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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00975637
First received: September 10, 2009
Last updated: January 20, 2011
Last verified: January 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

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

ClinicalTrials.gov processed this record on October 20, 2014