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Monoclonal Antibodies

Batoclimab for Graves' Eye Disease

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
Are ≥18 years of age at screening.
Have a clinical diagnosis of TED associated with active, moderate to severe TED with a CAS ≥4 in either eye at screening and Baseline.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 24
Awards & highlights

Study Summary

This trial tested a drug (680 mg, then 340 mg) on proptosis (bulging eyes) over 24 weeks to see if it works.

Who is the study for?
This trial is for adults over 18 with active, moderate to severe Thyroid Eye Disease (TED) diagnosed within the last year. Participants should not be planning surgery or other treatments for TED during the study and must have their thyroid disease under control. They cannot join if they've had recent steroid treatment, eye surgery, or irradiation, or if they have other autoimmune diseases that could affect the study.Check my eligibility
What is being tested?
The trial tests Batoclimab's effectiveness against a placebo in reducing eye bulging in TED patients. For 24 weeks, participants will receive either Batoclimab injections weekly—higher dose first then lower—or a dummy injection without any medication (placebo).See study design
What are the potential side effects?
While specific side effects of Batoclimab are not listed here, similar medications can cause reactions at the injection site, headaches, muscle pains and potentially impact immune function leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with severe thyroid eye disease.
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I have moderate to severe active thyroid eye disease.
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My tests show I have detectable thyroid-stimulating hormone receptor antibodies.

Timeline

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
Percentage of proptosis responders
Secondary outcome measures
Mean change from Baseline in CAS in the study eye
Mean change from Baseline in proptosis in the study eye
Percentage of participants with CAS of 0 or 1 in the study eye
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BatoclimabExperimental Treatment1 Intervention
Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be administered matching placebo SC weekly for 24 weeks.

Find a Location

Who is running the clinical trial?

Immunovant Sciences GmbHLead Sponsor
9 Previous Clinical Trials
936 Total Patients Enrolled

Media Library

Batoclimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05517421 — Phase 3
Graves' Ophthalmopathy Research Study Groups: Batoclimab, Placebo
Graves' Ophthalmopathy Clinical Trial 2023: Batoclimab Highlights & Side Effects. Trial Name: NCT05517421 — Phase 3
Batoclimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05517421 — Phase 3

Frequently Asked Questions

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

Has Batoclimab received clearance from the FDA?

"There is clinical evidence to support the safety of Batoclimab, which has been given a score of 3 on our risk assessment scale. This rating reflects the fact that it is currently undergoing Phase 3 trials with promising results regarding both efficacy and safety."

Answered by AI

Is enrollment currently open for this exploration?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical investigation is currently seeking participants; it was published online in December 1st 2022 and recently updated on the 19th of the same month. Approximately 100 people need to be recruited from two distinct facilities."

Answered by AI

What is the current population size within this clinical investigation?

"Affirmative. The information hosted on clinicaltrials.gov demonstrates that this medical investigation is actively searching for participants, which was first posted on December 1st 2022 and last edited on the 19th of December 2022. Approximately 100 patients will be enrolled from 2 separate facilities."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Site Number -1502
Site Number -1505
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
2022. "Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05517421.
~25 spots leftby Dec 2024
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