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WithdrawnNCT07408869Updated Jul 22, 2026

A Phase 1 Study of Cizutamig in IgE Mediated Diseases

A Phase 1 interventional study of Cizutamig in IgE-Mediated Hypersensitivity, IgE Mediated Food Allergy and IgE-Mediated Cow Milk Allergy, sponsored by Candid Therapeutics. Withdrawn at 1 site in Australia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-22.

Primary conditionMilk HypersensitivityRegistry: Hypersensitivity, ImmediateReclassifiedWhy we changed it
Registry
Hypersensitivity, Immediate — the first condition term the registry derived for this study.
ClinicalTrials.gg
Milk Hypersensitivity
Why
  1. The study's listed conditions name Milk Hypersensitivity, a narrower term within Hypersensitivity, Immediate.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Candid Therapeutics (part of UCB S.A.) · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Sponsor decision
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • IgE-Mediated Hypersensitivity
  • IgE Mediated Food Allergy
  • IgE-Mediated Cow Milk Allergy

Keywords

  • 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
03

In context

Milk Hypersensitivity Reclassified

147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.

Browse Milk Hypersensitivity studies →

Lead sponsor

Candid Therapeutics is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

First submitted before Candid Therapeutics became part of UCB S.A..

Browse Candid Therapeutics studies →All UCB S.A. studies →

Compared within Milk Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity, Immediate. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 >
    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

Exclusion criteria

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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    cizutamig (single dose)

    cizutamig will be dosed subcutaneously according to the cohort assignment

    Biological: Cizutamig

  • Experimental
    cizutamig (multiple dose)

    cizutamig will be dosed subcutaneously according to the cohort assignment

    Biological: Cizutamig

Interventions

  • BiologicalCizutamig

    cizutamig will be dosed SC according to the assigned cohort

06

What researchers measure

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

  5. PK Parameter: CL

    Time frame: Baseline to 24 Weeks

  6. PK Parameters: Vd

    Time frame: Baseline to 24 Weeks

  7. PK Parameters: t1/2

    Time frame: Baseline to 24 Weeks

  8. Anti-drug antibodies (ADAs)

    Time frame: Baseline to 24 Weeks

  9. Changes in body temperature

    Time frame: Baseline to 24 Weeks

  10. Changes to blood pressure

    systolic and diastolic

    Time frame: Baseline to 24 Weeks

  11. Changes in heart rate

    Time frame: Baseline to 24 Weeks

  12. Changes to respiratory rate

    Time frame: Baseline to 24 Weeks

  13. Changes to pulse oximetry

    Time frame: Baseline to 24 Weeks

  14. Changes in ECG parameters: QRS interval

    Time frame: Baseline to 24 Weeks

  15. Changes in ECG parameters: PR interval

    Time frame: Baseline to 24 Weeks

  16. Changes in ECG parameters: QTcB

    Time frame: Baseline to 24 Weeks

  17. Changes in ECG parameters: QTcF

    Time frame: Baseline to 24 Weeks

  18. Changes in ECG parameters: QT interval

    Time frame: Baseline to 24 Weeks

  19. Changes in ECG parameters: RR

    Time frame: Baseline to 24 Weeks

  20. Changes from baseline in safety laboratory assessments through end of study: serum chemistry

    Time frame: Baseline to 24 Weeks

  21. Changes from baseline in Red Blood Cell count

    Time frame: Baseline to 24 Weeks

  22. Changes from baseline in White Blood Cell count

    Time frame: Baseline to 24 Weeks

  23. Changes from baseline in Platelets

    Time frame: Baseline to 24 Weeks

  24. Changes from baseline in Hematocrit

    Time frame: Baseline to 24 Weeks

  25. Changes from baseline in Hemoglobin

    Time frame: Baseline to 24 Weeks

  26. Frequency and percentage of anti-drug antibodies (ADAs)

    Time frame: Baseline to 24 Weeks

07

Study locations

1 site
  • Nucleus Network
    Melbourne, Victoria 3004, Australia
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2026; primary completion for Dec 2026, 8 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 23, 2025
First posted
Feb 13, 2026
StartEst.
Apr 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Jul 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07408869
Lead sponsor
Candid Therapeutics
Responsible party
Sponsor
First posted
Feb 13, 2026
Start date
Apr 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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