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Monoclonal Antibodies

Observational cohort for Graves' Ophthalmopathy

Phase 3

Recruiting

Research Sponsored by Immunovant Sciences GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 24

Awards & highlights

Study Summary

This trial is an extension study for participants who have completed earlier studies. There are two groups in the study: an observational group and a treatment group. The observational group will look at how long the improvement

Who is the study for?

This trial is for individuals who have completed a previous study on thyroid eye disease (TED) at week 24, don't need urgent surgery, and haven't stopped using batoclimab permanently. They should not be planning any corrective procedures or other medical treatments for TED during the study.Check my eligibility

What is being tested?

The trial has two parts: one where participants are observed to see how long their improvement in eye bulging lasts without treatment, and another where the effectiveness of batoclimab is tested by checking if it reduces eye bulging.See study design

What are the potential side effects?

While specific side effects of batoclimab aren't listed here, similar medications can cause reactions at the injection site, muscle pain, headaches, general discomfort or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I don't need surgery or specific treatments for thyroid eye disease during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies

Secondary outcome measures

Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies

Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment CohortExperimental Treatment1 Intervention

Proptosis non-responders in feeder studies will be administered batoclimab of 680 milligram (mg) subcutaneous (SC) for 12 weeks followed by 340 mg SC for 12 weeks

Group II: Observational cohortExperimental Treatment1 Intervention

Proptosis responders in feeder studies will enter in a non-treatment observational study

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Immunovant Sciences GmbHLead Sponsor

9 Previous Clinical Trials

856 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many distinct sites can this study be accessed?

"This clinical trial is conducted at 5 active sites, including Site Number - 7550 located in Budapest, Site Number - 1520 situated in Glendora, and Site Number - 1513 based in Rochester. Additionally, there are other locations available for patient participation."

Answered by AI

Has the FDA granted approval for observational cohort studies?

"Based on our team's assessment at Power, the safety rating for the Observational cohort is considered a 3. This classification aligns with Phase 3 trials, which indicate the presence of efficacy data and multiple rounds of safety data to support it."

Answered by AI

How large is the patient population participating in this medical study?

"Indeed, as indicated by the information available on clinicaltrials.gov, this trial is actively seeking eligible participants. The initial posting of the trial occurred on November 6th, 2023 and it was last updated on January 5th, 2024. To complete enrollment for this study, a total of 180 patients will be recruited from five different locations."

Answered by AI

Are potential participants still able to apply for enrollment in this ongoing research study?

"Indeed, the information available on clinicaltrials.gov confirms that this particular study is actively seeking participants. The study was initially posted on November 6th, 2023 and underwent its most recent update on January 5th, 2024. There are five different locations where a total of 180 patients will be enrolled in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

2023. "Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05517447.