Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis - Full Text View

Purpose

The primary hypothesis of this trial is that there is a non-decreasing dose response in efficacy of AMG 827, as measured by percent improvement in Psoriasis Area and Severity Index (PASI) at week 12.

Condition	Intervention	Phase
Psoriasis	Drug: AMG 827 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

To establish a dose-response efficacy profile of AMG 827 compared with placebo as measured by the percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at week 12 and to identify an appropriate dose regimen for future trials [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the efficacy of AMG 827 as measured by the following: The proportion of subjects with a PASI 75 at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of AMG 827 as measured by the following: The proportion of subjects with a PASI 50, 90, and 100 at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the short term safety profile of AMG 827 in subjects with moderate to severe psoriasis [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To characterize the pharmacokinetics (PK) of AMG 827 in subjects with moderate to severe psoriasis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of AMG 827 as measured by the following: The proportion of subjects with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	198
Study Start Date:	December 2009
Study Completion Date:	September 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: III	Drug: AMG 827 210 mg SC
Experimental: II	Drug: AMG 827 140 mg SC
Experimental: IV	Drug: AMG 827 280 mg SC
Placebo Comparator: V	Drug: Placebo Placebo SC
Experimental: I	Drug: AMG 827 70 mg SC

Eligibility

Ages Eligible for Study:	18 Years to 70 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 received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.

Exclusion Criteria:

Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.
Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate psoriasis) that would interfere with evaluations of the effect of IP on psoriasis.
Subject has any active CTCAE grade 2 or higher infection
Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
Subject has used the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids
Subject has used the following therapies within 28 days of the first dose: Class I or II topical steroids, UVA therapy (with or without psoralen), or systemic psoriasis therapies
Subject has used the following therapies within 3 months of the first dose: adalimumab, alefacept, etanercept, infliximab, certolizumab, or live vaccines
Subject has used an anti-IL12/IL23 inhibitor within 6 months of the first dose
Subject has previously used an anti-IL17 biologic therapy, efalizumab, or rituximab

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975637

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 by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Papp KA, Leonardi C, Menter A, Ortonne JP, Krueger JG, Kricorian G, Aras G, Li J, Russell CB, Thompson EH, Baumgartner S. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med. 2012 Mar 29;366(13):1181-9.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00975637 History of Changes
Other Study ID Numbers:	20090062
Study First Received:	September 10, 2009
Last Updated:	January 20, 2011
Health Authority:	Australia: Therapeutic Goods Administration Canada: Health Canada Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) United States: Food and Drug Administration

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013