Trial Outcomes & Findings for A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis (NCT NCT05919082)
NCT ID: NCT05919082
Last Updated: 2025-03-21
Results Overview
The efficacy of LEO 90100 compared with Daivobet® ointment on severity and extent of stable plaque psoriasis was evaluated. The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema. Higher score showed worse outcome.
COMPLETED
PHASE3
604 participants
On Day 29
2025-03-21
Participant Flow
This study was conducted at 39 sites that enrolled participants in China from 21 June 2023 to 05 March 2024.
Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
LEO 90100
The participants received up to 15 g LEO 90100 foam once daily for 4 weeks.
|
Daivobet Ointment
The participants received up to 15 g Daivobet® ointment once daily for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
302
|
302
|
|
Overall Study
COMPLETED
|
290
|
291
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
| Measure |
LEO 90100
The participants received up to 15 g LEO 90100 foam once daily for 4 weeks.
|
Daivobet Ointment
The participants received up to 15 g Daivobet® ointment once daily for 4 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
9
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Investigator Decision
|
1
|
0
|
Baseline Characteristics
A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
LEO 90100
n=302 Participants
The participants received up to 15 g LEO 90100 foam once daily for 4 weeks.
|
Daivobet Ointment
n=302 Participants
The participants received up to 15 g Daivobet® ointment once daily for 4 weeks.
|
Total
n=604 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 13.45 • n=5 Participants
|
45.7 years
STANDARD_DEVIATION 13.07 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 13.25 • n=5 Participants
|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
273 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
549 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
224 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
438 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
302 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
604 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: On Day 29Population: All randomized participants.
The efficacy of LEO 90100 compared with Daivobet® ointment on severity and extent of stable plaque psoriasis was evaluated. The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema. Higher score showed worse outcome.
Outcome measures
| Measure |
LEO 90100
n=302 Participants
The participants received up to 15 g LEO 90100 foam once daily for 4 weeks.
|
Daivobet® Ointment
n=302 Participants
The participants received up to 15 g Daivobet® ointment once daily for 4 weeks.
|
|---|---|---|
|
Percentage of Participants With Physician's Global Assessment of Disease Severity (PGA) Score of 0 (Clear) or 1 (Almost Clear) at Day 29, With at Least a 2-point Reduction From Baseline
|
50.0 Percentage of Participants
Interval 44.36 to 55.64
|
42.4 Percentage of Participants
Interval 36.81 to 47.96
|
SECONDARY outcome
Timeframe: From Baseline to Day 29Population: All randomized participants.
The efficacy of LEO 90100 compared with Daivobet® ointment on severity and extent of stable plaque psoriasis was evaluated. The extent of psoriatic involvement will be recorded for each of the areas (trunk \[including the neck\] and the limbs \[such as arms and legs\]; excluding any involvement on face, scalp, genitals and skin folds) using the following scale: 0=no involvement, 1=\< 10%, 2=10%-29%, 3=30%-49%, 4=50%-69%, 5=70%-89%, 6=90%-100%. The severity of the psoriatic lesions in each of the areas will be recorded for each of the clinical signs of redness, thickness and scaliness. Each clinical sign is scored on a scale of 0-4, reflecting the average severity of all psoriatic lesions on the given body region. Higher score indicates more severity. The overall mPASI can range from 0 to 64.8.
Outcome measures
| Measure |
LEO 90100
n=302 Participants
The participants received up to 15 g LEO 90100 foam once daily for 4 weeks.
|
Daivobet® Ointment
n=302 Participants
The participants received up to 15 g Daivobet® ointment once daily for 4 weeks.
|
|---|---|---|
|
Percentage of Participants With Decrease in Modified Psoriasis Area and Severity Index of at Least 75% (mPASI-75) From Baseline to Day 29
|
63.6 Percentage of Participants
Interval 58.15 to 69.0
|
53.6 Percentage of Participants
Interval 48.02 to 59.27
|
SECONDARY outcome
Timeframe: From Baseline to Day 29Population: All randomized participants.
