Cizutamig in thyroid eye disease for adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and early clinical activity of cizutamig in patients with active moderate to severe TED due to Graves' disease. Participants will receive cizutamig according to a predefined protocol, with assessments focused on safety and pharmacology, plus initial signals of clinical activity. The trial aims to establish an initial safety profile and observe pharmacologic behavior in this patient population. Eligible adults are 18 to 75 years old with Graves' disease and active TED diagnosed per Chinese guidelines. Exclusion criteria target infection, major comorbidities, prior malignancy within 5 years, and other factors that could confound safety or risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18-75 years old at the time of signing the Informed Consent 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:

* 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 contraception as specified in the protocol

Where it's running

• The Second Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• The Eighth Affiliated Hospital of Southern Medical University (Shunde District People's Hospital of Foshan City)
  Foshan, Guangdong, China Recruiting
• Guangdong Provincial People's hospital
  Guangzhou, Guangdong, China Recruiting
• Xiangya Hospital of Central South University
  Changsha, Hubei, China Recruiting

Study contacts

• Study coordinator: Martin Zhuang
• Email: martin@candidrx.com
• Phone: +86 13918519658

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ETHY-001 safety and activity in Thyroid Eye Disease (TED)

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• Early risk stratification of thyroid eye disease in newly diagnosed Graves' disease

  This study tests whether early eye-related signs, blood and tear biomarkers, or eye surface features can predict who with Graves’ disease will develop thyroid eye disease within a year.

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• Linsitinib in moderate to severe Thyroid Eye Disease (TED)

  This study tests whether linsitinib can help people with moderate to severe TED associated with Graves' disease or Hashimoto's thyroiditis.

  Recruiting at 17 sites Phase 3 Sling Therapeutics, Inc. · Glendale, Arizona and 17 other locations · NCT07753603

• MHB018A injections for chronic moderate-to-severe thyroid eye disease

  This study tests whether MHB018A injections work better than a placebo for adults with chronic moderate-to-severe thyroid eye disease.

  Recruiting Phase 3 Minghui Pharmaceutical (Hangzhou) Ltd · Coral Gables, Florida · NCT07622121

• Treating Active Thyroid Eye Disease with MHB018A vs placebo

  In people with active moderate-to-severe TED, this study tests whether an antibody called MHB018A can help reduce eye inflammation and swelling compared with a placebo.

  Recruiting Phase 3 Minghui Pharmaceutical (Hangzhou) Ltd · Coral Gables, Florida · NCT07622108

• Tofacitinib for steroid‑resistant moderate-to-severe thyroid eye disease

  This will test whether taking oral tofacitinib (5 mg twice daily) for 24 weeks can reduce eye bulging and inflammation in adults with moderate-to-severe thyroid eye disease who don't respond to or cannot take high-dose steroids.

  Recruiting Phase 2 The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07547930

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.