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

August 8, 2020 updated by: Bausch Health Americas, Inc.

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

484

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 3M7
        • Research Site
      • Quebec, Canada, G1V 4X7
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada, T3A 2N1
        • Research Site
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3P9
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada, A1A 5E8
        • Research Site
    • Ontario
      • Waterloo, Ontario, Canada, N2J 1C4
        • Research Site
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • Research Site
  • France
      • Bordeaux Cedex, France, 33076
        • Research Site
      • Le Kremlin Bicetre, France, 94270
        • Research Site
      • Lille cedex, France, 59037
        • Research Site
      • Lyon Cédex 3, France, 69437
        • Research Site
      • Nantes cedex 1, France, 44093
        • Research Site
      • Paris, France, 75018
        • Research Site
      • Paris Cedex 10, France, 75475
        • Research Site
      • Reims Cedex, France, 51092
        • Research Site
  • Germany
      • Frankfurt, Germany, 60528
        • Research Site
      • Hannover, Germany, 30625
        • Research Site
      • Hildesheim, Germany, 31134
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
      • Lübeck, Germany, 23538
        • Research Site
  • Greece
      • Athens, Greece, 11527
        • Research Site
      • Athens, Greece, 16673
        • Research Site
      • Athens, Greece, 14561
        • Research Site
      • Larissa, Greece, 41110
        • Research Site
      • Thessaloniki, Greece, 56429
        • Research Site
  • Hungary
      • Budapest, Hungary, 1036
        • Research Site
      • Budapest, Hungary, 1023
        • Research Site
      • Eger, Hungary, 3300
        • Research Site
      • Nyiregyhaza, Hungary, 4400
        • Research Site
      • Szekesfehervar, Hungary, 8000
        • Research Site
      • Szolnok, Hungary, 5000
        • Research Site
      • Szombathely, Hungary, 9700
        • Research Site
  • Latvia
      • Riga, Latvia, 1001
        • Research Site
      • Riga, Latvia, 1002
        • Research Site
      • Riga, Latvia, 1005
        • Research Site
      • Riga, Latvia, 1003
        • Research Site
  • Mexico
    • Baja California Norte
      • Mexicali, Baja California Norte, Mexico, 21100
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Research Site
      • Guadalajara, Jalisco, Mexico, 44160
        • Research Site
      • Guadalajara, Jalisco, Mexico, 44620
        • Research Site
    • Sonora
      • Ciudad Obregon, Sonora, Mexico, 85000
        • Research Site
    • Yucatán
      • Merida, Yucatán, Mexico, 97133
        • Research Site
  • Poland
      • Gdansk, Poland, 80-952
        • Research Site
      • Gdynia, Poland, 81-384
        • Research Site
      • Grodzisk Mazowiecki, Poland, 05-825
        • Research Site
      • Katowice, Poland, 40-040
        • Research Site
      • Lodz, Poland, 90-436
        • Research Site
      • Lodz, Poland, 90-242
        • Research Site
      • Lublin, Poland, 20-607
        • Research Site
      • Poznan, Poland, 61-113
        • Research Site
      • Stalowa Wola, Poland, 37-450
        • Research Site
      • Swidnik, Poland, 21-040
        • Research Site
      • Warszawa, Poland, 01-192
        • Research Site
      • Warszawa, Poland, 04-141
        • Research Site
      • Warszawa, Poland, 02-118
        • Research Site
      • Warszawa, Poland, 02-653
        • Research Site
      • Wroclaw, Poland, 50-088
        • Research Site
      • Wroclaw, Poland, 50-368
        • Research Site
      • Wroclaw, Poland, 51-318
        • Research Site
      • Wroclaw, Poland, 53-658
        • Research Site
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454076
        • Research Site
      • Ekaterinburg, Russian Federation, 620076
        • Research Site
      • Kemerovo, Russian Federation, 650099
        • Research Site
      • Kursk, Russian Federation, 305007
        • Research Site
      • Moscow, Russian Federation, 125284
        • Research Site
      • Petrozavodsk, Russian Federation, 185019
        • Research Site
      • Saint-Petersburg, Russian Federation, 192242
        • Research Site
      • Saratov, Russian Federation, 410012
        • Research Site
      • Smolensk, Russian Federation, 214025
        • Research Site
      • Voronezh, Russian Federation, 394066
        • Research Site
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Cypress, California, United States, 90630
        • Research Site
      • Hemet, California, United States, 92543
        • Research Site
      • Huntington Beach, California, United States, 92646
        • Research Site
      • La Jolla, California, United States, 92037
        • Research Site
      • Palm Desert, California, United States, 92260
        • Research Site
      • Palo Alto, California, United States, 94304
        • Research Site
      • Victorville, California, United States, 92395
        • Research Site
    • Florida
      • Saint Petersburg, Florida, United States, 33705
        • Research Site
      • Sarasota, Florida, United States, 34239
        • Research Site
      • Tampa, Florida, United States, 33612
        • Research Site
      • Tampa, Florida, United States, 33614
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Research Site
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Research Site
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Research Site
    • Michigan
      • Battle Creek, Michigan, United States, 49017
        • Research Site
      • Grand Rapids, Michigan, United States, 49546
        • Research Site
      • Lansing, Michigan, United States, 48910
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Research Site
    • New York
      • Rochester, New York, United States, 14642
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Research Site
      • Tulsa, Oklahoma, United States, 74104
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Waco, Texas, United States, 76708
        • Research Site
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 27, 2013

First Submitted That Met QC Criteria

December 27, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 8, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110144
  • 2013-003553-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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