Back to resultsA Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease
Primary Purpose
Thyroid Eye Disease
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Satralizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Eye Disease
Eligibility Criteria
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
Sites / Locations
- Thrive Health Research LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Satralizumab
Placebo
Arm 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
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
Outcomes
Primary Outcome Measures
Percentage of participants achieving ≥ 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye
Provided there is no deterioration of proptosis (≥ 2mm increase) in the fellow eye
Secondary Outcome Measures
Change in proptosis from baseline to Week 24
Percentage of participants achieving >= 1 grade reduction/improvement in diplopia among participants with baseline diplopia
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05987423
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
May 17, 2025 (Anticipated)
Study Completion Date
May 17, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Satralizumab
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Satralizumab
Intervention Description
Satralizumab will be administered by SC injection.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered by SC injection
Primary Outcome Measure Information:
Title
Percentage of participants achieving ≥ 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye
Description
Provided there is no deterioration of proptosis (≥ 2mm increase) in the fellow eye
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change in proptosis from baseline to Week 24
Time Frame
Baseline, Week 24
Title
Percentage of participants achieving >= 1 grade reduction/improvement in diplopia among participants with baseline diplopia
Time Frame
Baseline, Week 24
Title
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)
Time Frame
Baseline, Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number GP44467 www.roche.com/about_roche/roche_worldwide.htm
Phone
888-662-6728 (U.S. Only)
Email
lobal-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Thrive Health Research LLC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90210
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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/).
Learn more about this trial
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease
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