ARS-2 for Chronic Urticaria

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ARS-2, an experimental therapy for chronic spontaneous urticaria (CSU), a condition that causes itchy hives and skin flares. The study aims to evaluate the effectiveness and safety of ARS-2 compared to a placebo (a non-active spray) using different doses of the treatment. Suitable candidates have experienced moderate to severe urticaria flares about once or twice a month, despite regular medication. Participants must be comfortable using a smartphone app to track their symptoms throughout the study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that ARS-2 is likely to be safe for humans?

Research has shown that ARS-2, a needle-free nasal spray containing a small amount of epinephrine, might be safe for treating chronic hives. Studies have found that this treatment can effectively manage flare-ups. Reports from earlier trials indicated that ARS-2 is generally well tolerated by patients, with no major safety issues or serious side effects. This evidence may reassure those considering participation in a clinical trial for ARS-2. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic urticaria?

Unlike the standard treatments for chronic urticaria, which often rely on antihistamines and corticosteroids, ARS-2 introduces a novel approach by using epinephrine as a nasal spray. This delivery method allows for potentially quicker relief by directly targeting the nasal passages, which can be advantageous for rapid symptom control. Researchers are particularly excited about ARS-2 because it may offer a faster onset of action compared to traditional oral medications, providing patients with more immediate relief from the discomfort of chronic hives.

What evidence suggests that ARS-2 might be an effective treatment for chronic urticaria?

Research has shown that ARS-2, a low-dose nasal spray with epinephrine, can quickly alleviate symptoms of chronic urticaria, a skin condition causing itchy hives. In this trial, participants will receive either a 0.5 mg or 1 mg dose of ARS-2, or a placebo. Previous studies demonstrated that both 0.5 mg and 1 mg doses improved symptoms within 5 minutes, with relief lasting up to 2 hours. This suggests that ARS-2 might offer fast relief for individuals experiencing moderate to severe flare-ups of chronic urticaria. The evidence supports its potential effectiveness by showing quick and lasting symptom reduction. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. jacionline.org jacionline.org/article/S0091-6749(23)02308-4/fulltext

ARS-2, Low-Dose Intranasal Epinephrine, Improves ... Both 1 mg and 2 mg doses of ARS-2 resulted in improvement starting at 5 minutes and persisting for 120 minutes post-dose; no changes were observed following the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06927999

NCT06927999 | An Outpatient Study of the Efficacy of ARS- ... Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) ...

3. ir.ars-pharma.com ir.ars-pharma.com/static-files/52c226ff-41af-4ba4-a146-01ad8bee2f5b

neffy® meets primary endpoints and shows rapid symptom ... “This study adds to the wealth of data supporting the efficacy and safety of neffy in the treatment of type I allergic reactions,” said Sarina ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12511800/

An Overview of Chronic Spontaneous Urticaria: Diagnosis ... It was found to be very effective in reducing UAS7 scores by 55% from baseline after a 30-day treatment course, which improved to an 82% ...

5. withpower.com withpower.com/trial/phase-2-urticaria-chronic-4-2025-7de89

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 ...

6. ir.ars-pharma.com ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-neffyr-meets-primary-endpoints-and

ARS Pharmaceuticals announces neffy® meets primary ... The trial met its primary endpoints with both 1 mg and 2 mg neffy demonstrating statistically significant and clinically meaningful changes from baseline.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11946961/

Update on the Treatment of Chronic Spontaneous Urticaria About 70% of patients with antihistamine-refractory CSU do not reach complete control with omalizumab, the second-line treatment. Novel ...