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

NCT04853992 | Completed Phase 2 Results

• 2 other identifiers: EXP-21772020-004961-38
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Cholinergic Urticaria

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)

  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.

  Baseline to Day 7

Secondary Outcomes (1)

• 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)

Study Arms (2)

Active - Placebo

EXPERIMENTAL

Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days

Drug: LEO 152020; Drug: LEO 152020 placebo

Placebo - Active

EXPERIMENTAL

Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days

Drug: LEO 152020; Drug: LEO 152020 placebo

Interventions

LEO 152020 DRUG

LEO 152020 is a small drug molecule which can block the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.

Active - Placebo; Placebo - Active

LEO 152020 placebo DRUG

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.

Active - Placebo; Placebo - Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with a history of Cholinergic urticaria diagnosis for ≥ 6 months
• Subject has active and uncontrolled Cholinergic urticaria disease at the time of screening and randomisation, as defined by the following:
• Urticaria control test \< 12 at screening
• Urticaria Activity Score post-provocation ≥ 3
• Recent history (within 6 months of screening) with documented inadequate response to standard dose as to marketing authorization of H1 antihistamines.

You may not qualify if:

• Other clearly dominating forms\* of urticaria as aetiology 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,
• Systemic drugs (e.g. oral drug) with antihistamine properties including H1 antihistamines and some antidepressants (e.g. tricyclic antidepressants) and H2 antihistamines 1 week prior to randomisation and throughout the trial. However, topical antihistamines in the form of nasal spray and eyedrops are allowed in the standard prescribed dose.

Sponsors & Collaborators

• JW Pharmaceutical: lead
• LEO Pharma: collaborator

Study Sites (6)

LEO Investigational Site

Aachen, 52074, Germany

Location

LEO Investigational Site

Berlin, 10117, Germany

Location

LEO Investigational Site

Dresden, 01307, Germany

Location

LEO Investigational Site

Freiburg im Breisgau, 79104, Germany

Location

LEO Investigational Site

Kiel, 24105, Germany

Location

LEO Investigational Site

München, 80802, Germany

Location

Related Publications (1)

• Grekowitz E, Metz M, Altrichter S, Bauer A, Brockow K, Heine G, Lionnet L, Saday KK, Hultsch T, Soerensen OE, Maurer M. Targeting histamine receptor 4 in cholinergic urticaria with izuforant (LEO 152020): results from a phase IIa randomized double-blind placebo-controlled multicentre crossover trial. Br J Dermatol. 2024 May 17;190(6):825-835. doi: 10.1093/bjd/ljae038.

  PMID: 38308655 DERIVED

Results Point of Contact

• Title: Clinical disclosure
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo-controlled
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each treatment period will last 7 days with a wash-out period of 7 days between treatments

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 22, 2021
• Study Start: May 10, 2021
• Primary Completion: July 8, 2022
• Study Completion: July 11, 2022
• Last Updated: April 22, 2024
• Results First Posted: March 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.

Locations

DE (6)