ARS-2 for Chronic Urticaria

Recruiting at 1 trial location

Overseen By Osnat Ehrman, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ARS Pharmaceuticals, Inc.

Must be taking: Chronic urticaria treatment

Must not be taking: Beta blockers

Disqualifiers: Cardiovascular disease, Major surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

42 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that participants should have been on a daily chronic treatment for at least 6 weeks. It seems likely that you can continue your current medications, but it's best to confirm with the study team.

What data supports the effectiveness of the drug ARS-2 for chronic urticaria?

The research highlights that omalizumab, a treatment for chronic urticaria that is not responsive to standard antihistamines, has shown significant improvements in urticaria activity scores. This suggests that treatments similar to ARS-2, if it shares components or mechanisms with omalizumab, may also be effective for chronic urticaria. ^{1 2 3 4 5}

How does the drug ARS-2 differ from other treatments for chronic urticaria?

The research does not provide specific information about ARS-2, so it's unclear how it differs from existing treatments for chronic urticaria. ^{1 6 7 8 9}

What is the purpose of this trial?

This is a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods. Subjects enrolled will have CSU with a history of moderate to severe acute exacerbations (or flares).

Eligibility Criteria

This trial is for outpatients with Chronic Spontaneous Urticaria (CSU) who often have moderate to severe flare-ups. Specific eligibility details are not provided, but typically participants must meet certain health criteria and not have conditions that would exclude them from safely participating.

Inclusion Criteria

My high blood pressure is under control without using beta blockers.

Not pregnant or breastfeeding based on a negative urine pregnancy test at baseline

Stable vital signs at screening: SBP ≥90 and ≤140 mmHg, DBP ≥50 and ≤90 mmHg, HR ≥45 and ≤100 bpm

Exclusion Criteria

I have a history of heart issues or abnormal heart test results.

Known hypersensitivity to any compound in the test product or any closely related compound

Participation in a clinical trial within 30 days prior to the first dose of study drug

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo three blinded treatment periods with ARS-2 or placebo

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ARS-2

Trial Overview The study tests the effectiveness of a drug called ARS-2 in treating CSU. Participants will receive either 0.5 mg epinephrine, 1 mg epinephrine, or a placebo in different periods of the study without knowing which one they're getting.

Participant Groups

Group I: 1 mg Active Control 1 Intervention

1 mg epinephrine per spray

Group II: 0.5 mg Active Control 1 Intervention

0.5 mg epinephrine per spray

Group III: Placebo Placebo Group 1 Intervention

Placebo solution nasal spray containing no active drug will be administered using the commercial sprayer device.

Who Is Running the Clinical Trial?

ARS Pharmaceuticals, Inc.

Lead Sponsor

Trials

4

Recruited

660+

Findings from Research

Recent advances in the classification and management of chronic urticaria emphasize the use of non-sedating H1-antihistamines, which can be administered in standard doses or increased up to four times if necessary, improving patient care.

For patients who do not respond to H1-antihistamines, omalizumab has been identified as a safe and effective treatment option, providing a new avenue for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights and advances in chronic urticaria: a Canadian perspective. Sussman, G., Hébert, J., Gulliver, W., et al.[2022]

In a phase II study involving 90 patients with chronic idiopathic urticaria (CIU) who were not adequately controlled by antihistamines, omalizumab at doses of 300 mg and 600 mg significantly reduced urticaria activity scores compared to placebo, showing rapid effects within 1 to 2 weeks.

Omalizumab was well tolerated, with a similar incidence of adverse events across all treatment groups, indicating its safety as an add-on therapy for patients with persistent symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. Saini, S., Rosen, KE., Hsieh, HJ., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Glucocorticoids for acute urticaria: study protocol for a double-blind non-inferiority randomised controlled trial. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Insights and advances in chronic urticaria: a Canadian perspective. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. [2022]

4. Sweden pubmed.ncbi.nlm.nih.gov

Treatment Patterns and Clinical Outcomes of Chronic Urticaria: Two-year Follow-up Results from the Scandinavian AWARE Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Benefit of Complete Response to Treatment in Patients With Chronic Spontaneous Urticaria-CURE Results. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of Urticaria Activity Score Over 7 Days (UAS7) Values Obtained from Once-Daily and Twice-Daily Versions: Results from the ASSURE-CSU Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Chronic Spontaneous Urticaria: The Devil's Itch. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Chronic urticaria: recent advances. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Chronic Spontaneous Urticaria in Belgium: Deciphering the Clinical Profile and Treatment of Patients Visiting an Urban City Immunology Department. [2023]