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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
Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines
Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0: A CAS ≥ 4 in either eye, and clinical evidence of worsened proptosis with: Proptosis ≥ 18 mm and/or Proptosis ≥ 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 24
Awards & highlights

Study Summary

This trial tests the effectiveness of a drug (batoclimab) for a medical condition (proptosis) over the course of 24 weeks.

Who is the study for?
This trial is for adults over 18 with active Thyroid Eye Disease (TED) diagnosed within the last year. Participants should have moderate to severe TED, not require immediate surgery, and have their thyroid disease under control or only mildly off-balance. They can't join if they've had recent steroid treatments, other autoimmune diseases that could affect the study, or past eye surgeries/irradiation for TED.Check my eligibility
What is being tested?
The study tests Batoclimab's effectiveness on eye bulging in TED patients. It compares a high dose followed by a lower dose of Batoclimab against a placebo over 24 weeks to see if there's an improvement in proptosis (eye protrusion).See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience reactions at the injection site, immune system responses due to antibody presence in Batoclimab, and potential general medication-related side effects like headaches or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate to severe active thyroid eye disease.
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I have severe eye bulging due to thyroid eye disease.
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My tests show I have anti-TSHR antibodies.
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I am 18 years old or older.

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
Malignant Neoplasms
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: NCT05524571 — Phase 3
Graves' Ophthalmopathy Research Study Groups: Batoclimab, Placebo
Graves' Ophthalmopathy Clinical Trial 2023: Batoclimab Highlights & Side Effects. Trial Name: NCT05524571 — Phase 3
Batoclimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05524571 — Phase 3

Frequently Asked Questions

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

Has the U.S. Food and Drug Administration granted Batoclimab their seal of approval?

"Based on existing clinical data, our team at Power assigns a safety rating of 3 to Batoclimab. This is because it has already completed several phases and numerous tests have been conducted demonstrating its efficacy."

Answered by AI

Are there any open spots for participants in this trial at present?

"That is correct. Clinicaltrials.gov reveals that this clinical trial, originally posted on May 1st 2023, is still recruiting participants. 100 individuals will be needed to enrol between the 2 designated sites."

Answered by AI

What is the cap on total enrollees for this clinical experiment?

"Affirmative. The records on clinicaltrials.gov demonstrate that the research is still recruiting patients, with initial posting occurring on May 1st 2023 and latest modification taking place February 28th 2023. This project requires 100 participants to be enrolled at two medical centres."

Answered by AI

Who else is applying?

What site did they apply to?
Site Number -1519
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I've had my thyroid removed 2017.. I had eye decompression surgery for graves that same year.. it has returned.. looking for a solution or some help with TED (Graves). Not sure what helps anymore.. I have a dr. in SanAntonio.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
2023. "Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05524571.
~32 spots leftby Dec 2024
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