Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares

ARS Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Urticaria

Treatments: Drug: ARS-1; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05496465

RELIEF-CSU1

Details and patient eligibility

About

Determine the effect of ARS-1 on a patient reported pruritus/hive score

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Male or female subject between the ages of 18 and 65 years.

• 2. Clinically diagnosed urticaria with acute symptom flares at least two (2) times a week while on a chronic treatment.

• 3. Body weight more than 30 kg and body mass index between 18 and 34 kg/m².

• 4. Has no medical history of hypertension and cardiovascular disease in the last 10 years.

• 5. At screening, has stable vital signs.

• 6. If female, is not pregnant or breastfeeding.

• 7. If male (with or without vasectomy), agree to the use of highly effective contraceptive methods at screening until 7 days after the last day of study drug.

  8. Is able to communicate clearly with the Investigator and staff. 9. Provide written informed consent prior to participating in the study.

Exclusion criteria

• 1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.
• 2. Patients receiving beta blocker due to potential interaction with the study drug.
• 3. Prior nasal fractures, severe nasal injuries or history of nasal disorders.
• 4. Clinically significant medical condition or physical exam finding.
• 5. Abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal ECG.
• 6. Mucosal inflammatory disorders.
• 7. Significant traumatic injury or major surgery within 30 days prior to study screening.
• 8. Has donated blood or had an acute loss of blood (>50 mL) during the 30 days before study drug administration.
• 9. Known hypersensitivity to any compound in the test product.
• 10. Participated in a clinical trial within 30 days prior to the first dose of study drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups, including a placebo group

ARS-1 1mg

Active Comparator group

Description:

1 mg per 100 µL dose of ARS-1

Treatment:

Drug: ARS-1

ARS-1 2mg

Active Comparator group

Description:

2 mg per 100 µL dose of ARS-1

Treatment:

Drug: ARS-1

Placebo

Placebo Comparator group

Description:

Placebo (100 µL)

Treatment:

Drug: Placebo