Clinical trial NCT05987423: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
Official title: A Phase III, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Moderate-to-Severe Thyroid Eye Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Thyroid Eye Disease
TED
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

- Clinical diagnosis of 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 3 months after the final dose of satralizumab

Primary outcomes:
measure: Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis from Baseline (Day 1) at Week 24 in the Study eye
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change in Proptosis
timeFrame: Baseline, Week 24, Week 48 and from Week 24 to Week 48
measure: Percentage of Participants Achieving ≥ 1 Grade Reduction/Improvement in Diplopia Among Participants with Baseline Diplopia
timeFrame: Baseline, Week 24, Week 48
measure: Percentage of Participants Achieving Absence of Motility-induced Pain
timeFrame: Week 24
measure: Percentage of Participants Achieving Absence of Spontaneous Pain
timeFrame: Week 24
measure: Percentage of Participants with a ≥ 6 Point Improvement in the Visual Functioning and Appearance Sub-Scale Scores of the Graves Ophthalmopathy Quality of Life (GO-QoL)
timeFrame: Baseline, Week 24, Week 48 and from Week 24 to Week 48
measure: Percentage of Participants Achieving Overall Response
timeFrame: Week 24. Week 48
measure: Percentage of Participants Achieiving ≥2 Point Reduction in Clinical Activity Score (CAS) in the Study eye
timeFrame: Baseline, Week 24, Week 48
measure: Percentage of Participants Acheiving CAS Value of 0 or 1 in the Study eye
timeFrame: Week 24
measure: Percentage of Participants Achieving ≥ 10 point Improvement in Ocular Surface Disease Index (OSDI) Overall Scores
timeFrame: Baseline, Week 24
measure: Change in OSDI Ocular Symptoms and Vision-related Function Subscale Scores
timeFrame: Baseline, Week 24
measure: Change in Oxford Corneal Staining Scores
timeFrame: Baseline, Week 24
measure: Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis at Week 48 in the Study eye
timeFrame: Week 48
measure: Percentage of Participants Requiring Surgical Intervention for TED
timeFrame: Up to Week 48
measure: Percentage of Participants With Worsening of Proptosis by ≥ 2 mm
timeFrame: Baseline, Week 48 and from Week 24 to Week 48
measure: Change in CAS
timeFrame: Baseline, Week 48 and from Week 24 to Week 48
measure: Percentage of Participants with Adverse Events (AEs), with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE V5)
timeFrame: Baseline, Week 72
measure: Serum Concentration of Satralizumab
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Thrive Health Research LLC
state: California
city: La Jolla
country: United States
facility: UCSD Shiley Eye Center
state: California
city: Wichita
country: United States
facility: Grene Vision Group, LLC
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan, Kellogg Eye Center
state: Michigan
city: Saint Joseph
country: United States
facility: Great Lakes Eye Care
state: Michigan
city: Great Neck
country: United States
facility: 'Northwell Health Physician Partners Ophthalmology
state: New York
city: Portland
country: United States
facility: EyeHealth Northwest
state: Oregon
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Salt Lake City
country: United States
facility: Eyelid Center of Utah
state: Utah
city: Morgantown
country: United States
facility: WVU Eye Institute
state: West Virginia
city: Capital Federal
country: Argentina
facility: Centro Oftalmológico Dr. Charles S.A.
city: Capital Federal
country: Argentina
facility: Oftalmos
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Buenos Aires Mácula
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
city: Mendoza
country: Argentina
facility: Centrovision Mendoza
city: Rosario
country: Argentina
facility: Grupo Laser Vision
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: East Melbourne
country: Australia
facility: Centre For Eye Research Australia
state: Victoria
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Tübingen
country: Germany
facility: Universitäts-Augenklinik Tübingen
city: Mongkok
country: Hong Kong
facility: Hong Kong Eye Hospital
city: Budapest
country: Hungary
facility: Budapest Retina Associates Kft.
city: Napoli
country: Italy
facility: A.O. U. Federico II
state: Campania
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli
state: Lazio
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Varese
country: Italy
facility: Ospedale Di Circolo E Fondazione Macchi
state: Lombardia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Aichi
country: Japan
facility: Aichi Medical University Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: Social Medical Corporation Tenjinkai Shinkoga Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Hyogo
country: Japan
facility: Kobe Kaisei Hospital Medical foundation
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health,Japan
city: Kyoto
country: Japan
facility: National Hospital Organization Kyoto Medical Center
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Tokyo
country: Japan
facility: Olympia Eye Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: