Psoriatic ArthritisPhase 3AMVISION-2NCT02024646

Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis

A Phase 3 study testing 210 mg brodalumab and 140 mg brodalumab in people with Psoriatic Arthritis, run by Bausch Health Americas, Inc. at 103 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriatic Arthritis
What is being tested?: 210 mg brodalumab and 140 mg brodalumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 484 participants
Where: 103 sitesin 10 countries
Study dates: Mar 2014to Oct 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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

Who cannot join

None listed.

Trial locations and contacts

103 sites in 10 countries.

Country

City, postcode or hospital

103 sites in 10 countries

United States31 sites

Research Site
Baton Rouge, Louisiana, 70809
Research Site
Battle Creek, Michigan, 49017
Research Site
Boston, Massachusetts, 02111
Research Site
Chesapeake, Virginia, 23320
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Chicago, Illinois, 60611
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Cypress, California, 90630
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Dallas, Texas, 75231
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Dallas, Texas, 75246
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Grand Rapids, Michigan, 49546
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Hemet, California, 92543
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Huntington Beach, California, 92646
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La Jolla, California, 92037
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Lansing, Michigan, 48910
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Las Vegas, Nevada, 89102
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Little Rock, Arkansas, 72205
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Oklahoma City, Oklahoma, 73103
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Paducah, Kentucky, 42003
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Palm Desert, California, 92260
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Palo Alto, California, 94304
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Peoria, Arizona, 85381
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Rochester, New York, 14642
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Sarasota, Florida, 34239
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Seattle, Washington, 98104
Research Site
St Louis, Missouri, 63141
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St. Petersburg, Florida, 33705
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Tampa, Florida, 33612
Research Site
Tampa, Florida, 33614
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Tulsa, Oklahoma, 74104
Research Site
Victorville, California, 92395
Research Site
Waco, Texas, 76708
Research Site
Wheaton, Maryland, 20902

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Poland18 sites

Research Site
Gdansk, 80-952
Research Site
Gdynia, 81-384
Research Site
Grodzisk Mazowiecki, 05-825
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Katowice, 40-040
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Lodz, 90-242
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Lodz, 90-436
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Lublin, 20-607
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Poznan, 61-113
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Stalowa Wola, 37-450
Research Site
Świdnik, 21-040
Research Site
Warsaw, 01-192
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Warsaw, 02-118
Research Site
Warsaw, 02-653
Research Site
Warsaw, 04-141
Research Site
Wroclaw, 50-088
Research Site
Wroclaw, 50-368
Research Site
Wroclaw, 51-318
Research Site
Wroclaw, 53-658

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Russia10 sites

Research Site
Chelyabinsk, 454076
Research Site
Kemerovo, 650099
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Kursk, 305007
Research Site
Moscow, 125284
Research Site
Petrozavodsk, 185019
Research Site
Saint Petersburg, 192242
Research Site
Saratov, 410012
Research Site
Smolensk, 214025
Research Site
Voronezh, 394066
Research Site
Yekaterinburg, 620076

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Canada9 sites

Research Site
Calgary, Alberta, T3A 2N1
Research Site
Québec, Quebec, G1V 3M7
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Québec, Quebec, G1V 4X7
Research Site
St. John's, Newfoundland and Labrador, A1A 5E8
Research Site
St. John's, Newfoundland and Labrador, A1C 5B8
Research Site
Trois-Rivières, Quebec, G8Z 1Y2
Research Site
Victoria, British Columbia, V8V 3P9
Research Site
Waterloo, Ontario, N2J 1C4
Research Site
Winnipeg, Manitoba, R3A 1M3

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France8 sites

Research Site
Bordeaux, 33076
Research Site
Le Kremlin-Bicêtre, 94270
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Lille, 59037
Research Site
Lyon Cédex 3, 69437
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Nantes, 44093
Research Site
Paris, 75018
Research Site
Paris, 75475
Research Site
Reims, 51092

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Hungary7 sites

Research Site
Budapest, 1023
Research Site
Budapest, 1036
Research Site
Eger, 3300
Research Site
Nyíregyháza, 4400
Research Site
Székesfehérvár, 8000
Research Site
Szolnok, 5000
Research Site
Szombathely, 9700

