, 12, 16, and 20
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.
4 secondary outcomes
CDAI Score Over Time
Time frame: Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Change From Baseline in CDAI Score Over Time
Time frame: 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
Time frame: 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
Time frame: Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
34 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brodalumab in people with Crohn's Disease, run by Amgen at 34 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, France, Australia, Belgium, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.