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Completed

NCT Number: NCT05683496

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

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

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Key information

Conditions

Thyroid Eye Disease Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Research Site, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lonigutamab

Drug

subcutaneous injection

Placebo

Drug

subcutaneous injection

Primary outcomes

  1. Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)

    Time frame: Day 1 to Day 169

    Safety and Tolerability

  2. Incidence and characterization of serious treatment emergent adverse events (TEAEs)

    Time frame: Day 1 to Day 169

    Safety and Tolerability

Secondary outcomes

  1. PK profile of lonigutamab

    Time frame: Day 1 to Day 169

    minimum observed concentration (Cmin)

  2. PK profile of lonigutamab

    Time frame: Day 1 to Day 169

    Maximum observed concentration (Cmax)

Sponsors and collaborators

Lead sponsor

ACELYRIN Inc.

Industry

Registry information

Official study title

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)

Acronym: TED

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2023
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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