Adults 18 to 70, any sex, with Rheumatoid Arthritis. 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.
Number of Participants With Treatment-emergent Adverse EventsPrimary· From first dose of study drug up to end of study (week 19).
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, including any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition.
A serious adverse event was defined as an adverse event that was fatal; was life threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other significant
Any treatment-emergent adverse event (TEAE)
Group
Value
95% CI
Placebo SC (Cohorts 1-3)
3
Placebo IV (Cohorts 5-6)
4
Brodalumab 50 mg SC (Cohort 1)
5
Brodalumab 140 mg SC (Cohort 2)
5
Brodalumab 210 mg SC (Cohort 3)
4
Brodalumab 420 mg IV (Cohort 5)
5
Brodalumab 700 mg IV (Cohort 6)
4
Serious TEAEs
Group
Value
95% CI
Placebo SC (Cohorts 1-3)
1
Placebo IV (Cohorts 5-6)
0
Brodalumab 50 mg SC (Cohort 1)
0
Brodalumab 140 mg SC (Cohort 2)
0
Brodalumab 210 mg SC (Cohort 3)
0
Brodalumab 420 mg IV (Cohort 5)
1
Brodalumab 700 mg IV (Cohort 6)
0
Treatment-related TEAEs
Group
Value
95% CI
Placebo SC (Cohorts 1-3)
1
Placebo IV (Cohorts 5-6)
2
Brodalumab 50 mg SC (Cohort 1)
0
Brodalumab 140 mg SC (Cohort 2)
3
Brodalumab 210 mg SC (Cohort 3)
2
Brodalumab 420 mg IV (Cohort 5)
2
Brodalumab 700 mg IV (Cohort 6)
0
Treatment-related serious TEAEs
Group
Value
95% CI
Placebo SC (Cohorts 1-3)
0
Placebo IV (Cohorts 5-6)
0
Brodalumab 50 mg SC (Cohort 1)
0
Brodalumab 140 mg SC (Cohort 2)
0
Brodalumab 210 mg SC (Cohort 3)
0
Brodalumab 420 mg IV (Cohort 5)
0
Brodalumab 700 mg IV (Cohort 6)
0
Discontinuation of study drug due to TEAE
Group
Value
95% CI
Placebo SC (Cohorts 1-3)
0
Placebo IV (Cohorts 5-6)
0
Brodalumab 50 mg SC (Cohort 1)
0
Brodalumab 140 mg SC (Cohort 2)
0
Brodalumab 210 mg SC (Cohort 3)
0
Brodalumab 420 mg IV (Cohort 5)
0
Brodalumab 700 mg IV (Cohort 6)
1
Deaths on study
Group
Value
95% CI
Placebo SC (Cohorts 1-3)
0
Placebo IV (Cohorts 5-6)
0
Brodalumab 50 mg SC (Cohort 1)
0
Brodalumab 140 mg SC (Cohort 2)
0
Brodalumab 210 mg SC (Cohort 3)
0
Brodalumab 420 mg IV (Cohort 5)
0
Brodalumab 700 mg IV (Cohort 6)
0
Number of Participants With Clinically Significant Changes in Safety Laboratory TestsPrimary· Blood samples were taken on days 2, 8, 15, 29, 43, 57, 71, 85, 106, and 127.
The investigator reviewed laboratory test results and determined whether an abnormal value in an individual study participant represented a change from prestudy values and determined if changes were clinically significant. The number of participants with clinically significant changes in lab values at any time during the study is reported.
Group
Value
95% CI
Placebo SC (Cohorts 1-3)
0
Placebo IV (Cohorts 5-6)
0
Brodalumab 50 mg SC (Cohort 1)
0
Brodalumab 140 mg SC (Cohort 2)
0
Brodalumab 210 mg SC (Cohort 3)
0
Brodalumab 420 mg IV (Cohort 5)
0
Brodalumab 700 mg IV (Cohort 6)
0
Number of Participants With Clinically Significant Changes in Physical Examination Findings, Vital Signs, or Electrocardiogram FindingsPrimary· From first dose of study drug up to 4 weeks after last dose; 14 weeks for Cohorts 1, 2, and 3 and 8 weeks for Cohorts 5 and 6.
Group
Value
95% CI
Placebo SC (Cohorts 1-3)
0
Placebo IV (Cohorts 5-6)
0
Brodalumab 50 mg SC (Cohort 1)
0
Brodalumab 140 mg SC (Cohort 2)
0
Brodalumab 210 mg SC (Cohort 3)
0
Brodalumab 420 mg IV (Cohort 5)
0
Brodalumab 700 mg IV (Cohort 6)
0
Number of Participants With Anti-brodalumab AntibodiesPrimary· Days 1 (pre-dose), 29 (pre-dose), 85, and 127
Samples were tested in a validated immunoassay for the presence of anti-brodalumab binding antibodies. Samples found to be positive for binding antibodies were further tested using a validated cell-based bioassay to determine if the antibodies were able to neutralize the activity of brodalumab.
Binding antibodies
Group
Value
95% CI
Placebo SC (Cohorts 1-3)
0
Placebo IV (Cohorts 5-6)
0
Brodalumab 50 mg SC (Cohort 1)
1
Brodalumab 140 mg SC (Cohort 2)
0
Brodalumab 210 mg SC (Cohort 3)
1
Brodalumab 420 mg IV (Cohort 5)
0
Brodalumab 700 mg IV (Cohort 6)
0
Neutralizing antibodies
Group
Value
95% CI
Placebo SC (Cohorts 1-3)
0
Placebo IV (Cohorts 5-6)
0
Brodalumab 50 mg SC (Cohort 1)
0
Brodalumab 140 mg SC (Cohort 2)
0
Brodalumab 210 mg SC (Cohort 3)
0
Brodalumab 420 mg IV (Cohort 5)
0
Brodalumab 700 mg IV (Cohort 6)
0
Time to Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous DosesSecondary· After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.
Day 1 (first dose)
Group
Value
95% CI
Brodalumab 50 mg SC (Cohort 1)
1.46
0.18 – 2.00
Brodalumab 140 mg SC (Cohort 2)
3.96
2.00 – 4.00
Brodalumab 210 mg SC (Cohort 3)
2.99
0.97 – 4.00
Day 71 (last dose)
Group
Value
95% CI
Brodalumab 50 mg SC (Cohort 1)
2.00
1.13 – 2.09
Brodalumab 140 mg SC (Cohort 2)
3.95
1.93 – 4.07
Brodalumab 210 mg SC (Cohort 3)
4.00
1.02 – 4.02
Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous DosesSecondary· After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.
Day 1 (first dose)
Group
Value
95% CI
Brodalumab 50 mg SC (Cohort 1)
0.742
± 0.522
Brodalumab 140 mg SC (Cohort 2)
5.67
± 2.98
Brodalumab 210 mg SC (Cohort 3)
16.6
± 8.97
Day 71 (last dose)
Group
Value
95% CI
Brodalumab 50 mg SC (Cohort 1)
1.35
± 1.07
Brodalumab 140 mg SC (Cohort 2)
5.93
± 5.15
Brodalumab 210 mg SC (Cohort 3)
18.4
± 7.21
Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Subcutaneous DosesSecondary· After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.
Day 1 (first dose)
Group
Value
95% CI
Brodalumab 50 mg SC (Cohort 1)
1.77
± 1.61
Brodalumab 140 mg SC (Cohort 2)
37.6
± 27.8
Brodalumab 210 mg SC (Cohort 3)
142
± 67.3
Day 71 (last dose)
Group
Value
95% CI
Brodalumab 50 mg SC (Cohort 1)
4.13
± 3.20
Brodalumab 140 mg SC (Cohort 2)
50.8
± 51.5
Brodalumab 210 mg SC (Cohort 3)
191
± 82.7
Accumulation Ratio for Brodalumab After Subcutaneous DosingSecondary· After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.
Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose).
Group
Value
95% CI
Brodalumab 50 mg SC (Cohort 1)
24.4
± 51.4
Brodalumab 140 mg SC (Cohort 2)
1.3
± 0.8
Brodalumab 210 mg SC (Cohort 3)
1.5
± 0.6
Time to Maximum Concentration of Brodalumab After Single and Multiple Intravenous DosesSecondary· After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.
Day 1 (first dose)
Group
Value
95% CI
Brodalumab 420 mg IV (Cohort 5)
4.07
3.40 – 22.27
Brodalumab 700 mg IV (Cohort 6)
0.92
0.82 – 1.53
Day 29 (last dose)
Group
Value
95% CI
Brodalumab 420 mg IV (Cohort 5)
0.98
0.77 – 4.02
Brodalumab 700 mg IV (Cohort 6)
0.83
0.57 – 4.55
Maximum Concentration of Brodalumab After Single and Multiple Intravenous DosesSecondary· After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.
Day 1 (first dose)
Group
Value
95% CI
Brodalumab 420 mg IV (Cohort 5)
111
± 19.2
Brodalumab 700 mg IV (Cohort 6)
240
± 44.8
Day 29 (last dose)
Group
Value
95% CI
Brodalumab 420 mg IV (Cohort 5)
127
± 12.1
Brodalumab 700 mg IV (Cohort 6)
655
± 949
Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Intravenous DosesSecondary· After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.
Day 1 (first dose)
Group
Value
95% CI
Brodalumab 420 mg IV (Cohort 5)
831
± 197
Brodalumab 700 mg IV (Cohort 6)
1840
± 602
Day 29 (last dose)
Group
Value
95% CI
Brodalumab 420 mg IV (Cohort 5)
951
± 307
Brodalumab 700 mg IV (Cohort 6)
2230
± 998
Accumulation Ratio for Brodalumab After Intravenous DosingSecondary· After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.
Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose).
Group
Value
95% CI
Brodalumab 420 mg IV (Cohort 5)
1.1
± 0.2
Brodalumab 700 mg IV (Cohort 6)
1.2
± 0.1
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug up to end of study (week 19)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This Phase 1b/2a study will evaluate safety, tolerability pharmacokinetics (PK) and pharmacodynamics (PD) of brodalumab when administered in multiple subcutaneous (SC) and intravenous (IV) doses in patients with active rheumatoid arthritis (RA) in combination with a stable dose of disease modulating anti-rheumatic drugs (DMARDs). Part A is dose escalation (to assess safety \& tolerability), and Part B is dose expansion (to assess clinical efficacy) at the highest tolerated dose level of brodalumab from Part A.
Publications & conference data
4 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 Rheumatoid Arthritis
Currently open trials in the same condition.
NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis
· Phase 1
· recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis
· recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
· Phase 1
· recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel
· EARLY_PHASE1
· recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
· Phase 1
· 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: 26 November 2021
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/NCT00771030.