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Austin Retina Associates | Main | Austin, TX

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A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease

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Roche

Status and phase

Enrolling
Phase 3

Conditions

TED
Thyroid Eye Disease

Treatments

Drug: Satralizumab
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05987423
GP44467
2023-503309-13 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of thyroid eye disease (TED) based on CAS

Exclusion criteria

  • Decrease in CAS or proptosis of >= 2 points or >= 2 mm, respectively, in the study eye between Screening and Study Baseline (Day 1)
  • Requiring immediate surgical ophthalmological intervention or planning corrective surgery or irradiation during the course of the study, in the judgment of the investigator
  • Identified pre-existing ophthalmic disease that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results, including corneal decompensation unresponsive to medical management and including ophthalmic diseases that will likely require prohibited therapy during the study
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
  • Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of satralizumab

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups, including a placebo group

Satralizumab
Experimental group
Description:
In the Part I period, participants will receive satralizumab every 4 weeks (q4w) followed by proptosis response-based individualized treatment in Part II of the study
Treatment:
Drug: Satralizumab
Placebo
Placebo Comparator group
Description:
In the part I period, participants will receive placebo every 4 weeks (q4w) followed by proptosis response-based individualized treatment in part II of the study
Treatment:
Other: Placebo

Trial contacts and locations

39

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Central trial contact

Reference Study ID Number GP44467 www.roche.com/about_roche/roche_worldwide.htm

Data sourced from clinicaltrials.gov

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