Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Adimanebart IV, Adimanebart SC - formulation B, Adimanebart- formulation B, Adimanebart SC - formulation C, Adimanebart- formulation C
Adimanebart · 1 trial · 2 indications
The 6-minute walk test (6MWT) measures the distance a participant walks in 6 minutes.
AE: adverse event; SAE: serious adverse event
| Arm | Type | Description |
|---|---|---|
| Double-blinded treatment period (DBTP) - Adimanebart IV | EXPERIMENTAL | Participants randomized to receive Adimanebart IV |
| Double-blinded treatment period (DBTP) - Placebo IV | PLACEBO_COMPARATOR | Participants randomized to receive Placebo IV |
| Open-label extension (OLE) - Adimanebart IV | EXPERIMENTAL | Participants receive Adimanebart IV |
| Name | Type | Description |
|---|---|---|
| Adimanebart IV | BIOLOGICAL | Intravenous infusion of Adimanebart |
| Placebo IV | OTHER | Intravenous infusion of Placebo |
Inclusion Criteria: DBTP: * At least 12 years of age. * Has a diagnosis of DOK7-, MUSK-, AGRN-, or LRP4-CMS with documented mutations. * Participants taking oral beta agonists (eg, albuterol, salbutamol, ephedrine) or other CMS medication must have been receiving the medication for at least 6 mont...
Adimanebart is an investigational monoclonal antibody developed by argenx SE for the treatment of Congenital Myasthenic Syndrome, a group of inherited neuromuscular junction disorders. It is currently in Phase 3 clinical development and has not been approved by the FDA. It is being studied in both adult and pediatric patients.
Adimanebart is being developed to treat Congenital Myasthenic Syndrome, specifically in patients with DOK7-, MUSK-, AGRN-, or LRP4-related forms of the condition. It is an investigational therapy in Phase 3 testing and is not yet approved for any indication. The Phase 3 study enrolls participants aged 12 years and older.
Adimanebart is developed by argenx SE, a biotechnology company that trades under the ticker ARGX. Argenx is the sponsor of the Phase 3 clinical program evaluating the monoclonal antibody in Congenital Myasthenic Syndrome. The company is responsible for the ongoing development of the asset.
Adimanebart is in Phase 3 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The Phase 3 trial is currently listed as not yet recruiting, with a planned enrollment of 105 participants.
Adimanebart is being evaluated in one Phase 3 clinical trial, NCT07746089, titled a study to assess efficacy and safety of Adimanebart in adult and pediatric participants with DOK7-, MUSK-, AGRN-, or LRP4- Congenital Myasthenic Syndromes. The trial is randomized, double-blind, and placebo-controlled, with a planned enrollment of 105 participants aged 12 years and older.
Adimanebart is also known by several alternative names, including Adimanebart IV and Adimanebart SC formulations A, B, and C, which are also written as Adimanebart- formulation A, B, and C. These names refer to the same monoclonal antibody asset developed by argenx SE for Congenital Myasthenic Syndrome.