Trials / Completed
CompletedNCT02973802
ATX-GD-59 in Patients With Graves Disease Not Treated With Anti-thyroid Therapy
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Apitope International NV · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ATX-GD-59 | Disease specific immune modulating treatment for Graves Disease |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-02-14
- Completion
- 2018-02-14
- First posted
- 2016-11-25
- Last updated
- 2019-06-14
- Results posted
- 2019-06-14
Locations
8 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02973802. Inclusion in this directory is not an endorsement.