Clinical Trial: ATX-GD-59 in Patients With Graves Disease Not Treated With Anti-thyroid Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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, Wit

Brief 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.

Detailed Summary:
Sponsor: Apitope International NV

Current Primary Outcome: Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 30 compared to baseline. [ Time Frame: 30 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in TSHR antibodies from baseline to week 30. [ Time Frame: 30 weeks ]
  • Change in serum free triiodothyronine (T3) from baseline to week 30. [ Time Frame: 30 weeks ]
  • Change in serum free thyroxine (T4) from baseline to week 30. [ Time Frame: 30 weeks ]
  • Change in serum thyroid stimulating hormone (TSH) from baseline to week 30. [ Time Frame: 30 weeks ]
  • Change from baseline in peripheral blood mononuclear cell (PBMC) T cell activity [ Time Frame: weeks 0, 18 and 22 ]
  • Change from baseline in IL-10 mRNA expression in PBMCs [ Time Frame: weeks 0, 18 and 22 ]
  • Change from baseline in biomarker signature of PBMC cells [ Time Frame: weeks 0, 18 and 22 ]


Original Secondary Outcome: Same as current

Information By: Apitope International NV

Dates:
Date Received: November 14, 2016
Date Started: September 2016
Date Completion: October 2017
Last Updated: April 3, 2017
Last Verified: April 2017