Effect of LEO 80185 Gel on the HPA Axis and Calcium Metabolism in Subjects With Extensive Psoriasis Vulgaris

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01229098
• Date of registration: 26/10/2010
• Primary sponsor: LEO Pharma
• Public title: Effect of LEO 80185 Gel on the HPA Axis and Calcium Metabolism in Subjects With Extensive Psoriasis Vulgaris
• Scientific title: A Phase 2 Maximal Use Systemic Exposure Study Evaluating the Safety and Efficacy of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Gel Applied Once Daily in Subjects With Extensive Psoriasis Vulgaris on the Scalp and Non-scalp Regions of the Body (Trunk and/or Limbs)
• Date of first enrolment: October 2010
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01229098
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: Shane Silver, MB
• Affiliation: Dermadvances Research, 203 Edmonton Street, Winnipeg, Manitoba R3C 1R4 Canada

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Signed and dated informed consent obtained following receipt of verbal and written
information about the study prior to any trial related activities (including any
wash-out period).

2. Age 18 years or above.

3. Either sex.

4. Any race or ethnicity.

5. Attending a hospital out-subject clinic or the private practice of a dermatologist
for treatment of psoriasis vulgaris.

6. Clinical diagnosis of psoriasis vulgaris involving non scalp regions of the body
(trunk and/or limbs) with or without involvement of the scalp.

7. At SV2 and Day 0 (Visit 1) a clinical diagnosis of psoriasis vulgaris which is:

- amenable to topical treatment with a maximum of 100 g of study medication per
week, and

- of an extent of between 15 and 30% of the body surface area (BSA) excluding
psoriasis on the face, genitals or skin folds.

- a disease severity on the trunk and/or limbs graded as at least moderate
according to the investigator's global assessment (IGA)

8. Subjects with normal HPA axis function at SV2 including a serum cortisol
concentration above 5 mcg/dL before ACTH challenge test and above 18 mcg/dL 30
minutes after ACTH challenge test.

9. Albumin-corrected serum calcium, below the upper reference limit at SV2.

10. Females of child-bearing potential must have a negative urine pregnancy test result
at baseline Visit SV2 and must agree to use a highly effective method of
contraception during the study. Highly effective methods are defined as ones which
results in a low failure rate (less than 1% per year) such as progestin-only
formulations (implants, injectables), some intra-uterine devices, or vasectomised
partner. Subjects must have used the contraceptive method continuously for at least 1
month prior to the pregnancy test and must continue using the contraceptive method
for at least 1 week after the last application of study medication (or until study
visit FU2 if applicable). A female is defined as not of child-bearing potential if
she is postmenopausal (12 months with no menses without an alternative medical
cause), or surgically sterile (tubal ligation/section, hysterectomy or bilateral
ovariectomy).

11. Able to communicate with the investigator and understand and comply with the
requirements of the study.

Exclusion Criteria:

12. A history of serious allergy, allergic asthma or serious allergic skin rash

13. Known or suspected hypersensitivity to any medication (including
ACTH/cosyntropin/tetracosactide) or to any component of the LEO 80185 gel or
CORTROSYN.

14. Systemic treatment with corticosteroids (including inhaled and nasal steroids) within
12 weeks prior to SV2 and during the study.

15. Systemic treatment with biological therapies (marketed or not marketed), with a
possible effect on psoriasis vulgaris within the following time period prior to Day 0
(Visit 1) and during the study:

- etanercept - within 4 weeks prior to Visit 1

- adalimumab, alefacept, infliximab -within 2 months prior to Visit 1

- ustekinumab, briakinumab - within 4 months prior to Visit 1

- experimental products - within 4 weeks/5 half-lives (whichever is longer) prior
to Visit 1

16. Systemic treatment with therapies other than biologicals, with a possible effect on
psoriasis vulgaris (e.g., retinoids, methotrexate, immunosuppressants) within 4 weeks
prior to Visit 1 (Day 0) or during the study.

17. PUVA or Grenz ray therapy within 4 weeks prior to Visit 1 (Day 0) or during the study

18. UVB therapy within 2 weeks prior to Visit 1 (Day 0) or during the study.

19. Topical treatment with corticosteroids or vitamin D analogues (calcipotriol,
calcitriol or tacalcitol) on any body location within 2 weeks prior to SV2 or during
the study.

20. Any topical treatment of psoriasis vulgaris on the scalp or trunk and/or limbs
(except for emollients and non-steroid medicated shampoos) within 2 weeks prior to
Visit 1 (Day 0) or during the study.

21. Oral calcium supplements, vitamin D supplements, antacids, thiazide and/or loop
diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2
and during the study. Note: Stable doses of oral vitamin D supplementation =400
IU/day is permitted provided there are no dose adjustments during the study period.

22. Planned initiation of, or changes to, concomitant medication that could affect
psoriasis vulgaris (e.g., betablockers, antimalarials, lithium, ACE inhibitors)
during the study.

23. Planned excessive exposure of treated areas to either natural or artificial sunlight
(e.g. sunlamps etc.) during the study that may affect the psoriasis vulgaris.

24. Oestrogen therapy (including contraceptives) or any other medication known to affect
cortisol levels or HPA axis integrity within 4 weeks prior to SV2 or during the
study.

25. Cytochrome P450 3A4 (CYP 3A4) inducers (e.g., barbiturates, phenytoin, rifampicin)
within 4 weeks prior to SV2 or during the study.

26. Systemic or topical cytochrome P450 3A4 (CYP 3A4) inhibitors (e.g., ketoconazole,
itraconazole, metronidazole) within 4 weeks prior to SV2 or during the study. Topical
ketoconazole within 2 weeks prior to SV2.

27. Hypoglycaemic sulfonamides within 4 weeks prior to the SV2 or during the study.

28. Antidepressant medications within 4 weeks prior to SV2 or during the study.

29. Not following nocturnal sleep patterns (e.g. night shift workers are excluded).

30. Known or suspected endocrine disorder that may affect the results of the ACTH
challenge test.

31. Clinical signs or symptoms of Cushing's disease or Addison's disease.

32. Known or suspected diabetes mellitus.

33. Known or suspected cardiac disorders associated with abnormal QT intervals or rhythm
disturbances including clinically significant bradycardia or tachycardia.

34. Known or suspected severe renal insufficiency or severe hepatic disorders.

35. Known or suspected disorders of calcium metabolism associated with hypercalcaemia.

36. Any clinically significant abnormality following review of screening laboratory tests
(blood and spot urine samples), physical examination or blood pressure/heart rate
measurement performed at SV2.

37. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.

38. Any of the following conditions present on the study treatment areas: viral (e.g.,
herpes or varicella) lesions of the skin, fungal and bacterial skin infections,
parasitic infections, skin m


Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Psoriasis Vulgaris

Intervention(s)

Drug: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)

Primary Outcome(s)

Safety [Time Frame: Up to 8 weeks]

Secondary Outcome(s)

Efficacy [Time Frame: Up to 8 weeks]

Secondary ID(s)

LEO 80185-G24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors