Clinical study to investigate whether the new drug (LEO 152020) is efficient and safe for the treatment of a special type of urticaria that is induced by sweating.

Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004961-38-DE

Enrollment

Registered

2021-01-21

Start date

2021-03-22

Completion date

Unknown

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholinergic urticaria MedDRA version: 21.1 Level: LLT Classification code 10008675 Term: Cholinergic urticaria System Organ Class: 100000004858

Interventions

Product Name: LEO 152020 film-coated tablet (50 mg) Pharmaceutical Form: Film-coated tablet CAS Number: 1429375-85-8 Current Sponsor code: LEO 152020 Other descriptive name: LEO 152020 sulfate monohyd

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subject with a history of CholU diagnosis for = 6 months - Subject has active and uncontrolled CholU disease at the time of screening and randomisation, as defined by the following: a. Urticaria control test (UCT) =65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: - Other clearly dominating forms* of urticaria as etiology for wheal and flare type reactions *These diseases are allowed as comorbidities, if cholinergic urticaria is the dominating form of chronic urticaria - Systemic immunosuppressive medications within 4 weeks prior to screening - Drugs with antihistamine properties including H1 antihistamines and H2 antihistamines 1 week prior to randomisation

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore the efficacy of LEO 152020 compared with placebo in patients with cholinergic urticaria.;Secondary Objective: To evaluate the safety of LEO 152020 compared with placebo in patients with cholinergic urticaria.;Primary end point(s): Change from baseline in post-provocation Urticaria Activity Score (UASprovo).;Timepoint(s) of evaluation of this end point: end of each 7-day treatment period - visit 3 (day 8); visit 5 (day 22 or 29)	—

Measure

Time frame

Main Objective: To explore the efficacy of LEO 152020 compared with placebo in patients with cholinergic urticaria.;Secondary Objective: To evaluate the safety of LEO 152020 compared with placebo in patients with cholinergic urticaria.;Primary end point(s): Change from baseline in post-provocation Urticaria Activity Score (UASprovo).;Timepoint(s) of evaluation of this end point: end of each 7-day treatment period - visit 3 (day 8); visit 5 (day 22 or 29)

—

Secondary

Measure	Time frame
Secondary end point(s): Number of treatment emergent adverse events (TEAE) per subject;Timepoint(s) of evaluation of this end point: Start of treatment period to 3 days after end treatment period	—

Countries

Germany

Contacts

Public ContactCliinical Operations Lead

LEO Pharma A/S

RCBDK@leo-pharma.com+4522868323

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 7, 2026