Satralizumab for Thyroid Eye Disease

(SatraGO-2 Trial)

Recruiting at 77 trial locations

Overseen By Reference Study ID Number GP44729 www.roche.com/about_roche/roche_worldwide.htm

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Disqualifiers: Pregnancy, Breastfeeding, Ophthalmic disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

127 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the idea that Satralizumab for Thyroid Eye Disease is an effective treatment?

The available research does not provide any data on the effectiveness of Satralizumab for Thyroid Eye Disease. Instead, it discusses other treatments like alemtuzumab and teprotumumab for this condition. Without specific data on Satralizumab, we cannot conclude its effectiveness for Thyroid Eye Disease based on the provided information. ^{1 2 3 4 5}

What safety data is available for Satralizumab in treating Thyroid Eye Disease?

The provided research does not contain safety data for Satralizumab (also known as Enspryng, SA-237, sapelizumab, satralizumab-mwge) in the treatment of Thyroid Eye Disease. The studies focus on Teprotumumab and Tocilizumab, which are different treatments for Thyroid Eye Disease. ^{2 4 5 6 7}

Is the drug Satralizumab a promising treatment for Thyroid Eye Disease?

The information provided does not mention Satralizumab as a treatment for Thyroid Eye Disease, so we cannot say if it is promising based on this data. ^{1 4 8 9 10}

How is the drug Satralizumab different from other drugs for thyroid eye disease?

Satralizumab is unique because it is primarily used for conditions like neuromyelitis optica spectrum disorder, and its application for thyroid eye disease is novel, potentially offering a different mechanism of action compared to existing treatments like teprotumumab, which targets the insulin-like growth factor 1 receptor (IGF-1R). ^{1 4 8 9 10}

What is the purpose of this trial?

This trial is testing an injectable medicine called satralizumab for people with thyroid eye disease. The medicine works by blocking a protein that causes inflammation, which can help reduce swelling and discomfort in the eyes. The study aims to see how safe and effective this treatment is for these patients.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for individuals with thyroid eye disease (TED), confirmed by a clinical diagnosis. Participants must meet specific medical criteria to join.

Inclusion Criteria

I have been diagnosed with thyroid eye disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part I

Participants receive satralizumab or placebo every 4 weeks

24 weeks

6 visits (in-person)

Treatment Part II

Proptosis response-based individualized treatment

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Satralizumab

Trial Overview The study tests satralizumab, an antibody targeting the IL-6 receptor, against a placebo in patients with TED to evaluate its effectiveness and safety.

Participant Groups

Group I: Satralizumab Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

In the part I period, participants will receive placebo q4w followed by proptosis response-based individualized treatment in part II of the study.

Satralizumab is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:

Approved in United States as Enspryng for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

Approved in European Union as Enspryng for:

• Neuromyelitis optica spectrum disorder (NMOSD)

Approved in Canada as Enspryng for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

Approved in Japan as Enspryng for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

Approved in Switzerland as Enspryng for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

Alemtuzumab-induced thyroid eye disease (AI-TED) can present with greater severity compared to conventional thyroid eye disease (TED), as indicated by an average clinical activity score of 3.3 among 16 patients studied, with some experiencing scores as high as 5.0 during active phases.

AI-TED may develop several months after the onset of Graves' disease, highlighting the need for healthcare providers to monitor patients for potential severe TED following treatment with alemtuzumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alemtuzumab-Induced Thyroid Eye Disease: A Comprehensive Case Series and Review of the Literature. Nirmalan, A., Blecher, N., Hyder, S., et al.[2023]

In a study of 18 patients with thyroid eye disease who did not respond to multiple steroid treatments, Tocilizumab significantly improved disease activity, as shown by a mean reduction of 5.89 points in the Clinical Activity Score (CAS).

Tocilizumab also led to a substantial decrease in thyroid-stimulating immunoglobulin (TSI) levels by 76.18% and improved symptoms such as proptosis and extraocular motility, with no severe side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of active corticosteroid-resistant graves' orbitopathy. Pérez-Moreiras, JV., Alvarez-López, A., Gómez, EC.[2022]

In a study of 162 multiple sclerosis patients treated with alemtuzumab, 44% developed thyroid dysfunction, primarily Graves' disease, with 16% referred for thyroid eye disease (TED) evaluation.

Some patients experienced severe TED requiring systemic immunosuppression, highlighting the need for regular monitoring and early referral to ophthalmology, especially for those with elevated TSH-receptor antibody levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune reconstitution after alemtuzumab therapy for multiple sclerosis triggering Graves' orbitopathy: a case series. Roos, JCP., Moran, C., Chatterjee, VK., et al.[2022]

In a study involving 51 patients with thyroid eye disease (TED), teprotumumab was found to be highly effective, with 89.2% of previously placebo-treated patients responding positively after receiving the treatment, showing a significant reduction in proptosis (eye bulging).

