Trial Outcomes & Findings for A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab (NCT NCT02173392)
NCT ID: NCT02173392
Last Updated: 2017-06-20
Results Overview
Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
145 participants
Primary outcome timeframe
60 days
Results posted on
2017-06-20
Participant Flow
Participant milestones
| Measure |
(Treatment A Day 1-28 + Treatment B Day 29-56)
210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28)" first, then followed by "Brodalumab (2 Pre-filled Syringes \[1.0mL + 0.5mL, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases
|
(Treatment B Days 1-28 + Treatment A Days 29-56)
210 mg SC Brodalumab (2 Pre-filled Syringes \[1.0mL + 0.5mL, Treatment B Days 1-28\])" first, then "Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
72
|
|
Overall Study
COMPLETED
|
59
|
68
|
|
Overall Study
NOT COMPLETED
|
14
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab
Baseline characteristics by cohort
| Measure |
(Treatment A Day 1-28 + Treatment B Day 29-56)
n=73 Participants
210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28)" first, then followed by "Brodalumab (2 Pre-filled Syringes \[1.0mL + 0.5mL, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases
|
(Treatment B Days 1-28 + Treatment 8 Days 29-56)
n=72 Participants
210 mg SC Brodalumab (2 Pre-filled Syringes \[1.0mL + 0.5mL, Treatment B Days 1-28\])" first, then "Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
40.8 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Number of participants analyzed reflects the combination of participants analyzed at period one and then again at period two
Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection
Outcome measures
| Measure |
Treatment A, Brodalumab (Single 1.5mL Pre-filled Syringe)
n=138 Participants
A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases
|
Treatment B,Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])
n=131 Participants
A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases
|
|---|---|---|
|
Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B.
|
13.8 milligrams per milliliter
Standard Deviation 7.85
|
14.8 milligrams per milliliter
Standard Deviation 7.70
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Participants analyzed is a combination of period 1 and period 2 participants results, thus the higher number of overall participants analyzed
Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection
Outcome measures
| Measure |
Treatment A, Brodalumab (Single 1.5mL Pre-filled Syringe)
n=138 Participants
A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases
|
Treatment B,Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])
n=131 Participants
A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases
|
|---|---|---|
|
Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab
|
125 (day*mg/mL)
Standard Deviation 69
|
149 (day*mg/mL)
Standard Deviation 81.5
|
SECONDARY outcome
Timeframe: 60 daysPresence of binding or neutralizing anti-brodalumab antibodies
Outcome measures
| Measure |
Treatment A, Brodalumab (Single 1.5mL Pre-filled Syringe)
n=141 Participants
A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases
|
Treatment B,Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])
n=131 Participants
A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases
|
|---|---|---|
|
Immunogenicity
|
0 participants
|
0 participants
|
Adverse Events
(Treatment A Day 1-28 + Treatment B Day 29-56)
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
(Treatment B Days 1-28 + Treatment A Days 29-56)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
(Treatment A Day 1-28 + Treatment B Day 29-56)
n=141 participants at risk
210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28)" first, then followed by "Brodalumab (2 Pre-filled Syringes \[1.0mL + 0.5mL, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases
|
(Treatment B Days 1-28 + Treatment A Days 29-56)
n=131 participants at risk
210 mg SC Brodalumab (2 Pre-filled Syringes \[1.0mL + 0.5mL, Treatment B Days 1-28\])" first, then "Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.8%
4/141
|
2.3%
3/131
|
|
Gastrointestinal disorders
Oropharyngeal Candidiasis
|
0.71%
1/141
|
0.76%
1/131
|
|
General disorders
Injection Site Reaction
|
2.1%
3/141
|
2.3%
3/131
|
|
General disorders
Hypersensitivity
|
0.71%
1/141
|
4.6%
6/131
|
|
Infections and infestations
Infections
|
7.1%
10/141
|
7.6%
10/131
|
|
General disorders
Injection Site haemorrhage
|
1.4%
2/141
|
0.76%
1/131
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.5%
5/141
|
1.5%
2/131
|
|
Nervous system disorders
Headache
|
7.1%
10/141
|
5.3%
7/131
|
|
Gastrointestinal disorders
Nausea
|
2.1%
3/141
|
1.5%
2/131
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
2/141
|
0.76%
1/131
|
|
Musculoskeletal and connective tissue disorders
Muscle Strain
|
1.4%
2/141
|
2.3%
3/131
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER