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

Thyroid Eye Disease Clinical Trial

— TED  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05683496
• Other study ID #: 421-01-02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 14, 2023
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: ACELYRIN Inc.
• Contact: Helliner Santulli, MD, PhD
• Phone: 805-456-4393
• Email: clinicaltrials[@]acelyrin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

Drug:
• lonigutamab
subcutaneous injection
• Placebo
subcutaneous injection

Locations

Country	Name	City	State
Australia	Clinical Research Site	Adelaide	South Australia
Australia	Clinical Research Site	East Melbourne	Victoria
Australia	Clinical Research Site	Nedlands	Western Australia
Australia	Clinical Research Site	Sydney	New South Wales
Australia	Clinical Research Site	Woolloongabba	Queensland
United States	Clinical Research Site	Ann Arbor	Michigan
United States	Clinical Research Site	Atlanta	Georgia
United States	Clinical Research Site	East Setauket	New York
United States	Clinical Research Site	Jacksonville	Florida
United States	Clinical Research Site	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
ACELYRIN Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)	Safety and Tolerability	Day 1 to Day 169
Primary	Incidence and characterization of serious treatment emergent adverse events (TEAEs)	Safety and Tolerability	Day 1 to Day 169
Secondary	PK profile of lonigutamab	minimum observed concentration (Cmin)	Day 1 to Day 169
Secondary	PK profile of lonigutamab	Maximum observed concentration (Cmax)	Day 1 to Day 169