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RecruitingNCT07597200Updated Sep 1, 2026

A Clinical Study of Cizutamig in Thyroid Eye Disease

A Phase 1 interventional study of Cizutamig will be dosed according to the protocol. in Thyroid Eye Disease, TED, sponsored by Candid Therapeutics. Recruiting at 14 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

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

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with thyroid eye disease (TED).

Read the detailed description

This is a Phase 1b, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of cizutamig in patients with thyroid eye disease (TED).

02

Conditions studied

  • Thyroid Eye Disease, TED

Browse trials for

03

In context

Graves Ophthalmopathy

199 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.

This study's planned enrollment of 38 is below the median of 63 across 146 interventional studies indexed under Graves Ophthalmopathy.

Browse Graves Ophthalmopathy 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 →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 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

  • 18-75 years old at the time of signing the Form
  • Diagnosis of Graves' Disease with active, moderate to severe TED in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Thyroid-Associated Ophthalmology (2022) at Screening and Day 1

Exclusion criteria

Exclusion Criteria:

  • Inadequate clinical laboratory parameters at Screening
  • Active infection present
  • Receipt of, or inability to discontinue, any of the excluded therapies
  • History of progressive multifocal leukoencephalopathy
  • History of primary immunodeficiency
  • Central nervous system disorders that the investigator considers would increase risk to the subject
  • Investigator-determined significant comorbidity(ies)
  • Have a diagnosis or history of malignant disease within 5 years prior to Screening
  • Active tuberculosis or lack of documentation of completed treatment for active pulmonary tuberculosis
  • History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of cizutamig
  • Pregnant or breastfeeding women
  • Patients who do not agree to use highly effective as specified in the protocol
Terms in these criteria, in plain language(2)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Cizutamig

    Drug: Cizutamig will be dosed according to the protocol.

Interventions

  • DrugCizutamig will be dosed according to the protocol.

    CND106

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline to Month 12

  2. Changes from baseline in vital signs through end of study: body temperature

    Time frame: Baseline to Month 12

  3. Changes from baseline in vital signs through end of study: heart rate

    Time frame: Baseline to Month 12

  4. Changes from baseline in vital signs through end of study: respiratory rate

    Time frame: Baseline to Month 12

  5. Changes from baseline in vital signs through end of study: blood pressure

    Time frame: Baseline to Month 12

  6. Changes from baseline in vital signs through end of study: pulse oximetry

    Time frame: Baseline to Month 12

  7. Changes from baseline in ECG parameters through end of study: PR interval

    Time frame: Baseline to Month 12

  8. Changes from baseline in ECG parameters through end of study: QRS interval

    Time frame: Baseline to Month 12

  9. Changes from baseline in ECG parameters through end of study: QTcF interval

    Time frame: Baseline to Month 12

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

    Time frame: Baseline to Month 12

  11. Changes from baseline in safety laboratory assessments through end of study: hematology

    Time frame: Baseline to Month 12

Secondary outcomes

  1. Pharmacokinetic (PK) parameters for Cizutamig: Cmax

    Time frame: Baseline to Month 12

  2. PK parameters for Cizutamig: time of maximum concentration

    Time frame: Baseline to Month 12

  3. PK parameters for Cizutamig: area under the concentration-time curve

    Time frame: Baseline to Month 12

  4. PK parameters for Cizutamig: clearance

    Time frame: Baseline to Month 12

  5. PK parameters for Cizutamig: volume of distribution

    Time frame: Baseline to Month 12

  6. PK parameters for Cizutamig: half-life

    Time frame: Baseline to Month 12

07

Study locations

14 of 14 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2026 (actual). Primary completion is estimated for May 2028, 24 months after the start.

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

Registered
May 13, 2026
First posted
May 19, 2026
StartActual
May 8, 2026
Primary completionEst.
May 31, 2028
CompletionEst.
Jun 30, 2028
Last update
Sep 1, 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 Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07597200
Lead sponsor
Candid Therapeutics
Responsible party
Sponsor
First posted
May 19, 2026
Start date
May 8, 2026
Primary completion
May 31, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Sep 1, 2026

Study contacts

Martin Zhuang
Contact
martin@candidrx.com
+86 13918519658

Oversight

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

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