Safety of MOON101 for the Treatment of Peanut Allergy (SURVEYOR)
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:
- the incidence and frequency of all treatment emergent adverse events (TEAEs) from baseline through study exit.
- to determine the highest tolerated dose for each participant, as defined by the highest MOON101 dose level administered which did not cause a dose-limiting symptom (DLS).
The study will compare MOON101 and placebo. All participants will receive both active MOON101 (peanut allergen) and placebo (no peanut allergen).
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
As U44-MNLT-01 is a first-in-human study (investigating the safety of MOON101), initial enrollment will consist of peanut allergic adult participants who will receive placebo and escalating doses of MOON101 followed by enrollment of peanut allergic adolescents (aged 12-17 years) and peanut allergic children (aged 4-11 years). Prior to enrollment of each additional group, a safety review will occur.
This study is designed as an open-label, single escalating dose study in 3 sequential groups: adults, adolescents, and children with peanut allergy. A total of approximately 40 participants will be enrolled. This will be an outpatient study and participants will have a screening visit, 5 treatment visits, a follow up phone call 24 hours following each dose, one in-clinic follow-up visit (7 ± 2 days following their last dose) and a follow-up phone call (14 ± 2 days following their last dose). Three groups will be enrolled sequentially. Group 1 will be adults (n=10), Group 2 will be adolescents (n=10) and Group 3 will be children (n=20). Each group will receive up to 5 escalating doses of the investigational product (IP) as tolerated, with matching placebo at each dose level.
The independent National Institutes of Allergy and Infectious Diseases (NIAID) Data and Safety Monitoring Board (DSMB) will meet periodically at specified times throughout the trial to review safety data and make recommendations regarding the start of Group 2 and Group 3.
An initial group (Group 1) of adults (ages 18-55 years) with peanut allergy will each receive up to 5 doses of placebo and up to 5 single escalating doses of the IP as tolerated. Participants will receive placebo and MOON101 coated with 1 μg, 10 µg, 25 µg, 50 µg and 100 µg of peanut extract (PE), as tolerated, every 7 days. Each participant will receive both a placebo dose and a MOON101 dose at each treatment visit. The placebo and MOON101 will each be applied to the volar aspect of the arm (right and left arm, respectively) for 3 minutes. Following review of Group 1 safety data by the DSMB, Group 2 (adolescents with peanut allergy, ages 12-17 years) will be enrolled and will conditionally receive the same dosing regimen as Group 1. Finally, Group 3 (children with peanut allergy, ages 4-11 years) will be enrolled and will conditionally receive the same dosing regimen following confirmation of safety in Group 2 by the DSMB. Modifications to the dosing regimen may occur as recommended by the DSMB.
Each participant will be in the study for approximately 73 days, including a screening visit, up to 5 dosing visits with a 24-hour follow-up phone call after each dosing visit, 1 in-clinic follow-up visit, and a follow-up phone call.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- 1. fázis
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Michelle C Widmann
- Telefonszám: 9196001819
- E-mail: trials@moonlighttx.com
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Samir Patel, PhD
- Telefonszám: 404-348-8294
- E-mail: trials@moonlighttx.com
Tanulmányi helyek
-
-
Arkansas
-
Little Rock, Arkansas, Egyesült Államok, 72202
- Toborzás
- Arkansas Children's Research Institute
-
Kapcsolatba lépni:
- Moonlight Project Manager
- Telefonszám: 919-600-1819
- E-mail: trials@moonlighttx.com
-
-
Georgia
-
Atlanta, Georgia, Egyesült Államok, 30329
- Toborzás
- Children's Healthcare of Atlanta
-
Kapcsolatba lépni:
- Moonlight Project Manager
- Telefonszám: 919-600-1819
- E-mail: trials@moonlighttx.com
-
-
Kansas
-
Overland Park, Kansas, Egyesült Államok, 66212
- Toborzás
- Dr. Vince Clinical Research
-
Kapcsolatba lépni:
- DVCR Project Manager
- Telefonszám: 864-238-7631
- E-mail: sroman@drvince.com
-
Kapcsolatba lépni:
- Moonlight Project Manager
- Telefonszám: 919-600-1819
- E-mail: trials@moonlighttx.com
-
-
Michigan
-
Ann Arbor, Michigan, Egyesült Államok, 48106
- Toborzás
- University of Michigan
-
Kapcsolatba lépni:
- Moonlight Project Manager
- Telefonszám: 919-600-1819
- E-mail: trials@moonlighttx.com
-
-
North Carolina
-
Chapel Hill, North Carolina, Egyesült Államok, 27599
- Toborzás
- University of North Carolina at Chapel Hill
-
Kapcsolatba lépni:
- Moonlight Project Manager
- Telefonszám: 919-600-1819
- E-mail: trials@moonlighttx.com
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Gyermek
- Felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion 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.
