The Pharmacokinetics of LEO 90105 (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Extensive Psoriasis Vulgaris

NCT01768013 | Completed Phase 1 Results

• 1 other identifier: MCB 0904
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (24)

• Pharmacokinetic: Cmax of Betamethasone Dipropionate

  The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined.

  Day 1

• Pharmacokinetic: Cmax of Betamethasone Dipropionate

  The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined

  Day 7

• Pharmacokinetic: Cmax of Betamethasone Dipropionate

  The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined

  Day 14

• Pharmacokinetic: AUClast of Betamethasone Dipropionate

  The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined

  Day 1

• Pharmacokinetic: AUClast of Betamethasone Dipropionate

  The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined

  Day 7

• Pharmacokinetic: AUClast of Betamethasone Dipropionate

  The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined

  Day 14

• Pharmacokinetic: Cmax of Betamethasone 17-propionate

  The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined

  Day 1

• Pharmacokinetic: Cmax of Betamethasone 17-propionate

  The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined

  Day 7

• Pharmacokinetic: Cmax of Betamethasone 17-propionate

  The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined

  Day 14

• Pharmacokinetic: AUClast of Betamethasone 17-propionate

  The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined

  Day 1

• Pharmacokinetic: AUClast of Betamethasone 17-propionate

  The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined

  Day 7

• Pharmacokinetic: AUClast of Betamethasone 17-propionate

  The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined

  Day 14

• Pharmacokinetic: Cmax of Calcipotriol

  The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined

  Day 1

• Pharmacokinetic: Cmax of Calcipotriol

  The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined

  Day 7

• Pharmacokinetic: Cmax of Calcipotriol

  The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined

  Day 14

• Pharmacokinetic: AUClast of Calcipotriol

  The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined

  Day 1

• Pharmacokinetic: AUClast of Calcipotriol

  The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined

  Day 7

• Pharmacokinetic: AUClast of Calcipotriol

  The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined

  Day 14

• Pharmacokinetic: Cmax of MC1080

  The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined

  Day 1

• Pharmacokinetic: Cmax of MC1080

  The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined

  Day 7

• Pharmacokinetic: Cmax of MC1080

  The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined

  Day 14

• Pharmacokinetic: AUClast of MC1080

  The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined

  Day 1

• Pharmacokinetic: AUClast of MC1080.

  To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined

  Day 7

• Pharmacokinetic: AUClast of MC1080.

  The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined

  Day 14

Secondary Outcomes (2)

• Efficacy: Percentage Change in m-PASI From Baseline to Day 28

  Baseline to Day 28

• Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.

  Day 28

Study Arms (1)

LEO 90105 Ointment

EXPERIMENTAL

Drug: LEO 90105

Interventions

LEO 90105 DRUG

Once daily for four weeks

LEO 90105 Ointment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese subjects having understood and signed a written informed consent form prior to any study related procedures being carried out (including activities related to the wash out period)
• years of age or above.
• Either sex.
• Clinical diagnosis of psoriasis vulgaris amenable to topical treatment involving arms and/or trunk and/or legs.
• Psoriasis vulgaris on the trunk/limbs (excluding psoriasis on the genitals/skin folds) of not more than 30% body surface area (BSA)
• An Investigator's global assessment of disease severity (IGA) on area(s) to be treated of moderate, severe or very severe and a m-PASI score of ≥12.
• Females of childbearing potential must have a negative result for a urine pregnancy test at Day 1 (Visit 1) and must agree to use an adequate method of birth control, as judged by the (sub)investigator, during the study. The contraceptive method should have started an adequate amount of time before the pregnancy test, which is dependent on the particular method used and as judged by the (sub)investigator, and must continue for at least 1 week after the last application of study medication. A female is defined as not of child-bearing potential if she is postmenopausal (12 months with no menses without an alter-native medical cause) or surgically sterile (tubal ligation /section, hysterectomy or bilateral ovariectomy).

You may not qualify if:

• Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the following time periods prior to Visit 1:
• etanercept, adalimumab, infliximab -3 months.
• ustekinumab - 4 months
• other products - within 3 months/5 half-lives (whichever is longer).
• Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immu-nosuppressants such as ciclosporin and methotrexate) within 4 weeks prior to Visit 1 (use of inhaled and nasal corticosteroids is allowed, use of systemic antihistamines is allowed).
• Topical treatment of scalp psoriasis with vitamin D analogues (e.g. calcipotriol, tacalcitol, maxacalcitol), or very potent WHO group IV corticosteroids within 2 weeks prior to Visit 1.
• PUVA therapy, UVB therapy or UVA therapy within 4 weeks prior to Visit 1.
• Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D analogues (e.g. calcipotriol, tacalcitol, maxacalcitol), or potent or very potent WHO group III or IV corticosteroids within 2 weeks prior to Visit 1.
• Topical treatment of psoriasis on area(s) to be treated with study medication within the 2-week period prior to Visit 1. (Use of emollients is allowed during this 2- week period, but not during the study.)
• Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris (e.g., beta-blockers, antimalaria drugs, lithium and ACE inhibitors) during the study.
• Topical treatment of conditions other than psoriasis with vitamin D analogues (e.g. calcipotriol, tacalcitol, maxacalcitol), or potent or very potent WHO group III or IV corti-costeroids within 2 weeks prior to Visit 1.
• Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis.
• Clinical signs or symptoms of Cushing's disease or Addison's disease
• Patients with any of the following disorders (a) or symptoms (b) present on the area(s) to be treated with study medication: (a) viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, atrophic skin, striae atrophicae, ichthyosis, acne rosacea, ulcers, burns, frostbite, wounds, or (b) fragility of skin veins.
• Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

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

00 45 44 94 58 88

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 15, 2013
• Study Start: July 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 12, 2025
• Results First Posted: December 30, 2013

Record last verified: 2015-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)