Crohn's Disease
Conditions
Keywords
Amgen, Crohn's, Inflammatory Bowel Disease, IBD, Irritable Bowel Syndrome, IBS, Inflammation, bowel, colon, gastrointestinal
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.
Detailed description
This study is an open-label extension of study 20090072 (NCT01150890) in adults with Crohn's disease.
Interventions
BIOLOGICALBrodalumab
Administered intravenously once every 4 weeks
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CDAI Score Over Time | Weeks 2, 4, 6, 8, 10, 12, 16, and 20 | 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. |
| 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 | — |
| Change From Baseline in CDAI Score Over Time | Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20 | 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. |
| 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). | Binding antibodies to brodalumab were detected using an anti-brodalumab immunoassay. |
Countries
Australia, Belgium, Canada, France, Netherlands, Poland, Spain, United States
Participant flow
Recruitment details
This study enrolled participants who had completed the week 12 visit of the parent study 20090072 (NCT01150890). The study was conducted at 28 centers in Australia, Belgium, Canada, Spain, France, Netherlands, Poland, and the United States (US).
Pre-assignment details
In this long-term open-label extension study participants were to receive brodalumab 350 mg every 4 weeks. Results are reported by treatment group assigned in the parent study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo / Brodalumab 350 mg Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks. | 20 |
| Brodalumab 210 mg / 350 mg Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. | 16 |
| Brodalumab 350 mg / 350 mg Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. | 20 |
| Brodaluamb 700 mg / 350 mg Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. | 11 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 2 | 0 |
| Overall Study | Disease Progression | 3 | 4 | 4 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Other | 1 | 0 | 0 | 0 |
| Overall Study | Study Termination | 13 | 8 | 11 | 9 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo / Brodalumab 350 mg | Brodalumab 210 mg / 350 mg | Brodalumab 350 mg / 350 mg | Brodaluamb 700 mg / 350 mg |
|---|---|---|---|---|---|
| Age, Continuous | 35.9 years STANDARD_DEVIATION 12 | 35.2 years STANDARD_DEVIATION 12 | 36.3 years STANDARD_DEVIATION 10 | 35.4 years STANDARD_DEVIATION 13.4 | 37.6 years STANDARD_DEVIATION 13.2 |
| Crohn's Disease Activity Index (CDAI) at Baseline of Extension Study | 243.67 score on a scale STANDARD_DEVIATION 102.89 | 257.70 score on a scale STANDARD_DEVIATION 126.6 | 251.72 score on a scale STANDARD_DEVIATION 85.23 | 233.50 score on a scale STANDARD_DEVIATION 110.74 | 226.76 score on a scale STANDARD_DEVIATION 65.49 |
| Crohn's Disease Activity Index (CDAI) at Baseline of Parent Study | 320.94 score on a scale STANDARD_DEVIATION 57.87 | 317.24 score on a scale STANDARD_DEVIATION 65.21 | 321.13 score on a scale STANDARD_DEVIATION 54.01 | 336.90 score on a scale STANDARD_DEVIATION 58.92 | 298.37 score on a scale STANDARD_DEVIATION 43.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 18 Participants | 12 Participants | 14 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 2 Participants | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 12 Participants | 2 Participants | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 51 Participants | 17 Participants | 11 Participants | 14 Participants | 9 Participants |
| Sex: Female, Male Female | 38 Participants | 9 Participants | 10 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Male | 29 Participants | 11 Participants | 6 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 36 / 67 |
| serious Total, serious adverse events | 15 / 67 |
Outcome results
Primary
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.
