Clinical trial NCT06106828: 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
Keywords: TED
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-10-30
Enrollment: 127
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 ≥ 2 millimetres (mm) 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, and 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 Achieving a ≥ 2 Point Reduction in Clinical Activity Score (CAS) in the Study Eye
timeFrame: Baseline, Week 24, and Week 48
measure: Percentage of Participants Achieving 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 up to Week 72
measure: Serum Concentration of Satralizumab
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Plastics-Orbit-Neuro
state: California
city: Danbury
country: United States
facility: Connecticut Eye Consultants, P.C.
state: Connecticut
city: Chicago
country: United States
facility: University of Illinois Eye and Ear Infirmary
state: Illinois
city: Philadelphia
country: United States
facility: Scheie Eye Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: San Antonio
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Toronto
country: Canada
facility: Toronto Retina Institute
state: Ontario
city: Montreal
country: Canada
facility: Universite de Montreal - Hopital Maisonneuve-Rosemont
state: Quebec
city: Beijing City
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Hospital of Ministry of Health
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
city: Xi'an City
country: China
facility: Xi'an Fourth Hospital
city: Nantes
country: France
facility: CHU Nantes - Hôtel Dieu
city: Paris
country: France
facility: CHNO Hopital des Quinze Vingts
city: Paris
country: France
facility: Fondation Rothschild
city: Jerusalem
country: Israel
facility: Hadassah MC
city: Petach Tikva
country: Israel
facility: Rabin MC
city: Ramat Gan
country: Israel
facility: Sheba medical center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Bydgoszcz
country: Poland
facility: Specjalistyczny O?rodek Okulistyczny Oculomedica
city: Gdansk
country: Poland
facility: Optimum Profesorskie Centrum Okulistyki
city: Coimbra
country: Portugal
facility: AIBILI - Association for Innovation and Biomedical Research on Light
city: Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d Hebron
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Valencia
country: Spain
facility: Hospital Universitario la Fe: Servicio de Oftalmologia
city: Brighton
country: United Kingdom
facility: Sussex Eye Hospital
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
city: Maidstone, Kent
country: United Kingdom
facility: Maidstone Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: