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Tests treatment safety and results for Urticaria Chronic
Official title An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
ClinicalTrials.gov ID: NCT06927999
What this study is testing
What is 0.5 mg epinephrine?
0.5 mg epinephrine is an investigational medicine, being studied as a potential treatment for urticaria chronic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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)...
- Has been on a daily chronic treatment for ≥ 6 weeks.
- Is willing to use a smartphone study application to record study assessments and AEs.
- Has body weight more than 15 kilogram (kg).
You likely can't join if
- Has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic...
- 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...
- Has had significant traumatic injury or major surgery within 30 days prior to study screening.
- Known hypersensitivity to any compound in the test product, or any other closely related compound (e.g., dihydropyridine-derived molecules).
- Has participated in a clinical trial within 30 days prior to the first dose of study drug.
See the full eligibility criteria
- 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...
- Has been on a daily chronic treatment for ≥ 6 weeks.
- Is willing to use a smartphone study application to record study assessments and AEs.
- Has body weight more than 15 kilogram (kg).
- Has no medical history of clinically significant hypertension and cardiovascular disease in the last 10 years
- If female, is not pregnant or breastfeeding based on a negative urine pregnancy test at baseline.
- Is able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and perform study procedures on the smartphone study application.
- Is willing and able to provide written informed consent prior to participating in the study.
- Controlled hypertension without beta blocker confirmed by the Investigator is acceptable.
- 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)
- 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...
- 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.
- Known hypersensitivity to any compound in the test product, or any other closely related compound (e.g., dihydropyridine-derived molecules).
- Has participated in a clinical trial within 30 days prior to the first dose of study drug.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Glenview, Illinois, United States
- Cincinnati, Ohio, United States
- Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glenview, Illinois, United States; Cincinnati, Ohio, United States; Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.