An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
ConditionUrticaria Chronic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorARS Pharmaceuticals, Inc.
About 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 does not accept healthy volunteersQualifiers
Is a male or female between the ages of 18 and 65 years, inclusive.
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.
Has been on a daily chronic treatment for ≥ 6 weeks.
Is willing to use a smartphone study application to record study assessments and AEs.
Disqualifiers
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.
Has any clinically significant medical condition or PE finding as deemed inappropriate by the Investigator.
Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram (ECG)
Has had significant traumatic injury or major surgery within 30 days prior to study screening.
Trial design
Design model
Crossover
Treatments tested in this trial
Placebo
DrugPlacebo solution nasal spray containing no active drug
0.5 mg epinephrine
Drug0.5 mg epinephrine per spray
1 mg epinephrine
Drug1 mg epinephrine per spray
Treatment groups
42 Participants
are divided into 3 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: 0.5 mgActive comparator 1 intervention
Group C: 1 mgActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch
Change in itch scores (Uniform Assessment System) - Range is a scale of 0-3. Zero is none and 3 is severe. \[UAS\] as compared to placebo at each timepoint on exacerbation days
Time frame
12 monthsSecondary outcomes
1
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on hive
Change in hive scores (Uniform Assessment System) - Range is a scale of 0-3. Zero is none and 3 is severe. \[UAS\] as compared to placebo at each timepoint on exacerbation days
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov