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Trial Radar IA
Lo studio clinico NCT07408869 per IgE-Mediated Hypersensitivity, IgE Mediated Food Allergy, IgE-Mediated Cow Milk Allergy è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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A Phase 1 Study of Cizutamig in IgE Mediated Diseases Fase I 20

Non ancora in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07408869 è uno studio interventistico di Fase I volto a esaminare il trattamento per IgE-Mediated Hypersensitivity, IgE Mediated Food Allergy, IgE-Mediated Cow Milk Allergy, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 marzo 2026, con l'obiettivo di raggiungere 20 partecipanti. Sotto la guida di Candid Therapeutics, dovrebbe concludersi entro il 1 dicembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 13 febbraio 2026.
Sommario breve
The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.
Descrizione dettagliata
This is a Phase 1b, open-label study evaluating the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.
Titolo ufficiale

A Phase 1b, Open-Label Study Evaluating the Pharmacodynamics, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Cizutamig in IgE Mediated Diseases

Patologie
IgE-Mediated HypersensitivityIgE Mediated Food AllergyIgE-Mediated Cow Milk Allergy
Altri ID dello studio
  • CND106-110
Numero NCT
NCT07408869
Data di inizio (effettiva)
2026-03
Ultimo aggiornamento pubblicato
2026-02-13
Data di completamento (stimata)
2026-12
Arruolamento (previsto)
20
Tipo di studio
Interventistico
FASE
Fase I
Stato
Non ancora in arruolamento
Parole chiave
peanut allergy
nut allergy
hazelnut allergy
walnut allergy
cashew allergy
milk allergy
egg allergy
soy allergy
wheat allergy
sesame allergy
cod allergy
salmon allergy
tuna allergy
lobster allergy
crab allergy
shrimp allergy
food allergy
rhinosinusitis
allergic rhinitis
asthma
urticaria
atopic dermatitis
immune system
cizutamig
T cell engager
Scopo principale
Trattamento
Allocazione
Non randomizzato
Modello di intervento
Sequenziale
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Sperimentalecizutamig (single dose)
cizutamig will be dosed subcutaneously according to the cohort assignment
Cizutamig
cizutamig will be dosed SC according to the assigned cohort
Sperimentalecizutamig (multiple dose)
cizutamig will be dosed subcutaneously according to the cohort assignment
Cizutamig
cizutamig will be dosed SC according to the assigned cohort
Esito primario
Misure di esitoDescrizione della misuraArco temporale
To evaluate the ability of cizutamig to reduce IgE levels
Change from baseline in serum IgE
Baseline to Week 12
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Incidence and severity of treatment-emergent adverse events through end of study
Baseline to Week 24
PK parameters: Cmax
Baseline to 24 Weeks
PK parameters: Tmax
Baseline to Week 24
PK parameters: AUC
Baseline to 24 Weeks
PK Parameter: CL
Baseline to 24 Weeks
PK Parameters: Vd
Baseline to 24 Weeks
PK Parameters: t1/2
Baseline to 24 Weeks
Anti-drug antibodies (ADAs)
Baseline to 24 Weeks
Changes in body temperature
Baseline to 24 Weeks
Changes to blood pressure
systolic and diastolic
Baseline to 24 Weeks
Changes in heart rate
Baseline to 24 Weeks
Changes to respiratory rate
Baseline to 24 Weeks
Changes to pulse oximetry
Baseline to 24 Weeks
Changes in ECG parameters: QRS interval
Baseline to 24 Weeks
Changes in ECG parameters: PR interval
Baseline to 24 Weeks
Changes in ECG parameters: QTcB
Baseline to 24 Weeks
Changes in ECG parameters: QTcF
Baseline to 24 Weeks
Changes in ECG parameters: QT interval
Baseline to 24 Weeks
Changes in ECG parameters: RR
Baseline to 24 Weeks
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Baseline to 24 Weeks
Changes from baseline in Red Blood Cell count
Baseline to 24 Weeks
Changes from baseline in White Blood Cell count
Baseline to 24 Weeks
Changes from baseline in Platelets
Baseline to 24 Weeks
Changes from baseline in Hematocrit
Baseline to 24 Weeks
Changes from baseline in Hemoglobin
Baseline to 24 Weeks
Frequency and percentage of anti-drug antibodies (ADAs)
Baseline to 24 Weeks
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti

  1. Patient meets at least one of the following:

    1. History of documented (skin prick test, in vitro testing, or food challenge), ongoing, IgE-mediated allergy to food (eg, peanut, hazelnut, walnut, cashew, milk, egg/egg white, soy, wheat, sesame, cod, salmon, tuna, lobster, crab and/or shrimp) with Screening total IgE ≥ 400 IU/mL
    2. Diagnosis of chronic rhinosinusitis with Screening total IgE > ULN
    3. Diagnosis of allergic rhinitis with Screening total IgE > ULN
    4. Diagnosis of asthma and classified as well controlled per 2024 Global Initiative for Asthma guidelines with Screening total IgE > ULN
    5. Diagnosis of chronic spontaneous urticaria with symptoms (eg, wheals or angioedema) for at least 6 weeks any time prior to screening and Screening total IgE > ULN
    6. Diagnosis of atopic dermatitis that has been present for at least 6 months before the screening visit and with Screening total IgE > ULN

  2. Agree to the use of highly effective contraception

  1. Elevated IgE levels for reasons other than the IgE mediated diseases
  2. Planned ingestion of food items to which they are allergic for the duration of the study (for food allergy patients)
  3. Current use of any allergen immunotherapy.
  4. Individuals whose allergen exposures in their home and/or work environments may be expected to change significantly during the trial period
  5. Inadequate clinical laboratory parameters at Screening
  6. Receipt of or inability to discontinue any excluded therapies
  7. Individuals who will decline blood products
  8. Active infection
  9. Serious mental illness, drug or alcohol abuse, dementia, or other condition that impair ability to sign ICF
  10. Individuals who are hypersensitive to intravenous immunoglobulin (IVIg)
  11. History of primary immunodeficiency
  12. History of CNS disease
  13. History of poorly controlled diabetes, chronic kidney disease, chronic pulmonary disease, uncontrolled cardiovascular disease, history of malignancy within 5 years
  14. History of severe allergic or anaphylactic reactions to mAb therapy (or recombination antibody-related fusion proteins) or any constituents of study drug
  15. Major surgery requiring the use of general anesthesia within 12 weeks prior to Screening or planned or expected major surgery during the study period
  16. Blood donation or significant blood loss within 30 days prior to screening
  17. Individuals considered to be part of a vulnerable population (eg, incarceration)
  18. Individuals that in the opinion of the Investigator, are not suitable for participation in the trial
  19. Inability to comply with protocol-mandated requirements
  20. A history of severe allergic or anaphylactic reactions related to the underlying IgE mediated disease
Candid Therapeutics logoCandid Therapeutics
Contatti principali dello studio
Contatto: Clinical Operations, +1 858-247-0550, [email protected]
1 Centri dello studio in 1 paesi

Victoria

Nucleus Network, Melbourne, Victoria, 3004, Australia
Candid Clinical Trial, Contatto