A Phase 2 Maximal Use Systemic Exposure (MUSE) study evaluating the safety and efficacy of
LEO 90100 used once daily in subjects with extensive psoriasis vulgaris.
Drug: LEO 90100
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Locations near you
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Full eligibility criteria for NCT01600222
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Signed and dated informed consent obtained prior to any trial related activities
(including any washout period)
Age 18 years or above
Any race or ethnicity
Any skin type
Attending a hospital out-patient clinic or the private practice of a dermatologist for treatment of psoriasis vulgaris
At SV2 and Day 0 (Visit 1), a clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs and the scalp which is;
amenable to topical treatment with a maximum of 120g of study medication per week
of an extent of between 15 and 30% of the body surface area (BSA) excluding psoriatic lesions of the face, genitals and skin folds
including at least 30% scalp involvement
of at least a moderate disease severity according to the investigators global assessment (IGA)
At SV2, a normal HPA axis function including a serum cortisol concentration above 5 mcg/dl before ACTH-challenge and above 18 mcg/dl 30 minutes after ACTH-challenge
At SV2, an albumin-corrected serum calcium below the upper reference range limit
At SV2, females of child-bearing potential must have a negative urine pregnancy result
Females of child-bearing potential must agree to use a highly effective method of contraception during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year)
Able to communicate with the investigator and understand and comply with the requirements of the study
A history of allergic asthma, serious allergy or serious allergic skin rash
Known or suspected hypersensitivity to component(s) of LEO 90100 or CORTROSYN
Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2
Systemic treatment with biological therapies (whether marketed or not marketed), with a possible effect on psoriasis vulgaris within the following time period prior to Day 0 (Visit 1);
etanercept - within 4 weeks
adalimumab, alefacept, infliximab - within 8 weeks
ustekinumab - within 16 weeks
other products - within 4 weeks/5 half-lives (whichever is longer)
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 Day 0 (Visit 1)
Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. retinoids, methotrexate, cyclosporine and other immunosuppressants) within 4 weeks prior to Day 0 (Visit 1)
PUVA therapy within 4 weeks prior to Day 0 (Visit 1)
UVB therapy within 2 weeks prior to day 0 (Visit 1).
Topical treatment with corticosteroids or vitamin D analogues on any body location within 2 weeks prior to SV2
Any topical treatment of psoriasis vulgaris on the trunk, limbs or scalp (except for emollients and non-medicated shampoos) within 2 weeks prior to Day 0 (Visit 1)
Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g., betablockers, antimalarials, lithium, ACE inhibitors) during the study
Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin within 4 weeks prior to SV2. Note: Stable doses of oral vitamin D supplementation ≤400 IU/day is permitted provided there are no dose adjustments during the study period
Planned initiation of, or changes to concomitant medication that could affect calcium metabolism (e.g. antacids, thiazide and/or loop diuretics, antiepileptics) during the study
Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sunlamps etc.) during the study
Oestrogen therapy (including contraceptives), antidepressant medications and any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to SV2
Cytochrome P450 3A4 (CYP 3A4) inducers (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to SV2
Systemic cytochrome P450 3A4 (CYP 3A4) inhibitors (e.g., ketoconazole, itraconazole, metronidazole) within 4 weeks prior to SV2
Topical cytochrome P450 3A4 (CYP 3A4) inhibitors (e.g., ketoconazole) within 2 weeks prior to SV2
Non-nocturnal sleep patterns (e.g. night shift workers)
Any of the following conditions, whether known or suspected:
depression and endocrine disorders (e.g. Cushing's disease, Addison's disease, diabetes mellitus) known to affect cortisol levels or HPA axis integrity
disorders of calcium metabolism associated with hypercalcaemia
cardiac disorders associated with abnormal QT intervals or rhythm disturbances including clinically significant bradycardia or tachycardia
severe renal insufficiency
severe hepatic disorders
Any clinically significant abnormality following blood pressure/heart rate measurement or review of screening laboratory tests (blood and spot urine samples) collected at SV2
Any clinically significant abnormality following physical examination at SV1
Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Any of the following conditions present on the study treatment areas (trunk, limbs and scalp): viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds
Other inflammatory skin disorders (e.g. seborrhoeic dermatitis and contact dermatitis) that may confound the evaluation of psoriasis vulgaris
Current participation in any other interventional clinical trial
Previously enrolled in this trial
Known or suspected of not being able to comply with the trial protocol (e.g., alcoholism, drug dependency or psychotic state)
Females who are pregnant, wishing to become pregnant during the study or who are breast-feeding
All locations for NCT01600222
Guildford Dermatology Specialists
Surrey, British Columbia, Canada, V3R 6A7
PerCuro Clinical Research
Victoria, British Columbia, Canada, V8V 3P9
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, Canada, R3C 0N2
Maritime Medical Research Center
Bathurst, New Brunswick, Canada, E2A 4Z9
Barrie, Ontario, Canada, L4M 6L2
Courtice, Ontario, Canada, L1E 3C3
London, Ontario, Canada, N5X 2P1
The Centre for Dermatology
Richmond Hill, Ontario, Canada, L4B 1A5
K. Papp Clinical Research
Waterloo, Ontario, Canada, N2J 1C4
Centre de Dermatologie Maizerets
Quebec City, Quebec, Canada, G1J 1X7
Trial results for NCT01600222
Participant Flow: Overall Study
35 / 37
Completed / Started
Serious Adverse Events
0 / 37
Affected / At Risk
Other Adverse Events
4 / 37
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT01600222. The sponsor of the trial is LEO Pharma and it is looking for 37 volunteers for the current phase.
Official trial title: A Phase 2 Maximal Use Systemic Exposure (MUSE) Study Evaluating the Safety and Efficacy of LEO 90100 Used Once Daily in Subjects With Extensive Psoriasis Vulgaris
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