An Open-Label Trial of Veligrotug in Participants With Thyroid Eye Disease Who Previously Responded to Teprotumumab

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorViridian Therapeutics, Inc.

About this trial

This is a clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab treatment but subsequently had a disease recurrence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must have a diagnosis of TED with associated signs and symptoms.

Must have completed an initial full course of treatment (8 infusions over approximately 21 weeks) with teprotumumab ≥9 months prior to screening.

Must have a documented clinical response to teprotumumab.

Must have evidence of recurrence following the completion of prior teprotumumab treatment course, as measured by exophthalmometer in the study eye.

Disqualifiers

Must not have sight-threatening TED (eg, dysthyroid optic neuropathy).

Must not have received IGF-1R inhibitor therapy within 9 months prior to screening or received any IGF-1R inhibitor other than teprotumumab at any time.

Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to the first dose.

Must not have received other immunosuppressive drugs for any condition, including TED, within 12 weeks prior to the first dose or any other therapy for TED (except for artificial tears) within 8 weeks prior to the first dose.

Trial design

Design model

Single group

Treatments tested in this trial

  • veligrotrug (LUMVOA™)

    Drug

    intravenous infusions

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: 5 IV infusions of 10 mg/kg of veligrotugExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability of veligrotrug (LUMVOA™)

Treatment Emergent Adverse Event (TEAE) incidence rate

Time frame
Through Week 15

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: