LEO 90100 aerosol foam compared to calcipotriol plus betamethasone dipropionate gel in subjects with psoriasis vulgaris

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2013-004686-14-FR
• Date of registration: 22/06/2015
• Prospective Registration: No
• Primary sponsor: LEO Pharma A/S
• Public title: LEO 90100 aerosol foam compared to calcipotriol plus betamethasone dipropionate gel in subjects with psoriasis vulgaris
• Scientific title: LEO 90100 aerosol foam compared to calcipotriol plus betamethasone dipropionate gel in subjects with psoriasis vulgaris - The PSO-ABLE trial
• Date of first enrolment: 27/05/2014
• Target sample size: 460
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004686-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France, United States

Contacts

• Name: Kathrine Drud-Olsson
• Affiliation: LEO Pharma A/S

• Name: Kathrine Drud-Olsson
• Affiliation: LEO Pharma A/S

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age 18 years or above
2. Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2 to 30% of the Body Surface Area (BSA)
3. Physician's Global Assessment of disease severity
(PGA) of at least mild on trunk and limbs
4. m-PASI score of at least 2 on the trunk and limbs
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
1. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
2. Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- etanercept – within 4 weeks prior to randomisation
- adalimumab, infliximab – within 8 weeks prior to randomisation
- ustekinumab – within 16 weeks prior to randomisation
- other products – within 4 weeks/5 half-lives prior to randomisation (whichever is longer)
3. 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
randomisation)
4. Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
5. Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation
6. Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation
7. Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation
8. Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation
9. Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Psoriasis vulgaris
MedDRA version: 18.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858

Intervention(s)

Product Code: LEO 90100
Pharmaceutical Form: Cutaneous foam
INN or Proposed INN: CALCIPOTRIOL HYDRATE
CAS Number: 147657-22-5
Other descriptive name: CALCIPOTRIOL MONOHYDRATE
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 0.05-
INN or Proposed INN: BETAMETHASONE DIPROPIONATE
CAS Number: 5593-20-4
Other descriptive name: BETAMETHASONE DIPROPIONATE
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Cutaneous foam
Route of administration of the placebo: Cutaneous use

Trade Name: Daivobet/Dovobet gel
Product Name: Daivobet/Dovovet gel
Pharmaceutical Form: Gel
INN or Proposed INN: CALCIPOTRIOL MONOHYDRATE
CAS Number: 147657-22-5
Other descriptive name: CALCIPOTRIOL MONOHYDRATE
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 0.05-
INN or Proposed INN: BETAMETHASONE DIPROPIONATE
CAS Number: 5593-20-4
Other descriptive name: BETAMETHASONE DIPROPIONATE
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 0.50-
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Cutaneous use

Primary Outcome(s)

Main Objective: To compare the efficacy of treatment with LEO 90100 at
Week 4 to that of calcipotriol plus betamethasone
dipropionate (BDP) gel at Week 8 in subjects with
psoriasis vulgaris

Primary end point(s): Subjects with ‘treatment success’ (‘clear’ or ‘almost clear’
for subjects with at least moderate disease at baseline,
‘clear’ for subjects with mild disease at baseline)
according to the PGA at Week 4 for LEO 90100 and at
Week 8 for calcipotriol BDP gel

Secondary Objective: To compare the safety and efficacy of treatment with LEO 90100 to that of calcipotriol BDP
gel for up to 12 weeks in subjects with psoriasis vulgaris

Timepoint(s) of evaluation of this end point: 4 and 8 weeks

Secondary Outcome(s)

Secondary end point(s): - PASI 75 at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel
- Time to ‘treatment success’ according to PGA
- Change in itch as assessed by the Visual Analogue Scale (VAS) from baseline (Day 0) to Week 4 for LEO 90100 and to Week 8 for calcipotriol BDP at Week 8

Timepoint(s) of evaluation of this end point: 4 and 8 weeks

Secondary ID(s)

LP0053-1003

Source(s) of Monetary Support

LEO Pharma A/S

Ethics review

Status: Approved
Approval date: 30/04/2014
Contact:

Results

• Results available: Yes
• Date Posted: 17/07/2016
• Date Completed: 04/03/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004686-14/results