Effect of LEO 90100 on the HPA Axis and Calcium Metabolism in Subjects With Extensive Psoriasis VulgarisExtensive Psoriasis Vulgaris

NCT01600222 | Completed Phase 2 Results

• 1 other identifier: LEO 90100-30
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (4)

• Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After Adrenocorticotrophic Hormone-challenge (ACTH-challenge)

  HPA-axis testing by means of the rapid standard-dose cosyntropin test (ACTH-challenge test) for detection of adrenal suppression.

  Day 28

• Change in Albumin-corrected Serum Calcium From Baseline to Day 28

  The effect of LEO 90100 on calcium metabolism was evaluated based on change in albumin-corrected serum calcium from Baseline to Day 28.

  Baseline and Day 28

• Change in 24-hour Urinary Calcium Excretion From Baseline to Day 28

  The effect of LEO 90100 on calcium metabolism was evaluated based on change in 24-hour urinary calcium excretion from Baseline to Day 28 in 24-hour.

  Baseline and Day 28

• Change in 24-hour Urinary Calcium:Creatinine Ratio From Baseline to Day 28

  The effect of LEO 90100 on calcium metabolism was evaluated based on change in urinary calcium:creatinine ratio from Baseline to Day 28.

  Baseline and Day 28

Secondary Outcomes (16)

• Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Day 28

  Day 28

• Number of Participants With an Adverse Drug Reaction (ADR)

  Baseline to Day 28

• Change in Serum Phosphate From Baseline to Day 28

  Baseline and Day 28

• Change in 24-hour Urinary Phosphate Excretion From Baseline to Day 28

  Baseline and Day 28

• Change in Urinary Phosphate: Creatinine Ratio From Baseline to Day 28

  Baseline and Day 28

Study Arms (1)

LEO 90100

EXPERIMENTAL

Drug: LEO 90100

Interventions

LEO 90100 DRUG

Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)

LEO 90100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (10)

Guildford Dermatology Specialists

Surrey, British Columbia, V3R 6A7, Canada

Location

PerCuro Clinical Research

Victoria, British Columbia, V8V 3P9, Canada

Location

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Maritime Medical Research Center

Bathurst, New Brunswick, E2A 4Z9, Canada

Location

Ultranova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

Co-Medica

Courtice, Ontario, L1E 3C3, Canada

Location

Mediprobe Research

London, Ontario, N5X 2P1, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Centre de Dermatologie Maizerets

Québec, Quebec, G1J 1X7, Canada

Location

Related Publications (2)

• Taraska V, Tuppal R, Olesen M, Bang Pedersen C, Papp K. Fixed combination aerosol foam calcipotriene (Cal) 0.005% plus betamethasone 0.064% (as dipropionate; BD) exhibits no impact on the HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a multicenter, single-arm, Phase II, 4-week MUSE study. Semin Cutan Med Surg. 2015;34 S1:PA-29.

  RESULT

• Taraska V, Tuppal R, Olesen M, Bang Pedersen C, Papp K. Fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) exhibits no impact on the HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a multicenter, single-arm, Phase II, 4-week MUSE study. Semin Cutan Med Surg 2014;33:abst PA-13.

  RESULT

Related Links

• Clinical Trials at LEO Pharma

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

ctr.disclosure@leo-pharma.com

+45 44945888

Study Officials

• Vicki Taraska

  Winnipeg Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 17, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 7, 2025
• Results First Posted: September 16, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)