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LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

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ClinicalTrials.gov Identifier: NCT02899962
Recruitment Status : Completed
First Posted : September 14, 2016
Results First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Tracking Information
First Submitted Date  ICMJE September 9, 2016
First Posted Date  ICMJE September 14, 2016
Results First Submitted Date  ICMJE July 10, 2020
Results First Posted Date  ICMJE August 20, 2020
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE February 15, 2017
Actual Primary Completion Date June 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2020)
Time to First Relapse [ Time Frame: From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal) ]
Time to first relapse (at least 'mild' according to the Physician's Global Assessment of disease severity [PGA]). The investigator was to grade the severity of psoriasis of the trunk and limbs using Physician's global assessment of disease severity 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2016)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2020)
  • Proportion of Days in Remission During the Maintenance Phase [ Time Frame: From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal) ]
    Remission defined as 'clear' or 'almost clear' according to the PGA. The investigator was to grade using a global assessment of the disease severity of psoriasis of the trunk and limbs using the PGA 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4
  • Number of Relapses During the Maintenance Phase [ Time Frame: From Randomisation (Week 4) until End of Treatment (Week 56) ]
    Defined as number of 4-week periods with use of once-daily rescue investigational medicinal product
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2016)
  • 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
  • Number of Relapses During the Maintenance Phase [ Time Frame: From Randomisation (Week 4;Visit 2) until End of Treatment (Week 56; Visit 15) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
Official Title  ICMJE LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis Vulgaris
Intervention  ICMJE
  • Drug: LEO 90100 aerosol foam
    LEO 90100 aerosol foam twice weekly
  • Drug: LEO 90100 aerosol foam vehicle
    LEO 90100 aerosol foam vehicle twice weekly
Study Arms  ICMJE
  • Active Comparator: LEO 90100 aerosol foam
    Topical application twice weekly for 52 weeks
    Intervention: Drug: LEO 90100 aerosol foam
  • Placebo Comparator: LEO 90100 aerosol foam vehicle
    Topical application twice weekly for 52 weeks
    Intervention: Drug: LEO 90100 aerosol foam vehicle
Publications * Stein Gold L, Alonso-Llamazares J, Lacour JP, Warren RB, Tyring SK, Kircik L, Yamauchi P, Lebwohl M; PSO-LONG Trial Investigators. PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis. Adv Ther. 2020 Nov;37(11):4730-4753. doi: 10.1007/s12325-020-01497-6. Epub 2020 Sep 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2019)
722
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2016)
832
Actual Study Completion Date  ICMJE June 26, 2019
Actual Primary Completion Date June 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02899962
Other Study ID Numbers  ICMJE LP0053-1004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Lebwohl, MD Icahn School of Medicine at Mount Sinai
PRS Account LEO Pharma
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP