Study of Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects - Full Text View

Purpose

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.

Condition	Intervention	Phase
Moderate to Severe Plaque Psoriasis	Drug: 210 mg brodalumab Drug: 140 mg brodalumab Drug: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Static Physician Global Assessment (sPGA) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis
Improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis

Secondary Outcome Measures:

Static Physician Global Assessment (sPGA) score [ Time Frame: 12 weeks and 52 weeks ] [ Designated as safety issue: No ]
Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis
Improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis
Patient reported outcomes. Symptom score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Subject-reported outcomes assessment
Subject incidence of adverse events [ Time Frame: 12 weeks and 5 years ] [ Designated as safety issue: Yes ]
Safety profile of brodalumab
Subject incidence of adverse events of interest [ Time Frame: 12 weeks and 5 years ] [ Designated as safety issue: Yes ]
Safety profile of brodalumab
Presence of anti-brodalumab antibodies [ Time Frame: 12 weeks and 5 years ] [ Designated as safety issue: Yes ]
Safety profile of brodalumab

Estimated Enrollment:	600
Study Start Date:	August 2012
Estimated Study Completion Date:	September 2018
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 210 mg brodalumab 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.	Drug: 210 mg brodalumab 210 mg brodalumab administered subcutaneous (SC) Drug: placebo Placebo administered subcutaneous (SC)
Experimental: 140 mg brodalumab 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.	Drug: 140 mg brodalumab 140 mg brodalumab administered subcutaneous (SC) Drug: placebo Placebo administered subcutaneous (SC)
Placebo Comparator: placebo Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.	Drug: 210 mg brodalumab 210 mg brodalumab administered subcutaneous (SC) Drug: placebo Placebo administered subcutaneous (SC)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708590

Show 78 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01708590 History of Changes
Other Study ID Numbers:	20120102, 2012-000651-13
Study First Received:	September 10, 2012
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration France: Ministry of Health Canada: Health Canada Germany: Ministry of Health Poland: Ministry of Health Switzerland: Swiss Medic

Keywords provided by Amgen:

psoriasis, brodalumab, AMG 827

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013

Study of Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-1)