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

Phase 1

Recruiting

• Conditions: Thyroid Eye Disease
• Interventions: Drug: lonigutamab; Drug: Placebo

• Registration Number: NCT05683496
• Lead Sponsor: ACELYRIN Inc.

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2023-01-12
• Study First Posted: 2023-01-13
• Study Start: 2023-02-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	lonigutamab	Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21
Cohort 1	Placebo	Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21
Cohort 2	lonigutamab	multiple doses of dose 2 of lonigutamab administered SC injection weekly
Cohort 3	lonigutamab	multiple doses of lonigutamab dose 3 administered SC injection every 4 weeks.
Cohort 4	lonigutamab	multiple doses of lonigutamab dose 4 administered SC injection every 4 or 3 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PK profile of lonigutamab	Day 1 to Day 169	Maximum observed concentration (Cmax)

Trial Locations

Locations (1)

Clinical Research Site; 🇦🇺 Nedlands, Western Australia, Australia