Trial Outcomes & Findings for LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs) (NCT NCT01188928)

Last Updated: 2025-03-10

Results Overview

The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1152 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-03-10

Participant Flow

The first subject's first visit was on 27-SEP-2010 and the last subject's last visit was on 29-MAR-2011. Hence the study had a duration of 26 weeks.

Participant milestones

Participant milestones
Measure	LEO 80185 Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol Calcipotriol 50 mcg/g in the topical suspension vehicle	Topical Suspension Vehicle The topical suspension vehicle alone
Overall Study STARTED	482	479	96	95
Overall Study COMPLETED	444	417	82	77
Overall Study NOT COMPLETED	38	62	14	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEO 80185 n=482 Participants Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone n=479 Participants Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol n=96 Participants Calcipotriol 50 mcg/g in the topical suspension vehicle	Topical Suspension Vehicle n=95 Participants The topical suspension vehicle alone	Total n=1152 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 13.4 • n=5 Participants	48.5 years STANDARD_DEVIATION 13.8 • n=7 Participants	48 years STANDARD_DEVIATION 13.7 • n=5 Participants	49.4 years STANDARD_DEVIATION 13.0 • n=4 Participants	48.6 years STANDARD_DEVIATION 13.5 • n=21 Participants
Sex: Female, Male Female	198 Participants n=5 Participants	193 Participants n=7 Participants	36 Participants n=5 Participants	35 Participants n=4 Participants	462 Participants n=21 Participants
Sex: Female, Male Male	284 Participants n=5 Participants	286 Participants n=7 Participants	60 Participants n=5 Participants	60 Participants n=4 Participants	690 Participants n=21 Participants
Region of Enrollment United States	482 participants n=5 Participants	479 participants n=7 Participants	96 participants n=5 Participants	95 participants n=4 Participants	1152 participants n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	LEO 80185 n=482 Participants Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone n=479 Participants Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol n=96 Participants Calcipotriol 50 mcg/g in the topical suspension vehicle	Topical Suspension Vehicle n=95 Participants The topical suspension vehicle alone
Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4	64 participants	60 participants	5 participants	2 participants

PRIMARY outcome

Timeframe: week 8

Outcome measures

Outcome measures
Measure	LEO 80185 n=482 Participants Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone n=479 Participants Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol n=96 Participants Calcipotriol 50 mcg/g in the topical suspension vehicle	Topical Suspension Vehicle n=95 Participants The topical suspension vehicle alone
Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8	140 participants	103 participants	14 participants	6 participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks

At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.

Outcome measures

Outcome measures
Measure	LEO 80185 n=482 Participants Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone n=479 Participants Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol n=96 Participants Calcipotriol 50 mcg/g in the topical suspension vehicle	Topical Suspension Vehicle n=95 Participants The topical suspension vehicle alone
Mean Percentage Change in PASI From Baseline to Week 4	-46.4 percentage of change in PASI Standard Deviation 30.2	-42.7 percentage of change in PASI Standard Deviation 29.4	-32.2 percentage of change in PASI Standard Deviation 27.3	-17.4 percentage of change in PASI Standard Deviation 36.8

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Outcome measures
Measure	LEO 80185 n=482 Participants Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone n=479 Participants Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol n=96 Participants Calcipotriol 50 mcg/g in the topical suspension vehicle	Topical Suspension Vehicle n=95 Participants The topical suspension vehicle alone
Mean Percentage Change in PASI From Baseline to Week 8	-55.8 percentage of change in PASI Standard Deviation 34.4	-48.6 percentage of change in PASI Standard Deviation 35.8	-43.6 percentage of change in PASI Standard Deviation 34.1	-20.9 percentage of change in PASI Standard Deviation 49.1

Adverse Events

LEO 80185

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Betamethasone

Serious events: 7 serious events

Other events: 15 other events

Deaths: 0 deaths

Calcipotriol

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Topical Suspension Vehicle

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LEO 80185 n=482 participants at risk Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone n=479 participants at risk Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol n=96 participants at risk Calcipotriol 50 mcg/g in the topical suspension vehicle	Topical Suspension Vehicle n=95 participants at risk The topical suspension vehicle alone
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/482	0.21% 1/479 • Number of events 1	0.00% 0/96	0.00% 0/95
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/482	0.21% 1/479 • Number of events 1	0.00% 0/96	0.00% 0/95
Infections and infestations Cellulitis	0.00% 0/482	0.21% 1/479 • Number of events 1	0.00% 0/96	0.00% 0/95
Hepatobiliary disorders Cholecystitis acute	0.00% 0/482	0.21% 1/479 • Number of events 1	0.00% 0/96	0.00% 0/95
Renal and urinary disorders Haematuria	0.00% 0/482	0.21% 1/479 • Number of events 1	0.00% 0/96	0.00% 0/95
Vascular disorders Hypertension	0.21% 1/482 • Number of events 1	0.00% 0/479	0.00% 0/96	0.00% 0/95
Renal and urinary disorders Nephrolithiasis	0.00% 0/482	0.21% 1/479 • Number of events 1	0.00% 0/96	0.00% 0/95
Surgical and medical procedures Stent placement	0.00% 0/482	0.21% 1/479 • Number of events 1	0.00% 0/96	0.00% 0/95
Psychiatric disorders Suicidal ideation	0.00% 0/482	0.21% 1/479 • Number of events 1	0.00% 0/96	0.00% 0/95
Psychiatric disorders Suicide attempt	0.00% 0/482	0.00% 0/479	0.00% 0/96	1.1% 1/95 • Number of events 1

Other adverse events

Other adverse events
Measure	LEO 80185 n=482 participants at risk Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone n=479 participants at risk Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol n=96 participants at risk Calcipotriol 50 mcg/g in the topical suspension vehicle	Topical Suspension Vehicle n=95 participants at risk The topical suspension vehicle alone
Infections and infestations Nasopharyngitis	2.9% 14/482	3.1% 15/479	5.2% 5/96	3.2% 3/95

Additional Information

Clinical Trial Disclosure Manager

Leo Pharma A/S

Phone: +45 4494 5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Prior to submitting or presenting a manuscript relating to the clinical trial to a publisher, reviewer, or other outside person, the Investigator shall provide to LEO a copy of all such manuscripts, and LEO shall have rights to review and comment. Upon the request of LEO the Investigator shall remove any confidential information (other than results generated by the Investigator) prior to submitting or presenting the manuscripts.
Publication restrictions are in place

Restriction type: OTHER