Trial Outcomes & Findings for Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria (NCT NCT04853992)
NCT ID: NCT04853992
Last Updated: 2024-04-22
Results Overview
The Urticaria Activity Score (UAS) rates a participants' number of wheals and their itch severity on a scale from 0 to 6, with 6 being the most severe. UAS is assessed after provocation of urticaria by moderate exercise to cause sweating.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline to Day 7
Results posted on
2024-04-22
Participant Flow
Participant milestones
| Measure |
Active - Placebo
Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days
LEO 152020: LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
LEO 152020 placebo: LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.
|
Placebo - Active
Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days
LEO 152020: LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
LEO 152020 placebo: LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.
|
|---|---|---|
|
Treatment Period A
STARTED
|
11
|
9
|
|
Treatment Period A
COMPLETED
|
11
|
8
|
|
Treatment Period A
NOT COMPLETED
|
0
|
1
|
|
Wash Out
STARTED
|
11
|
8
|
|
Wash Out
COMPLETED
|
10
|
8
|
|
Wash Out
NOT COMPLETED
|
1
|
0
|
|
Treatment Period B
STARTED
|
10
|
8
|
|
Treatment Period B
COMPLETED
|
10
|
8
|
|
Treatment Period B
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Active - Placebo
Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days
LEO 152020: LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
LEO 152020 placebo: LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.
|
Placebo - Active
Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days
LEO 152020: LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
LEO 152020 placebo: LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.
|
|---|---|---|
|
Treatment Period A
Adverse Event
|
0
|
1
|
|
Wash Out
Met exclusion criteria for next treatment phase
|
1
|
0
|
Baseline Characteristics
Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
Baseline characteristics by cohort
| Measure |
Active - Placebo
n=11 Participants
Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days
LEO 152020: LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
LEO 152020 placebo: LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.
|
Placebo - Active
n=9 Participants
Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days
LEO 152020: LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
LEO 152020 placebo: LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25 years
n=5 Participants
|
25 years
n=7 Participants
|
25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 7Population: Full analysis set
The Urticaria Activity Score (UAS) rates a participants' number of wheals and their itch severity on a scale from 0 to 6, with 6 being the most severe. UAS is assessed after provocation of urticaria by moderate exercise to cause sweating.
Outcome measures
| Measure |
Active
n=19 Participants
In this cross over study all participants received active treatment.
|
Placebo
n=18 Participants
In this cross over study all participants received placebo
|
|---|---|---|
|
Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)
|
-1.1 scores on a scale
Standard Deviation 2.1
|
-0.5 scores on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: From start of each treatment period (day 1 for the 1st treatment period or day 15 or 22 for the 2nd treatment period) until 3 days after end of each treatment period (day 11 for the 1st treatment period or day 25 or 32 for the 2nd treatment period)Population: Safety analysis set
Outcome measures
| Measure |
Active
n=19 Participants
In this cross over study all participants received active treatment.
|
Placebo
n=19 Participants
In this cross over study all participants received placebo
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events
|
9 Number of AEs
|
5 Number of AEs
|
Adverse Events
Active
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active
n=19 participants at risk
In this cross over study all participants received active treatment.
|
Placebo
n=19 participants at risk
In this cross over study all participants received placebo
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.5%
2/19 • Number of events 2 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
0.00%
0/19 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
|
Gastrointestinal disorders
Haematochezia
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
0.00%
0/19 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
|
Gastrointestinal disorders
Nausea
|
15.8%
3/19 • Number of events 3 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
|
Infections and infestations
COVID-19
|
0.00%
0/19 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
|
Infections and infestations
Gingivitis
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
0.00%
0/19 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
|
Investigations
Blood immunoglobulin E increased
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
0.00%
0/19 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/19 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/19 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
0.00%
0/19 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
1/19 • Number of events 1 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
0.00%
0/19 • From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor seeks publication of all clinical trials in peer-reviewed journals within 18 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 18 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER