A Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy

Q: Who can participate in NCT06927375?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06927375?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Clinical Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy: A Prospective Exploratory Study

A Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy (NCT06927375) is a Phase 4 interventional studying Thyroid-Associated Ophthalmopathy, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Thyroid-associated ophthalmopathy (TAO) is a serious, progressive, vision-threatening autoimmune disease that can be categorized into mild, moderate, and severe stages based on severity. The activity of TAO is commonly evaluated using the Clinical Activity Score (CAS). Tocilizumab serves as a second-line treatment option for patients with moderate to severe active TAO. Additionally, it is common for TAO patients to experience anxiety, which may exacerbate their condition and negatively impact prognosis. Therefore, we have designed this randomized controlled study to evaluate the impact of Flupentixol Melitracen (Lepan) on the treatment outcomes of participants receiving Tocilizumab (Actemra).

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Thyroid-Associated Ophthalmopathy subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Aged between 18 and 80 years (inclusive). - Meets internationally recognized diagnostic criteria for TED with the more severely affected eye in moderate to severe active phase. Meeting any one of the following criteria qualifies as moderate to severe: an exophthalmos ≥2 mm compared with normal values for sex and race; presence of inconstant to constant diplopia; a lid retraction ≥2 mm. A Clinical Activity Score (CAS) of ≥3 or a score of 2 combined with MRI evidence indicating active disease is defined as active. - Normal thyroid function within one month prior to enrollment: including those currently taking antithyroid drugs or not requiring medication, with FT3 and FT4 levels within normal range and TSH either normal or decreased. - HAMA (Hamilton Anxiety Rating Scale) score of ≥14. - Voluntary participation and provision of willing to sign a consent form. Who Should NOT Join This Trial: - Severe cardiac, hepatic, or renal insufficiency (including myocardial ischemia or myocardial infarction, arrhythmias, and heart failure; ALT, AST ≥ 3 times the upper limit of normal; eGFR \< 60 ml/min/1.73 m²). - communicable disease. - Pregnancy or planning to become pregnant. - Currently breastfeeding. - Received radioactive iodine treatment or hepatitis vaccination within three months prior to enrollment. - Received systemic immunotherapy for TAO, including oral or intravenous glucocorticoids, other immunosuppressants, or orbital radiotherapy within one month prior to enrollment. - Planning to undergo other treatments during the course of this study. - Severe mental disorders that affect compliance. - Presence of other clinically significant or unstable systemic diseases. - Patients who are unlikely to complete the entire course of treatment. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Aged between 18 and 80 years (inclusive). * Meets internationally recognized diagnostic criteria for TED with the more severely affected eye in moderate to severe active phase. Meeting any one of the following criteria qualifies as moderate to severe: an exophthalmos ≥2 mm compared with normal values for sex and race; presence of inconstant to constant diplopia; a lid retraction ≥2 mm. A Clinical Activity Score (CAS) of ≥3 or a score of 2 combined with MRI evidence indicating active disease is defined as active. * Normal thyroid function within one month prior to enrollment: including those currently taking antithyroid drugs or not requiring medication, with FT3 and FT4 levels within normal range and TSH either normal or decreased. * HAMA (Hamilton Anxiety Rating Scale) score of ≥14. * Voluntary participation and provision of informed consent. Exclusion Criteria: * Severe cardiac, hepatic, or renal insufficiency (including myocardial ischemia or myocardial infarction, arrhythmias, and heart failure; ALT, AST ≥ 3 times the upper limit of normal; eGFR \< 60 ml/min/1.73 m²). * communicable disease. * Pregnancy or planning to become pregnant. * Currently breastfeeding. * Received radioactive iodine treatment or hepatitis vaccination within three months prior to enrollment. * Received systemic immunotherapy for TAO, including oral or intravenous glucocorticoids, other immunosuppressants, or orbital radiotherapy within one month prior to enrollment. * Planning to undergo other treatments during the course of this study. * Severe mental disorders that affect compliance. * Presence of other clinically significant or unstable systemic diseases. * Patients who are unlikely to complete the entire course of treatment.

Treatments Being Tested

DRUG

Tocilizumab(400mg) combined with Flupentixol Melitracen(0.5mg:10mg)

Tocilizumab (Actemra) is administered via intravenous infusion at a dose of 400 mg at Weeks 0, 4, and 8. Flupentixol/Melitracen is given orally at a dose of 0.5 mg/10 mg twice daily for 8 consecutive weeks starting from Week 0.

DRUG

Tocilizumab(400mg)

Tocilizumab (Actemra) is administered via intravenous infusion at a dose of 400 mg at Weeks 0, 4, and 8.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06927375), the sponsor (Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06927375 clinical trial studying?

Thyroid-associated ophthalmopathy (TAO) is a serious, progressive, vision-threatening autoimmune disease that can be categorized into mild, moderate, and severe stages based on severity. The activity of TAO is commonly evaluated using the Clinical Activity Score (CAS). Tocilizumab serves as a second-line treatment option for patients with moderate to severe active TAO. Additionally, it is common for TAO patients to experience anxiety, which may exacerbate their condition and negatively impact prognosis. Therefore, we have designed this randomized controlled study to evaluate the impact of Flup… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06927375?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06927375?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06927375. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06927375. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.