Efficacy and Safety of Lonigutamab in Subjects With Thyroid Eye Disease (TED)

A Phase 1/2, Adaptive, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of Lonigutamab in Subjects With Thyroid Eye Disease (TED)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05683496

Acronym

TED

Enrollment

Registered

2023-01-13

Start date

2023-02-14

Completion date

2025-05-26

Last updated

2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Eye Disease

Keywords

TED

Brief summary

Phase 1/2, multicenter, multiple dose clinical study designed to evaluate lonigutamab in subjects with TED.

Interventions

DRUGlonigutamab

subcutaneous injection

DRUGPlacebo

subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-masked, placebo-controlled and open label

Intervention model description

Up to 4 cohorts are planned, with each cohort receiving one of 5 different treatment doses

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Male or female, ≥18 and ≤75 years of age. * Proptosis defined in the study eye as ≥3 mm above normal. * Clinical Activity Score (CAS) ≥4 (using a 7-item scale) for the most severely affected eye * Onset of active TED symptoms prior to baseline * Must agree to use highly effective contraception as specified in the protocol Key

Exclusion criteria

* Pathology related to inflammatory bowel disease or irritable bowel syndrome. * Clinically significant pathology related to hearing or history of hearing impairment * Optic neuropathy * Corneal decompensation unresponsive to medical management. * Previous orbital irradiation (for any cause) or any previous surgical treatment for TED. * Subjects with diabetes or hemoglobin A1c >6.0% at screening * Any steroid use (intravenous \[IV\] or oral) with a cumulative dose equivalent to >3 g of methylprednisolone for the treatment of TED within the last year. * Previous steroid use (IV or oral) specifically for the treatment of TED not to exceed 1 g total dose in the 8 weeks prior to Screening. * Previous use of teprotumumab or any other IGF-1 receptor (IGF-1R) inhibitor. * Any previous treatment with a biologic drug for the treatment of TED (eg, rituximab and tocilizumab) * Any other immunosuppressive agent within 1 month of screening. * Cohort 4 only: Prior history of craniofacial surgery or medical conditions that could alter orbital or facial features.

Design outcomes

Primary

Measure	Time frame	Description
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)	Day 1 to Day 169	Safety and Tolerability
Incidence and characterization of serious treatment emergent adverse events (TEAEs)	Day 1 to Day 169	Safety and Tolerability

Secondary

Measure	Time frame	Description
PK profile of lonigutamab	Day 1 to Day 169	minimum observed concentration (Cmin)

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026