Trial Outcomes & Findings for LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis (NCT NCT02668692)

Last Updated: 2025-03-10

Results Overview

'Overall improvement' for the target lesion on the scalp, defined as 'substantial resolution' of clinical signs and/or at least 'moderately improved' in the general change in the lesion. 'Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the lesion.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

213 participants

Primary outcome timeframe

End of Week 4

Results posted on

2025-03-10

Participant Flow

The trial had 213 participants enrolled and 206 participants randomized.

Participant milestones

Participant milestones
Measure	LEO 80185 Gel LEO 80185 gel: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions	Dovobet® Ointment Dovobet® ointment: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
Overall Study STARTED	101	105
Overall Study COMPLETED	100	105
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	LEO 80185 Gel LEO 80185 gel: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions	Dovobet® Ointment Dovobet® ointment: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
Overall Study Adverse Event	1	0

Baseline Characteristics

LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEO 80185 Gel n=101 Participants LEO 80185 gel: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions	Dovobet® Ointment n=105 Participants Dovobet® ointment: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions	Total n=206 Participants Total of all reporting groups
Age, Continuous	51.0 years STANDARD_DEVIATION 13.7 • n=5 Participants	54.3 years STANDARD_DEVIATION 14.2 • n=7 Participants	52.7 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	84 Participants n=7 Participants	151 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	21 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment Japan	101 Participants n=5 Participants	105 Participants n=7 Participants	206 Participants n=5 Participants

PRIMARY outcome

Timeframe: End of Week 4

Population: All 206 randomised subjects are included in the full analysis set (FAS): 101 in the LEO 80185 group and 105 in the Dovobet® group. The per protocol analysis set (PPAS) was defined by excluding subjects from the FAS based on a review of protocol deviations. PPAS includes 94 subjects in the LEO 80185 group and 100 in the Dovobet® group.

Outcome measures

Outcome measures
Measure	LEO 80185 Gel n=101 Participants LEO 80185 gel: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions	Dovobet® Ointment n=105 Participants Dovobet® ointment: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp Not overall improvement	2 Participants	4 Participants
Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp Overall improvement	99 Participants	101 Participants

SECONDARY outcome

Timeframe: End of Week 4

'Overall Improvement' for the target lesion on the non-scalp area of the body, defined as 'substantial resolution' of clinical signs and/or at least 'moderately improved' in the general change in the lesion. 'Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the lesion.

Outcome measures

Outcome measures
Measure	LEO 80185 Gel n=101 Participants LEO 80185 gel: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions	Dovobet® Ointment n=105 Participants Dovobet® ointment: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
Number of Subjects With 'Overall Improvement' for the Target Lesion on the Non-scalp Area of the Body Overall improvement	83 Participants	99 Participants
Number of Subjects With 'Overall Improvement' for the Target Lesion on the Non-scalp Area of the Body Not overall improvement	18 Participants	6 Participants

SECONDARY outcome

Timeframe: From Baseline to end of Week 4 (Visit 1-4)

Population: The per protocol analysis set (PPAS) was defined by excluding subjects from the full analysis set (FAS) based on a review of protocol deviations. PPAS includes 94 subjects in the LEO 80185 group and 100 in the Dovobet® group.

Severity was recorded for each of the 3 clinical signs according to the 9-point scales\* below. \*intermediate intervals (0.5, 1.5, 2.5, 3.5) serve as mid points between the defined grades. Redness 0=none (no erythema) 1. slight (faint erythema, pink to very light red) 2. mild (definite light red erythema) 3. moderate (dark red erythema) 4. severe (very dark red erythema) Thickness 0=none (no plaque elevation) 1. slight (slight, barely perceptible elevation) 2. mild (definite elevation but not thick) 3. moderate (definite elevation, thick plaque with sharp edge) 4. severe (very thick plaque with sharp edge) Scaliness 0=none (no scaling) 1. slight (sparse, fine scale, lesions only partially covered) 2. mild (coarser scales, most of lesions covered) 3. moderate (entire lesion covered with coarse scales) 4. severe (very thick coarse scales, possibly fissured) Negative change denotes a decrease in the score and therefore a decrease in disease severity.

Outcome measures

Outcome measures
Measure	LEO 80185 Gel n=94 Participants LEO 80185 gel: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions	Dovobet® Ointment n=100 Participants Dovobet® ointment: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
The Change in the Sum of the Scores (Total Sign Score) for the Severity of the 3 Clinical Signs:Thickness, Scaliness, Redness From Baseline to End of Week 4 (Visit 1-4) for Each Target Lesion. Scalp (PPAS)	-6.43 Scores on a scale Standard Deviation 1.91	-6.79 Scores on a scale Standard Deviation 1.90
The Change in the Sum of the Scores (Total Sign Score) for the Severity of the 3 Clinical Signs:Thickness, Scaliness, Redness From Baseline to End of Week 4 (Visit 1-4) for Each Target Lesion. Non-scalp (PPAS)	-5.31 Scores on a scale Standard Deviation 2.44	-6.46 Scores on a scale Standard Deviation 2.05

Adverse Events

LEO 80185 Gel

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Dovobet® Ointment

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LEO 80185 Gel n=101 participants at risk LEO 80185 gel: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions	Dovobet® Ointment n=105 participants at risk Dovobet® ointment: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
Infections and infestations Meningitis	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).

Other adverse events

Additional Information

Clinical Trial Disclosure Manager

LEO Pharma A/S

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	LEO 80185 Gel n=101 participants at risk LEO 80185 gel: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions	Dovobet® Ointment n=105 participants at risk Dovobet® ointment: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
Blood and lymphatic system disorders Anaemia	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.95% 1/105 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Blood and lymphatic system disorders Leukocytosis	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Eye disorders Glaucoma	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Gastrointestinal disorders Chelitis	0.00% 0/101 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.95% 1/105 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Gastrointestinal disorders Stomatitis	0.00% 0/101 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.95% 1/105 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
General disorders Oedema peripheral	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Infections and infestations Folliculitis	2.0% 2/101 • Number of events 2 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.95% 1/105 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Infections and infestations Herpes zoster	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Infections and infestations Influenza	0.00% 0/101 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.95% 1/105 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Infections and infestations Kaposi's varicelliform eruption	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Infections and infestations Nasopharyngitis	3.0% 3/101 • Number of events 3 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	1.9% 2/105 • Number of events 2 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Infections and infestations Ophthalmic herpes simplex	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Infections and infestations Tinea pedis	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Injury, poisoning and procedural complications Overdose	0.00% 0/101 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.95% 1/105 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Investigations Blood bilirubin increased	0.00% 0/101 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.95% 1/105 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Investigations Glucose urine present	2.0% 2/101 • Number of events 2 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Investigations Platelet count decreased	0.00% 0/101 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.95% 1/105 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Investigations White blood cell count increased	0.00% 0/101 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.95% 1/105 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Musculoskeletal and connective tissue disorders Arthralgia	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Musculoskeletal and connective tissue disorders Arthritis	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Skin and subcutaneous tissue disorders Alopecia areata	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.99% 1/101 • Number of events 1 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).	0.00% 0/105 • From signing of Informed Consent Form up to 14 days after last visit (Week 4).