Trial Outcomes & Findings for A Proof of Concept Study Comparing Three Doses of an Oral Solution of LEO 22811 With a Placebo Oral Solution for the Treatment of Psoriasis Vulgaris (NCT NCT01116895)

Last Updated: 2025-03-07

Results Overview

The investigator made assessments of the extent and severity of clinical signs of the participant's psoriasis on specific areas of the body in terms of three clinical signs: redness, thickness and scaliness. The extent of psoriatic involvement was recorded for each of four areas; head, arms, trunk and legs using the following scale: 0\. = no involvement 1. = \<10% 2. = 10-29% 3. = 30-49% 4. = 50-69% 5. = 70-89% 6. = 90-100% For each clinical sign a single score (0, 1, 2, 3 or 4) reflecting the average severity of all psoriatic lesions on the given body region was determined. PASI was calculated based on the investigator's assessment of the disease locally (head, trunk, arm, legs) using the following formula: Head: 0.1 (R + T + S)E = W Arms: 0.2 (R + T + S)E = X Trunk: 0.3 (R + T + S)E = Y Legs: 0.4 (R + T + S)E = Z R = score for redness; T = score for thickness, S = score for scaliness; E = score for extent The sum of W+X+Y+Z gives the total PASI that ranges from 0 to 72.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

Baseline (Day 0) to end of treatment (Day 84)

Results posted on

2025-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	LEO 22811 0.5 mg LEO 22811 0.5 mg: Oral solution	LEO 22811 1.5 mg LEO 22811 1.5 mg: Oral solution	LEO 22811 3.0 mg LEO 22811 3.0 mg: Oral solution	Placebo Placebo: Oral solution
Overall Study STARTED	16	15	18	14
Overall Study COMPLETED	12	8	14	11
Overall Study NOT COMPLETED	4	7	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Proof of Concept Study Comparing Three Doses of an Oral Solution of LEO 22811 With a Placebo Oral Solution for the Treatment of Psoriasis Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEO 22811 0.5 mg n=16 Participants LEO 22811 0.5 mg: Oral solution	LEO 22811 1.5 mg n=15 Participants LEO 22811 1.5 mg: Oral solution	LEO 22811 3.0 mg n=18 Participants LEO 22811 3.0 mg: Oral solution	Placebo n=14 Participants Placebo: Oral solution	Total n=63 Participants Total of all reporting groups
Age, Continuous	47.5 years STANDARD_DEVIATION 9.3 • n=5 Participants	49.8 years STANDARD_DEVIATION 14.1 • n=7 Participants	42.4 years STANDARD_DEVIATION 13.6 • n=5 Participants	44.9 years STANDARD_DEVIATION 12.0 • n=4 Participants	46.0 years STANDARD_DEVIATION 12.5 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	11 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants	13 Participants n=4 Participants	52 Participants n=21 Participants
Region of Enrollment Canada	7 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	30 Participants n=21 Participants
Region of Enrollment France	9 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	7 Participants n=4 Participants	33 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0) to end of treatment (Day 84)

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Placebo: Oral solution	LEO 22811 0.5 mg n=16 Participants LEO 22811 0.5 mg: Oral solution	LEO 22811 1.5 mg n=15 Participants LEO 22811 1.5 mg: Oral solution	LEO 22811 3.0 mg n=18 Participants LEO 22811 3.0 mg: Oral solution
Percentage Change in Psoriasis Area and Severity Index (PASI)	-5.6 percentage of change in PASI index score Standard Deviation 44.9	-7.6 percentage of change in PASI index score Standard Deviation 29.1	-0.3 percentage of change in PASI index score Standard Deviation 43.5	-12.7 percentage of change in PASI index score Standard Deviation 45.2

SECONDARY outcome

Timeframe: From baseline (Day 0) to end of treatment (Day 84)

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Placebo: Oral solution	LEO 22811 0.5 mg n=16 Participants LEO 22811 0.5 mg: Oral solution	LEO 22811 1.5 mg n=15 Participants LEO 22811 1.5 mg: Oral solution	LEO 22811 3.0 mg n=18 Participants LEO 22811 3.0 mg: Oral solution
Participants With at Least 75% Reduction in PASI (PASI 75) Yes	0 Participants	1 Participants	0 Participants	2 Participants
Participants With at Least 75% Reduction in PASI (PASI 75) No	14 Participants	15 Participants	15 Participants	16 Participants

SECONDARY outcome

Timeframe: From baseline (Day 0) to end of treatment (Day 84)

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Placebo: Oral solution	LEO 22811 0.5 mg n=16 Participants LEO 22811 0.5 mg: Oral solution	LEO 22811 1.5 mg n=15 Participants LEO 22811 1.5 mg: Oral solution	LEO 22811 3.0 mg n=18 Participants LEO 22811 3.0 mg: Oral solution
Participants With at Least 50% Reduction in PASI (PASI 50) No	12 Participants	15 Participants	13 Participants	14 Participants
Participants With at Least 50% Reduction in PASI (PASI 50) Yes	2 Participants	1 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: At end of treatment (Day 84)

At Visits 1 to 8 the investigator made a global assessment of the disease severity (IGA) using a 6-point scale (clear, almost clear, mild, moderate, severe, very severe). This assessment represents average lesion severity on head, trunk, arm and legs. The assessment was based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. Participants classified as clear or almost clear according to IGA was considered to have "controlled disease".

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Placebo: Oral solution	LEO 22811 0.5 mg n=16 Participants LEO 22811 0.5 mg: Oral solution	LEO 22811 1.5 mg n=15 Participants LEO 22811 1.5 mg: Oral solution	LEO 22811 3.0 mg n=18 Participants LEO 22811 3.0 mg: Oral solution
Participants With "Controlled Disease" According to the Investigators' Global Assessment (IGA) Controlled	0 Participants	0 Participants	0 Participants	1 Participants
Participants With "Controlled Disease" According to the Investigators' Global Assessment (IGA) Non-controlled	14 Participants	16 Participants	15 Participants	17 Participants

SECONDARY outcome

Timeframe: At end of treatment (Day 84)

"Satisfactory response" was defined as participants classified as "Clear" or "Almost Clear" or "Mild" according to the IGA.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Placebo: Oral solution	LEO 22811 0.5 mg n=16 Participants LEO 22811 0.5 mg: Oral solution	LEO 22811 1.5 mg n=15 Participants LEO 22811 1.5 mg: Oral solution	LEO 22811 3.0 mg n=18 Participants LEO 22811 3.0 mg: Oral solution
Participants With Satisfactory Response According to IGA Satisfactory	2 Participants	1 Participants	1 Participants	2 Participants
Participants With Satisfactory Response According to IGA Unsatisfactory	12 Participants	15 Participants	14 Participants	16 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

LEO 22811 0.5 mg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

LEO 22811 1.5 mg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

LEO 22811 3.0 mg

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=14 participants at risk Placebo: Oral solution	LEO 22811 0.5 mg n=16 participants at risk LEO 22811 0.5 mg: Oral solution	LEO 22811 1.5 mg n=15 participants at risk LEO 22811 1.5 mg: Oral solution	LEO 22811 3.0 mg n=18 participants at risk LEO 22811 3.0 mg: Oral solution
Renal and urinary disorders Proteinurea	0.00% 0/14 • From Day 0 to Follow-up (Day 122 + 28±2 days)	0.00% 0/16 • From Day 0 to Follow-up (Day 122 + 28±2 days)	6.7% 1/15 • Number of events 1 • From Day 0 to Follow-up (Day 122 + 28±2 days)	0.00% 0/18 • From Day 0 to Follow-up (Day 122 + 28±2 days)
Reproductive system and breast disorders Prostatitis	0.00% 0/14 • From Day 0 to Follow-up (Day 122 + 28±2 days)	6.2% 1/16 • Number of events 1 • From Day 0 to Follow-up (Day 122 + 28±2 days)	0.00% 0/15 • From Day 0 to Follow-up (Day 122 + 28±2 days)	0.00% 0/18 • From Day 0 to Follow-up (Day 122 + 28±2 days)

Other adverse events

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 Individual publications or presentations of data by one or more Investigator(s) shall not be made before the results of the joint publication have been made public. The company retains the right to have any publication submitted to the company for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
Publication restrictions are in place

Restriction type: OTHER