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Promising drug trial for thyroid eye disease halted early

NCT ID NCT04737330

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called secukinumab in adults with active, moderate to severe thyroid eye disease, a condition that causes bulging eyes and discomfort. The trial aimed to see if the drug could reduce eye bulging and inflammation. However, the study was stopped early and only 28 people took part, so the results are not conclusive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Secukinumab
What this could lead to
If this treatment had worked, it could have pointed toward a new option for controlling thyroid eye disease without surgery.
What could go wrong
The trial was stopped early with only 28 participants, so we have very little data. It is unclear if secukinumab is effective or safe for this condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

28 people

The number who actually took part.

Started

Nov 2021

Finished

May 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Patient had to be able to understand and communicate with the investigator and comply with the requirements of the study and had to give a written, signed and dated informed consent before any study assessment was performed. * Male or non-pregnant, non-lactating female patients ≥ 18 years of age. * Clinical diagnosis of active, moderate to severe TED (not sight-threatening) in the study eye at Baseline associated with 2 or more of the following: * Lid retraction \>= 2 mm * Moderate or severe soft tissue involvement * Exophthalmos \>= 3 mm above normal * Inconstant or constant diplopia * Onset of TED symptoms fewer than 12 months prior to Baseline. * CAS \>= 4 (on a 7-point scale, with a score of \>= 3 indicating active TED) in the more severely affected (study) eye at Screening and Baseline. Note: Proptosis is the primary qualifier for selection of the study eye. In case both eyes showed a similar degree of proptosis, other inflammatory signs and symptoms (CAS) were taken into account by the investigator for the selection of the study eye. * Peripheral euthyroidism or mild hypo-/hyperthyroidism defined as free T3 (fT3) and free T4 (fT4) \< 30% above/below normal limits at Screening. Every effort was to be made to correct the mild hypo-/hyperthyroidism promptly and to maintain the euthyroid state until the end of this study. * Orbital MRI assessment available confirming the diagnosis of TED for patients initially presenting with hypo- or euthyroidism (without treatment for hyperthyroidism) before or at the time of TED diagnosis (to rule out other potential causes of orbital signs and symptoms. Key Exclusion Criteria: * Improvement in CAS of \>= 2 points and/or improvement in proptosis of \>= 2 mm in the study eye between Screening and Baseline. * Signs of sight-threatening TED defined by optic neuropathy or severe corneal injury. * Patients, in the opinion of the investigator, requiring immediate or urgent medical treatment with glucocorticoids for TED. * Patients requiring immediate surgical ophthalmological intervention or planning corrective surgery/irradiation during the course of the study. * Decreased best corrected visual acuity (BCVA) as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect or color defect within the last 6 months. * Any other ophthalmic and/or orbital disease or condition that might interfere with the assessment of TED. * Previous orbital radiotherapy. * Previous ophthalmological/orbital surgery for TED (e.g., orbital decompression). * Previous use of biological agents for the treatment of TED. * Previous use of systemic, non-biologic, immunomodulatory agents for the treatment of TED (e.g., mycophenolate or cyclosporine). * Previous exposure to secukinumab or other biologic drugs directly targeting IL-17A or the IL 17 receptor (e.g., ixekizumab, brodalumab). * Previous treatment with rituximab, tocilizumab or teprotumumab. * Previous use of systemic corticosteroids for the treatment of TED, except for oral corticosteroids with a cumulative dose equivalent to \< 1 g oral prednisone/prednisolone if the corticosteroid was discontinued at least 4 weeks prior to Baseline. * Previous treatment with any cell-depleting therapies including but not limited to anti-cluster of differentiation 20 (CD20) or investigational agents (e.g., CAMPATH, anti CD4, anti-CD5, anti-CD3, anti-CD19). * Use of other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer. * Previous or ongoing use of prohibited treatments (see Appendix 16.1.1-Protocol Section 6.2.2). Respective washout periods detailed in this section needed to be adhered to. * History of hypersensitivity to any of the study drug constituents. Other protocol defined Inclusion/Exclusion may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Frankfurt, 60318, Germany

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106, Germany

  • Novartis Investigative Site

    Göttingen, 37075, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

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