Time frame: From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
Population: All enrolled participants who received at least one dose of brodalumab in the extension study
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo / Brodalumab 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | All treatment-emergent adverse events (TEAEs) | 14 Participants |
| Placebo / Brodalumab 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Serious adverse events | 4 Participants |
| Placebo / Brodalumab 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal adverse events | 0 Participants |
| Placebo / Brodalumab 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs leading to discontinuation of study drug | 4 Participants |
| Placebo / Brodalumab 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs leading to discontinuation from study | 3 Participants |
| Placebo / Brodalumab 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related treatment-emergent adverse events | 8 Participants |
| Placebo / Brodalumab 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related serious adverse events | 2 Participants |
| Placebo / Brodalumab 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related fatal adverse events | 0 Participants |
| Placebo / Brodalumab 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related TEAEs leading to discontinuation of study drug | 2 Participants |
| Placebo / Brodalumab 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment related TEAEs leading to discontinuation from study | 1 Participants |
| Brodalumab 210 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal adverse events | 0 Participants |
| Brodalumab 210 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related TEAEs leading to discontinuation of study drug | 1 Participants |
| Brodalumab 210 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs leading to discontinuation of study drug | 1 Participants |
| Brodalumab 210 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs leading to discontinuation from study | 2 Participants |
| Brodalumab 210 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related treatment-emergent adverse events | 9 Participants |
| Brodalumab 210 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related serious adverse events | 2 Participants |
| Brodalumab 210 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment related TEAEs leading to discontinuation from study | 1 Participants |
| Brodalumab 210 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related fatal adverse events | 0 Participants |
| Brodalumab 210 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | All treatment-emergent adverse events (TEAEs) | 12 Participants |
| Brodalumab 210 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Serious adverse events | 4 Participants |
| Brodalumab 350 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related fatal adverse events | 0 Participants |
| Brodalumab 350 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related serious adverse events | 1 Participants |
| Brodalumab 350 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment related TEAEs leading to discontinuation from study | 1 Participants |
| Brodalumab 350 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | All treatment-emergent adverse events (TEAEs) | 18 Participants |
| Brodalumab 350 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs leading to discontinuation of study drug | 3 Participants |
| Brodalumab 350 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related treatment-emergent adverse events | 14 Participants |
| Brodalumab 350 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related TEAEs leading to discontinuation of study drug | 1 Participants |
| Brodalumab 350 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Serious adverse events | 5 Participants |
| Brodalumab 350 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs leading to discontinuation from study | 3 Participants |
| Brodalumab 350 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal adverse events | 0 Participants |
| Brodaluamb 700 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs leading to discontinuation from study | 1 Participants |
| Brodaluamb 700 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related fatal adverse events | 0 Participants |
| Brodaluamb 700 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related treatment-emergent adverse events | 2 Participants |
| Brodaluamb 700 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment related TEAEs leading to discontinuation from study | 0 Participants |
| Brodaluamb 700 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related serious adverse events | 1 Participants |
| Brodaluamb 700 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Serious adverse events | 2 Participants |
| Brodaluamb 700 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal adverse events | 0 Participants |
| Brodaluamb 700 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs leading to discontinuation of study drug | 1 Participants |
| Brodaluamb 700 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | All treatment-emergent adverse events (TEAEs) | 8 Participants |
| Brodaluamb 700 mg / 350 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-related TEAEs leading to discontinuation of study drug | 0 Participants |
Primary
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.
Time frame: Baseline of the parent study and weeks 2, 4, 6, 8, 10, 12, 16, and 20
Population: Participants in the full analysis set with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 4 | 23.1 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 10 | 62.5 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 16 | 100.0 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 12 | 83.3 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 2 | 23.5 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 6 | 38.5 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 20 | 100.0 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 8 | 40.0 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 20 | 0.0 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 10 | 20.0 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 6 | 33.3 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 4 | 36.4 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 8 | 42.9 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 12 | 25.0 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 2 | 21.4 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 12 | 62.5 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 16 | 33.3 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 2 | 50.0 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 20 | 100.0 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 6 | 53.3 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 8 | 40.0 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 10 | 27.3 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 4 | 47.4 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 20 | 50.0 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 2 | 54.5 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 4 | 55.6 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 6 | 42.9 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 8 | 83.3 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 10 | 100.0 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 12 | 80.0 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved a CDAI Response | Week 16 | 100.0 percentage of participants |
Primary
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.
Time frame: Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Population: Participants in the full analysis set with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 4 | 15.4 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 10 | 37.5 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 16 | 75.0 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 12 | 50.0 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 2 | 5.9 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 6 | 23.1 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 20 | 100.0 percentage of participants |
| Placebo / Brodalumab 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 8 | 40.0 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 20 | 0.0 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 10 | 0.0 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 6 | 0.0 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 4 | 9.1 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 8 | 0.0 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 12 | 0.0 percentage of participants |
| Brodalumab 210 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 2 | 7.1 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 12 | 50.0 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 16 | 33.3 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 2 | 27.8 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 20 | 100.0 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 6 | 33.3 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 8 | 13.3 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 10 | 18.2 percentage of participants |
| Brodalumab 350 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 4 | 26.3 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 20 | 0.0 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 2 | 27.3 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 4 | 22.2 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 6 | 28.6 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 8 | 50.0 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 10 | 75.0 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 12 | 60.0 percentage of participants |
| Brodaluamb 700 mg / 350 mg | Percentage of Participants Who Achieved Clinical Remission | Week 16 | 0.0 percentage of participants |
Secondary
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.
Time frame: Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Population: Participants in the full analysis set with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo / Brodalumab 350 mg | CDAI Score Over Time | Week 4 | 274.21 score on a scale | Standard Deviation 154.79 |
| Placebo / Brodalumab 350 mg | CDAI Score Over Time | Week 10 | 196.56 score on a scale | Standard Deviation 157.07 |
| Placebo / Brodalumab 350 mg | CDAI Score Over Time | Week 16 | 103.61 score on a scale | Standard Deviation 48.6 |
| Placebo / Brodalumab 350 mg | CDAI Score Over Time | Week 12 | 120.47 score on a scale | Standard Deviation 93.27 |
| Placebo / Brodalumab 350 mg | CDAI Score Over Time | Week 2 | 291.71 score on a scale | Standard Deviation 159.01 |
| Placebo / Brodalumab 350 mg | CDAI Score Over Time | Week 6 | 257.09 score on a scale | Standard Deviation 154.96 |
| Placebo / Brodalumab 350 mg | CDAI Score Over Time | Week 20 | 101.60 score on a scale | Standard Deviation 62.32 |
| Placebo / Brodalumab 350 mg | CDAI Score Over Time | Week 8 | 250.95 score on a scale | Standard Deviation 167.25 |
| Brodalumab 210 mg / 350 mg | CDAI Score Over Time | Week 20 | 212.42 score on a scale | — |
| Brodalumab 210 mg / 350 mg | CDAI Score Over Time | Week 10 | 274.81 score on a scale | Standard Deviation 90.7 |
| Brodalumab 210 mg / 350 mg | CDAI Score Over Time | Week 6 | 274.48 score on a scale | Standard Deviation 93.41 |
| Brodalumab 210 mg / 350 mg | CDAI Score Over Time | Week 4 | 244.11 score on a scale | Standard Deviation 62.6 |
| Brodalumab 210 mg / 350 mg | CDAI Score Over Time | Week 8 | 248.03 score on a scale | Standard Deviation 70.86 |
| Brodalumab 210 mg / 350 mg | CDAI Score Over Time | Week 12 | 317.49 score on a scale | Standard Deviation 27.14 |
| Brodalumab 210 mg / 350 mg | CDAI Score Over Time | Week 2 | 285.41 score on a scale | Standard Deviation 86.69 |
| Brodalumab 350 mg / 350 mg | CDAI Score Over Time | Week 12 | 224.79 score on a scale | Standard Deviation 131.61 |
| Brodalumab 350 mg / 350 mg | CDAI Score Over Time | Week 16 | 220.67 score on a scale | Standard Deviation 178.45 |
| Brodalumab 350 mg / 350 mg | CDAI Score Over Time | Week 2 | 235.12 score on a scale | Standard Deviation 100.66 |
| Brodalumab 350 mg / 350 mg | CDAI Score Over Time | Week 20 | 145.33 score on a scale | — |
| Brodalumab 350 mg / 350 mg | CDAI Score Over Time | Week 6 | 241.13 score on a scale | Standard Deviation 134.06 |
