Trial intelligence / Profile preview

RELIEF-CSU1: ARS-1 in Frequent Urticaria Flares

NCT05496465Phase 2

Key facts

Status
Completed
Start
Jul 2022
Primary completion
Feb 2024
Countries
1
Modality
Small Molecules, Device-based Delivery
Conditions
urticaria
01

Overview

Phase 2, randomised trial of eurneffy in urticaria (2 arms), sponsored by ARS Pharmaceuticals. Primary endpoint: Urticaria Activity Score at 120 minutes. Started Jul 2022; status: completed.

02

Design

2 arms
Study design
Randomized
  • Sequence 1

    1 mg ARS-1 IN -> placebo -> 2 mg ARS-1 IN

  • Sequence 2

    2 mg ARS-1 IN -> placebo -> 1 mg ARS-1 IN

03

Who it enrols

Adults aged 18-65 with clinically diagnosed urticaria experiencing frequent acute flares despite chronic treatment, with BMI 18-34 kg/m2, excluding those with cardiovascular disease, hypertension, or taking beta blockers.

04

Endpoints

Primary

  • Urticaria Activity Score

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