Trial · NCT04853992

Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria

NCT04853992, Phase 2, Completed, JW Pharmaceutical; results first posted 2024-03-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria. Trials, record NCT04853992. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04853992

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
NCT number: NCT04853992
Status: Completed
Phases: Phase 2
Enrollment: 20 participants, actual
Lead sponsor: JW Pharmaceutical
Conditions: Cholinergic Urticaria
Interventions: LEO 152020, LEO 152020 placebo
First posted: 2021-04-22
Last updated: 2024-04-22
Other registries' IDs: eudract:2020-004961-38
Results first posted: 2024-03-21

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)	Baseline to Day 7	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.
Secondary	Number of Treatment Emergent Adverse Events	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)

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)	Baseline to Day 7	Full analysis set	scores on a scale	MEAN
SECONDARY	Number of Treatment Emergent Adverse Events	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)	Safety analysis set	Number of AEs	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)	Active	-1.1	Standard Deviation 2.1	scores on a scale
Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)	Placebo	-0.5	Standard Deviation 1.7	scores on a scale
Number of Treatment Emergent Adverse Events	Active	9		Number of AEs
Number of Treatment Emergent Adverse Events	Placebo	5		Number of AEs

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period A	STARTED	Active - Placebo	11
Treatment Period A	STARTED	Placebo - Active	9
Treatment Period A	COMPLETED	Active - Placebo	11
Treatment Period A	COMPLETED	Placebo - Active	8
Treatment Period A	NOT COMPLETED	Active - Placebo	0
Treatment Period A	NOT COMPLETED	Placebo - Active	1
Wash Out	STARTED	Active - Placebo	11
Wash Out	STARTED	Placebo - Active	8
Wash Out	COMPLETED	Active - Placebo	10
Wash Out	COMPLETED	Placebo - Active	8

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain upper	Gastrointestinal disorders	Active	2	19	2
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	1	19	1
other	Diarrhoea	Gastrointestinal disorders	Active	1	19	1
other	Diarrhoea	Gastrointestinal disorders	Placebo	0	19	0
other	Haematochezia	Gastrointestinal disorders	Active	1	19	1
other	Haematochezia	Gastrointestinal disorders	Placebo	0	19	0
other	Nausea	Gastrointestinal disorders	Active	3	19	3
other	Nausea	Gastrointestinal disorders	Placebo	1	19	1
other	COVID-19	Infections and infestations	Active	0	19	0
other	COVID-19	Infections and infestations	Placebo	1	19	1

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active	0	19
Total, all-cause mortality	Placebo	0	19
Total, other adverse events	Active	9	19
Total, other adverse events	Placebo	6	19
Total, serious adverse events	Active	0	19
Total, serious adverse events	Placebo	0	19

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38308655	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Active vs Placebo: deaths from any cause	Trial comparisons
Active vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04853992

GET https://conductscience.org/api/trials/v1/NCT04853992/events?page=2

API reference For AI assistants