| Brodalumab 350 mg / 350 mg | CDAI Score Over Time | Week 8 | 267.51 score on a scale | Standard Deviation 173.2 |
| Brodalumab 350 mg / 350 mg | CDAI Score Over Time | Week 10 | 276.37 score on a scale | Standard Deviation 138.48 |
| Brodalumab 350 mg / 350 mg | CDAI Score Over Time | Week 4 | 256.22 score on a scale | Standard Deviation 125.24 |
| Brodaluamb 700 mg / 350 mg | CDAI Score Over Time | Week 20 | 223.11 score on a scale | Standard Deviation 13.52 |
| Brodaluamb 700 mg / 350 mg | CDAI Score Over Time | Week 2 | 197.71 score on a scale | Standard Deviation 81.22 |
| Brodaluamb 700 mg / 350 mg | CDAI Score Over Time | Week 4 | 192.04 score on a scale | Standard Deviation 54.62 |
| Brodaluamb 700 mg / 350 mg | CDAI Score Over Time | Week 6 | 219.91 score on a scale | Standard Deviation 121.19 |
| Brodaluamb 700 mg / 350 mg | CDAI Score Over Time | Week 8 | 159.39 score on a scale | Standard Deviation 66.53 |
| Brodaluamb 700 mg / 350 mg | CDAI Score Over Time | Week 10 | 127.57 score on a scale | Standard Deviation 46.38 |
| Brodaluamb 700 mg / 350 mg | CDAI Score Over Time | Week 12 | 159.91 score on a scale | Standard Deviation 61.03 |
| Brodaluamb 700 mg / 350 mg | CDAI Score Over Time | Week 16 | 186.11 score on a scale | Standard Deviation 10.05 |
Secondary
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.
Time frame: Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Population: Participants in the full analysis set with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo / Brodalumab 350 mg | Change From Baseline in CDAI Score Over Time | Week 6 | -55.4 score on a scale | Standard Deviation 101.4 |
| Placebo / Brodalumab 350 mg | Change From Baseline in CDAI Score Over Time | Week 16 | -162.1 score on a scale | Standard Deviation 51.3 |
| Placebo / Brodalumab 350 mg | Change From Baseline in CDAI Score Over Time | Week 8 | -48.7 score on a scale | Standard Deviation 143.2 |
| Placebo / Brodalumab 350 mg | Change From Baseline in CDAI Score Over Time | Week 4 | -49.7 score on a scale | Standard Deviation 112.5 |
| Placebo / Brodalumab 350 mg | Change From Baseline in CDAI Score Over Time | Week 20 | -164.1 score on a scale | Standard Deviation 53.8 |
| Placebo / Brodalumab 350 mg | Change From Baseline in CDAI Score Over Time | Week 12 | -174.5 score on a scale | Standard Deviation 76 |
| Placebo / Brodalumab 350 mg | Change From Baseline in CDAI Score Over Time | Week 2 | -25.8 score on a scale | Standard Deviation 128 |
| Placebo / Brodalumab 350 mg | Change From Baseline in CDAI Score Over Time | Week 10 | -116.1 score on a scale | Standard Deviation 103.5 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 2 | -35.0 score on a scale | Standard Deviation 90.8 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 4 | -79.2 score on a scale | Standard Deviation 67.6 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 20 | -61.3 score on a scale | — |
| Brodalumab 210 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 6 | -51.5 score on a scale | Standard Deviation 106.7 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 8 | -84.6 score on a scale | Standard Deviation 79.8 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 10 | -45.3 score on a scale | Standard Deviation 81.5 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 12 | -20.7 score on a scale | Standard Deviation 69.1 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 2 | -97.0 score on a scale | Standard Deviation 106.9 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 4 | -78.2 score on a scale | Standard Deviation 107.3 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 12 | -80.8 score on a scale | Standard Deviation 120.4 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 10 | -56.1 score on a scale | Standard Deviation 146.5 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 20 | -109.7 score on a scale | — |
| Brodalumab 350 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 6 | -84.3 score on a scale | Standard Deviation 128.3 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 16 | -55.9 score on a scale | Standard Deviation 155.5 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 8 | -55.4 score on a scale | Standard Deviation 157.2 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 20 | -91.8 score on a scale | Standard Deviation 57.2 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 4 | -101.1 score on a scale | Standard Deviation 62 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 2 | -100.7 score on a scale | Standard Deviation 83.7 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 6 | -67.8 score on a scale | Standard Deviation 127.6 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 8 | -150.4 score on a scale | Standard Deviation 35.6 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 10 | -182.6 score on a scale | Standard Deviation 32.7 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 12 | -160.2 score on a scale | Standard Deviation 50.3 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in CDAI Score Over Time | Week 16 | -128.8 score on a scale | Standard Deviation 33.6 |
