At a glance
ClinicalIndex Comparison Record- ✓Confirmed Graves' disease diagnosis not currently on anti-thyroid therapy
- ✓Quantifiable TSHR antibody levels
- ✓Elevated free T3 and/or free T4 (free T3 not exceeding 15 pmol/L, free T4 not exceeding 35 pmol/L) with undetectable TSH
- ✓HLA-DRB1*15, HLA-DRB1*03, and/or HLA-DRB1*04 positive
- ✕Treatment with anti-thyroid drugs (e.g., carbimazole) within 3 months prior to Study Day 1
- ✕Prior radioiodine therapy or thyroidectomy (partial or complete)
- ✕Moderate or severe orbitopathy including optic nerve compression requiring steroids and/or clinical activity score >3
- ✕Large compressive goiter causing difficulty swallowing or breathing
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Proof of Principle Study of ATX-GD-59 in Male and Female Subjects With Graves' Disease Not Currently Treated With Anti-thyroid Therapy: An Open Label Study, With an Upward Titration Over Five Dose Levels Administered by Intradermal Injection
In Brief
A Phase 1 clinical trial evaluating ATX-GD-59 for Graves Disease. Completed, enrolled 12 participants across 8 sites.
Detailed Summary
Phase 1 study to assess the safety and biological activity of ATX-GD-59 in patients with Graves Disease not currently treated with anti-thyroid therapy. This will be an open label dose titration involving injections on 10 occasions, each two weeks apart. After dosing is complete there will be a 12 week follow up period. Blood samples will be drawn throughout the study to monitor safety and the body's response to the injections. Thyroid function will be measured throughout the trial to monitor Graves disease progression.
Study Details
Timeline
Interventions
Disease specific immune modulating treatment for Graves Disease