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A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy

7. september 2026 opdateret af: Longbio Pharma (Suzhou) Co., Ltd.

A Multicenter, Randomized, Open-Label Phase II Clinical Trial to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy

This is a multicenter, randomized, open-label Phase II clinical study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity profiles of LP-003 injection in participants with Wheat dependent exercise induced anaphylaxis. Its primary objective is to explore and preliminarily evaluate the efficacy of LP-003 Injection in the participants with Wheat dependent exercise induced anaphylaxis, as well as to investigate its safety, pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

12

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Peking Union Medical College Hospital
        • Ledende efterforsker:
          • Kai Guan
        • Kontakt:

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

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Aged ≥12 years and ≤60 years, male or female;
  • History of wheat or gluten allergy;
  • Positive skin prick test (SPT) to the allergen (wheat or gluten), and/or positive allergen-specific immunoglobulin E (sIgE) to food allergen (crude wheat/gluten extract or ω 5 gliadin) at screening or within three months prior to screening;
  • Dose-limiting symptoms occurred at a cumulative dose of ≤24 g gluten protein during the food-exercise challenge test at screening;
  • No plan to conceive and agree to use effective contraceptive measures throughout the trial period;
  • The participant and/or parent/legal representative understands and voluntarily signs the informed consent form.

Exclusion Criteria:

  • Allergic to LP-003 Injection or its excipients;
  • Uncontrolled asthma or severe asthma at screening;
  • Any severe disease;
  • History of severe allergic reactions to wheat or gluten;
  • Not enough washing-out period for previous therapy before the food exercise challenge at screening.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: LP-003 Dose 1
Participants will receive subcutaneous injection of LP-003 Injection at Dose 1.
Biologisk: LP-003 Injection
s.c. injection, Q8W
Eksperimentel: LP-003 Dose 2
Participants will receive subcutaneous injection of LP-003 Injection at Dose 2.
Biologisk: LP-003 Injection
s.c. injection, Q8W

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of participants who consumed a cumulative dose of 24 g gluten protein without dose limiting symptoms in the food exercise challenge test.
Tidsramme: Week 24
Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum tolerated cumulative dose of gluten protein (the highest dose without dose-limiting symptoms) in the food exercise challenge test
Tidsramme: Week 24
Week 24
Proportion of participants who used any rescue medication (e.g., albuterol, epinephrine, or others) within 24 weeks
Tidsramme: Week 24
Week 24
Change from baseline in the age-specific Food Allergy Quality of Life Questionnaire (FAQLQ).
Tidsramme: Week 24
The Food Allergy Quality of Life Questionnaires (FAQLQ) are disease-specific health-related quality of life (HRQL) questionnaires for patients with food allergy. FAQLQ-Teenager Form consists of 23 items and FAQLQ-Adult Form consists of 29 items. The raw score for each item ranges from 0 to 6, which is recorded as 1 to 7. Higher scores indicate greater impairment of food allergy-related quality of life.
Week 24
Change from baseline in the age-specific Food Allergy Independent Measure (FAIM).
Tidsramme: Week 24
The FAIM (Food Allergy Independent Measure) consists of 7 items and each item is rated from 0 to 6, and a higher total score reflects a higher perceived risk or probability of experiencing an adverse event. The FAIM can therefore be seen as a patient-reported measure of perceived severity.
Week 24
Incidence of Treatment-Emergent Adverse Events (TEAEs) .
Tidsramme: Up to approximately 36 weeks
Incidence and severity of TEAEs from first dose to end of study are recorded.
Up to approximately 36 weeks
Serum concentrations of LP-003
Tidsramme: Up to approximately 36 weeks
Up to approximately 36 weeks
Concentrations of free immunoglobulin E (IgE) and total IgE
Tidsramme: Up to approximately 36 weeks
Up to approximately 36 weeks
Anti-drug antibodies (ADA), and neutralizing antibodies (Nab)
Tidsramme: Up to approximately 36 weeks
Up to approximately 36 weeks

Andre resultatmål

Resultatmål
Tidsramme
Change from baseline in individual cut-off values of Basophil Activation Test (BAT).
Tidsramme: Week 24
Week 24
Change from baseline in the positive sensitization rate of allergen-specific IgE (sIgE)
Tidsramme: Week 24
Week 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Longbio Pharma (Suzhou) Co., Ltd.

Efterforskere

  • Ledende efterforsker: Kai Guan, Peking Union Medical College Hospital

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 (Anslået)

4. september 2026

Primær færdiggørelse (Anslået)

16. juli 2027

Studieafslutning (Anslået)

15. oktober 2027

Datoer for studieregistrering

Først indsendt

7. september 2026

Først indsendt, der opfyldte QC-kriterier

7. september 2026

Først opslået (Faktiske)

11. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P10-LP003-06

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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