NCT02973802

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

Completed Phase 1 Results posted Last updated 14 March 2019

What this trial tests

Phase 1 trial testing ATX-GD-59 in Graves Disease in 12 participants. Completed in 14 February 2018.

Timeline

1 September 2016

Primary endpoint
14 February 2018

14 February 2018

Quick facts

Lead sponsor	Apitope International NV
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 September 2016
Primary completion	14 February 2018
Estimated completion	14 February 2018
Sites	8 locations across United Kingdom

Drugs / interventions tested

• ATX-GD-59 — full drug profile →

Conditions studied

• Graves Disease — all drugs for Graves Disease →

Sponsor

Apitope International NV — full company profile →

Who can join

Adults 18 to 65, any sex, with Graves Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Occurrence of Treatment Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), and Laboratory Abnormalities up to Week 22 Compared to Baseline.
  Time frame: 22 weeks
  An adverse event (AE) was defined as any untoward medical occurrence in a subject administered study drug that did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavourable and unintended sign, symptom, disease or outcome of death temporally associated with the use of study drug, whether or not considered causally related to the study drug. Treatment em

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antigen-Specific Immunotherapy with Thyrotropin Receptor Peptides in Graves' Hyperthyroidism: A Phase I Study.
   Pearce SHS, Dayan C, Wraith DC, Barrell K, et al · · 2019 · cited 74× · PMID 31194638 · DOI 10.1089/thy.2019.0036
2. Characterizing the Interplay of Lymphocytes in Graves' Disease.
   Hansen M, Cheever A, Weber KS, O'Neill KL. · · 2023 · cited 13× · PMID 37047805 · DOI 10.3390/ijms24076835
3. 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