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LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

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ClinicalTrials.gov Identifier: NCT02899962
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief 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.


Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: LEO 90100 aerosol foam Drug: LEO 90100 aerosol foam vehicle Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 832 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: LEO 90100 aerosol foam
Topical application twice weekly for 52 weeks
Drug: LEO 90100 aerosol foam
LEO 90100 aerosol foam twice weekly
Placebo Comparator: LEO 90100 aerosol foam vehicle
Topical application twice weekly for 52 weeks
Drug: LEO 90100 aerosol foam vehicle
LEO 90100 aerosol foam vehicle twice weekly



Primary Outcome Measures :
  1. Time to first relapse [ Time Frame: From Randomisation (Week 4; Visit 2) until End of Treatment (Week 56; Visit 15) ]
    Relapse defined as at least "mild" according to the PGA


Secondary Outcome Measures :
  1. Number of days in remission during the maintenance phase [ Time Frame: From Randomisation (Week 4; Visit 2) until End of Treatment (Week 56; Visit 15) ]
    Remission defined as 'clear' or 'almost clear' according to the PGA

  2. Number of relapses during the maintenance phase [ Time Frame: From Randomisation (Week 4;Visit 2) until End of Treatment (Week 56; Visit 15) ]
    Defined as number of 4-week periods with use of once-daily rescue IMP



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899962


Contacts
Contact: LEO Pharma A/S +1 877-557-1168 disclosure@leo-pharma.com

  Show 63 Study Locations
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Mark Lebwohl, MD Icahn School of Medicine at Mount Sinai

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02899962     History of Changes
Other Study ID Numbers: LP0053-1004
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases