CompletedPhase 1/2

A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis

36 participantsStarted 2007-02

Plain-language summary

This is a two-arm, parallel group, double-blind, placebo-controlled proof-of-concept study comparing 3 mg/kg of AIN457 to placebo. Subjects with a diagnosis of moderate to severe stable plaque psoriasis will be randomized to receive either AIN457 or placebo. AIN457 or placebo will be administered by single infusion at baseline and subjects will be observed for up to 26 weeks following the infusion.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Coverage of the body surface area (BSA) of 10% or more with plaques
✓. A score of 3 or more on the IGA scale

Exclusion criteria

✕. 2 months washout prior to screening for etanercept, adalimumab, or infliximab.
✕. 1 month washout prior to screening for cyclosporine, mycophenolate, tacrolimus, and any systemic immunosuppressants including, but not limited to, methotrexate, azathioprine, 6-thioguanine, mercaptopurine, and hydroxyurea

What they're measuring

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score

Timeframe: Baseline, Week 4

Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score

Timeframe: Baseline, Week 4

Trial details

NCT IDNCT00669916

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-11

Results submitted2015-01-28

View on ClinicalTrials.gov More Plaque Psoriasis trials