Trial reportThe Journal of clinical endocrinology and metabolism2023
Proof-of-concept and Randomized, Placebo-controlled Trials of an FcRn Inhibitor, Batoclimab, for Thyroid Eye Disease.
Trial report in The Journal of clinical endocrinology and metabolism, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Efficacy and safety of immunosuppressants and monoclonal antibodies in adults with myasthenia gravis: a systematic review and network meta-analysis.Journal of translational medicine · 2024Pooled it
- Efficacy and safety of the innovative monoclonal antibodies in adults with generalized myasthenia gravis: a Bayesian network analysis.Frontiers in immunology · 2023Pooled it
- Secukinumab in Moderate-to-Severe Graves Orbitopathy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study.The Journal of clinical endocrinology and metabolism · 2026Trial
- Impact of Batoclimab Treatment on LDL-C with and Without Coadministration of Atorvastatin: Results from a Phase I Randomized Study in Healthy Participants.Drug safety · 2025Trial
- Pharmacokinetics, Pharmacodynamics, and Safety of Intravenous Efgartigimod and Subcutaneous Efgartigimod PH20 in Healthy Chinese Participants.Drugs in R&D · 2024Trial
- Proof-of-concept and Randomized, Placebo-controlled Trials of an FcRn Inhibitor, Batoclimab, for Thyroid Eye Disease.The Journal of clinical endocrinology and metabolism · 2023Trial
- Non-surgical management of thyroid eye disease: a pilot survey of oculoplastic surgeons.International ophthalmology · 2026Article
- FcRn Inhibition in Autoantibody-Mediated Autoimmune Diseases: From Broad Immunosuppression to Precision IgG Modulation.Mediterranean journal of rheumatology · 2026Review
- Targeting FcRn for immunomodulation: a promising therapy in autoimmune inflammatory rheumatic diseases.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2026Review
- Approach to the patient: therapeutic mitigation of lacrimal manifestations in thyroid eye disease.The Journal of clinical endocrinology and metabolism · 2026Review
- What has changed in thyroid eye disease in the last five years (2020-2025).European thyroid journal · 2026Review
- How to manage thyroid eye disease: recent advances - a narrative review.Drugs in context · 2026Review
- Cytokines and drugs targeting cytokines in Graves' disease and thyroid eye disease.Frontiers in immunology · 2026Review
- How to manage autoimmune hyperthyroidism (Graves' disease): from differential diagnosis to emerging immunological therapies.Drugs in context · 2026Review
- Sirolimus for the treatment of Graves' orbitopathy.Thyroid research · 2025Review
- PDGFRαAdvanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties.mAbs · 2025Article
- Unravelling the pathogenic mechanisms in Graves' orbitopathy.European thyroid journal · 2025Review
- Redefining Treatment Paradigms in Thyroid Eye Disease: Current and Future Therapeutic Strategies.Journal of clinical medicine · 2025Review
- Can chimeric antigen receptors - based therapy bring a gleam of hope for thyroid-associated ophthalmopathy and other autoimmune diseases?Medical review (2021) · 2025Article
Corrections and comments
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Authors and funding
28 authors at 16 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextInhibition of the neonatal fragment crystallizable receptor (FcRn) reduces pathogenic thyrotropin receptor antibodies (TSH-R-Ab) that drive pathology in thyroid eye disease (TED).
objectiveWe report the first clinical studies of an FcRn inhibitor, batoclimab, in TED.
designProof-of-concept (POC) and randomized, double-blind placebo-controlled trials.
settingMulticenter.
participantsPatients with moderate-to-severe, active TED.
interventionIn the POC trial, patients received weekly subcutaneous injections of batoclimab 680 mg for 2 weeks, followed by 340 mg for 4 weeks. In the double-blind trial, patients were randomized 2:2:1:2 to weekly batoclimab (680 mg, 340 mg, 255 mg) or placebo for 12 weeks. MAIN OUTCOME: Change from baseline in serum anti-TSH-R-Ab and total IgG (POC); 12-week proptosis response (randomized trial).
resultsThe randomized trial was terminated because of an unanticipated increase in serum cholesterol; therefore, data from 65 of the planned 77 patients were analyzed. Both trials showed marked decreases in pathogenic anti-TSH-R-Ab and total IgG serum levels (P < .001) with batoclimab. In the randomized trial, there was no statistically significant difference with batoclimab vs placebo in proptosis response at 12 weeks, although significant differences were observed at several earlier timepoints. In addition, orbital muscle volume decreased (P < .03) at 12 weeks, whereas quality of life (appearance subscale) improved (P < .03) at 19 weeks in the 680-mg group. Batoclimab was generally well tolerated, with albumin reductions and increases in lipids that reversed upon discontinuation.
conclusionsThese results provide insight into the efficacy and safety of batoclimab and support its further investigation as a potential therapy for TED.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.