Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Siltuximab · 1 trial · 3 indications
Defined as the change in the worst pain intensity between baseline and day 85. Worst pain is measured using the 11-point Pain Intensity Numerical Rating Scale (NRS), where scores range from 0 (no pain) to 10 (worst pain ever) of the maximum SWN-related pain experienced over the past week
| Arm | Type | Description |
|---|---|---|
| Sub-study A: Siltuximab | EXPERIMENTAL | The treatment period includes a double-blind treatment period (days 1-84) and an open-label treatment period (days 85-168). All participants will receive siltuximab during this drug sub-study. Twenty (20) participants will be randomized to receive either Siltuximab or matching placebo during the double-blind treatment period. All participants will receive siltuximab during the open-label treatment period. Participants will complete study procedures as outlined: * Double-Blind Treatment period: Administration of Siltuximab versus matching placebo in pre-determined dose once every 21 days (for 4 cycles). * Open-Label Treatment period: Administration of Siltuximab in pre-determined dose once every 21 days (for 4 cycles). |
| Sub-study B: Erenumab-Aooe | EXPERIMENTAL | The treatment period includes a single-blind treatment period (days 1-84) and an open-label treatment period (days 85-168). All participants will receive erenumab-aooe during this drug sub-study. Twenty (20) participants will receive a randomization assignment to receive either Erenumab-Aooe or matching placebo during the single-blind treatment period. All participants will receive erenumab-aooe during the open-label treatment period. Participants will complete study procedures as outlined: * Single-Blind treatment period (days 1 - 84): Administration of Erenumab-Aooe versus matching placebo in pre-determined dose once every 28 days (for 3 cycles). * Open-Label Treatment period (days 85-168): Administration of Erenumab-Aooe in pre-determined dose once every 28 days (for 3 cycles). |
| Name | Type | Description |
|---|---|---|
| Siltuximab | DRUG | A chimeric immunoglobulin G mAb, via intravenous infusion. |
| Erenumab-Aooe | DRUG | Human monoclonal antibody, single-dose prefilled SureClick® autoinjector, via subcutaneous injection. |
| Siltuximab Matching Placebo | DRUG | Dextrose 5% in water, via intravenous infusion. |
| Erenumab-Aooe Matching Placebo | DRUG | 0.9% saline, 1 mL single-dose prefilled syringe, via subcutaneous injection. |
Inclusion Criteria for Master Study: * Patients must have a confirmed diagnosis schwannomatosis by fulfilling either clinical or molecular diagnosis. * Clinical diagnosis: A clinical diagnosis of schwannomatosis is confirmed by either of the two following criteria: * Two or more non-intradermal ...
Siltuximab is being studied for the treatment of pain associated with Schwannomatosis, a condition characterized by the growth of schwannomas. It is currently in Phase 2 clinical development as an investigational therapy for this chronic pain indication.
Siltuximab is a monoclonal antibody, classified as a -mab, that is being evaluated for its ability to modulate pain in Schwannomatosis. The specific molecular target is not disclosed in the available information, but its antibody modality suggests it acts on a specific protein involved in the disease process.
Siltuximab is being developed by United Therapeutics Corporation, a biopharmaceutical company listed on the stock exchange under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the drug's efficacy in treating pain related to Schwannomatosis.
Siltuximab is currently in Phase 2 clinical trials. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical evaluation to determine its safety and effectiveness for the treatment of pain in Schwannomatosis.
Siltuximab is being studied in a Phase 2 clinical trial with the identifier NCT05684692, titled 'Screening Trial for Pain Relief in Schwannomatosis (STARFISH)'. This randomized, double-blind, controlled trial is recruiting 40 participants in the United States and is currently active.
Siltuximab is also known by other names, though specific alternative names are not provided in the available information. It is a distinct monoclonal antibody being developed by United Therapeutics for pain in Schwannomatosis, and it should not be confused with other drugs without verifying the active ingredient.