Overview

This trial is active, not recruiting.

Condition moderate to severe plaque psoriasis
Treatments 210 mg brodalumab, 140 mg brodalumab, ustekinumab, placebo
Phase phase 3
Sponsor Amgen
Start date August 2012
End date September 2014
Trial size 1831 participants
Trial identifier NCT01708603, 20120103

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
210 mg brodalumab
210 mg brodalumab administered SC
(Experimental)
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab
140 mg brodalumab administered SC
(Active Comparator)
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
ustekinumab
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
(Placebo Comparator)
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
210 mg brodalumab
210 mg brodalumab administered SC
placebo
Placebo administered SC

Primary Outcomes

Measure
Improvement in Psoriasis Area and Severity Index (PASI)
time frame: 12 weeks
Static Physician Global Assessment (sPGA) score
time frame: 12 weeks

Secondary Outcomes

Measure
Improvement in Psoriasis Area and Severity Index (PASI)
time frame: 12 weeks
Static Physician Global Assessment (sPGA) score
time frame: 12 weeks and 52 weeks
Patient reported outcomes symptom score
time frame: 12 weeks
Subject incidence of adverse events
time frame: 12 weeks and 5 years
Subject incidence of adverse events of interest
time frame: 12 weeks and 5 years
Presence of anti-brodalumab antibodies
time frame: 12 weeks and 5 years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2
Description NOTE: Detailed Description: data not entered.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Amgen.