AMVISION-2: Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02024646
• Collaborator: (none)
• Enrollment: 484
• Locations: 103
• Arms: 3
• Duration (Months): 19
• Patients Per Site: 4.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Drug: 210 mg brodalumab; Drug: 140 mg brodalumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 484 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 210 mg brodalumab Administered via subcutaneous injections.	Drug: 210 mg brodalumab; 210 mg brodalumab administered via subcutaneous injection.; Other Names: AMG 827
Experimental: 140 mg brodalumab Administered via subcutaneous injection.	Drug: 140 mg brodalumab; 140 mg brodalumab administered via subcutaneous injection.; Other Names: AMG 827
Placebo Comparator: Placebo Administered via subcutaneous injection until week 24.	Drug: Placebo; Placebo administered via subcutaneous injection until week 24.

Outcome Measures

Primary Outcome Measures

1. ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 [Baseline and 16 Weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal interphalangeal joints). Subjects must have at least

1 psoriatic skin lesion. Exclusion Criteria:

• -Subject has known history of active tuberculosis.

• Subject has a planned surgical intervention between baseline and the week 52 evaluation.

• Subject has an active infection or history of infections.

• Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the Investigator to be clinically significant and uncontrolled.

• Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.

Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)

• Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Peoria	Arizona	United States	85381
2	Research Site	Little Rock	Arkansas	United States	72205
3	Research Site	Cypress	California	United States	90630
4	Research Site	Hemet	California	United States	92543
5	Research Site	Huntington Beach	California	United States	92646
6	Research Site	La Jolla	California	United States	92037
7	Research Site	Palm Desert	California	United States	92260
8	Research Site	Palo Alto	California	United States	94304
9	Research Site	Victorville	California	United States	92395
10	Research Site	Saint Petersburg	Florida	United States	33705
11	Research Site	Sarasota	Florida	United States	34239
12	Research Site	Tampa	Florida	United States	33612
13	Research Site	Tampa	Florida	United States	33614
14	Research Site	Chicago	Illinois	United States	60611
15	Research Site	Paducah	Kentucky	United States	42003
16	Research Site	Baton Rouge	Louisiana	United States	70809
17	Research Site	Wheaton	Maryland	United States	20902
18	Research Site	Boston	Massachusetts	United States	02111
19	Research Site	Battle Creek	Michigan	United States	49017
20	Research Site	Grand Rapids	Michigan	United States	49546
21	Research Site	Lansing	Michigan	United States	48910
22	Research Site	Saint Louis	Missouri	United States	63141
23	Research Site	Las Vegas	Nevada	United States	89102
24	Research Site	Rochester	New York	United States	14642
25	Research Site	Oklahoma City	Oklahoma	United States	73103
26	Research Site	Tulsa	Oklahoma	United States	74104
27	Research Site	Dallas	Texas	United States	75231
28	Research Site	Dallas	Texas	United States	75246
29	Research Site	Waco	Texas	United States	76708
30	Research Site	Chesapeake	Virginia	United States	23320
31	Research Site	Seattle	Washington	United States	98104
32	Research Site	Calgary	Alberta	Canada	T3A 2N1
33	Research Site	Victoria	British Columbia	Canada	V8V 3P9
34	Research Site	Winnipeg	Manitoba	Canada	R3A 1M3
35	Research Site	St. John's	Newfoundland and Labrador	Canada	A1A 5E8
36	Research Site	St. John's	Newfoundland and Labrador	Canada	A1C 5B8
37	Research Site	Waterloo	Ontario	Canada	N2J 1C4
38	Research Site	Trois-Rivieres	Quebec	Canada	G8Z 1Y2
39	Research Site	Quebec		Canada	G1V 3M7
40	Research Site	Quebec		Canada	G1V 4X7
41	Research Site	Bordeaux Cedex		France	33076
42	Research Site	Le Kremlin Bicetre		France	94270
43	Research Site	Lille cedex		France	59037
44	Research Site	Lyon Cédex 3		France	69437
45	Research Site	Nantes cedex 1		France	44093
46	Research Site	Paris Cedex 10		France	75475
47	Research Site	Paris		France	75018
48	Research Site	Reims Cedex		France	51092
49	Research Site	Frankfurt		Germany	60528
50	Research Site	Hannover		Germany	30625
51	Research Site	Hildesheim		Germany	31134
52	Research Site	Leipzig		Germany	04103
53	Research Site	Lübeck		Germany	23538
54	Research Site	Athens		Greece	11527
55	Research Site	Athens		Greece	14561
56	Research Site	Athens		Greece	16673
57	Research Site	Larissa		Greece	41110
58	Research Site	Thessaloniki		Greece	56429
59	Research Site	Budapest		Hungary	1023
60	Research Site	Budapest		Hungary	1036
61	Research Site	Eger		Hungary	3300
62	Research Site	Nyiregyhaza		Hungary	4400
63	Research Site	Szekesfehervar		Hungary	8000
64	Research Site	Szolnok		Hungary	5000
65	Research Site	Szombathely		Hungary	9700
66	Research Site	Riga		Latvia	1001
67	Research Site	Riga		Latvia	1002
68	Research Site	Riga		Latvia	1003
69	Research Site	Riga		Latvia	1005
70	Research Site	Mexicali	Baja California Norte	Mexico	21100
71	Research Site	Guadalajara	Jalisco	Mexico	44160
72	Research Site	Guadalajara	Jalisco	Mexico	44620
73	Research Site	Guadalajara	Jalisco	Mexico	44650
74	Research Site	Ciudad Obregon	Sonora	Mexico	85000
75	Research Site	Merida	Yucatán	Mexico	97133
76	Research Site	Gdansk		Poland	80-952
77	Research Site	Gdynia		Poland	81-384
78	Research Site	Grodzisk Mazowiecki		Poland	05-825
79	Research Site	Katowice		Poland	40-040
80	Research Site	Lodz		Poland	90-242
81	Research Site	Lodz		Poland	90-436
82	Research Site	Lublin		Poland	20-607
83	Research Site	Poznan		Poland	61-113
84	Research Site	Stalowa Wola		Poland	37-450
85	Research Site	Swidnik		Poland	21-040
86	Research Site	Warszawa		Poland	01-192
87	Research Site	Warszawa		Poland	02-118
88	Research Site	Warszawa		Poland	02-653
89	Research Site	Warszawa		Poland	04-141
90	Research Site	Wroclaw		Poland	50-088
91	Research Site	Wroclaw		Poland	50-368
92	Research Site	Wroclaw		Poland	51-318
93	Research Site	Wroclaw		Poland	53-658
94	Research Site	Chelyabinsk		Russian Federation	454076
95	Research Site	Ekaterinburg		Russian Federation	620076
96	Research Site	Kemerovo		Russian Federation	650099
97	Research Site	Kursk		Russian Federation	305007
98	Research Site	Moscow		Russian Federation	125284
99	Research Site	Petrozavodsk		Russian Federation	185019
100	Research Site	Saint-Petersburg		Russian Federation	192242
101	Research Site	Saratov		Russian Federation	410012
102	Research Site	Smolensk		Russian Federation	214025
103	Research Site	Voronezh		Russian Federation	394066

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT02024646
• Other Study ID Numbers: 20110144; 2013-003553-16
• First Posted: Dec 31, 2013
• Last Update Posted: Aug 20, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Bausch Health Americas, Inc.: Psoriatic Arthritis; Brodalumab; AMG 827
• Additional relevant MeSH terms: Arthritis; Arthritis, Psoriatic; Brodalumab; Antibodies, Monoclonal

Study Results

Participant Flow

Arm/Group Title	210 mg Brodalumab	140 mg Brodalumab	Placebo
Arm/Group Description	Administered via subcutaneous injections. 210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection.	Administered via subcutaneous injection. 140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection.	Administered via subcutaneous injection until week 24. Placebo: Placebo administered via subcutaneous injection until week 24.
Period Title: Overall Study
STARTED	163	160	161
COMPLETED	131	135	133
NOT COMPLETED	32	25	28

Baseline Characteristics

Arm/Group Title	210 mg Brodalumab	140 mg Brodalumab	Placebo	Total
Arm/Group Description	Administered via subcutaneous injections. 210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection.	Administered via subcutaneous injection. 140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection.	Administered via subcutaneous injection until week 24. Placebo: Placebo administered via subcutaneous injection until week 24.	Total of all reporting groups
Overall Participants	163	160	161	484
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	45	48	49	48
Sex: Female, Male (Count of Participants)
Female	84 51.5%	80 50%	85 52.8%	249 51.4%
Male	79 48.5%	80 50%	76 47.2%	235 48.6%
Region of Enrollment (participants) [Number]
Greece	3 1.8%	6 3.8%	2 1.2%	11 2.3%
Canada	9 5.5%	14 8.8%	9 5.6%	32 6.6%
Latvia	6 3.7%	6 3.8%	3 1.9%	15 3.1%
Russian Federation	20 12.3%	17 10.6%	19 11.8%	56 11.6%
Hungary	3 1.8%	9 5.6%	8 5%	20 4.1%
United States	42 25.8%	37 23.1%	43 26.7%	122 25.2%
Poland	62 38%	57 35.6%	58 36%	177 36.6%
Mexico	4 2.5%	5 3.1%	4 2.5%	13 2.7%
France	7 4.3%	2 1.3%	2 1.2%	11 2.3%
Germany	7 4.3%	7 4.4%	13 8.1%	27 5.6%

Outcome Measures

1. Primary Outcome

Title	ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16
Description	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.
Time Frame	Baseline and 16 Weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	210 mg Brodalumab	140 mg Brodalumab	Placebo
Arm/Group Description	Administered via subcutaneous injections. 210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection.	Administered via subcutaneous injection. 140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection.	Administered via subcutaneous injection until week 24. Placebo: Placebo administered via subcutaneous injection until week 24.
Measure Participants	146	141	146
Number [Percentage of Participants]	41.8 25.6%	48.9 30.6%	24.7 15.3%

Adverse Events

Arm/Group Title	210 mg Brodalumab		140 mg Brodalumab		Placebo
Arm/Group Description	Administered via subcutaneous injections. 210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection.		Administered via subcutaneous injection. 140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection.		Administered via subcutaneous injection until week 24. Placebo: Placebo administered via subcutaneous injection until week 24.
All Cause Mortality
	210 mg Brodalumab		140 mg Brodalumab		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	210 mg Brodalumab		140 mg Brodalumab		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/163 (3.1%)		3/160 (1.9%)		5/161 (3.1%)
Blood and lymphatic system disorders
ALT increased	1/163 (0.6%)		0/160 (0%)		1/161 (0.6%)
AST Increased	0/163 (0%)		0/160 (0%)		1/161 (0.6%)
Haemorrhoidal haemorrhage	0/163 (0%)		1/160 (0.6%)		0/161 (0%)
Cardiac disorders
Myocardial Infarction	0/163 (0%)		0/160 (0%)		2/161 (1.2%)
Injury, poisoning and procedural complications
Fibula Fracture	1/163 (0.6%)		0/160 (0%)		0/161 (0%)
Cerebrovascular Accident	0/163 (0%)		1/160 (0.6%)		0/161 (0%)
Skin and subcutaneous tissue disorders
Bursitis	1/163 (0.6%)		0/160 (0%)		0/161 (0%)
Psoriatic Arthropathy	1/163 (0.6%)		0/160 (0%)		0/161 (0%)
Skin Infection	1/163 (0.6%)		0/160 (0%)		0/161 (0%)
Surgical and medical procedures
Abortion Induced	0/163 (0%)		1/160 (0.6%)		0/161 (0%)
Vascular disorders
Carotid Artery Stenosis	0/163 (0%)		0/160 (0%)		1/161 (0.6%)
Other (Not Including Serious) Adverse Events
	210 mg Brodalumab		140 mg Brodalumab		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	91/163 (55.8%)		85/160 (53.1%)		83/161 (51.6%)
Gastrointestinal disorders
Diarrhoea	13/163 (8%)		6/160 (3.8%)		4/161 (2.5%)
Nausea	7/163 (4.3%)		8/160 (5%)		4/161 (2.5%)
Dyspepsia	0/163 (0%)		1/160 (0.6%)		3/161 (1.9%)
General disorders
Fatigue	1/163 (0.6%)		1/160 (0.6%)		3/161 (1.9%)
Chest Pain	0/163 (0%)		1/160 (0.6%)		4/161 (2.5%)
peripheral Swelling	0/163 (0%)		3/160 (1.9%)		3/161 (1.9%)
Ligament Sprain	4/163 (2.5%)		0/160 (0%)		3/161 (1.9%)
Infections and infestations
Nasopharyngitis	28/163 (17.2%)		17/160 (10.6%)		7/161 (4.3%)
Upper Respiratory Tract Infection	16/163 (9.8%)		16/160 (10%)		2/161 (1.2%)
Sinusitus	10/163 (6.1%)		2/160 (1.3%)		2/161 (1.2%)
Oral Herpes	6/163 (3.7%)		3/160 (1.9%)		0/161 (0%)
Bronchitis	5/163 (3.1%)		4/160 (2.5%)		2/161 (1.2%)
Urinary Tract Infection	5/163 (3.1%)		8/160 (5%)		1/161 (0.6%)
Pharyngitis	4/163 (2.5%)		5/160 (3.1%)		4/161 (2.5%)
Influenza	2/163 (1.2%)		2/160 (1.3%)		3/161 (1.9%)
Laryngitis	2/163 (1.2%)		4/160 (2.5%)		3/161 (1.9%)
Herpes Zoster	0/163 (0%)		0/160 (0%)		3/161 (1.9%)
Injury, poisoning and procedural complications
Contusion	4/163 (2.5%)		7/160 (4.4%)		5/161 (3.1%)
Metabolism and nutrition disorders
Gout	5/163 (3.1%)		0/160 (0%)		0/161 (0%)
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy	8/163 (4.9%)		7/160 (4.4%)		0/161 (0%)
Spinal Pain	8/163 (4.9%)		0/160 (0%)		1/161 (0.6%)
Arthralgia	5/163 (3.1%)		6/160 (3.8%)		4/161 (2.5%)
Back Pain	3/163 (1.8%)		4/160 (2.5%)		5/161 (3.1%)
Arthritis	2/163 (1.2%)		2/160 (1.3%)		3/161 (1.9%)
Muscle Spasms	1/163 (0.6%)		4/160 (2.5%)		4/161 (2.5%)
Nervous system disorders
Headache	5/163 (3.1%)		5/160 (3.1%)		5/161 (3.1%)
Respiratory, thoracic and mediastinal disorders
Cough	5/163 (3.1%)		2/160 (1.3%)		5/161 (3.1%)
Oropharyngeal Pain	3/163 (1.8%)		5/160 (3.1%)		6/161 (3.7%)
Sinus Congestion	2/163 (1.2%)		7/160 (4.4%)		1/161 (0.6%)
Skin and subcutaneous tissue disorders
Rash	6/163 (3.7%)		3/160 (1.9%)		1/161 (0.6%)
Vascular disorders
Hypertension	4/163 (2.5%)		7/160 (4.4%)		1/161 (0.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.