A Phase 1 Study of Cizutamig in IgE Mediated Diseases

April 14, 2026 updated by: Candid Therapeutics

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1b, open-label study evaluating the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Nucleus Network
        • Contact:
          • Candid Clinical Trial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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

Exclusion Criteria:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cizutamig (single dose)
cizutamig will be dosed subcutaneously according to the cohort assignment
Biological: Cizutamig
cizutamig will be dosed SC according to the assigned cohort
Experimental: cizutamig (multiple dose)
cizutamig will be dosed subcutaneously according to the cohort assignment
Biological: Cizutamig
cizutamig will be dosed SC according to the assigned cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the ability of cizutamig to reduce IgE levels
Time Frame: Baseline to Week 12
Change from baseline in serum IgE
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of treatment-emergent adverse events through end of study
Time Frame: Baseline to Week 24
Baseline to Week 24
PK parameters: Cmax
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
PK parameters: Tmax
Time Frame: Baseline to Week 24
Baseline to Week 24
PK parameters: AUC
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
PK Parameter: CL
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
PK Parameters: Vd
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
PK Parameters: t1/2
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Anti-drug antibodies (ADAs)
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes in body temperature
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes to blood pressure
Time Frame: Baseline to 24 Weeks
systolic and diastolic
Baseline to 24 Weeks
Changes in heart rate
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes to respiratory rate
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes to pulse oximetry
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes in ECG parameters: QRS interval
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes in ECG parameters: PR interval
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes in ECG parameters: QTcB
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes in ECG parameters: QTcF
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes in ECG parameters: QT interval
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes in ECG parameters: RR
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes from baseline in Red Blood Cell count
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes from baseline in White Blood Cell count
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes from baseline in Platelets
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes from baseline in Hematocrit
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Changes from baseline in Hemoglobin
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks
Frequency and percentage of anti-drug antibodies (ADAs)
Time Frame: Baseline to 24 Weeks
Baseline to 24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Candid Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CND106-110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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