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 an investigational small molecule being developed for the treatment of Thyroid Eye Disease (TED), a condition affecting the tissues around the eyes. It is currently in clinical development and has not been approved by regulatory authorities. The drug is being studied to evaluate its efficacy and safety in patients with this condition.
Lonigutamab is being developed by ACELYRIN, INC., a biopharmaceutical company. The company's stock is traded under the ticker symbol SLRN. ACELYRIN is conducting clinical trials to evaluate the drug's potential as a treatment for Thyroid Eye Disease.
Lonigutamab is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing to assess its safety and efficacy in patients with Thyroid Eye Disease.
Lonigutamab has been studied in one clinical trial with the identifier NCT05683496. This Phase 1 trial, titled 'Efficacy and Safety of Lonigutamab in Subjects With Thyroid Eye Disease (TED),' was a randomized, double-blind, controlled study that enrolled 31 participants. The trial was conducted in the United States and Australia and has been completed.
Lonigutamab is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial evaluated its safety and efficacy in Thyroid Eye Disease, but the drug has not yet received regulatory approval and remains under investigation.