Safety and Efficacy of Calcipotriol plus Betamethasone Dipropionate Gel in Adolescent Subjects (Aged 12 to 16 Years, 11 months) with Scalp and Body Psoriasis

Phase 1

• Conditions: Psoriasis of the scalp and body; MedDRA version: 18.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-001538-16-DE
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-05
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria for All Subjects:
1. Signed informed consent given by parent(s), or legal guardian(s), or by the subject (according to national law) following their receipt of verbal and written information about the trial.
2. Subjects will receive verbal and written information and will provide written assent to the trial.
3. Subjects 12 to 16 years, 11 months of age.
4. Either sex.
5. Any race or ethnicity.
6. Clinical signs of psoriasis vulgaris on both the scalp and body (trunk and/or limbs).
7. A serum albumin-corrected calcium below the upper reference limit at SV2.
8. Females of child-bearing potential must have a negative urine pregnancy test result and must agree to use a highly effective method of contraception during the trial. Highly effective methods are defined as ones which result in a low failure rate (less than 1% per year).
9. Subjects fulfilling national requirements/law for participation in this trial.

Additional Inclusion Criteria for Subjects Performing HPA Axis and PK Assessments (assigned U.S. and German sites only):
10. At SV2 and Visit 1, a clinical diagnosis of scalp and body (trunk and/or limbs) psoriasis
which is:
a. of an extent of 10 to 35% of the body surface area (excluding psoriatic lesions of
the face and sensitive areas), and
b. of at least moderate severity according to the investigator’s global assessment of
disease severity on the body
11. At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
a. more than or equal to 20% of the scalp area, and
b. of at least moderate severity according to the investigator’s global assessment of
disease severity on the scalp.
12. Subjects with a normal HPA axis function at SV2 including serum cortisol concentration
above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl
30 minutes after ACTH challenge.
13. At Visit 1, weighing at least 30kg

Additional Inclusion Criteria for Subjects Not Performing HPA Axis and PK Assessments:
14. At SV2 and Visit 1, a clinical diagnosis of body (trunk and/or limbs) psoriasis which is:
a. more than or equal to 3% of the body surface area (excluding psoriatic lesions of
the face and sensitive areas), and
b. of at least mild severity according to the investigator’s global assessment of
disease severity on the body.
15. At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
a. more than or equal to 10% of the scalp area, and
b. of at least mild severity according to the investigator’s global assessment of
disease severity on the scalp, and
c. for subjects aged 12 to < 15 years with a BSA = 1.3 m2, amenable to topical
treatment with a maximum of 55 g of investigational product per week, and
d. for subjects aged 12 to < 15 years with a BSA > 1.3 m2, amenable to topicaltreatment with a maximum of 75 g of investigational product per week, and
e. for subjects aged > 15 years with a BSA = 1.7 m2, amenable to topical treatment
with a maximum of 75 g of investigational product per week, and
f. for subjects aged > 15 years with a BSA > 1.7 m2, amenable to topical treatment
with a maximum of 100 g of investigational product per week.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Main exclusion criteria for all subjects:
1. A history of hypersensitivity to any component of the LEO 80185 gel
2. Systemic treatment with biological therapies with a possible effect on scalp and/or body psoriasis within the following time period prior to Visit 1 and during the trial.
3. Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis within 4 weeks prior to Visit 1 (Day 0) or during the trial.
4. UVB therapy within 2 weeks prior to Visit 1 or during the trial.
5. Any topical treatment on the scalp and body including corticosteroids within 2 weeks prior to Visit 1 or during the trial.
6. Systemic calcium, vitamin D supplementation > 400 IU/day, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 or during the trial.
7. Planned initiation of, or changes to, concomitant medication that could affect psoriasis during the trial.
8. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
9. Subjects with any of the following conditions present on the treatment areas on scalp and/or body: 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, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.
10. Other inflammatory skin diseases that may confound the evaluation of scalp and/or body psoriasis.
11. Planned excessive exposure to sun during the trial that may affect scalp and/or body psoriasis.
12. Known or suspected severe renal insufficiency or severe hepatic disorders.
13. Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
14. Any clinically significant abnormality following review of screening laboratory tests (blood and urine samples), physical examination or blood pressure/heart rate measurement performed at SV2.
15. Current participation in any other interventional clinical trial.
16. Previously treated with LEO 80185 in this trial.
17. Subjects who have received treatment with any non-marketed drug within a month prior to SV1 or longer, if the class of substance required a longer wash-out.
18. Subjects or parent(s) or legal guardian(s) known or suspected of being unlikely to comply with the Clinical Trial Protocol
19. Females who are pregnant, or of child-bearing potential and wishing to become pregnant during the trial, or who are breast-feeding.
20. Females of child-bearing potential with positive pregnancy test at SV2.
21. Subject (or their partner) not using an adequate method of contraception according to national requirements.

Additional exclusion criteria for subjects performing HPA axis and PK assessments (assigned U.S. and German
sites only):
22. A history of serious allergy, allergic asthma or serious allergic skin rash.
23. Known or suspected hypersensitivity to any component of CORTROSYN® (including ACTH/cosyntropin/tetracosactide).
24. Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 or during the trial.
25. 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 trial.
26. Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to SV2 or during

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified