Phase 2
Completed N=37
Effect of LEO 90100 on the HPA Axis and Calcium Metabolism in Subjects With Extensive Psoriasis VulgarisExtensive Psoriasis Vulgaris
Source: ClinicalTrials.gov NCT01600222 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After Adrenocorticotrophic Hormone-challenge (ACTH-challenge) — 0 Subjects
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After Adrenocorticotrophic Hormone-challenge (ACTH-challenge) |
— | — |
| PRIMARY Change in Albumin-corrected Serum Calcium From Baseline to Day 28 |
0.014 | — |
| PRIMARY Change in 24-hour Urinary Calcium Excretion From Baseline to Day 28 |
-0.49 | — |
| PRIMARY Change in 24-hour Urinary Calcium:Creatinine Ratio From Baseline to Day 28 |
-0.0300 | — |
| SECONDARY Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Day 28 |
— | — |
| SECONDARY Number of Participants With an Adverse Drug Reaction (ADR) |
1 | — |
| SECONDARY Change in Serum Phosphate From Baseline to Day 28 |
0.030 | — |
| SECONDARY Change in 24-hour Urinary Phosphate Excretion From Baseline to Day 28 |
-0.25 | — |
| SECONDARY Change in Urinary Phosphate: Creatinine Ratio From Baseline to Day 28 |
1.847 | — |
| SECONDARY Change in Serum Alkaline Phosphatase (ALP) From Baseline to Day 28 |
-1.5 | — |
| SECONDARY Change in Plasma Parathyroid Hormone (PTH) From Baseline to Day 28 |
0.893 | — |
| SECONDARY Change in Blood Pressure From Baseline to Day 28 |
-1.5; -2.2 | — |
| SECONDARY Change in Heart Rate From Baseline to Day 28 |
0.2 | — |
| SECONDARY Number of Subjects Who Discontinued From the Study |
— | — |
| SECONDARY Pharmacokinetic Evaluation Cmax |
52.2; 148; 55.9; 24.4 | — |
| SECONDARY Pharmacokinetic Evaluation AUClast |
36.5; 683.6; 82.5; 59.3 | — |
| SECONDARY Pharmacokinetic Evaluation AUCinf |
NA; NA; NA; NA | — |
| SECONDARY Pharmacokinetic Evaluation Tmax |
1.0000; 2.0830; 2.000; 5.0000 | — |
| SECONDARY Pharmacokinetic Evaluation T1/2 |
NA; NA; NA; NA | — |
| SECONDARY Efficacy Evaluation |
48.6; 45.9 | — |
Eligibility Criteria
Inclusion Criteria
- Signed and dated informed consent obtained prior to any trial related activities (including any washout period)
- Age 18 years or above
- Either sex
- 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
Exclusion Criteria
- A history of allergic asthma, serious allergy or serious allergic skin rash
- Known or suspected hypersensitivity to component(s) of LEO 90100 or CORTROSYN (including cosyntropin/tetracosactide)
- 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 i
Data sourced from ClinicalTrials.gov (NCT01600222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.