Undersøgelse af effektivitet, sikkerhed og tolerabilitet af remibrutinib hos voksne deltagere med allergi over for jordnødder
18. maj 2026 opdateret af: Novartis Pharmaceuticals
En måneds, efterforsker og deltagerblindet undersøgelse for at undersøge effektiviteten og sikkerheden af remibrutinib (LOU064) ved multiple dosisniveauer hos voksne deltagere med jordnøddeallergi
En undersøgelse for at evaluere sikkerheden, effektiviteten og tolerabiliteten af remibrutinib ved tre doser versus placebo hos voksne deltagere, som har en bekræftet allergi over for jordnødder.
Effekten vil blive målt ved deltagernes evne til at tolerere stigende doser af jordnøddeprotein under en oral fødevareudfordring efter 1 måneds undersøgelsesbehandling.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Dette er et en måneds, fase 2, multicenter, randomiseret, investigator- og deltagerblindet, placebokontrolleret undersøgelse for at vurdere sikkerheden, effektiviteten og tolerabiliteten af remibrutinib (LOU064) i 3 doser oral tablet to gange dagligt hos deltagere med en medicinsk bekræftet diagnose af IgE-medieret jordnøddeallergi.
Deltagerne vil blive randomiseret til remibrutinib lav, medium eller høj dosis i en behandlingsperiode på en måned (op til 5 uger).
Deltagerne vil have orale fødevareudfordringer i begyndelsen af undersøgelsen og i slutningen af behandlingsperioden for at vurdere deres symptomer fra stigende doser af jordnøddeallergen.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
76
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35209
- Allervie Clinical Research
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72202
- Arkansas Children's Hospital
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California
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Los Angeles, California, Forenede Stater, 90025
- California Allergy and Asthma Medical Group
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Walnut Creek, California, Forenede Stater, 94598
- Allergy and Asthma Clin Res Inc
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80907
- Asthma and Allergy Associates P C
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Denver, Colorado, Forenede Stater, 80230
- Colorado Allergy and Asthma Ctr PC
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20010
- Childrens National Hospital
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Idaho
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Boise, Idaho, Forenede Stater, 83706
- Treasure Valley Medical Research
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Illinois
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Normal, Illinois, Forenede Stater, 61761
- Midwest Allergy Sinus Asthma SC
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River Forest, Illinois, Forenede Stater, 60305
- Asthma and Allergy Center of Chicago S C
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40509
- Bluegrass Allergy Research
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Lexington, Kentucky, Forenede Stater, 40509
- Bluegrass Allergy Research .
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Louisville, Kentucky, Forenede Stater, 40217
- Family Allergy and Asthma
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins Hospital
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Chevy Chase, Maryland, Forenede Stater, 20815
- Institute for Asthma and Allergy PC
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Clinical Trials Office
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New Jersey
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Berlin, New Jersey, Forenede Stater, 08009
- CenExel HRI
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Ohio
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Columbus, Ohio, Forenede Stater, 43213
- CR Services Acquisition US Main center
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Columbus, Ohio, Forenede Stater, 43213
- CR Services Acquisition US
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74136
- Vital Prospects Clinical Research Institute
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Texas
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El Paso, Texas, Forenede Stater, 79924
- Western Sky Medical Research
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Utah
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Sandy City, Utah, Forenede Stater, 84093
- Allergy Associates of Utah
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Washington
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Seattle, Washington, Forenede Stater, 98115
- Seattle Allergy and Asthma Rsch
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 51 år (Voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Sygehistorie med allergi over for jordnødder
- Positiv jordnødde-IgE >=6kUA/L
- Positiv hudpriktest for jordnøddeallergen under screening for undersøgelse
- Positiv Oral Food Challenge til peanut under screening for undersøgelse
- Vilje til at overholde undersøgelsesplan og procedurer og undgå andre allergener i studieperioden
Ekskluderingskriterier:
- Anamnese med alvorlig eller livstruende overfølsomhedshændelse, der førte til ICU-indlæggelse eller intubation inden for 60 dage efter screening
- Ukontrolleret astma
- Blødningsrisiko eller koagulationsforstyrrelser
- Brug af antikoagulantia eller anti-blodplader (aspirin eller clopidogrel kan være tilladt)
- Historie om splenektomi
- Enhver væsentlig sygdom, der ville bringe patientens sikkerhed i fare. Dette omfatter, men er ikke begrænset til: kræfthistorie, betydelig hjertesygdom/historie, hæmatologiske lidelser, GI-blødninger, aktiv infektionsproces, leversygdom, nyresygdom, immunologisk sygdom (stabil diabetes og skjoldbruskkirtelsygdom kan tillades), alkohol- eller stofmisbrug mv.
Andre protokoldefinerede inklusions-/udelukkelseskriterier kan være gældende.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
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oral tablets
Andre navne:
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Eksperimentel: LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
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oral tablets
Andre navne:
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Eksperimentel: LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
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oral tablets
Andre navne:
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Eksperimentel: Placebo + LOU064 25 mg
Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.
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orale tabletter
oral tablets
Andre navne:
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Placebo komparator: Placebo
Placebo was administered orally twice per day, on Days 1 through 28.
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orale tabletter
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Tidsramme: Week 4
|
Responder rate was defined as the percentage of participants tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC).
The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose.
Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator.
Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
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Week 4
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Tidsramme: Week 4
|
Responder rate was defined as the percentage of participants tolerating a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC).
The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose.
Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator.
Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
|
Week 4
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Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Tidsramme: Week 4
|
Responder rate was defined as the percentage of participants tolerating a single dose of >= 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC).
The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose.
Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator.
Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
|
Week 4
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Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms - Placebo+LOU064 25 mg and Placebo
Tidsramme: Week 4
|
Responder rate was defined as the percentage of participants tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC).
The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose.
Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator.
Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
|
Week 4
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Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 3000mg During the DBPCFC
Tidsramme: 4 weeks
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Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 3000 mg during the DBPCFC conducted at one month, will be categorized as 4 levels: None, Mild, Moderate, Severe.
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4 weeks
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Change From Baseline of Peanut-specific IgE (Including Peanut Components)
Tidsramme: Baseline, Day 25 pre-dose and Day 31 (End of Study)
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IgE is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.
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Baseline, Day 25 pre-dose and Day 31 (End of Study)
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Change From Baseline of Peanut-specific IgG4 (Including Peanut Components)
Tidsramme: Baseline, Day 25 pre-dose and Day 31 (End of Study)
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IgG4 is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.
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Baseline, Day 25 pre-dose and Day 31 (End of Study)
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Change From Screening in Allergen-specific Skin Prick Test (SPT) Mean Wheal Diameters
Tidsramme: Baseline, Day 26
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An allergen specific skin prick test (SPT) is a commonly used diagnostic tool.
In this study a titration SPT using peanut allergen provided additional information on the impact of Bruton's tyrosine kinase (BTK) suppression on skin mast cells.
Skin reactions were recorded after 15 minutes of applying allergen to the pricked location.
The size of the wheel and flare (the longest diameter and the midpoint orthogonal diameter) at each site were recorded.
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Baseline, Day 26
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Maximum Observed Blood Concentration (Cmax) of LOU064
Tidsramme: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
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Cmax is the maximum (peak) observed blood concentration of LOU064 after dose administration.
Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher).
The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
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Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
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Area Under Blood Concentration-time Curve (AUClast) of LOU064
Tidsramme: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
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AUClast is the area under the blood concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of LOU064.
Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher).
The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
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Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
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Area Under Plasma Concentration-time Curve (AUCtau) of LOU064
Tidsramme: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
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AUCtau is the area under the plasma concentration-time curve.
Estimation of AUCtau values required extrapolation of the concentration-time profile from the last measured time-point at 4 h to the end of dosing interval at 12 h post-dose.
In some cases, this extrapolation was not possible.
For this reason, the number of participants with measurable AUCtau values was less when compared to those with AUClast.
Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher).
The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
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Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
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Time to Reach Maximum Observed Blood Concentration (Tmax) of LOU064
Tidsramme: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
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Tmax is the time to reach maximum (peak) of LOU064 blood concentration after single-dose administration (time).
Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher).
The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
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Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
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Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000mg During the DBPCFC
Tidsramme: 4 weeks
|
Responder rate was defined as the percentage of participants tolerating a single dose of >= 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC).
The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose.
Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator.
Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
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4 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. oktober 2022
Primær færdiggørelse (Faktiske)
11. marts 2025
Studieafslutning (Faktiske)
11. marts 2025
Datoer for studieregistrering
Først indsendt
31. maj 2022
Først indsendt, der opfyldte QC-kriterier
20. juni 2022
Først opslået (Faktiske)
27. juni 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CLOU064I12201
- 2021-006950-30 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Novartis er forpligtet til at dele med kvalificerede eksterne forskere, adgang til data på patientniveau og understøttende kliniske dokumenter fra kvalificerede undersøgelser. Disse anmodninger gennemgås og godkendes af et uafhængigt bedømmelsespanel på grundlag af videnskabelig fortjeneste. Alle opgivne data er anonymiseret for at respektere privatlivets fred for patienter, der har deltaget i forsøget i overensstemmelse med gældende love og regler.
Tilgængeligheden af denne forsøgsdata er i overensstemmelse med kriterierne og processen beskrevet på www.clinicalstudydatarequest.com
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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