Adults 18 to 65, any sex, with Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Achieved Clinical Remission at Week 6Primary· 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.
Group
Value
95% CI
Placebo
3.1
Brodalumab 210 mg
3.1
Brodalumab 350 mg
15.2
Brodalumab 700 mg
9.1
Percentage of Participants Who Achieved a CDAI Response at Week 6Secondary· 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.
Group
Value
95% CI
Placebo
12.5
Brodalumab 210 mg
16.1
Brodalumab 350 mg
27.3
Brodalumab 700 mg
15.2
Change From Baseline in CDAI at Week 6Secondary· 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.
Group
Value
95% CI
Placebo
-28.2
± 86.0
Brodalumab 210 mg
-8.7
± 95.3
Brodalumab 350 mg
-35.4
± 105.6
Brodalumab 700 mg
-0.6
± 105.9
Number of Participants With Treatment-emergent Adverse Events (TEAEs)Secondary· 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 hospitaliz
Maximum Observed Concentration (Cmax) of BrodalumabSecondary· 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.
After first dose
Group
Value
95% CI
Brodalumab 210 mg
53.1
± 6.40
Brodalumab 350 mg
96.4
± 17.6
Brodalumab 700 mg
184
± 64.9
After second dose
Group
Value
95% CI
Brodalumab 210 mg
54.5
± 1.08
Brodalumab 350 mg
98.7
± 20.6
Brodalumab 700 mg
171
± 63.2
Time to Maximum Observed Concentration (Tmax) of BrodalumabSecondary· 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.
After first dose
Group
Value
95% CI
Brodalumab 210 mg
0.034
0.028 – 0.22
Brodalumab 350 mg
0.034
0.021 – 0.050
Brodalumab 700 mg
0.036
0.024 – 0.047
After second dose
Group
Value
95% CI
Brodalumab 210 mg
0.031
0.026 – 0.039
Brodalumab 350 mg
0.033
0.024 – 0.042
Brodalumab 700 mg
0.029
0.024 – 0.039
Area Under the Serum Concentration Versus Time Curve, From Time Zero to the Last Measurable Concentration (AUClast) for BrodalumabSecondary· 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.
After first dose
Group
Value
95% CI
Brodalumab 210 mg
243
± 61.0
Brodalumab 350 mg
501
± 190
Brodalumab 700 mg
1428
± 715
After second dose
Group
Value
95% CI
Brodalumab 210 mg
164
± 124
Brodalumab 350 mg
622
± 330
Brodalumab 700 mg
1558
± 691
Area Under the Serum Concentration Versus Time Curve From Time Zero to 28 Days (AUC0-28) for BrodalumabSecondary· 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.
After first dose
Group
Value
95% CI
Brodalumab 210 mg
243
± 61.0
Brodalumab 350 mg
501
± 190
Brodalumab 700 mg
1432
± 714
After second dose
Group
Value
95% CI
Brodalumab 210 mg
164
± 124
Brodalumab 350 mg
595
± 268
Brodalumab 700 mg
1434
± 597
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug up to week 12..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04305327 — Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis
· Phase 3
· terminated
NCT04306315 — Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and
· Phase 4
· completed
NCT05132231 — Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Wor
· active not recruiting
NCT04979520 — Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa
· EARLY_PHASE1
· completed
NCT04533737 — Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Respons
· Phase 4
· terminated
Other recruiting trials for Crohn's Disease
Currently open trials in the same condition.
NCT07273188 — 68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease
· EARLY_PHASE1
· recruiting
NCT07184944 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti
· Phase 3
· recruiting
NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea
· recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD
· Phase 3
· recruiting
NCT07184931 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ
· Phase 3
· recruiting
Other Amgen trials
Trials by the same sponsor.
NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly
· Phase 3
· not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer
· Phase 1
· not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
· Phase 1
· not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen
· Phase 2
· recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 3 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01150890.