Secondary
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
Population: Participants in the full analysis set with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo / Brodalumab 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 2 | 13.0 mg/dL | Standard Deviation 33.9 |
| Placebo / Brodalumab 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 10 | 11.5 mg/dL | Standard Deviation 31.9 |
| Placebo / Brodalumab 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 12 | 2.9 mg/dL | Standard Deviation 9.7 |
| Placebo / Brodalumab 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 6 | 5.2 mg/dL | Standard Deviation 14.1 |
| Placebo / Brodalumab 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 20 | -3.0 mg/dL | Standard Deviation 3.4 |
| Placebo / Brodalumab 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 8 | 15.5 mg/dL | Standard Deviation 49.2 |
| Placebo / Brodalumab 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 16 | 1.0 mg/dL | Standard Deviation 18.1 |
| Placebo / Brodalumab 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 4 | -0.8 mg/dL | Standard Deviation 9.9 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 8 | -2.4 mg/dL | Standard Deviation 15 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 12 | 1.2 mg/dL | Standard Deviation 19.1 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 16 | 0.2 mg/dL | — |
| Brodalumab 210 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 2 | 10.7 mg/dL | Standard Deviation 53.8 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 4 | -0.8 mg/dL | Standard Deviation 17.9 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 6 | 5.9 mg/dL | Standard Deviation 26.2 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 10 | 4.3 mg/dL | Standard Deviation 28.8 |
| Brodalumab 210 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 20 | -3.2 mg/dL | — |
| Brodalumab 350 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 4 | -8.1 mg/dL | Standard Deviation 25.9 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 20 | -1.1 mg/dL | — |
| Brodalumab 350 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 16 | -9.5 mg/dL | Standard Deviation 11.5 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 10 | 0.9 mg/dL | Standard Deviation 34.1 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 2 | -3.5 mg/dL | Standard Deviation 22.9 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 8 | 3.7 mg/dL | Standard Deviation 19.9 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 12 | 15.4 mg/dL | Standard Deviation 34.9 |
| Brodalumab 350 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 6 | -5.1 mg/dL | Standard Deviation 30 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 12 | -11.5 mg/dL | Standard Deviation 17.9 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 8 | 7.2 mg/dL | Standard Deviation 49.5 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 10 | -1.2 mg/dL | Standard Deviation 2.3 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 4 | 9.9 mg/dL | Standard Deviation 52.4 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 2 | 3.2 mg/dL | Standard Deviation 19.8 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 16 | -15.0 mg/dL | Standard Deviation 23.5 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 20 | -10.9 mg/dL | Standard Deviation 21.1 |
| Brodaluamb 700 mg / 350 mg | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Week 6 | 17.5 mg/dL | Standard Deviation 25.9 |
Secondary
Number of Participants Who Developed Anti-brodalumab Binding Antibodies
Binding antibodies to brodalumab were detected using an anti-brodalumab immunoassay.
Time frame: Blood samples were collected at study entry, week 4, 24 and at last visit (maximum time on study was 32 weeks).
Population: Enrolled participants who received at least one dose of brodalumab in the extension study and with available antibody results
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo / Brodalumab 350 mg | Number of Participants Who Developed Anti-brodalumab Binding Antibodies | 0 Participants |
| Brodalumab 210 mg / 350 mg | Number of Participants Who Developed Anti-brodalumab Binding Antibodies | 0 Participants |
| Brodalumab 350 mg / 350 mg | Number of Participants Who Developed Anti-brodalumab Binding Antibodies | 0 Participants |
| Brodaluamb 700 mg / 350 mg | Number of Participants Who Developed Anti-brodalumab Binding Antibodies | 0 Participants |