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Sponsor ID
20090062

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

Sponsor ID
20090062
Clinicaltrials.gov ID
NCT00975637
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
AMG 827
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
198
Additional Study Details

Protocol Summary

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

Timeframe: 12 weeks

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

Timeframe: 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

Timeframe: 12 weeks

To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12

Timeframe: 12 weeks

To evaluate the short term safety profile of AMG 827 in subjects with moderate to severe psoriasis

Timeframe: 12 weeks

To characterize the pharmacokinetics (PK) of AMG 827 in subjects with moderate to severe psoriasis

Timeframe: 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

Timeframe: 12 weeks

Study Documents

Study Synopsis
Available Language(s): English
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Locations

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Study Info
Age
18 - 70 Years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Dec 2009 - N/A
    Inclusion and Exclusion 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