NCT05683496CompletedPhase 1
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- ACELYRIN Inc.
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
Study Overview
Brief Summary
Phase 1/2, multicenter, multiple dose clinical study designed to evaluate lonigutamab in subjects with TED.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-masked, placebo-controlled and open label
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Cohort 1
Experimental
Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21
Intervention: lonigutamab (Drug)
Cohort 1
Experimental
Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21
Intervention: Placebo (Drug)
Cohort 2
Experimental
multiple doses of dose 2 of lonigutamab administered SC injection weekly
Intervention: lonigutamab (Drug)
Cohort 3
Experimental
multiple doses of lonigutamab dose 3 administered SC injection every 4 weeks.
Intervention: lonigutamab (Drug)
Cohort 4
Experimental
multiple doses of lonigutamab dose 4 administered SC injection every 4 or 3 weeks.
Intervention: lonigutamab (Drug)
Outcomes
Primary Outcomes
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
Time Frame: Day 1 to Day 169
Safety and Tolerability
Incidence and characterization of serious treatment emergent adverse events (TEAEs)
Time Frame: Day 1 to Day 169
Safety and Tolerability
Secondary Outcomes
- PK profile of lonigutamab(Day 1 to Day 169)
Investigators
Study Sites (1)
Loading locations...
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Related News
Acelyrin's Lonigutamab Shows Promise in Thyroid Eye Disease Phase 1/2 Trial• Acelyrin's lonigutamab, a subcutaneous anti-IGF-1R antibody, demonstrated clinical responses in patients with thyroid eye disease (TED) in a Phase 1/2 trial.
• The trial (NCT05683496) evaluated the safety and efficacy of lonigutamab in three cohorts with active TED, using varying dosing regimens.
• Lonigutamab binds to a distinct IGF-1R epitope, leading to receptor internalization and potentially improved clinical response durability.
• The data were presented at the Endocrine Society’s Annual Meeting (ENDO 2024) as a late-breaking oral presentation.2 years agoAcelyrin's Lonigutamab Shows Promise in Thyroid Eye Disease with Subcutaneous Delivery• Acelyrin's lonigutamab, a subcutaneous anti-IGF-1R antibody, demonstrates clinical responses in patients with thyroid eye disease (TED).
• Phase 1/2 trial data showed rapid improvements in proptosis and clinical activity scores within three weeks of the first dose.
• A Phase 2b/3 trial is planned for the second half of 2024, potentially leading to regulatory submission for lonigutamab in TED.
• Lonigutamab's subcutaneous delivery offers a potentially favorable safety profile compared to intravenous treatments like Tepezza.2 years ago