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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-14

Study Completion Date

2025-05-26

Brief Summary

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

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Detailed Description

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Conditions

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Thyroid Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-masked, placebo-controlled and open label

Study Groups

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Cohort 1

Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21

Group Type EXPERIMENTAL

lonigutamab

Intervention Type DRUG

subcutaneous injection

Placebo

Intervention Type DRUG

subcutaneous injection

Cohort 2

multiple doses of dose 2 of lonigutamab administered SC injection weekly

Group Type EXPERIMENTAL

lonigutamab

Intervention Type DRUG

subcutaneous injection

Cohort 3

multiple doses of lonigutamab dose 3 administered SC injection every 4 weeks.

Group Type EXPERIMENTAL

lonigutamab

Intervention Type DRUG

subcutaneous injection

Cohort 4

multiple doses of lonigutamab dose 4 administered SC injection every 4 or 3 weeks.

Group Type EXPERIMENTAL

lonigutamab

Intervention Type DRUG

subcutaneous injection

Interventions

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lonigutamab

subcutaneous injection

Intervention Type DRUG

Placebo

subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No