Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lonigutamab · 1 trial · 1 indication
Safety and Tolerability
Safety and Tolerability
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21 |
| Cohort 2 | EXPERIMENTAL | multiple doses of dose 2 of lonigutamab administered SC injection weekly |
| Cohort 3 | EXPERIMENTAL | multiple doses of lonigutamab dose 3 administered SC injection every 4 weeks. |
| Cohort 4 | EXPERIMENTAL | multiple doses of lonigutamab dose 4 administered SC injection every 4 or 3 weeks. |
| Name | Type | Description |
|---|---|---|
| lonigutamab | DRUG | subcutaneous injection |
| Placebo | DRUG | subcutaneous injection |
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 ef...
Lonigutamab is being developed for the treatment of thyroid eye disease (TED), an autoimmune condition affecting the tissue around the eyes. It is an investigational monoclonal antibody and has not been approved for any indication. Its clinical program has focused on patients 18 years and older with TED.
Lonigutamab is being developed by ACELYRIN, INC., which trades on the Nasdaq under the ticker SLRN. ACELYRIN is the sponsor of the clinical program evaluating the drug in thyroid eye disease.
Lonigutamab is in Phase 1 clinical development. It is an investigational monoclonal antibody and is not approved by the FDA or any other regulatory agency. One Phase 1 trial in thyroid eye disease has been completed, and no trials are currently listed as active.
Lonigutamab has been studied in the Phase 1 trial NCT05683496, titled "Efficacy and Safety of Lonigutamab in Subjects With Thyroid Eye Disease (TED)." The trial enrolled 31 participants across the United States and Australia, was randomized, double-blind, and controlled, and is now completed.
The Phase 1 trial of lonigutamab in thyroid eye disease, NCT05683496, enrolled 31 participants. It was a randomized, double-blind, controlled study conducted in the United States and Australia in adults 18 years and older with thyroid eye disease, and it has been completed.
No. Lonigutamab is an investigational monoclonal antibody in Phase 1 development for thyroid eye disease and has not received FDA approval. Its only listed clinical trial, NCT05683496, has been completed, and no active trials are currently recorded for the program.