No new safety concerns were identified during the study, although mild hearing impairment was reported in some cases; this suggests that teprotumumab is a safe option for patients with TED, even those with longer disease durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teprotumumab Efficacy, Safety, and Durability in Longer-Duration Thyroid Eye Disease and Re-treatment: OPTIC-X Study. Douglas, RS., Kahaly, GJ., Ugradar, S., et al.[2022]

In a study of 22 patients receiving teprotumumab for thyroid eye disease, 38.6% of ears showed hearing loss that met criteria for ototoxicity, particularly affecting high and middle frequencies.

Older patients were more likely to experience hearing loss after treatment, highlighting the need for regular audiometric testing to monitor hearing function during teprotumumab therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and Patterns of Hearing Dysfunction in Patients Treated with Teprotumumab. Keen, JA., Correa, T., Pham, C., et al.[2023]

In a study of 27 patients treated with teprotumumab for thyroid eye disease, 81.5% developed new otologic symptoms, with tinnitus and ear fullness being the most common, but only 45.5% of those with hearing loss experienced symptom resolution after treatment.

Teprotumumab was associated with sensorineural hearing loss in 5 out of 6 patients tested, and a prior history of hearing loss was identified as a significant risk factor, highlighting the need for careful monitoring and screening for hearing issues in patients undergoing this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hearing Dysfunction After Treatment With Teprotumumab for Thyroid Eye Disease. Sears, CM., Azad, AD., Amarikwa, L., et al.[2023]

In a study of 131 patients with thyroid eye disease treated with teprotumumab, 77% experienced significant improvement in proptosis, indicating the drug's efficacy in reducing eye bulging associated with the condition.

While 81.7% of patients reported adverse events, most were mild and reversible; however, serious adverse events occurred in some cases, leading to treatment discontinuation in 12.2% of patients, highlighting the need for careful monitoring and patient education regarding potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teprotumumab-Related Adverse Events in Thyroid Eye Disease: A Multi-Center Study. Shah, SA., Amarikwa, L., Sears, CM., et al.[2023]

In a study of nine patients with chronic thyroid eye disease (TED) and low clinical activity scores, treatment with teprotumumab resulted in a significant average reduction of 4.0 mm in proptosis (eye bulging) immediately after treatment, indicating its efficacy.

Despite some reported side effects, such as myalgias and hair thinning, teprotumumab appears to be a promising treatment option for patients with chronic TED, as evidenced by sustained proptosis reduction observed in follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teprotumumab for chronic thyroid eye disease. Ozzello, DJ., Dallalzadeh, LO., Liu, CY.[2022]

Teprotumumab significantly reduces proptosis (eye bulging) and inflammation in patients with chronic Thyroid Eye Disease (TED), with an average reduction of 3.5 mm in proptosis after treatment.

In a study of 31 patients who received an average of 7 infusions, 67% of those with diplopia (double vision) experienced a significant improvement, and there was a notable reduction in both muscle and fat tissue volume in the orbits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teprotumumab for the treatment of chronic thyroid eye disease. Ugradar, S., Kang, J., Kossler, AL., et al.[2022]

Teprotumumab, an IGF-1R inhibitor approved for thyroid eye disease (TED), has shown effectiveness in improving symptoms like proptosis and diplopia even in patients with long-standing disease or those who have not responded to previous treatments.

Recent reports suggest that teprotumumab can benefit patients regardless of disease duration or inflammation markers, indicating its potential as a versatile treatment option for TED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of teprotumumab therapy in patients with long-duration thyroid eye disease. Subramanian, PS., Cho, RI., Kahana, A.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Alemtuzumab-Induced Thyroid Eye Disease: A Comprehensive Case Series and Review of the Literature. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of active corticosteroid-resistant graves' orbitopathy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Immune reconstitution after alemtuzumab therapy for multiple sclerosis triggering Graves' orbitopathy: a case series. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Teprotumumab Efficacy, Safety, and Durability in Longer-Duration Thyroid Eye Disease and Re-treatment: OPTIC-X Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Frequency and Patterns of Hearing Dysfunction in Patients Treated with Teprotumumab. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Hearing Dysfunction After Treatment With Teprotumumab for Thyroid Eye Disease. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Teprotumumab-Related Adverse Events in Thyroid Eye Disease: A Multi-Center Study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Teprotumumab for chronic thyroid eye disease. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Teprotumumab for the treatment of chronic thyroid eye disease. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy of teprotumumab therapy in patients with long-duration thyroid eye disease. [2023]