Exclusion Criteria:
- 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 prior to Screening.
- 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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Szekvenciális hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Dose A
1ug MOON101 and Placebo stamps
|
MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).
|
|
Kísérleti: Dose B
10ug MOON101 and Placebo stamps
|
MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).
|
|
Kísérleti: Dose C
25ug MOON101 and Placebo stamps
|
MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).
|
|
Kísérleti: Dose D
50ug MOON101 and Placebo stamps
|
MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).
|
|
Kísérleti: Dose E
100ug MOON101 (two 50ug MOON101 stamps) and one Placebo stamp
|
MOON101-100 is two microneedle stamps (a square stainless steel array) coated with 50 ug of peanut extract (active drug) each.
Two stamps are used to administer a 100ug dose of peanut extract in Dose E.
|
|
Placebo Comparator: Placebo
microneedle stamp with no peanut extract on it
|
MOON101-0 is a microneedle stamp (a square stainless steel array) coated with 0 ug of peanut extract (active drug).
There is no peanut extract on the MOON101-0 stamp.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Treatment Emergent Adverse Events (TEAEs)
Időkeret: baseline (Day 1) through study exit (Day 45)
|
Incidence and frequency of all TEAEs
|
baseline (Day 1) through study exit (Day 45)
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
TEAEs excluding application site reactions (ASRs)
Időkeret: baseline (Day 1) through study exit (Day 45)
|
Incidence and frequency of all TEAEs, excluding application site reactions (ASRs)
|
baseline (Day 1) through study exit (Day 45)
|
|
Serious Adverse Events (SAEs)
Időkeret: baseline (Day 1) through study exit (Day 45)
|
Incidence and frequency of SAEs
|
baseline (Day 1) through study exit (Day 45)
|
|
Adverse Events (AEs)
Időkeret: baseline (Day 1) through study exit (Day 45)
|
Incidence and frequency of treatment-related or possibly related AEs
|
baseline (Day 1) through study exit (Day 45)
|
|
Application Site Reactions (ASRs)
Időkeret: Visit 2 (Day 1)
|
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
|
Visit 2 (Day 1)
|
|
Application Site Reactions (ASRs)
Időkeret: Visit 3 (Day 8 +/-2)
|
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
|
Visit 3 (Day 8 +/-2)
|
|
Application Site Reactions (ASRs)
Időkeret: Visit 4 (Day 15 +/-2)
|
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
|
Visit 4 (Day 15 +/-2)
|
|
Application Site Reactions (ASRs)
Időkeret: Visit 5 (Day 22 +/-2)
|
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
|
Visit 5 (Day 22 +/-2)
|
|
Application Site Reactions (ASRs)
Időkeret: Visit 6 (Day 29 +/-2)
|
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
|
Visit 6 (Day 29 +/-2)
|
|
Highest Tolerated Dose of MOON101
Időkeret: Baseline (Day 1) through study exit (Day 45)
|
Highest tolerated dose for each participant, as defined by the highest MOON101 dose level administered which did not cause a dose-limiting symptom (DLS).
|
Baseline (Day 1) through study exit (Day 45)
|
|
Treatment discontinuation due to related AEs
Időkeret: baseline (Day 1) through study exit (Day 45)
|
Number of treatment discontinuations due to related AEs
|
baseline (Day 1) through study exit (Day 45)
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi szék: Brian P Vickery, MD, Professor of Pediatrics, Emory University
- Kutatásvezető: Samir Patel, PhD, Moonlight Therapeutics, Inc.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- U44-MNLT-01
- U44AI165328 (Az Egyesült Államok NIH támogatása/szerződése)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
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