BridgeMD
Tests treatment safety and results for Peanut Allergy
Official title Safety of MOON101 for the Treatment of Peanut Allergy
ClinicalTrials.gov ID: NCT07580898
What this study is testing
What is Dose A?
Dose A is an investigational medicine, being studied as a potential treatment for peanut allergy.
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
- The goal of this open-label, single escalating dose study in 3 sequential groups: adults, adolescents, and children with peanut allergy is to assess the safety of MOON101. The main question it aims to answer is: 1.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 55
You may be able to join if
- Participant and/or parent/guardian must understand and provide written informed consent and assent.
- Aged 4 to 55 years per applicable enrolling group below of any sex/race/ethnicity at informed consent and assent (if applicable) form signature:
- Group 1: Adults; ages 18-55 years
- Group 2: Adolescents; ages 12-17 years
- Group 3: Children; ages 4-11 years
You likely can't join if
- Laboratory evidence of liver or renal disease.
- Poorly controlled or severe asthma/wheezing
- Previous use of any form of peanut allergen immunotherapy within the 6 months prior to Screening.
- Previous use of any biologic therapies such as omalizumab, dupilumab, benralizumab, reslizumab, tezepelumab, or any other immunomodulatory or...
- Current use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), or calcium channel blockers.
- Treatment with a burst of oral, intramuscular (IM), intra-articular (IA), or intravenous (IV) steroids of more than two days within 30 days of...
See the full eligibility criteria
- Participant and/or parent/guardian must understand and provide written informed consent and assent.
- Aged 4 to 55 years per applicable enrolling group below of any sex/race/ethnicity at informed consent and assent (if applicable) form signature:
- Group 1: Adults; ages 18-55 years
- Group 2: Adolescents; ages 12-17 years
- Group 3: Children; ages 4-11 years
- A physician-confirmed medical history of peanut allergy within minutes to 2 hours of ingesting peanut.
- A peanut SPT with mean wheal diameter as defined by age.
- Laboratory evidence of liver or renal disease.
- Poorly controlled or severe asthma/wheezing
- Previous use of any form of peanut allergen immunotherapy within the 6 months prior to Screening.
- Previous use of any biologic therapies such as omalizumab, dupilumab, benralizumab, reslizumab, tezepelumab, or any other immunomodulatory or immunosuppressive therapy (not including corticosteroids) within the 6 months...
- Current use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), or calcium channel blockers.
- Treatment with a burst of oral, intramuscular (IM), intra-articular (IA), or intravenous (IV) steroids of more than two days within 30 days of Screening.
- Unable to temporarily discontinue antihistamines (5 half-lives of the antihistamine) prior to SPT.
- Unable to discontinue topical steroids to the testing application site for 24 hours prior to testing. Other inclusion/exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Atlanta, Georgia, United States
- Overland Park, Kansas, United States
- Ann Arbor, Michigan, United States
- Chapel Hill, North Carolina, United States
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, 4 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Atlanta, Georgia, United States; Overland Park, Kansas, United States; Ann Arbor, Michigan, United States; Chapel Hill, North Carolina, United States. 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.