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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01708629
Other study ID # 20120104
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 2012
Est. completion date October 2015

Study information

Verified date December 2019
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.


Description:

This study assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.


Recruitment information / eligibility

Status Terminated
Enrollment 1881
Est. completion date October 2015
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Subject has had stable moderate to severe plaque psoriasis for at least 6 months

- Subject has involved body surface area (BSA) = 10%, PASI = 12, and sPGA = 3 at screening and at baseline

Exclusion Criteria:

- Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations

- Subject has known history of Crohn's disease

- Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol

- Subject has not stopped using certain psoriasis therapies as defined in the study protocol

- Subject has previously used ustekinumab or any anti-IL-17 biologic therapy

- Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study

- Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
210 mg brodalumab
210 mg brodalumab administered SC
140 mg brodalumab
140 mg brodalumab administered SC
ustekinumab
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
placebo
placebo administered SC

Locations

Country Name City State
Australia Research Site Camperdown New South Wales
Australia Research Site Darlinghurst New South Wales
Australia Research Site Fremantle Western Australia
Australia Research Site Hectorville South Australia
Australia Research Site Kogarah New South Wales
Australia Research Site St Leonards New South Wales
Australia Research Site Sydney New South Wales
Australia Research Site Westmead New South Wales
Belgium Research Site Brugge
Belgium Research Site Brussels
Belgium Research Site Edegem
Belgium Research Site Gent
Belgium Research Site Leuven
Belgium Research Site Liege
Belgium Research Site Montigny-le-Tilleul
Canada Research Site Barrie Ontario
Canada Research Site Calgary Alberta
Canada Research Site Drummondville Quebec
Canada Research Site Halifax Nova Scotia
Canada Research Site Hamilton Ontario
Canada Research Site Markham Ontario
Canada Research Site Montreal Quebec
Canada Research Site Richmond Hill Ontario
Canada Research Site Saint-Hyacinthe Quebec
Canada Research Site St. John's Newfoundland and Labrador
Canada Research Site St. John's Newfoundland and Labrador
Canada Research Site Toronto Ontario
Canada Research Site Toronto Ontario
Canada Research Site Toronto Ontario
Canada Research Site Vancouver British Columbia
Canada Research Site Winnipeg Manitoba
Canada Research Site Winnipeg Manitoba
France Research Site Créteil
France Research Site Limoges
France Research Site Nice
France Research Site Poitiers
France Research Site Saint Priest en Jarez
France Research Site Toulouse Cedex 9
France Research Site Vandoeuvre les Nancy
Greece Research Site Athens
Greece Research Site Chaïdári Athens
Greece Research Site Ioannina
Greece Research Site Larissa
Greece Research Site Maroussi
Greece Research Site Thessaloniki
Greece Research Site Thessaloniki
Hungary Research Site Bekescsaba
Hungary Research Site Budapest
Hungary Research Site Gyula
Hungary Research Site Szeged
Hungary Research Site Szolnok
Hungary Research Site Szombathely
Italy Research Site Bologna
Italy Research Site Genova
Italy Research Site Milano
Italy Research Site Milano
Italy Research Site Roma
Italy Research Site Roma
Latvia Research Site Riga
Latvia Research Site Riga
Latvia Research Site Riga
Latvia Research Site Ventspils
Poland Research Site Bialystok
Poland Research Site Dabrówka
Poland Research Site Gdansk
Poland Research Site Iwonicz Zdroj
Poland Research Site Katowice
Poland Research Site Krakow
Poland Research Site Kraków
Poland Research Site Lodz
Poland Research Site Lublin
Poland Research Site Poznan
Poland Research Site Stalowa-Wola
Poland Research Site Swidnik
Poland Research Site Warszawa
Poland Research Site Warszawa
Russian Federation Research Site Ekaterinburg
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Saint-Petersburg
Russian Federation Research Site Saratov
Russian Federation Research Site St. Petersburg
United States Research Site Alpharetta Georgia
United States Research Site Ann Arbor Michigan
United States Research Site Arlington Heights Illinois
United States Research Site Atlanta Georgia
United States Research Site Bartlett Tennessee
United States Research Site Bellaire Texas
United States Research Site Beverly Hills California
United States Research Site Birmingham Alabama
United States Research Site Boca Raton Florida
United States Research Site Boise Idaho
United States Research Site Bronx New York
United States Research Site Burbank California
United States Research Site Champaign Illinois
United States Research Site Cincinnati Ohio
United States Research Site Clarksburg West Virginia
United States Research Site Clarkston Michigan
United States Research Site Cleveland Ohio
United States Research Site Clinton Township Michigan
United States Research Site Coral Gables Florida
United States Research Site Dallas Texas
United States Research Site Dallas Texas
United States Research Site Denver Colorado
United States Research Site East Windsor New Jersey
United States Research Site Encino California
United States Research Site Exton Pennsylvania
United States Research Site Farmington Connecticut
United States Research Site Fremont California
United States Research Site Fullerton California
United States Research Site Greer South Carolina
United States Research Site Henderson Nevada
United States Research Site High Point North Carolina
United States Research Site Hoboken New Jersey
United States Research Site Hollywood Florida
United States Research Site Houston Texas
United States Research Site Houston Texas
United States Research Site Houston Texas
United States Research Site Indianapolis Indiana
United States Research Site Irvine California
United States Research Site Jacksonville Florida
United States Research Site Johnston Rhode Island
United States Research Site Lake Oswego Oregon
United States Research Site Las Vegas Nevada
United States Research Site Los Angeles California
United States Research Site Louisville Kentucky
United States Research Site Macon Georgia
United States Research Site Maywood Illinois
United States Research Site Miami Florida
United States Research Site Mobile Alabama
United States Research Site Nashville Tennessee
United States Research Site New Albany Indiana
United States Research Site New York New York
United States Research Site Norfolk Virginia
United States Research Site Normal Illinois
United States Research Site Ocala Florida
United States Research Site Overland Park Kansas
United States Research Site Overland Park Kansas
United States Research Site Owensboro Kentucky
United States Research Site Phoenix Arizona
United States Research Site Portland Oregon
United States Research Site Richmond Virginia
United States Research Site Riverside California
United States Research Site Rochester New York
United States Research Site Sacramento California
United States Research Site Salt Lake City Utah
United States Research Site San Diego California
United States Research Site San Diego California
United States Research Site San Francisco California
United States Research Site Spokane Washington
United States Research Site Tamarac Florida
United States Research Site Trumbull Connecticut
United States Research Site Verona New Jersey
United States Research Site Webster Texas
United States Research Site Wheaton Illinois
United States Research Site Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Greece,  Hungary,  Italy,  Latvia,  Poland,  Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed. 12 weeks
Primary Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear). 12 weeks
See also
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Completed NCT02601469 - Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis Phase 2
Completed NCT05600036 - A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis Phase 2
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Completed NCT01987843 - Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 2
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Withdrawn NCT00747032 - To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis Phase 3
Completed NCT00581100 - Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis Phase 4
Suspended NCT01228656 - Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate Phase 2
Completed NCT00540618 - A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis Phase 2
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