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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
  Purpose
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.

Condition Intervention Phase
Psoriasis
Drug: 70 mg SC
Drug: 210 mg SC
Drug: 140 mg SC
Drug: 280 mg SC
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, 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 Valeant Pharmaceuticals International, Inc.:

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: 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.


Secondary Outcome Measures:
  • 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.


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: 140 mg SC
140 mg SC
Drug: 140 mg SC
140 mg SC
Other Name: AMG 827
Experimental: 70 mg SC
70 mg SC
Drug: 70 mg SC
70 mg SC
Other Name: AMG 827
Experimental: 280 mg SC
280 mg SC
Drug: 280 mg SC
280 mg SC
Other Name: AMG 827
Placebo Comparator: 210 mg SC
210 mg SC
Drug: 210 mg SC
210 mg SC
Other Name: AMG 827
Experimental: Placebo
Placebo
Drug: Placebo
Placebo SC

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00975637     History of Changes
Other Study ID Numbers: 20090062
Study First Received: September 10, 2009
Results First Received: November 2, 2016
Last Updated: February 8, 2017
Individual Participant Data  
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 28, 2017