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Clinical trial

Phase 2a Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria

ID
Name
EXP-2177
Description
Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria
Trial arms
Trial start
2021-05-10
Estimated PCD
2022-07-08
Trial end
2022-07-11
Status
Completed
Phase
Early phase I
Treatment
LEO 152020
LEO 152020 is a small drug molecule which can block the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
Arms:
Active - Placebo, Placebo - Active
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.
Arms:
Active - Placebo, Placebo - Active
Size
20
Primary endpoint
Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)
Baseline to Day 7
Eligibility criteria
Main Inclusion Criteria: * 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: 1. Urticaria control test \< 12 at screening 2. 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. Main Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each treatment period will last 7 days with a wash-out period of 7 days between treatments', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Placebo-controlled', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2024-04-22

1 organization

1 product

1 indication

Organization
JW Pharmaceutical
Product
LEO 152020
Indication
Cholinergic Urticaria