Safety of Moon101 for the Treatment of Peanut Allergy

Study Description

The goal of this study is to assess the safety of treating adults, adolescents and children who have peanut allergy with an experimental treatment, called MOON101.

Study Eligibility

Inclusion Criteria

Individuals who meet all of the following inclusion criteria are eligible for study enrollment:

1. Participant and/or parent/guardian must understand and provide written informed consent and assent if applicable as per local standards prior to any study assessments being performed.
2. Aged 4 to 55, Arkansas site 4 to 34 years, per applicable enrolling group below of any sex/race/ethnicity at informed consent and assent (if applicable) form signature:
   • Group 1: Adults; ages 18-34 years
   • Group 2: Adolescents; ages 12-17 years
   • Group 3: Children; ages 4-11 years
3. A physician-confirmed medical history of peanut allergy, which includes the development of immediate hypersensitivity symptoms (e.g., urticaria, flushing, rhinorrhea and sneezing, throat tightness or hoarseness, wheezing, vomiting) within minutes to two hours of ingesting peanut.
4. A peanut SPT with mean wheal diameter (average of longest diameter and mid-point orthogonal diameter) as defined by age:
   • Ages 4-5 years: peanut SPT with mean wheal diameter difference of ≥ 6.0 mm compared to a negative saline control at Screening
   • Ages 6-34 years: peanut SPT with mean wheal diameter difference of ≥ 8.0 mm compared to a negative saline control at Screening
5. Serum peanut-specific IgE level by ImmunoCAP ≥ 14 kUa/L at Screening.
6. If participant is of childbearing potential, must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1.
7. For participants of childbearing potential, they must use an acceptable method of contraception, including abstinence from heterosexual intercourse, hormonal contraceptives (e.g., oral, injectable, implantable, insertable, and transdermal patch), intrauterine device (with or without hormones), or double-barrier method (e.g., condom and spermicide) for 30 days prior to Screening, during the study, and for 30 days following the last administration of investigational product (IP).
   • Female volunteers of nonchildbearing potential should be surgically sterile (e.g., have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation/occlusion) or in a post-menopausal state (at least one year without menses).
   • Male volunteers agree to use a double-barrier method (e.g., condom and spermicide) or agree to remain abstinent from heterosexual intercourse at the time of Screening, during the study, and for 90 days following the last administration of IP.
   • Male volunteers agree not to donate sperm at the time of Screening, during the study, and for 90 days following the last administration of IP.
8. Be willing to be trained and demonstrate proper technique on use of an epinephrine auto-injector and be willing to bring their epinephrine auto-injector to every visit for the duration of the study.

Note: IM epinephrine will be available and provided by the sites at all participant visits. It is recommended that participants and/or parents/guardians (if applicable) bring epinephrine auto-injectors in the unlikely but possible event of a delayed reaction that occurs after leaving the clinical site. If the participant does not have an epinephrine auto-injector, one will be provided by the clinical site.

Exclusion Criteria

Individuals who meet any of these exclusion criteria are not eligible for study enrollment:

1. Currently pregnant or lactating and breast-feeding or planning to become pregnant during the study.
2. Laboratory evidence of liver disease (aspartate aminotransferase [AST] greater than 2 times the upper limit of the normal range [ULN] of the testing laboratory) at Screening.
3. Laboratory evidence of renal disease (serum creatinine greater than 1.5 times the ULN of the testing laboratory) at Screening.
4. Any clinically significant laboratory abnormalities, in the opinion of the investigator, at Screening.
5. History of life-threatening anaphylaxis (e.g., Consortium for Food Allergy Research [CoFAR] Grade 4 event [see APPENDIX II] and/or one requiring respiratory support or intensive care unit [ICU] admission).
6. Poorly controlled or severe asthma/wheezing defined by at least one of the following criteria:
   1. Global Initiative for Asthma (GINA) criteria regarding asthma control latest guidelines; see APPENDIX III;
   2. History of two or more systemic corticosteroid courses within six months of Screening or one course of systemic corticosteroids within three months of Screening to treat asthma/wheezing;
   3. Prior intubation/mechanical ventilation for asthma/wheezing;
   4. One hospitalization or emergency department (ED) visit for asthma/wheezing within six months of Screening;
   5. Forced expiratory volume in one second (FEV1) < 80% of predicted or FEV1/forced vital capacity (FVC) < 75%, with or without controller medications (only for participants who are aged seven years or older and are able to perform spirometry), children aged 4–11 years that have documented inability to adequately perform spirometry may be enrolled if peak expiratory flow rate (PEFR) is > 80% of predicted;
   6. Inhaled corticosteroid (ICS) dosing of > 500 mcg daily fluticasone (or equivalent ICS based on the National Heart, Lung, and Blood Institute [NHLBI] Guidelines for the Diagnosis and Management of Asthma 2007, Expert Panel Report [EPR-3]- APPENDIX IV).
7. History of hemodynamically significant cardiovascular disease such as coronary artery disease, uncontrolled hypertension or serious ventricular arrhythmias, or any other disorder in which epinephrine is contraindicated.
8. History of chronic lung disease, EoE, human immunodeficiency virus (HIV), hepatitis B surface Ag virus (HBV), or hepatitis C Ab virus (HCV).
9. Participation in any interventional study for the treatment of food allergy (including peanut allergy) in the past 6 months prior to Screening.
10. Received an investigational vaccine or investigational drug within 30 days of Screening.
11. Currently in the up-dosing phase of AIT. Participants on a stable maintenance dose of AIT may be enrolled. Note: MOON101 will be administered no sooner than 48 hours after an AIT dose.
12. Poor control or persistent activation of atopic dermatitis or any other severe generalized dermatologic disease per investigator judgment.
13. Previous use of any form of peanut allergen immunotherapy (e.g., oral, epicutaneous, or sublingual) within the 6 months prior to Screening.
14. Previous use of any biologic therapies such as omalizumab, dupilumab, benralizumab, reslizumab, tezepelumab, or any other immunomodulatory (not including stable AIT as mentioned above) or immunosuppressive therapy (not including corticosteroids) within the 6 months prior to Screening.
15. Current use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), or calcium channel blockers.
16. 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.
17. Unable to temporarily discontinue antihistamines (5 half-lives of the antihistamine) prior to SPT.
18. Unable to discontinue topical steroids to the testing application site for 24 hours prior to testing (SPT, MOON101, or placebo).
19. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site Principal Investigator (PI), may pose additional risks from participation in the study, may interfere with the participant’s ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
20. Is an employee of Moonlight Therapeutics, Inc, or has a family member who is an employee of Moonlight Therapeutics, Inc.

Contact Information

Recruitment Coordinator: Marissa Pilcher
501-364-3031, pilchermr@archildrens.org

Lead Study Nurse/Coordinator: Casey Heffington, RN
501-364-1976, heffingtonc@archildrens.org

Lead Study Doctor/Principal Investigator: Stacie Jones, M.D.
501-364-1060, jonesstaciem@uams.edu