Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab 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 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.

Condition	Intervention	Phase
Moderate to Severe Plaque Psoriasis	Drug: 210 mg brodalumab Drug: 140 mg brodalumab Drug: ustekinumab 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 and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Ustekinumab

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

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
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

Secondary Outcome Measures:

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
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
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:	1800
Study Start Date:	September 2012
Estimated Study Completion Date:	October 2018
Estimated Primary Completion Date:	September 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 schedule 1, 2, 3, or 4.	Drug: 210 mg brodalumab 210 mg brodalumab administered SC
Experimental: 140 mg brodalumab Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.	Drug: 140 mg brodalumab 140 mg brodalumab administered SC
Active Comparator: ustekinumab Administered by subcutaneous (SC) injection per the labeled dosing regimen.	Drug: ustekinumab 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
Placebo Comparator: Placebo Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.	Drug: 210 mg brodalumab 210 mg brodalumab administered SC Drug: placebo placebo administered 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708629

Contacts

Contact: Amgen Call Center

866-572-6436

Show 146 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:	NCT01708629 History of Changes
Other Study ID Numbers:	20120104
Study First Received:	September 21, 2012
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration Australia: Therapeutic Goods Association (TGA) Belgium: Federal Agency for Medicines and Health Products Canada: Health Canada France: National Agency for Medicines and Health Products Safety (ANSM) Greece: National Drug Organization (EOF) Hungary: National Institute for Pharmacy Italy: IRCCS Azienda Ospedaliera Universitaria San Martino-IST-Istituto Nazionale per la Ricerca sul Cancro Latvia: State Agency of Medicines Poland: The Office for Registration of Medical Products, Medical Devices and Biocidal Products Russia: Ministry of Healthcare and Social Development of the Russian Federation

Keywords provided by Amgen:

psoriasis, brodalumab, AMG 827

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-3)