The efficacy of LEO 90100 compared with Daivobet® ointment on severity and extent of stable plaque psoriasis was evaluated. The extent of psoriatic involvement will be recorded for each of the areas (trunk \[including the neck\] and the limbs \[such as arms and legs\]; excluding any involvement on face, scalp, genitals and skin folds) using the following scale: 0=no involvement, 1=\< 10%, 2=10%-29%, 3=30%-49%, 4=50%-69%, 5=70%-89%, 6=90%-100%. The severity of the psoriatic lesions in each of the areas will be recorded for each of the clinical signs of redness, thickness and scaliness. Each clinical sign is scored on a scale of 0-4, reflecting the average severity of all psoriatic lesions on the given body region. Higher score indicates more severity. The overall mPASI can range from 0 to 64.8.
Outcome measures
| Measure |
LEO 90100
n=302 Participants
The participants received up to 15 g LEO 90100 foam once daily for 4 weeks.
|
Daivobet® Ointment
n=302 Participants
The participants received up to 15 g Daivobet® ointment once daily for 4 weeks.
|
|---|---|---|
|
Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29
|
33.1 Percentage of Participants
Interval 27.8 to 38.42
|
24.5 Percentage of Participants
Interval 19.65 to 29.35
|
SECONDARY outcome
Timeframe: From Baseline to Day 43Population: All participants who are exposed to the IMP. Participants were analyzed according to the treatment they actually received.
The safety of LEO 90100 compared with Daivobet® ointment treating stable plaque psoriasis was evaluated. Only treatment emergent adverse events (TEAEs) have been reported for this outcome measure. An event was considered treatment-emergent if it started after the first investigational medicinal product (IMP) administration or if it started before the first IMP administration and worsened in severity after the first IMP administration.
Outcome measures
| Measure |
LEO 90100
n=300 Participants
The participants received up to 15 g LEO 90100 foam once daily for 4 weeks.
|
Daivobet® Ointment
n=301 Participants
The participants received up to 15 g Daivobet® ointment once daily for 4 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Leading to Permanent Discontinuation from investigational medicinal product (IMP)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Leading to Withdrawals from the Trial
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
77 Participants
|
68 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Leading to Deaths
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Serious
|
4 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Non-Serious
|
75 Participants
|
68 Participants
|
Adverse Events
LEO 90100
Daivobet Ointment
Serious adverse events
| Measure |
LEO 90100
n=300 participants at risk
The participants received up to 15 g LEO 90100 foam once daily for 4 weeks.
|
Daivobet Ointment
n=301 participants at risk
The participants received up to 15 g Daivobet® ointment once daily for 4 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.33%
1/300 • Number of events 1 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
0.00%
0/301 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.33%
1/300 • Number of events 1 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
0.00%
0/301 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
|
Infections and infestations
Appendicitis
|
0.33%
1/300 • Number of events 1 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
0.00%
0/301 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.33%
1/300 • Number of events 1 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
0.00%
0/301 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
Other adverse events
| Measure |
LEO 90100
n=300 participants at risk
The participants received up to 15 g LEO 90100 foam once daily for 4 weeks.
|
Daivobet Ointment
n=301 participants at risk
The participants received up to 15 g Daivobet® ointment once daily for 4 weeks.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
14/300 • Number of events 14 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
6.0%
18/301 • Number of events 18 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
|
Infections and infestations
Folliculitis
|
2.3%
7/300 • Number of events 7 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
1.3%
4/301 • Number of events 4 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
|
Infections and infestations
Tinea versicolour
|
1.3%
4/300 • Number of events 4 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
1.00%
3/301 • Number of events 3 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
|
Infections and infestations
Fungal infection
|
1.0%
3/300 • Number of events 3 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
0.00%
0/301 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
|
Investigations
Cortisol decreased
|
2.3%
7/300 • Number of events 7 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
2.0%
6/301 • Number of events 6 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
|
Investigations
Urine calcium/creatinine ratio increased
|
2.0%
6/300 • Number of events 6 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
1.7%
5/301 • Number of events 5 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
|
General disorders
Application site pain
|
1.0%
3/300 • Number of events 3 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
0.33%
1/301 • Number of events 1 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
|
General disorders
Application site pruritus
|
1.0%
3/300 • Number of events 3 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
0.33%
1/301 • Number of events 1 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
|
General disorders
Pyrexia
|
1.0%
3/300 • Number of events 3 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
0.33%
1/301 • Number of events 1 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
|
General disorders
Application site paraesthesia
|
1.0%
3/300 • Number of events 3 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
0.00%
0/301 • Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. All the TEAEs that were accounted throughout the study have been included in this section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER