Phase 3
Completed N=650
LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
Source: ClinicalTrials.gov NCT02899962 ↗Enrolled (actual)
650
Serious AEs
2.4%
Results posted
Aug 2020
Primary outcomePrimary: Time to First Relapse — 56; 30 days — p=<0.001
◆ Published Evidence
Emerging
9citations · ~2 / year
PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis.
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.
Linked Publications (3)
-
PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis.
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Impact of fixed-dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52-week randomized, double-blind, PSO-LONG trial.
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Long-Term Proactive Treatment of Plaque Psoriasis with Calcipotriene/Betamethasone Dipropionate Foam Prolongs Remission and Reduces Relapses Irrespective of Patient Baseline Characteristics.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Relapse |
56; 30 | <0.001 sig |
| SECONDARY Proportion of Days in Remission During the Maintenance Phase |
70.2; 60.8 | <0.001 sig |
| SECONDARY Number of Relapses During the Maintenance Phase |
2.0; 3.1 | <0.001 sig |
Eligibility Criteria
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 hypothalamic-pituitary-adrenal (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
Data sourced from ClinicalTrials.gov (NCT02899962) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.