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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.


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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

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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
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