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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05987423




Registration number
NCT05987423
Ethics application status
Date submitted
5/07/2023
Date registered
14/08/2023

Titles & IDs
Public title
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease
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
Secondary ID [1] 0 0
2023-503309-13
Secondary ID [2] 0 0
GP44467
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid Eye Disease 0 0
TED 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants achieving = 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Change in proptosis
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Percentage of participants achieving >= 1 grade reduction/improvement in diplopia among participants with baseline diplopia
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
Baseline, Week 24

Eligibility
Key inclusion criteria
- Clinical diagnosis of thyroid eye disease (TED) based on CAS
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/05/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Adelaide Hospital; Opthamology Department - Adelaide
Recruitment hospital [3] 0 0
Centre For Eye Research Australia - East Melbourne
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
West Virginia
Country [11] 0 0
Argentina
State/province [11] 0 0
Capital Federal
Country [12] 0 0
Argentina
State/province [12] 0 0
Ciudad Autonoma Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Ciudad Autónoma de Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Mendoza
Country [15] 0 0
Argentina
State/province [15] 0 0
Rosario
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Germany
State/province [17] 0 0
Essen
Country [18] 0 0
Germany
State/province [18] 0 0
Freiburg
Country [19] 0 0
Germany
State/province [19] 0 0
Marburg
Country [20] 0 0
Germany
State/province [20] 0 0
Münster
Country [21] 0 0
Germany
State/province [21] 0 0
Tübingen
Country [22] 0 0
Hong Kong
State/province [22] 0 0
Mongkok
Country [23] 0 0
Italy
State/province [23] 0 0
Campania
Country [24] 0 0
Italy
State/province [24] 0 0
Lazio
Country [25] 0 0
Italy
State/province [25] 0 0
Lombardia
Country [26] 0 0
Italy
State/province [26] 0 0
Toscana
Country [27] 0 0
Japan
State/province [27] 0 0
Aichi
Country [28] 0 0
Japan
State/province [28] 0 0
Fukuoka
Country [29] 0 0
Japan
State/province [29] 0 0
Hokkaido
Country [30] 0 0
Japan
State/province [30] 0 0
Hyogo
Country [31] 0 0
Japan
State/province [31] 0 0
Kitakyushu-shi
Country [32] 0 0
Japan
State/province [32] 0 0
Kyoto
Country [33] 0 0
Japan
State/province [33] 0 0
Miyazaki
Country [34] 0 0
Japan
State/province [34] 0 0
Osaka
Country [35] 0 0
Japan
State/province [35] 0 0
Tokyo
Country [36] 0 0
Singapore
State/province [36] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number GP44467 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05987423