Trial Outcomes & Findings for Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis (NCT NCT02029495)
NCT ID: NCT02029495
Last Updated: 2017-05-19
Results Overview
An ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
478 participants
Primary outcome timeframe
16 weeks
Results posted on
2017-05-19
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
|
159
|
158
|
161
|
|
Overall Study
COMPLETED
|
158
|
158
|
159
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
210 mg Brodalumab
n=159 Participants
Administered via subcutaneous injections
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection
|
140 mg Brodalumab
n=158 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=478 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
144 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
427 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 12.24 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 12.80 • n=7 Participants
|
48.1 years
STANDARD_DEVIATION 11.79 • n=5 Participants
|
49 years
STANDARD_DEVIATION 12.28 • n=4 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
230 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
248 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
155 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
459 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
27 participants
n=5 Participants
|
71 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
35 participants
n=5 Participants
|
107 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
2 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
50 participants
n=5 Participants
|
45 participants
n=7 Participants
|
44 participants
n=5 Participants
|
139 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Region of Enrollment
Slovakia
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
France
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Estonia
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksAn ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components).
Outcome measures
| Measure |
210 mg Brodalumab
n=121 Participants
Administered via subcutaneous injections
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection
|
140 mg Brodalumab
n=118 Participants
Administered via subcutaneous injection
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection
|
Placebo
n=122 Participants
Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24.
|
|---|---|---|---|
|
American College of Rheumatology (ACR) 20 Response
|
0 percentage of participants
Interval 0.0 to 0.0
|
21.8 percentage of participants
Interval 10.6 to 33.1
|
36.5 percentage of participants
Interval 22.8 to 45.3
|
SECONDARY outcome
Timeframe: 16 WeeksPASI75 indicates that the subject has had a response of a 75% reduction on the severity of the psoriasis area based of off effected area size, erythema, scaling, and itching.
Outcome measures
| Measure |
210 mg Brodalumab
n=61 Participants
Administered via subcutaneous injections
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection
|
140 mg Brodalumab
n=72 Participants
Administered via subcutaneous injection
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection
|
Placebo
n=60 Participants
Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24.
|
|---|---|---|---|
|
Psoriasis Area and Severity Index (PASI)75
|
70.3 percentage of participants
Interval 57.6 to 82.9
|
55.6 percentage of participants
Interval 27.9 to 56.6
|
0 percentage of participants
Interval 0.0 to 0.0
|
Adverse Events
210 mg Brodalumab
Serious events: 10 serious events
Other events: 84 other events
Deaths: 0 deaths
140 mg Brodalumab
Serious events: 5 serious events
Other events: 79 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
210 mg Brodalumab
n=158 participants at risk
Administered via subcutaneous injections
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection
|
140 mg Brodalumab
n=158 participants at risk
Administered via subcutaneous injection
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection
|
Placebo
n=159 participants at risk
Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24.
|
|---|---|---|---|
|
Eye disorders
Lens Dislocation
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/158
|
0.63%
1/158
|
0.00%
0/159
|
|
Skin and subcutaneous tissue disorders
Drug reaction with Eosinaphilia and Systematic symptoms
|
0.00%
0/158
|
0.63%
1/158
|
0.00%
0/159
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc protusion
|
0.00%
0/158
|
0.00%
0/158
|
0.63%
1/159
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/158
|
0.63%
1/158
|
0.00%
0/159
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
0.00%
0/158
|
0.63%
1/158
|
0.63%
1/159
|
|
Injury, poisoning and procedural complications
Eye Injury
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
|
Injury, poisoning and procedural complications
Injury
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
|
Injury, poisoning and procedural complications
Iris Injury
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
|
Injury, poisoning and procedural complications
Keratorhexis
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
|
Infections and infestations
Urosepsis
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squimos Cell Carcinoma of the Vulva
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/158
|
0.00%
0/158
|
0.63%
1/159
|
|
Psychiatric disorders
Major Depression
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
|
Psychiatric disorders
Depression
|
0.00%
0/158
|
0.00%
0/158
|
0.63%
1/159
|
|
General disorders
Dizziness
|
0.00%
0/158
|
0.63%
1/158
|
0.00%
0/159
|
Other adverse events
| Measure |
210 mg Brodalumab
n=158 participants at risk
Administered via subcutaneous injections
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection
|
140 mg Brodalumab
n=158 participants at risk
Administered via subcutaneous injection
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection
|
Placebo
n=159 participants at risk
Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.2%
24/158
|
17.7%
28/158
|
4.4%
7/159
|
|
Infections and infestations
Upper Respiratory tract Infection
|
5.7%
9/158
|
5.7%
9/158
|
5.0%
8/159
|
|
Gastrointestinal disorders
Diarrheoa
|
1.3%
2/158
|
3.2%
5/158
|
1.9%
3/159
|
|
Nervous system disorders
Headache
|
3.2%
5/158
|
1.9%
3/158
|
1.9%
3/159
|
|
Vascular disorders
Hypertension
|
6.3%
10/158
|
1.3%
2/158
|
1.9%
3/159
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
0.00%
0/158
|
1.9%
3/158
|
3.1%
5/159
|
|
Infections and infestations
bronchitis
|
3.8%
6/158
|
3.2%
5/158
|
1.3%
2/159
|
|
Infections and infestations
Sinusitis
|
1.9%
3/158
|
1.9%
3/158
|
1.3%
2/159
|
|
Infections and infestations
Rhinitis
|
2.5%
4/158
|
0.00%
0/158
|
1.9%
3/159
|
|
Infections and infestations
urinary Tract Infection
|
1.3%
2/158
|
0.00%
0/158
|
1.9%
3/159
|
|
Infections and infestations
Viral infection
|
1.3%
2/158
|
0.00%
0/158
|
0.00%
0/159
|
|
Infections and infestations
gastroenteritis
|
0.63%
1/158
|
1.9%
3/158
|
0.63%
1/159
|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
5/158
|
2.5%
4/158
|
0.63%
1/159
|
|
Psychiatric disorders
insomnia
|
0.63%
1/158
|
1.9%
3/158
|
0.63%
1/159
|
|
Psychiatric disorders
Depression
|
0.00%
0/158
|
0.00%
0/158
|
1.3%
2/159
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/158
|
1.3%
2/158
|
0.00%
0/159
|
|
Psychiatric disorders
Major Depression
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/158
|
1.3%
2/158
|
0.00%
0/159
|
|
Nervous system disorders
Dizziness
|
0.63%
1/158
|
1.3%
2/158
|
0.63%
1/159
|
|
Cardiac disorders
Palpations
|
0.00%
0/158
|
0.00%
0/158
|
1.3%
2/159
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal Pain
|
1.3%
2/158
|
0.63%
1/158
|
1.3%
2/159
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.63%
1/158
|
0.00%
0/158
|
1.3%
2/159
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/158
|
0.00%
0/158
|
1.9%
3/159
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.63%
1/158
|
0.00%
0/158
|
3.1%
5/159
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
2/158
|
1.3%
2/158
|
0.63%
1/159
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/158
|
0.00%
0/158
|
1.3%
2/159
|
|
General disorders
fatigue
|
0.63%
1/158
|
0.63%
1/158
|
1.3%
2/159
|
|
General disorders
Odema Peripheral
|
0.63%
1/158
|
0.00%
0/158
|
1.3%
2/159
|
|
General disorders
Odema
|
0.00%
0/158
|
0.00%
0/158
|
1.3%
2/159
|
|
Investigations
Blood Pressure Increased
|
1.3%
2/158
|
0.00%
0/158
|
0.00%
0/159
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER