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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulgaris. A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.

Details

After an initial 4-week period of once-daily treatment with open-label active LEO 90100 aerosol foam, subjects who qualify for randomisation will continue into a 52-week maintenance treatment period with twice-weekly application of randomised LEO 90100 aerosol foam / LEO 90100 aerosol foam vehicle.

If the subject experiences a relapse of psoriasis, the active lesions will be treated for 4 weeks with open-label active LEO 90100 aerosol foam.

Keywords

Psoriasis Vulgaris

Eligibility

You can join if…

Open to people ages 18 years and up

  • A clinical diagnosis of psoriasis vulgaris for at least 6 months involving the trunk and/or limbs, amenable to treatment with maximum of 100 g of trial medication per week
  • Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the body surface area (BSA)
  • A target lesion/target location of at least 3 cm at its longest axis located on the body (i.e., not on the scalp, face or intertriginous areas), scoring at least 1('mild') for each of redness, thickness and scaliness, and at least 4 in total by the Investigator's Assessment of Severity of the Target Lesion/Location

For subjects participating in HPA-axis testing, furthermore:

  • An extent of psoriasis vulgaris on trunk and/or limbs of disease severity (PGA) of at least 'moderate' affecting between 10 and 30% of the body surface area (BSA)excluding psoriatic lesions of genitals and skin folds at Visit 1.

You CAN'T join if...

  • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to

Visit 1:

  • etanercept - within 4 weeks prior to Visit 1
  • adalimumab, infliximab - within 8 weeks prior to Visit 1
  • ustekinumab - within 16 weeks prior to Visit 1
  • secukinumab - within 12 weeks prior to Visit 1
  • other products - within 4 weeks/5 half-lives prior to Visit 1 (whichever is longer)
  • Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to Visit 1
  • Systemic treatment with apremilast within 4 weeks prior to Visit 1
  • Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to Visit 1
  • Ultraviolet B (UVB) therapy within 2 weeks prior to Visit 1
  • Severe and/or extensive scalp psoriasis which, in the opinion of the investigator,requires treatment with potent or super-potent corticosteroids which will be prohibited during the trial

For subjects participating in HPA-axis testing, furthermore:

  • Antidepressive medications within 4 weeks prior to Visit 1 or during the trial.Oestrogen therapy (including contraceptives), antidepressant medications and any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to baseline

Locations

  • Center for Dermatology Clinical Research accepting new patients
    Fremont, California, 94538, United States
  • Clinical Science Institute accepting new patients
    Santa Monica, California, 90404, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
LEO Pharma
ID
NCT02899962
Phase
Phase 3
Lead Scientist
Tina Bhutani
Study Type
Interventional
Last Updated
June 1, 2017
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