Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Claseprubart · 4 trials · 3 indications
The MG-ADL score is an 8-item patient reported outcome (PRO) instrument. The MG-ADL targets symptoms of disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of the MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability.
Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability. A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT score.
Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
Number of participants with TEAEs and treatment-emergent SAEs will be reported.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Intravenous (IV) infusion of Placebo on Day 1 followed by subcutaneous (SC) injections of Placebo every 2 weeks (Q2W) starting at Week 1 (Day 8). |
| Claseprubart Q2W | EXPERIMENTAL | IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart Q2W starting at Week 1 (Day 8). |
| Claseprubart Every 4 weeks (Q4W) | EXPERIMENTAL | IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart or Placebo Q2W starting at Week 1 (Day 8), with doses alternating between claseprubart and placebo. |
| Claseprubart (Part A) | EXPERIMENTAL | Claseprubart intravenous (IV) loading dose on Day 1. Claseprubart subcutaneous (SC) once every 2 weeks for up to 13 weeks. |
| Claseprubart (Part B) | EXPERIMENTAL | Claseprubart SC once every 2 weeks for up to 52 weeks. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Placebo SC once every 2 weeks for up to 52 weeks. |
| Claseprubart (Optional OLE) | EXPERIMENTAL | Claseprubart SC once every 2 weeks for up to 104 weeks. |
| Claseprubart 300 mg Q2W | EXPERIMENTAL | - |
| Claseprubart 600 mg Q2W | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Claseprubart | DRUG | IV loading dose on Day 1 |
| Placebo | DRUG | IV infusion on Day 1 |
Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out 2. Weight range between 40-130 kg at Screening 3. Diagnosis of gMG by the following tests: 1. Acetylcholine receptor antibody (AChR Ab) positive, and 2. One of the following: ...
Claseprubart is an investigational small molecule being developed for chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy, and generalized myasthenia gravis. It is currently in Phase 3 clinical trials for generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, and Phase 2 trials for multifocal motor neuropathy.
Claseprubart targets C1s, a component of the complement system. By inhibiting C1s, it aims to modulate the complement pathway involved in the pathogenesis of autoimmune neurological conditions. This mechanism is being studied in conditions like generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
Claseprubart is being developed by Dianthus Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DNTH. The company is conducting clinical trials for this investigational drug across multiple neurological indications.
Claseprubart is in Phase 3 clinical development for generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. It is also being studied in Phase 2 trials for multifocal motor neuropathy and generalized myasthenia gravis. The drug is investigational and not yet approved by regulatory authorities.
Claseprubart is being evaluated in several trials. NCT07647510 is a Phase 3 study in generalized myasthenia gravis (EMERGE) with 195 participants. NCT06858579 is a Phase 3 study in chronic inflammatory demyelinating polyneuropathy (CAPTIVATE) with 256 participants. NCT06537999 is a Phase 2 study in multifocal motor neuropathy with 46 participants. NCT06282159 is a Phase 2 study in generalized myasthenia gravis (MAGIC) with 65 participants.
Yes, Claseprubart is also known as DNTH103. Clinical trial records for the drug use both names, with DNTH103 appearing in study titles for chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy, and generalized myasthenia gravis trials.