An International, Multi-centre, Prospective, Non-controll... | NCT02038569

Label	Type	Description	Intervention Names
LEO 80185 gel	Experimental		Drug: LEO 80185 gel

Name	Type	Description	Arm Group Labels	Other Names
LEO 80185 gel	Drug		LEO 80185 gel

Measure	Description	Time Frame
Adverse Drug Reactions (ADRs)	Number of Adverse Drug Reactions (ADRs)	8 weeks
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4	Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4	30 minutes after ACTH-challenge at Week 4
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8	Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 8	30 minutes after ACTH-challenge at Week 8
Change in Albumin-corrected Serum Calcium From Baseline to Week 4	Change in albumin-corrected serum calcium from baseline to Week 4	From baseline to Week 4
Change in Albumin-corrected Serum Calcium From Baseline to Week 8	Change in albumin-corrected serum calcium from baseline to Week 8	From baseline to Week 8
Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment	Change in albumin-corrected serum calcium from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.	From baseline to end of treatment
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4

Measure	Description	Time Frame
Adverse Events (AEs)	Number of Adverse Events (AEs)	8 weeks
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 4	Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 4

Eligibility Module

Eligibility Criteria

Inclusion Criteria (all subjects):

Clinical signs of psoriasis vulgaris on both the scalp and body (trunk and/or limbs)
At SV2 and Visit 1, a clinical diagnosis of scalp and body (trunk and/or limbs) psoriasis which is:
- of an extent of 10 to 35% of the body surface area (excluding psoriatic lesions of the face and sensitive areas. Sensitive areas include armpits, groin, under the breasts and in other skin folds around the genitals and buttocks), and
- of at least moderate severity according to the investigator's global assessment of disease severity on the body.
A serum albumin-corrected calcium level below the upper reference limit at SV2

Inclusion Criteria (for subjects performing HPA axis assessments):

At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
- more than or equal to 20% of the scalp area, and
- of at least moderate severity according to the investigator's global assessment of disease severity on the scalp.
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.

Inclusion Criteria (for subjects not performing HPA axis assessments):

At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
- more than or equal to 10% of the scalp area, and
- of at least moderate severity according to the investigator's global assessment of disease severity on the scalp.

Exclusion Criteria (all subjects):

Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to Visit 1 and during the trial:
- etanercept - within 4 weeks prior to Visit 1
- adalimumab, infliximab - within 2 months prior to Visit 1
- ustekinumab - within 4 months prior to Visit 1
- experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1
Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g., retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the trial.
UVB therapy within 2 weeks prior to Visit 1 or during the trial.
Any topical treatment on the scalp and body (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the trial.
Systemic calcium, vitamin D supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 or during the trial.
Planned initiation of, or changes to, concomitant medication that could affect psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the trial.
Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
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.
Other inflammatory skin diseases that may confound the evaluation of scalp and/or body psoriasis.
Planned excessive exposure to sun during the trial that may affect scalp and/or body psoriasis.
Known or suspected severe renal insufficiency or severe hepatic disorders.
Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
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.
Current participation in any other interventional clinical trial.
Previously enrolled in this trial.
Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within a month prior to SV1 or longer, if the class of substance required a longer wash-out as defined above (e.g., biological treatments).
Subjects or parent(s) or legal guardian known or suspected of being unlikely to comply with the Clinical Trial Protocol (e.g., alcoholism, drug dependency or psychotic state).
Females who are pregnant, or of child-bearing potential and wishing to become pregnant during the trial, or who are breast-feeding.
Females of child-bearing potential with positive pregnancy test at SV2.
Subject (or their partner) not using an adequate method of contraception according to national requirements.

Exclusion Criteria (for subjects performing HPA axis assessments)

A history of serious allergy, allergic asthma or serious allergic skin rash.
Known or suspected hypersensitivity to any component of CORTROSYN® (including ACTH/cosyntropin/tetracosactide)
Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 or during the trial.
Topical treatment with corticosteroids within 2 weeks prior to SV2 or during the trial.
Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.
Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to SV2 or during the trial.
Systemic or topical cytochrome P450 inhibitors (e.g., ketoconazole, itraconazole, metronidazole) within 4 weeks prior to SV2 or during the trial. Topical ketoconazole 2 weeks prior to SV2.
Hypoglycemic sulfonamides within 4 weeks prior to SV2 or during the trial.
Antidepressive medications within 4 weeks prior to SV2 or during the trial.
Known or suspected endocrine disorder that may affect the results of the ACTH challenge test.
Clinical signs or symptoms of Cushing's disease or Addison's disease.
Subjects with diabetes mellitus.
Known or suspected cardiac condition.
Not following nocturnal sleep patterns.

Name	Affiliation	Role
Lawrence Eichenfield, MD	Rady Chilidren's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Rady's Children Hospital		San Diego	California	92132	United States
Clinical Research Center, Morsani Center for Advanced Healthcare

ID	Title	Description
FG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 17, 2013	Aug 10, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Adverse Drug Reactions (ADRs)

Number of Adverse Drug Reactions (ADRs)

Safety analysis set

Posted

Number

Number of adverse drug reactions

8 weeks

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.

Units	Counts
Participants	OG000107

Title

Denominators

Categories

Blood cortisol decreased

Title	Measurements
	OG0002

Blood parathyroid hormone increased

Title	Measurements
	OG0001

Acne

Primary

Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4

Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4

Per protocol analysis set

Posted

Count of Participants

Participants

30 minutes after ACTH-challenge at Week 4

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.

Units	Counts
Participants	OG000

Primary

Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8

Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 8

Per protocol analysis set

Posted

Count of Participants

Participants

30 minutes after ACTH-challenge at Week 8

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.

Units	Counts
Participants	OG000

Primary

Change in Albumin-corrected Serum Calcium From Baseline to Week 4

Change in albumin-corrected serum calcium from baseline to Week 4

Safety analysis set.

Posted

Mean

Standard Deviation

mmol/L

From baseline to Week 4

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.

Units	Counts
Participants	OG000107

Primary

Change in Albumin-corrected Serum Calcium From Baseline to Week 8

Change in albumin-corrected serum calcium from baseline to Week 8

Safety analysis set.

Posted

Mean

Standard Deviation

mmol/L

From baseline to Week 8

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.

Units	Counts
Participants	OG000107

Primary

Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment

Change in albumin-corrected serum calcium from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.

Safety analysis set.

Posted

Mean

Standard Deviation

mmol/L

From baseline to end of treatment

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.

Units	Counts
Participants	OG000

Primary

Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4

Change in 24-hour urinary calcium excretion from baseline to Week 4

Safety analysis set

Posted

Mean

Standard Deviation

mmol/24hr

From baseline to Week 4

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.

Units	Counts
Participants	OG000107

Primary

Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8

Change in 24-hour urinary calcium excretion from baseline to Week 8

Safety analysis set

Posted

Mean

Standard Deviation

mmol/24hr

From baseline to Week 8

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.

Units	Counts
Participants	OG000107

Primary

Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment

Change in 24-hour urinary calcium excretion from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.

Safety analysis set

Posted

Mean

Standard Deviation

mmol/24hr

From baseline to end of treatment

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.

Units	Counts
Participants	OG000

Secondary

Adverse Events (AEs)

Number of Adverse Events (AEs)

Safety analysis set

Posted

Number

Adverse Events

8 weeks

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts
Participants	OG000

Secondary

Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 4

Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 4

Per protocol analysis set

Posted

Count of Participants

Participants

30 and 60 minutes after ACTH-challenge at Week 4

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts
Participants	OG000

Secondary

Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 8

Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 8

Per protocol analysis set

Posted

Count of Participants

Participants

30 and 60 minutes after ACTH-challenge at Week 8

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts
Participants	OG000

Secondary

Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4

Change in urinary calcium:creatinine ratio from baseline to Week 4

Safety analysis set

Posted

Mean

Standard Deviation

mmol/g

From baseline to Week 4

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts
Participants	OG000

Secondary

Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8

Change in urinary calcium:creatinine ratio from baseline to Week 8

Safety analysis set

Posted

Mean

Standard Deviation

mmol/g

From baseline to Week 8

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts
Participants	OG000

Secondary

Change in Serum Alkaline Phosphatase From Baseline to Week 4

Change in serum alkaline phosphatase from baseline to Week 4

Safety analysis set

Posted

Mean

Standard Deviation

mmol/L

From baseline to Week 4

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts
Participants	OG000

Secondary

Change in Serum Alkaline Phosphatase From Baseline to Week 8

Change in serum alkaline phosphatase from baseline to Week 8

Safety analysis set

Posted

Mean

Standard Deviation

mmol/L

From baseline to Week 8

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts
Participants	OG000

Secondary

Pharmacokinetic Evaluation AUC(0-t)

AUC(0-t) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, and no subjects had enough positive samples to allow calculation AUC(0-t) for betamethasone dipropionate. Betamethasone 17-propionate was only detected in 12 samples from 5 subjects, and only 2 subjects had enough positive samples to calculate AUC(0-t). The mean value of AUC(0-t) for these 2 subjects is presented for betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.

PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.

Posted

Mean

Standard Deviation

pg*h/mL

Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Secondary

Pharmacokinetic Evaluation AUC(0-infinity)

AUC(0-infinity) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, and no subjects had enough positive samples to allow calculation AUC(0-infinity) for betamethasone dipropionate. Betamethasone 17-propionate was only detected in 12 samples from 5 subjects, and only 2 subjects had enough positive samples to calculate AUC(0-infinity). The mean value of AUC(0-infinity) for these 2 subjects is presented for betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.

The terms AUC(0-infinity) and AUC(all) are interchangeable, AUC(0-infinity) was used in the protocol whereas AUC(all) was used in the report. AUC(0-infinity) has been used here to be consistent with the protocol.

PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.

Posted

Mean

Standard Deviation

pg*h/mL

Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Secondary

Pharmacokinetic Evaluation C(Max)

C(max) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects, therefore pharmacokinetic profiles could not be calculated. Presented C(max) values for betamethasone dipropionate and betamethasone 17-propionate are the the single highest concentrations measured in any sample at any time. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.

PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.

Posted

Number

pg/mL

Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts

Secondary

Pharmacokinetic Evaluation T(Max)

T(max) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects. Therefore it was not possible to calculate T(max) for betamethasone dipropionate and betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.

PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.

Posted

Number

Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts
Participants

Secondary

Pharmacokinetic Evaluation T(½)

T(½) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects, therefore it was not possible to calculate T(½) for betamethasone dipropionate or betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.

PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.

Posted

Number

Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts
Participants

Secondary

Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity on the Body at End of Treatment

Subjects with "Controlled disease" (i.e., "Clear" or "Almost clear" for subjects with at least "Moderate" disease at baseline, "Clear" for subjects with "Mild" disease at baseline) according to the investigator's global assessment of disease severity on the body at end of treatment, defined as the last value recorded up to and including Week 8.

Full analysis set

Posted

Count of Participants

Participants

End of treatment

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts
Participants	OG000

Secondary

Percentage Change in PASI From Baseline to End of Treatment

Percentage change in Psoriasis area and severity index (PASI) score from baseline to end of treatment, defined as the last value recorded up to and including Week 8. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease.

Full analysis set

Posted

Mean

Standard Deviation

Percentage change in PASI score

From baseline to end of treatment

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts

Secondary

Subjects With "Controlled Disease" According to the Patient's Global Assessment of Disease Severity on the Body at End of Treatment

Subjects with "Controlled disease" (i.e., "Clear" or "Almost clear" for subjects with at least "Moderate" disease at baseline, "Clear" for subjects with "Mild" disease at baseline) according to the patient's global assessment of disease severity on the body at end of treatment, defined as the last value recorded up to and including Week 8.

Full analysis set

Posted

Count of Participants

Participants

End of treatment

ID	Title	Description
OG000	LEO 80185 Gel	LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0006 events6 affected107 at risk
Rhinitis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0002 events2 affected107 at risk
Folliculitis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Hordeolum	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Impetigo	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Peritonsillar abscess	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Viral infection	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Blood parathyroid hormone increased	Investigations	MedDRA (15.1)	Non-systematic Assessment	EG0005 events4 affected107 at risk
Blood cortisol decreased	Investigations	MedDRA (15.1)	Non-systematic Assessment	EG0002 events2 affected107 at risk
Eosinophil count increased	Investigations	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Headache	Nervous system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0008 events6 affected107 at risk
Balance disorder	Nervous system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Dizziness	Nervous system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Syncope	Nervous system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0002 events2 affected107 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0002 events2 affected107 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Sunburn	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Constipation	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (15.1)	Non-systematic Assessment	EG0003 events3 affected107 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Sleep disorder	Psychiatric disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk
Wisdom teeth removal	Surgical and medical procedures	MedDRA (15.1)	Non-systematic Assessment	EG0001 events1 affected107 at risk