Not Yet RecruitingPhase 1

A Phase 1 Study of Cizutamig in IgE Mediated Diseases

Australia20 participantsStarted 2026-04

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Patient meets at least one of the following:
✓. 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
✓. 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
✓. Diagnosis of atopic dermatitis that has been present for at least 6 months before the screening visit and with Screening total IgE \> ULN
✓. Agree to the use of highly effective contraception

Exclusion criteria

✕. 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
✕. Inadequate clinical laboratory parameters at Screening
✕. Receipt of or inability to discontinue any excluded therapies
✕. Individuals who will decline blood products
✕. Active infection

What they're measuring

To evaluate the ability of cizutamig to reduce IgE levels

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT07408869

SponsorCandid Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Clinical Operations

+1 858-247-0550 ClinicalTrials@candidrx.com

View on ClinicalTrials.gov More IgE-Mediated Hypersensitivity trials