Epinephrine for Chronic spontaneous urticaria

Inclusion criteria

• {"criterion_text":"- Is a male or female between the ages of 18 and 65 years, inclusive.\n- Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) approximately 1-2 times a month or every other month consistently during the past year while on a chronic treatment. Enrolled subjects will record UAS daily for urticaria and VAS daily for angioedema during the screening period, which will serve as baseline.\n- Has been on a daily chronic treatment for ≥ 6 weeks.\n- Is willing to use a smartphone study application to record study assessments and AEs.\n- Has no medical history of clinically significant hypertension and cardiovascular disease in the last 10 years. Controlled hypertension without beta blocker confirmed by the Investigator is acceptable.\n- At screening, has stable vital signs in the following ranges (after 5 minutes of rest): • Systolic blood pressure (SBP) ≥90 and ≤140 milliliters of mercury (mmHg) • Diastolic blood pressure (DBP) ≥50 and ≤90 mmHg • Heart rate (HR) ≥45 and ≤100 beats per minute (bpm) Note: Each blood pressure (BP) should be taken after at least 5 minutes rest in a chair with back supported, legs uncrossed, and upper arm bared (slight recline for comfort ispermitted). If vital signs are out of range, the Investigator may obtain two additional readings, so that up to 3 consecutive assessments are made within 1 hour.\n- If female, is not pregnant or breastfeeding based on a negative urine pregnancy test at baseline and each clinical site visit.\n- Is able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and perform study procedures on the smartphone study application.\n- Is willing and able to provide written informed consent prior to participating in the study"}

Exclusion criteria

• {"criterion_text":"- 1. Has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.\n- 2. Has any clinically significant medical condition or physical exam (PE) finding as deemed inappropriate by the Investigator\n- 3. Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram (ECG) (e.g., second- or third-degree heart block, uncontrolled arrhythmia, QTcF [Fridericia’s correction] interval >450 msec for male subjects and >470 msec for female subjects).\n- 4. Has had significant traumatic injury or major surgery within 30 days prior to study screening\n- 5. Known hypersensitivity to any compound in the test product, or any other closely related compound (e.g., dihydropyridine-derived molecules).\n- 6. Has participated in a clinical trial within 30 days prior to the first dose of study drug. Participation in an observational (non-interventional) study is not excluded as long as there are no scheduling conflicts with this study\n- 7. Has an immediate family member of the Investigator, or an employee of the study center, with direct involvement in the proposed study, or other studies under the direction of the Investigator or study center or is in a dependent relationship with a study center employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress."}

Primary endpoints

• {"endpoint_text":"- Change in itch score (Uniform Assessment System [UAS] as compared to placebo at each timepoint on exacerbation days\n- Change in hive score (UAS) as compared to placebo at each timepoint on exacerbation days","definition_or_measurement_approach":"Measured using the Uniform Assessment System (UAS) itch and hive scores compared versus placebo at each timepoint on exacerbation days."}

Secondary endpoints

• {"endpoint_text":"- • Time to a 1-point decrease in itch and hive scores (UAS) • Time to a 2-point decrease in itch and hive scores (UAS) • Time to resolution • Time to recurrence within 24 hours","definition_or_measurement_approach":"Measured using UAS (Uniform Assessment System) scores; time-to-event endpoints based on changes in UAS and recurrence within 24 hours."}
• {"endpoint_text":"- • Time to a 1-point decrease in itch and hive scores (UAS) • Time to a 2-point decrease in itch and hive scores (UAS) • Time to resolution • Time to recurrence within 24 hours","definition_or_measurement_approach":"Measured using UAS (Uniform Assessment System) scores; time-to-event endpoints based on changes in UAS and recurrence within 24 hours."}
• {"endpoint_text":"- • Time to return to resolution by patient-rated visual analog scale (VAS) • Time to recurrence of symptoms within 24 hours • Change in pain (VAS) • Change in size of angioedema based on photographs","definition_or_measurement_approach":"Patient-rated Visual Analog Scale (VAS) for resolution and pain; angioedema size assessed from patient-taken photographs; time-to-event endpoints for recurrence within 24 hours."}
• {"endpoint_text":"- • Adverse events (AEs)","definition_or_measurement_approach":"Safety assessed by recording adverse events (AEs) throughout the study."}

Germany

Earliest CTIS Part Ii Submission Date

20-08-2025

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

174

Number Of Sites

1

Number Of Participants

22

Primary sponsor

Full Name

Ars Pharmaceuticals IRL Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland