Psoriasis VulgarisPhase 3NCT02899962
LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
A Phase 3 study testing LEO 90100 aerosol foam in people with Psoriasis Vulgaris, run by LEO Pharma at 58 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 90100 aerosol foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 722 participants
- Where
- 58 sitesin 6 countries
- Study dates
- 15 Feb 2017to 26 Jun 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
58 sites in 6 countries.
58 sites in 6 countries
United States21 sites
Arlington Dermatology
Arlington Heights, Illinois, 60005
Clarkston Skin Research
Clarkston, Michigan, 48346
Colorado Medical Research Center
Denver, Colorado, 80210
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, 08520
Center for Dermatology Clinical Research
Fremont, California, 94538
Rivergate Dermatology Clinical Research Center
Goodlettsville, Tennessee, 37072
Beyer Research
Kalamazoo, Michigan, 49009
The Skin Wellness Center
Knoxville, Tennessee, 37922
Derm Research
Louisville, Kentucky, 40217
International Dermatology Research
Miami, Florida, 33144
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Mount Sinai School of Medicine
New York, New York, 10029
Sadick Research Group
New York, New York, 10075
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213
Skin Search of Rochester
Rochester, New York, 14623
DermAssociates
Rockville, Maryland, 20850
Clinical Trials of Texas
San Antonio, Texas, 78229
Clinical Science Institute
Santa Monica, California, 90404
Premier Clinical Research
Spokane, Washington, 99202
Center for Clinical Studies
Webster, Texas, 77598
Canada12 sites
CCA Medical Research
Ajax, Ontario, L1S 7K8
Maritime Medical Research Centre
Bathurst, New Brunswick, E2A 4Z9
Brunwick Dermatology Center
Fredericton, New Brunswick, E3B 1G9
Dermatrials Research Incorporated
Hamilton, Ontario, L8N 1V6
The Guenther Dermatology Research Centre
London, Ontario, N6A 3B4
Lynderm Research
Markham, Ontario, L3P 1X2
SKiN Center for Dermatology
Peterborough, Ontario, K9J 5K2
Clinique du Dre Isabelle Delorme Inc
Québec, Quebec, J2B 5L4
Dr. Chih-ho Hong Medical
Surrey, British Columbia, V3R 6A7
Pacific Dermaesthetics
Vancouver, British Columbia, V6E 4M3
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
Wiseman Dermatology Research
Winnipeg, Manitoba, R3M 3Z4
Germany9 sites
Klinik und Poliklinik für Dermatologie
Dresden, 01307
Universitätsklinikum Erlangen
Erlangen, 91054
Universitätsklinikum Essen (AöR), Klinik für Dermatologie
Essen, 54122
SRH Wald-Klinikum Gera
Gera, 07548
SCIderm GmbH
Hamburg, 20354
UKSH - Campus Lübeck
Lübeck, 23538
Michael Sebastian
Mahlow, 15831
LMU Poliklinik Derma & Allergo
München, 80337
Gemein. Weber & Crainic
Schweinfurt, 97421
United Kingdom7 sites
Burbage Surgery
Burbage, Leicstershire, LE10 2SE
Ashgate Medical Practice
Chesterfield, Derbyshire, S40 4AA
Chapel Allerton Hospital
Leeds, West Yorkshire, LS7 4SA
Sherbourne Medical Centre
Royal Leamington Spa, Warwickshire, CV32 4RA
Dermatopharmacology Department
Salford, M6 8HD
Wansford and Kings Cliffe Prac
Wansford, Cambridgeshire, PE8 6PL
Albany House Medical Centre
Wellingborough, Northamptonshire, NN8 4RW
France5 sites
CHRU de Brest - Hôpital Morvan
Brest, 29609
C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
Nice, 06202
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033
C.H.U. de Saint-Etienne Service de Dermatologie
Saint-Etienne, Saint-Etienne, 42055
Centre Hospitalier de Valence
Valence, 26000
Poland4 sites
Małopolskie Centrum Kliniczne
Krakow, 31-123
NZOZ Med-laser
Lublin, 20-079
Solumed
Poznan, 60-425
Kliniczny Szpital Wojewódzki, Klinika Dermatologii
Rzeszów, 35-030
About this study
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.
Read the 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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 90100 aerosol foam, LEO 90100 aerosol foam vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 90100 aerosol foamDrug
LEO 90100 aerosol foam twice weekly
LEO 90100 aerosol foam vehicleDrug
LEO 90100 aerosol foam vehicle twice weekly
| Study group | Role | What they receive |
|---|---|---|
| LEO 90100 aerosol foam | Active comparator | Topical application twice weekly for 52 weeks Receives: Drug: LEO 90100 aerosol foam |
| LEO 90100 aerosol foam vehicle | Placebo comparator | Topical application twice weekly for 52 weeks Receives: Drug: LEO 90100 aerosol foam vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Relapse
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
Measured: From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)
Secondary outcomes (2)
Proportion of Days in Remission During the Maintenance Phase
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
Measured: From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
Number of Relapses During the Maintenance Phase
Defined as number of 4-week periods with use of once-daily rescue investigational medicinal product
Measured: From Randomisation (Week 4) until End of Treatment (Week 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start15 Feb 2017
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Lebwohl, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899962
- Sponsor's protocol ID
- LP0053-1004
- Status last verified
- Aug 2020
- First submitted
- 9 Sep 2016
- Last updated
- 20 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guenther L, Takhar A, Megna M, Sebastian M, Nyholm N, Thoning H, Levin LA. 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. J Eur Acad Dermatol Venereol. 2022 Jul;36(7):1054-1063. doi: 10.1111/jdv.18053. Epub 2022 Mar 28.
PubMed 35297108Lebwohl MG, Papp KA, Morch MH, Bernasconi MYJ, Warren RB. Long-Term Proactive Treatment of Plaque Psoriasis with Calcipotriene/Betamethasone Dipropionate Foam Prolongs Remission and Reduces Relapses Irrespective of Patient Baseline Characteristics. Dermatol Ther (Heidelb). 2021 Oct;11(5):1657-1665. doi: 10.1007/s13555-021-00585-x. Epub 2021 Aug 2.
PubMed 34339017Stein 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.
PubMed 32965655
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT02899962
- Acronym / sponsor ID
- LP0053-1004
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Posted 20 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 90100 aerosol foam | Active comparator | Drug: LEO 90100 aerosol foamTopical application twice weekly for 52 weeks |
| LEO 90100 aerosol foam vehicle | Placebo comparator | Drug: LEO 90100 aerosol foam vehicleTopical application twice weekly for 52 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEO 90100 aerosol foamLEO 90100 aerosol foam twice weekly | Drug | LEO 90100 aerosol foam |
| LEO 90100 aerosol foam vehicleLEO 90100 aerosol foam vehicle twice weekly | Drug | LEO 90100 aerosol foam vehicle |
Primary outcome
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
2 secondary outcomes
Proportion of Days in Remission During the Maintenance Phase
Time frame: From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
Number of Relapses During the Maintenance Phase
Time frame: From Randomisation (Week 4) until End of Treatment (Week 56)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35297108Guenther L, Takhar A, Megna M, Sebastian M, Nyholm N, Thoning H, Levin LA. 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. J Eur Acad Dermatol Venereol. 2022 Jul;36(7):1054-1063. doi: 10.1111/jdv.18053. Epub 2022 Mar 28.
- Derived from this study: PubMed 34339017Lebwohl MG, Papp KA, Morch MH, Bernasconi MYJ, Warren RB. Long-Term Proactive Treatment of Plaque Psoriasis with Calcipotriene/Betamethasone Dipropionate Foam Prolongs Remission and Reduces Relapses Irrespective of Patient Baseline Characteristics. Dermatol Ther (Heidelb). 2021 Oct;11(5):1657-1665. doi: 10.1007/s13555-021-00585-x. Epub 2021 Aug 2.
- Derived from this study: PubMed 32965655Stein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Lebwohl, MD principal investigator
Icahn School of Medicine at Mount Sinai
58 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LEO 90100 aerosol foam in people with Psoriasis Vulgaris, run by LEO Pharma at 58 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Canada, Germany, United Kingdom, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Relapse (time frame: From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02899962, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.