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A Phase 1 Study of Cizutamig in IgE Mediated Diseases

ConditionsIgE-Mediated HypersensitivityIgE Mediated Food AllergyIgE-Mediated Cow Milk Allergy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCandid Therapeutics

About this trial

The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Diagnosis of chronic rhinosinusitis with Screening total IgE > ULN

Diagnosis of allergic rhinitis with Screening total IgE > ULN

Diagnosis of asthma and classified as well controlled per 2024 Global Initiative for Asthma guidelines with Screening total IgE > ULN

Disqualifiers

Elevated IgE levels for reasons other than the IgE mediated diseases

Planned ingestion of food items to which they are allergic for the duration of the study (for food allergy patients)

Current use of any allergen immunotherapy.

Individuals whose allergen exposures in their home and/or work environments may be expected to change significantly during the trial period

Trial design

Design model

Sequential

Treatments tested in this trial

  • Cizutamig

    Biological/Vaccine

    cizutamig will be dosed SC according to the assigned cohort

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: cizutamig (single dose)Experimental treatment 1 intervention
Group B: cizutamig (multiple dose)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the ability of cizutamig to reduce IgE levels

Change from baseline in serum IgE

Time frame
Baseline to Week 12

Secondary outcomes

1

Incidence and severity of treatment-emergent adverse events through end of study

Time frame
Baseline to Week 24
2

PK parameters: Cmax

Time frame
Baseline to 24 Weeks
3

PK parameters: Tmax

Time frame
Baseline to Week 24
4

PK parameters: AUC

Time frame
Baseline to 24 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Candid Therapeutics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: