Trial · NCT01150890
Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease
NCT01150890, Phase 2, Terminated, Amgen; results first posted 2022-01-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease. Trials, record NCT01150890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01150890
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease
- NCT number
- NCT01150890
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 130 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Crohn's Disease
- Interventions
- Brodalumab, Placebo
- First posted
- 2010-06-25
- Last updated
- 2022-01-03
- Other registries' IDs
- eudract:2010-019544-39
- Results first posted
- 2022-01-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Clinical Remission at Week 6 | Week 6 | 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 | Percentage of Participants Who Achieved a CDAI Response at Week 6 | Week 6 | 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. |
| Secondary | Change From Baseline in CDAI at Week 6 | Baseline and week 6 | 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. A negative change from baseline indicates improvement. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug up to week 12. | An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have 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. A serious AE is an adverse event that met at least one of the following 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. The investigator assessed whether each AE was possibly related to the study drug. |
| Secondary | Maximum Observed Concentration (Cmax) of Brodalumab | After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85. | An optional pharmacokinetic (PK) substudy was offered to participants at a subset of sites and required additional informed consent. Serum concentrations of brodalumab were measured using a validated analytical method, enzyme-linked immusosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay was 0.0500 μg/mL. |
| Secondary | Time to Maximum Observed Concentration (Tmax) of Brodalumab | After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85. | An optional pharmacokinetic (PK) substudy was offered to participants at a subset of sites and required additional informed consent. Serum concentrations of brodalumab were measured using a validated analytical method, enzyme-linked immusosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay was 0.0500 μg/mL. |
| Secondary | Area Under the Serum Concentration Versus Time Curve, From Time Zero to the Last Measurable Concentration (AUClast) for Brodalumab | After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85. | An optional pharmacokinetic (PK) substudy was offered to participants at a subset of sites and required additional informed consent. Serum concentrations of brodalumab were measured using a validated analytical method, enzyme-linked immusosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay was 0.0500 μg/mL. |
| Secondary | Area Under the Serum Concentration Versus Time Curve From Time Zero to 28 Days (AUC0-28) for Brodalumab | After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, and 57. | An optional pharmacokinetic (PK) substudy was offered to participants at a subset of sites and required additional informed consent. Serum concentrations of brodalumab were measured using a validated analytical method, enzyme-linked immusosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay was 0.0500 μg/mL. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Clinical Remission at Week 6 | Week 6 | The full analysis set included all randomized participants; missing data were analyzed using the non-responder imputation method. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a CDAI Response at Week 6 | Week 6 | Full analysis set; non-responder imputation was used. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in CDAI at Week 6 | Baseline and week 6 | Full analysis set; missing CDAI scores were imputed using baseline values. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug up to week 12. | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Concentration (Cmax) of Brodalumab | After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85. | The PK analysis set includes participants in the PK substudy who received at least one dose of brodalumab and who provided valid drug concentration data at each sampling time point in Weeks 1 to 4, or in Week 5 to 12, and for whom at least one PK parameter or endpoint could be adequately estimated. | μg/mL | MEAN |
| SECONDARY | Time to Maximum Observed Concentration (Tmax) of Brodalumab | After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85. | The PK analysis set with available data | days | MEDIAN |
| SECONDARY | Area Under the Serum Concentration Versus Time Curve, From Time Zero to the Last Measurable Concentration (AUClast) for Brodalumab | After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85. | The PK analysis set with available data. | day*μg/mL | MEAN |
| SECONDARY | Area Under the Serum Concentration Versus Time Curve From Time Zero to 28 Days (AUC0-28) for Brodalumab | After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, and 57. | The PK analysis set with available data. | day*μg/mL | MEAN |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Clinical Remission at Week 6 | Placebo | 3.1 | percentage of participants | ||
| Percentage of Participants Who Achieved Clinical Remission at Week 6 | Brodalumab 210 mg | 3.1 | percentage of participants | ||
| Percentage of Participants Who Achieved Clinical Remission at Week 6 | Brodalumab 350 mg | 15.2 | percentage of participants | ||
| Percentage of Participants Who Achieved Clinical Remission at Week 6 | Brodalumab 700 mg | 9.1 | percentage of participants | ||
| Percentage of Participants Who Achieved a CDAI Response at Week 6 | Placebo | 12.5 | percentage of participants | ||
| Percentage of Participants Who Achieved a CDAI Response at Week 6 | Brodalumab 210 mg | 16.1 | percentage of participants | ||
| Percentage of Participants Who Achieved a CDAI Response at Week 6 | Brodalumab 350 mg | 27.3 | percentage of participants | ||
| Percentage of Participants Who Achieved a CDAI Response at Week 6 | Brodalumab 700 mg | 15.2 | percentage of participants | ||
| Change From Baseline in CDAI at Week 6 | Placebo | -28.2 | Standard Deviation 86.0 | score on a scale | |
| Change From Baseline in CDAI at Week 6 | Brodalumab 210 mg | -8.7 | Standard Deviation 95.3 | score on a scale |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 32 | |
| Overall Study | STARTED | Brodalumab 210 mg | 32 | |
| Overall Study | STARTED | Brodalumab 350 mg | 33 | |
| Overall Study | STARTED | Brodalumab 700 mg | 33 | |
| Overall Study | Received Study Drug | Placebo | 32 | |
| Overall Study | Received Study Drug | Brodalumab 210 mg | 31 | |
| Overall Study | Received Study Drug | Brodalumab 350 mg | 32 | |
| Overall Study | Received Study Drug | Brodalumab 700 mg | 33 | |
| Overall Study | COMPLETED | Placebo | 28 | |
| Overall Study | COMPLETED | Brodalumab 210 mg | 19 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events204
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 32 | |
| other | Anaemia | Blood and lymphatic system disorders | Brodalumab 210 mg | 0 | 31 | |
| other | Anaemia | Blood and lymphatic system disorders | Brodalumab 350 mg | 0 | 32 | |
| other | Anaemia | Blood and lymphatic system disorders | Brodalumab 700 mg | 1 | 33 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 3 | 32 | |
| other | Abdominal pain | Gastrointestinal disorders | Brodalumab 210 mg | 2 | 31 | |
| other | Abdominal pain | Gastrointestinal disorders | Brodalumab 350 mg | 3 | 32 | |
| other | Abdominal pain | Gastrointestinal disorders | Brodalumab 700 mg | 0 | 33 | |
| other | Abdominal tenderness | Gastrointestinal disorders | Placebo | 2 | 32 | |
| other | Abdominal tenderness | Gastrointestinal disorders | Brodalumab 210 mg | 0 | 31 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Brodalumab 210 mg | ||
| Total, all-cause mortality | Brodalumab 350 mg | ||
| Total, all-cause mortality | Brodalumab 700 mg | ||
| Total, other adverse events | Placebo | 20 | 32 |
| Total, other adverse events | Brodalumab 210 mg | 21 | 31 |
| Total, other adverse events | Brodalumab 350 mg | 23 | 32 |
| Total, other adverse events | Brodalumab 700 mg | 20 | 33 |
| Total, serious adverse events | Placebo | 2 | 32 |
| Total, serious adverse events | Brodalumab 210 mg | 3 | 31 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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