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

NCT02973802 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-06-14

Study results available
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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

  • Graves Disease

Interventions

BIOLOGICAL

ATX-GD-59

Disease specific immune modulating treatment for Graves Disease

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • European Commission

    collaborator OTHER

  • Apitope International NV

    lead INDUSTRY

Principal Investigators

  • Simon HS Pearce · Royal Victoria Infirmary

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-02-14
Completion
2018-02-14

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02973802 on ClinicalTrials.gov