Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Overview

About this study

The purpose of this study is 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion criteria:

1. Are ≥18 years of age at screening.

2. 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

3. Have moderate to severe active TED, as defined by European Group on Graves'
Orbitopathy (EUGOGO) guidelines.

4. Have onset of active TED within 12 months prior to screening.

5. Have documented evidence of detectable anti-TSHR-Ab at screening.

6. Are not expected to require immediate surgical intervention and are not planning
corrective surgery/irradiation or medical therapy for TED during the course of the
study.

7. Are euthyroid with the Baseline disease under control or have mild hypo- or
hyperthyroidism.

Additional inclusion criteria are defined in the protocol.

Exclusion criteria:

1. Have decreased best corrected visual acuity due to optic neuropathy.

2. Have at least a 2-point decrease in CAS or ≥2 mm decrease in proptosis between
screening and Baseline assessments in either eye.

3. Have used any steroid (intravenous or oral) for the treatment of TED or other
conditions within 4 weeks prior to screening.

4. Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1 g
of methylprednisolone for the treatment of TED.

5. Have known autoimmune disease other than TED, that, in the opinion of the
Investigator, would interfere with the course and conduct of the study.

6. Had previous orbital irradiation or surgery for TED.

Additional exclusion criteria are defined in the protocol.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/8/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Marius Stan, M.D.

Open for enrollment

Contact information:

Elainey Hardtke

(507) 538-4122

Hardtke.Elainey@mayo.edu

More information

Publications

Publications are currently not available