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

September 10, 2009
January 20, 2011
December 2009
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00975637 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Drug: AMG 827
    70 mg SC
  • Drug: AMG 827
    210 mg SC
  • Drug: AMG 827
    140 mg SC
  • Drug: AMG 827
    280 mg SC
  • Drug: Placebo
    Placebo SC
  • Experimental: III
    Intervention: Drug: AMG 827
  • Experimental: II
    Intervention: Drug: AMG 827
  • Experimental: IV
    Intervention: Drug: AMG 827
  • Placebo Comparator: V
    Intervention: Drug: Placebo
  • Experimental: I
    Intervention: Drug: AMG 827

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
198
September 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00975637
20090062
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP