Status:
TERMINATED
A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Thyroid Eye Disease
Graves Orbitopathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Thyroid eye disease (TED) is a rare autoimmune, inflammatory disorder of the orbit and represents the most common extra-thyroidal manifestation of Graves' disease (GD). Several lines of evidence sugge...
Detailed Description
This study consisted of the following 3 periods: 1. Screening period (Week -6 to Baseline): Participants' eligibility was assessed during the Screening period, which occurred for a maximum of 6 w...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04737330
Start Date
November 29 2021
End Date
May 16 2023
Last Update
January 9 2025
Active Locations (5)
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1
Novartis Investigative Site
Essen, Germany, 45147
2
Novartis Investigative Site
Frankfurt, Germany, 60318
3
Novartis Investigative Site
Freiburg im Breisgau, Germany, 79106
4
Novartis Investigative Site
Göttingen, Germany, 37075