Study of efficacy and safety of secukinumab in adult patients with active, moderate to severe thyroid eye disease

Phase 1

Active, not recruiting

• Conditions: Active, moderate to severe thyroid eye disease; MedDRA version: 20.1Level: PTClassification code 10060742Term: Endocrine ophthalmopathySystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2020-001611-24-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-26
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
2. Male or non-pregnant, non-lactating female patients = 18 years of age.
3. 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
4. Onset of TED symptoms fewer than 12 months prior to Baseline.
5. 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 show a similar degree of proptosis, other inflammatory signs and symptoms (CAS) should be taken into account by the investigator for the selection of the study eye.
6. Peripheral euthyroidism or mild hypo-/hyperthyroidism defined as free T3 (fT3) and free T4 (fT4) < 30% above/below normal limits at Screening. Every effort should be made to correct the mild hypo-/hyperthyroidism promptly and to maintain the euthyroid state until the end of this study.
7. 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

1. Improvement in CAS of = 2 points and/or improvement in proptosis of = 2 mm in the study eye between Screening and Baseline.
2. Signs of sight-threatening TED defined by optic neuropathy or severe corneal injury.
3. Patients, in the opinion of the investigator, requiring immediate or urgent medical treatment with glucocorticoids for TED.
4. Patients requiring immediate surgical ophthalmological intervention or planning corrective surgery/irradiation during the course of the study.
5. 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.
6. Any other ophthalmic and/or orbital disease or condition that might interfere with the assessment of TED.
7. Previous orbital radiotherapy.
8. Previous ophthalmological/orbital surgery for TED (e.g. orbital decompression).
9. Previous use of biological agents for the treatment of TED.
10. Previous use of systemic, non-biologic, immunomodulatory agents for the treatment of TED (e.g., mycophenolate or cyclosporine).
11. Previous exposure to secukinumab or other biologic drugs directly targeting IL-17A or the IL-17 receptor (e.g., ixekizumab, brodalumab).
12. Previous treatment with rituximab, tocilizumab or teprotumumab.
13. 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.
14. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19).
15. Use of other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer.
16. Previous or ongoing use of prohibited treatments. Respective washout periods have to be adhered to.
17. History of hypersensitivity to any of the study drug constituents.

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified