LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
Status: | Active, not recruiting |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/5/2019 |
Start Date: | February 15, 2017 |
End Date: | May 2019 |
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.
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.
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.
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.
INCLUSION CRITERIA:
- 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.
EXCLUSION CRITERIA:
- 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
We found this trial at
22
sites
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