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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05987423
Registration number
NCT05987423
Ethics application status
Date submitted
5/07/2023
Date registered
14/08/2023
Date last updated
6/06/2024
Titles & IDs
Public title
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease
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Scientific 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
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Secondary ID [1]
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2023-503309-13
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Secondary ID [2]
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GP44467
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Thyroid Eye Disease
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TED
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Inflammatory and Immune System
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Autoimmune diseases
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Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Satralizumab
Other interventions - Placebo
Experimental: Satralizumab - 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
Placebo Comparator: Placebo - 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: Drugs: Satralizumab
Satralizumab will be administered by SC injection.
Other interventions: Placebo
Placebo will be administered by SC injection
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of participants achieving = 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye
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Assessment method [1]
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Provided there is no deterioration of proptosis (= 2mm increase) in the fellow eye
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [1]
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Change in proptosis
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Assessment method [1]
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [2]
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Percentage of participants achieving >= 1 grade reduction/improvement in diplopia among participants with baseline diplopia
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Assessment method [2]
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Timepoint [2]
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Baseline, Week 24
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Secondary outcome [3]
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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)
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Assessment method [3]
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Timepoint [3]
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Baseline, Week 24
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Eligibility
Key inclusion criteria
- Clinical diagnosis of thyroid eye disease (TED) based on CAS
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/10/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
4/05/2026
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Sydney Eye Hospital - Sydney
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Recruitment hospital [2]
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Royal Adelaide Hospital; Opthamology Department - Adelaide
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Recruitment hospital [3]
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Centre For Eye Research Australia - East Melbourne
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Michigan
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United States of America
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Oregon
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Texas
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Utah
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West Virginia
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Argentina
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Capital Federal
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Mendoza
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Argentina
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Rosario
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Germany
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Berlin
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Marburg
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Germany
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Münster
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Germany
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Tübingen
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Hong Kong
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Mongkok
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Italy
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Campania
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Toscana
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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kitakyushu-shi
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Japan
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Kyoto
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Japan
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Miyazaki
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Japan
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Osaka
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Japan
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Tokyo
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Singapore
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Singapore
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05987423
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Reference Study ID Number GP44467 www.roche.com/about_roche/roche_worldwide.htm
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Address
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Country
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Phone
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888-662-6728 (U.S. Only)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05987423
Download to PDF