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

ACELYRIN

Status and phase: Completed; Phase 2; Phase 1

Conditions: Thyroid Eye Disease

Treatments: Drug: lonigutamab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05683496

421-01-02

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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31 participants in 4 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: lonigutamab

Cohort 2

Experimental group

Description:

multiple doses of dose 2 of lonigutamab administered SC injection weekly

Treatment:

Drug: lonigutamab

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: lonigutamab

Cohort 4

Experimental group

Description:

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

Treatment:

Drug: lonigutamab