A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease (NCT05907668) | Clinical Trial Compass
CompletedPhase 2
A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
Germany32 participantsStarted 2023-05-15
Plain-language summary
The purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to GD who have failed to achieve euthyroidism on antithyroid drugs (ATDs).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Who Achieved Normalization of Free Triiodothyronine (FT3) and Free Thyroxine (FT4), or Have FT3 and/or FT4 Below the Lower Limit of Normal (LLN) at Week 24 Without Increase in ATD Dose Compared to Baseline