Trial Outcomes & Findings for Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis (NCT NCT02024646)
NCT ID: NCT02024646
Last Updated: 2020-08-20
Results Overview
ACR20 is used as a measurement of the proportion of subjects who are reaching a 20% improvement of tender an swollen joint counts. The higher percent of subjects reaching a higher improvement percentage shows greater success.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
484 participants
Primary outcome timeframe
Baseline and 16 Weeks
Results posted on
2020-08-20
Participant Flow
Participant milestones
| Measure |
210 mg Brodalumab
Administered via subcutaneous injections.
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection.
|
140 mg Brodalumab
Administered via subcutaneous injection.
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection.
|
Placebo
Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24.
|
|---|---|---|---|
|
Overall Study
STARTED
|
163
|
160
|
161
|
|
Overall Study
COMPLETED
|
131
|
135
|
133
|
|
Overall Study
NOT COMPLETED
|
32
|
25
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
210 mg Brodalumab
n=163 Participants
Administered via subcutaneous injections.
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection.
|
140 mg Brodalumab
n=160 Participants
Administered via subcutaneous injection.
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection.
|
Placebo
n=161 Participants
Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24.
|
Total
n=484 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45 years
n=5 Participants
|
48 years
n=7 Participants
|
49 years
n=5 Participants
|
48 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
249 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
235 Participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
14 participants
n=7 Participants
|
9 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Region of Enrollment
Latvia
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
19 participants
n=5 Participants
|
56 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
3 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
37 participants
n=7 Participants
|
43 participants
n=5 Participants
|
122 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
62 participants
n=5 Participants
|
57 participants
n=7 Participants
|
58 participants
n=5 Participants
|
177 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
France
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
27 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16 WeeksPopulation: The Primary Analysis Set consists of all randomized subjects who had the opportunity to complete the week 16 visit prior to termination of the study. The numbers in the outcome measure data table reflect the percentage of subjects achieving ACR20.
ACR20 is used as a measurement of the proportion of subjects who are reaching a 20% improvement of tender an swollen joint counts. The higher percent of subjects reaching a higher improvement percentage shows greater success.
Outcome measures
| Measure |
210 mg Brodalumab
n=146 Participants
Administered via subcutaneous injections.
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection.
|
140 mg Brodalumab
n=141 Participants
Administered via subcutaneous injection.
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection.
|
Placebo
n=146 Participants
Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24.
|
|---|---|---|---|
|
ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16
|
41.8 Percentage of Participants
|
48.9 Percentage of Participants
|
24.7 Percentage of Participants
|
Adverse Events
210 mg Brodalumab
Serious events: 5 serious events
Other events: 91 other events
Deaths: 0 deaths
140 mg Brodalumab
Serious events: 3 serious events
Other events: 85 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
210 mg Brodalumab
n=163 participants at risk
Administered via subcutaneous injections.
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection.
|
140 mg Brodalumab
n=160 participants at risk
Administered via subcutaneous injection.
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection.
|
Placebo
n=161 participants at risk
Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ALT increased
|
0.61%
1/163
|
0.00%
0/160
|
0.62%
1/161
|
|
Skin and subcutaneous tissue disorders
Bursitis
|
0.61%
1/163
|
0.00%
0/160
|
0.00%
0/161
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.61%
1/163
|
0.00%
0/160
|
0.00%
0/161
|
|
Skin and subcutaneous tissue disorders
Psoriatic Arthropathy
|
0.61%
1/163
|
0.00%
0/160
|
0.00%
0/161
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
0.61%
1/163
|
0.00%
0/160
|
0.00%
0/161
|
|
Surgical and medical procedures
Abortion Induced
|
0.00%
0/163
|
0.62%
1/160
|
0.00%
0/161
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/163
|
0.00%
0/160
|
1.2%
2/161
|
|
Blood and lymphatic system disorders
AST Increased
|
0.00%
0/163
|
0.00%
0/160
|
0.62%
1/161
|
|
Vascular disorders
Carotid Artery Stenosis
|
0.00%
0/163
|
0.00%
0/160
|
0.62%
1/161
|
|
Injury, poisoning and procedural complications
Cerebrovascular Accident
|
0.00%
0/163
|
0.62%
1/160
|
0.00%
0/161
|
|
Blood and lymphatic system disorders
Haemorrhoidal haemorrhage
|
0.00%
0/163
|
0.62%
1/160
|
0.00%
0/161
|
Other adverse events
| Measure |
210 mg Brodalumab
n=163 participants at risk
Administered via subcutaneous injections.
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection.
|
140 mg Brodalumab
n=160 participants at risk
Administered via subcutaneous injection.
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection.
|
Placebo
n=161 participants at risk
Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
17.2%
28/163
|
10.6%
17/160
|
4.3%
7/161
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.8%
16/163
|
10.0%
16/160
|
1.2%
2/161
|
|
Infections and infestations
Sinusitus
|
6.1%
10/163
|
1.2%
2/160
|
1.2%
2/161
|
|
Infections and infestations
Oral Herpes
|
3.7%
6/163
|
1.9%
3/160
|
0.00%
0/161
|
|
Infections and infestations
Bronchitis
|
3.1%
5/163
|
2.5%
4/160
|
1.2%
2/161
|
|
Infections and infestations
Urinary Tract Infection
|
3.1%
5/163
|
5.0%
8/160
|
0.62%
1/161
|
|
Infections and infestations
Pharyngitis
|
2.5%
4/163
|
3.1%
5/160
|
2.5%
4/161
|
|
Infections and infestations
Influenza
|
1.2%
2/163
|
1.2%
2/160
|
1.9%
3/161
|
|
Infections and infestations
Laryngitis
|
1.2%
2/163
|
2.5%
4/160
|
1.9%
3/161
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/163
|
0.00%
0/160
|
1.9%
3/161
|
|
Metabolism and nutrition disorders
Gout
|
3.1%
5/163
|
0.00%
0/160
|
0.00%
0/161
|
|
Nervous system disorders
Headache
|
3.1%
5/163
|
3.1%
5/160
|
3.1%
5/161
|
|
Vascular disorders
Hypertension
|
2.5%
4/163
|
4.4%
7/160
|
0.62%
1/161
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
5/163
|
1.2%
2/160
|
3.1%
5/161
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.8%
3/163
|
3.1%
5/160
|
3.7%
6/161
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
1.2%
2/163
|
4.4%
7/160
|
0.62%
1/161
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
13/163
|
3.8%
6/160
|
2.5%
4/161
|
|
Gastrointestinal disorders
Nausea
|
4.3%
7/163
|
5.0%
8/160
|
2.5%
4/161
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/163
|
0.62%
1/160
|
1.9%
3/161
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
6/163
|
1.9%
3/160
|
0.62%
1/161
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
4.9%
8/163
|
4.4%
7/160
|
0.00%
0/161
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
4.9%
8/163
|
0.00%
0/160
|
0.62%
1/161
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
5/163
|
3.8%
6/160
|
2.5%
4/161
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.8%
3/163
|
2.5%
4/160
|
3.1%
5/161
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.2%
2/163
|
1.2%
2/160
|
1.9%
3/161
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.61%
1/163
|
2.5%
4/160
|
2.5%
4/161
|
|
General disorders
Fatigue
|
0.61%
1/163
|
0.62%
1/160
|
1.9%
3/161
|
|
General disorders
Chest Pain
|
0.00%
0/163
|
0.62%
1/160
|
2.5%
4/161
|
|
General disorders
peripheral Swelling
|
0.00%
0/163
|
1.9%
3/160
|
1.9%
3/161
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
4/163
|
4.4%
7/160
|
3.1%
5/161
|
|
General disorders
Ligament Sprain
|
2.5%
4/163
|
0.00%
0/160
|
1.9%
3/161
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place