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Mexico6 sites

Research Site
Ciudad Obregón, Sonora, 85000
Research Site
Guadalajara, Jalisco, 44160
Research Site
Guadalajara, Jalisco, 44620
Research Site
Guadalajara, Jalisco, 44650
Research Site
Mérida, Yucatán, 97133
Research Site
Mexicali, Baja California Norte, 21100

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Germany5 sites

Research Site
Frankfurt, 60528
Research Site
Hanover, 30625
Research Site
Hildesheim, 31134
Research Site
Leipzig, 04103
Research Site
Lübeck, 23538

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Greece5 sites

Research Site
Athens, 11527
Research Site
Athens, 14561
Research Site
Athens, 16673
Research Site
Larissa, 41110
Research Site
Thessaloniki, 56429

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Latvia4 sites

Research Site
Riga, 1001
Research Site
Riga, 1002
Research Site
Riga, 1003
Research Site
Riga, 1005

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About this study

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

Conditions: Psoriatic Arthritis
Being tested: 210 mg brodalumab, 140 mg brodalumab, Placebo
Keywords: Psoriatic Arthritis, Brodalumab, AMG 827
Medical subject headings: Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

210 mg brodalumabDrug
Also called AMG 827
210 mg brodalumab administered via subcutaneous injection.
140 mg brodalumabDrug
Also called AMG 827
140 mg brodalumab administered via subcutaneous injection.
PlaceboDrug
Placebo administered via subcutaneous injection until week 24.

Study groups in NCT02024646
Study group	Role	What they receive
210 mg brodalumab	Experimental	Administered via subcutaneous injections. Receives: Drug: 210 mg brodalumab
140 mg brodalumab	Experimental	Administered via subcutaneous injection. Receives: Drug: 140 mg brodalumab
Placebo	Placebo comparator	Administered via subcutaneous injection until week 24. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16
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.
Measured: Baseline and 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Oct 2015

First posted31 Dec 2013 (estimated)
Study startMar 2014
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 484 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02024646
Sponsor's protocol ID: 20110144
Other IDs: 2013-003553-16
Acronym: AMVISION-2
Status last verified: Aug 2020
First submitted: 27 Dec 2013
Last updated: 20 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis

All Psoriatic Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02024646
Acronym / sponsor ID: AMVISION-2 / 20110144
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis, Brodalumab, AMG 827
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 484 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 31 Dec 2013 (estimated)
Results: Posted 20 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
210 mg brodalumab	Experimental	Drug: 210 mg brodalumabAdministered via subcutaneous injections.
140 mg brodalumab	Experimental	Drug: 140 mg brodalumabAdministered via subcutaneous injection.
Placebo	Placebo comparator	Drug: PlaceboAdministered via subcutaneous injection until week 24.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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
-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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
210 mg brodalumabAlso: AMG 827210 mg brodalumab administered via subcutaneous injection.	Drug	210 mg brodalumab
140 mg brodalumabAlso: AMG 827140 mg brodalumab administered via subcutaneous injection.	Drug	140 mg brodalumab
PlaceboPlacebo administered via subcutaneous injection until week 24.	Drug	Placebo

Primary outcome

ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16
Time frame: 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.

Results and safety

Results posted to the registry on 20 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
210 mg Brodalumab	163	131
140 mg Brodalumab	160	135
Placebo	161	133

Primary outcome: ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16

Time frame: Baseline and 16 Weeks. Number. Unit: Percentage of Participants

Measure	210 mg Brodalumab n = 146	140 mg Brodalumab n = 141	Placebo n = 146
Value	41.8	48.9	24.7

Population analysed: 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.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
210 mg Brodalumab	5 of 163 (3.1%)	91 of 163 (55.8%)	Not reported
140 mg Brodalumab	3 of 160 (1.9%)	85 of 160 (53.1%)	Not reported
Placebo	5 of 161 (3.1%)	83 of 161 (51.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Psoriatic Arthritis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

103 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 210 mg brodalumab and 140 mg brodalumab in people with Psoriatic Arthritis, run by Bausch Health Americas, Inc. at 103 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Poland, Russia, Canada, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 (time frame: Baseline and 16 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02024646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.