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New drug batoclimab shows promise for Hard-to-Treat Graves' disease

NCT ID NCT05907668

Disease control Sponsor: Immunovant Sciences GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tested a drug called batoclimab in 35 adults with Graves' disease whose thyroid hormone levels were still high despite taking standard antithyroid drugs. The goal was to see if batoclimab could help bring those levels back to normal or below over 24 weeks. Batoclimab works by blocking a protein that affects the immune system's attack on the thyroid.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
batoclimab
What this could lead to
If successful, batoclimab could offer a new treatment option for people with Graves' disease whose thyroid levels remain high despite standard therapy.
What could go wrong
This is a small, early-phase proof-of-concept study with only 35 participants. It may not show clear benefit, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

32 people

The number who actually took part.

Started

May 2023

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have serologically confirmed GD as documented by presence of elevated stimulatory thyrotropin receptor antibody (TSH-R-Ab) level (i.e., \> specimen-to-reference ratio of 140%) at the Screening Visit. * Have active hyperthyroidism due to GD with the following laboratory values at the Screening Visit: * TSH \< LLN * FT3 \> upper limit of normal (ULN) and \<=5 \* ULN * FT4 \> ULN and \<=5 \* ULN Note: Participants who have T3 thyrotoxicosis (i.e TSH \<LLN, FT3 \> ULN and ≤5× ULN, but FT4 within normal range) at the Screening Visit may be enrolled, if they have serologically confirmed GD as per Inclusion Criterion 1. * Are willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule. Exclusion Criteria: * History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or history or presence of thyroid storm. * History of treatment with radioactive iodine or thyroid surgery. * Total immunoglobulin G (IgG) level \<6 grams per liter (g/L) at the Screening Visit. * Albumin level \<3.5 grams per deciliter (g/dL) (\<35 g/L) at the Screening Visit. * Absolute neutrophil count \<1000 cells per cubic millimeter (cells/mm\^3) at the Screening Visit. Other, more specific exclusion criteria are defined in the protocol.

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Conditions

The condition(s) this trial relates to.

Graves disease hyperthyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graves disease

Contacts and locations

Locations

  • Site Number - 6505

    Mainz, 55131, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.