Last reviewed · How we verify
NCT05524571
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
Phase 3 trial testing Batoclimab in Thyroid Eye Disease in 86 participants. Completed in 3 March 2026.
3 February 2026
Quick facts
| Lead sponsor | Immunovant Sciences GmbH |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 86 |
| Start date | 5 January 2023 |
| Primary completion | 3 February 2026 |
| Estimated completion | 3 March 2026 |
| Sites | 45 locations across New Zealand, Slovakia, Belgium, Germany, Hungary, Puerto Rico, Australia, United States |
Drugs / interventions tested
- Batoclimab — full drug profile →
- Placebo
Conditions studied
- Thyroid Eye Disease — all drugs for Thyroid Eye Disease →
Sponsor
Immunovant Sciences GmbH — full company profile →
Who can join
18 and older, any sex, with Thyroid Eye Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Antibodies to watch in 2025.
Crescioli S, Kaplon H, Wang L, Visweswaraiah J, et al · · 2025 · cited 87× · PMID 39711140 · DOI 10.1080/19420862.2024.2443538 -
Proof-of-concept and Randomized, Placebo-controlled Trials of an FcRn Inhibitor, Batoclimab, for Thyroid Eye Disease.
Kahaly GJ, Dolman PJ, Wolf J, Giers BC, et al · · 2023 · cited 42× · PMID 37390454 · DOI 10.1210/clinem/dgad381 -
The changing landscape of thyroid eye disease: current clinical advances and future outlook.
Moledina M, Damato EM, Lee V. · · 2024 · cited 37× · PMID 38374366 · DOI 10.1038/s41433-024-02967-9 -
Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress.
Gjølberg TT, Mester S, Calamera G, Telstad JS, et al · · 2025 · cited 10× · PMID 40156757 · DOI 10.1007/s40259-025-00708-2 -
Targeted immunotherapies for Graves' thyroidal & orbital diseases.
Lee ACH, Kahaly GJ. · · 2025 · cited 8× · PMID 40145088 · DOI 10.3389/fimmu.2025.1571427 -
The evolving therapeutic landscape of Graves' disease in adults: present and future.
Stan MN, Dosiou C. · · 2025 · cited 1× · PMID 40622195 · DOI 10.1530/etj-25-0078 -
Can chimeric antigen receptors - based therapy bring a gleam of hope for thyroid-associated ophthalmopathy and other autoimmune diseases?
Zhou W, Zhu X, Shi Y. · · 2025 · PMID 40838106 · DOI 10.1515/mr-2024-0099
Verify or expand the search:
- PubMed search for NCT05524571
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Batoclimab
Trials testing the same drug.
- NCT05517421 — Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease · Phase 3 · completed
Other recruiting trials for Thyroid Eye Disease
Currently open trials in the same condition.
- NCT07423013 — Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease. · NA · recruiting
- NCT07113262 — A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease · Phase 3 · recruiting
- NCT06557850 — A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease · Phase 1 · active not recruiting
- NCT06625411 — An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED) · Phase 3 · active not recruiting
- NCT06625398 — An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED) · Phase 3 · active not recruiting
Other Immunovant Sciences GmbH trials
Trials by the same sponsor.
- NCT05907668 — A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease · Phase 2 · completed
- NCT05517421 — Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease · Phase 3 · completed
- NCT04253236 — To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA). · Phase 2 · terminated
- NCT03938545 — ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy · Phase 2 · terminated
- NCT03863080 — A Study of RVT-1401 in Myasthenia Gravis (MG) Patients · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05524571 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Immunovant Sciences GmbH
- Last refreshed: 1 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05524571.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing