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Clinical Trials/EUCTR2020-001611-24-DE
EUCTR2020-001611-24-DE
Active, not recruiting
Phase 1

A two-year multi-center Phase 3 study to investigate the efficacy and safety of secukinumab in adult patients with active, moderate to severe thyroid eye disease (ORBIT), with a randomized, parallel-group, double-blind, placebo-controlled, 16-week treatment period, and a follow-up/retreatment period - ORBIT

ovartis Pharma GmbH0 sites70 target enrollmentOctober 26, 2020
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DrugsCosentyx

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ovartis Pharma GmbH
Enrollment
70
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 26, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ovartis Pharma GmbH

Eligibility Criteria

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.

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).

Outcomes

Primary Outcomes

Not specified

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