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)
Status: Completed
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Phase 1/2, multicenter, multiple dose clinical study designed to evaluate lonigutamab in subjects with TED.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Clinical Research Site
Jacksonville
Georgia
Clinical Research Site
Atlanta
Michigan
Clinical Research Site
Ann Arbor
New York
Clinical Research Site
East Setauket
Clinical Research Site
New York
West Virginia
Clinical Research Site
Morgantown
Other Locations
Australia
Clinical Research Site
Adelaide
Clinical Research Site
East Melbourne
Clinical Research Site
Nedlands
Clinical Research Site
Sydney
Clinical Research Site
Woolloongabba
Time Frame
Start Date: 2023-02-14
Completion Date: 2025-05-26
Participants
Target number of participants: 31
Treatments
Experimental: Cohort 1
Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21
Experimental: Cohort 2
multiple doses of dose 2 of lonigutamab administered SC injection weekly
Experimental: Cohort 3
multiple doses of lonigutamab dose 3 administered SC injection every 4 weeks.
Experimental: Cohort 4
multiple doses of lonigutamab dose 4 administered SC injection every 4 or 3 weeks.
Related Therapeutic Areas
Sponsors
Leads: ACELYRIN Inc.