Overview

This trial is active, not recruiting.

Condition moderate to severe plaque psoriasis
Treatments 210 mg brodalumab, 140 mg brodalumab, placebo
Phase phase 3
Sponsor Amgen
Start date August 2012
End date May 2014
Trial size 661 participants
Trial identifier NCT01708590, 2012-000651-13, 20120102

Summary

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

A second purpose of this study is to assess the safety and efficacy when brodalumab is replaced with placebo in some participants compared with the participants who are still receiving the 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 placebo or continued treatment. Participants are retreated at return of disease.
210 mg brodalumab
210 mg brodalumab administered subcutaneous (SC)
placebo
Placebo administered subcutaneous (SC)
(Experimental)
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.
140 mg brodalumab
140 mg brodalumab administered subcutaneous (SC)
placebo
Placebo administered subcutaneous (SC)
(Placebo Comparator)
Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.
210 mg brodalumab
210 mg brodalumab administered subcutaneous (SC)
placebo
Placebo administered subcutaneous (SC)

Primary Outcomes

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

Secondary Outcomes

Measure
Static Physician Global Assessment (sPGA) score
time frame: 12 weeks and 52 weeks
Improvement in Psoriasis Area and Severity Index (PASI)
time frame: 12 weeks
Patient reported outcomes. Symptom score
time frame: 12 weeks
Subject incidence of adverse events
time frame: 12 weeks and 5 years and 3 months
Subject incidence of adverse events of interest
time frame: 12 weeks and 5 years and 3 months
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 must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling - 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 stopped using certain psoriasis therapies as defined in the study protocol - Subject has previously used any anti-IL-17 biologic therapy

Additional Information

Official title A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Amgen.