A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease (SatraGO-2)

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06106828

Collaborator

(none)

120

Enrollment

Arms

42.6

Anticipated Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Thyroid Eye Disease	Drug: Satralizumab Other: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 29, 2023

Anticipated Primary Completion Date :

May 17, 2025

Anticipated Study Completion Date :

May 17, 2027

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Satralizumab Satralizumab will be administered by SC injection.
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	Other: Placebo Placebo will be administered by SC injection

Arm

Intervention/Treatment

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

Drug: Satralizumab

Satralizumab will be administered by SC injection.

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

Other: Placebo

Placebo will be administered by SC injection

Outcome Measures

Primary Outcome Measures

Percentage of participants achieving ≥ 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye [Baseline, Week 24]
Provided there is no deterioration of proptosis (≥ 2mm increase) in the fellow eye

Secondary Outcome Measures

Change in proptosis from baseline to Week 24 [Baseline, Week 24]
Percentage of participants achieving >= 1 grade reduction/improvement in diplopia among participants with baseline diplopia [Baseline, Week 24]
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) [Baseline, Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT06106828

Other Study ID Numbers:

GP44729

First Posted:

Oct 30, 2023

Last Update Posted:

Oct 30, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hoffmann-La Roche

TED

Additional relevant MeSH terms:

Eye Diseases

Graves Ophthalmopathy

Thyroid Diseases

Study Results

No Results Posted as of Oct 30, 2023