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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00975637
First received: September 10, 2009
Last updated: February 8, 2017
Last verified: February 2017
September 10, 2009
February 8, 2017
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: Baseline and 12 weeks ]
At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score.
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 ]
Complete list of historical versions of study NCT00975637 on ClinicalTrials.gov Archive Site
Percent of Body Surface Area (BSA) Affected by Psoriasis [ Time Frame: Baseline and Week 12 ]
To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12. At the baseline of the study the subject would need to have at least a 10% BSA; at week 12 they were again assessed to see what change ion percentage of BSA has occurred.
  • To characterize the pharmacokinetics (PK) of AMG 827 in subjects with moderate to severe psoriasis [ Time Frame: 12 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • To Evaluate the Efficacy of AMG 827 as Measured by the Following: Body Surface Area (BSA) Involvement at Weeks 12 [ Time Frame: 12 weeks ]
  • To evaluate the short term safety profile of AMG 827 in subjects with moderate to severe psoriasis [ Time Frame: 12 weeks ]
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 study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12. Subjects were randomized ina 1:1:1:1:1 ratio. Subjects randomized to receive AMG 827 received 70, 140, or 210 mg at day 1 and weeks 4 and 8.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Drug: 70 mg SC
    70 mg SC
    Other Name: AMG 827
  • Drug: 210 mg SC
    210 mg SC
    Other Name: AMG 827
  • Drug: 140 mg SC
    140 mg SC
    Other Name: AMG 827
  • Drug: 280 mg SC
    280 mg SC
    Other Name: AMG 827
  • Drug: Placebo
    Placebo SC
  • Experimental: 140 mg SC
    140 mg SC
    Intervention: Drug: 140 mg SC
  • Experimental: 70 mg SC
    70 mg SC
    Intervention: Drug: 70 mg SC
  • Experimental: 280 mg SC
    280 mg SC
    Intervention: Drug: 280 mg SC
  • Placebo Comparator: 210 mg SC
    210 mg SC
    Intervention: Drug: 210 mg SC
  • Experimental: Placebo
    Placebo
    Intervention: Drug: Placebo

*   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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Australia,   Canada,   Denmark,   France,   United States
 
NCT00975637
20090062
Not Provided
Not Provided
Plan to Share IPD: Yes
Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc.
Not Provided
Study Director: MD Amgen
Valeant Pharmaceuticals International, Inc.
February 2017

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