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Also known as DNTH103
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 by Dianthus Therapeutics, Inc. for neurologic autoimmune conditions. It is in Phase 3 clinical development for generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, and in Phase 2 development for multifocal motor neuropathy. It has not been approved by the FDA.
Claseprubart is being studied for generalized myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy. These are neurologic conditions in which the immune system attacks nerve or neuromuscular junction components. All of these uses remain investigational, as the drug is still in clinical development and has not received FDA approval.
Claseprubart targets C1s, a serine protease in the classical complement pathway. By binding C1s, the drug is designed to inhibit classical complement activation, a mechanism being evaluated in antibody-mediated neurologic disorders such as generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
Claseprubart is being developed by Dianthus Therapeutics, Inc., which trades on the Nasdaq under the ticker DNTH. The company is running Phase 3 and Phase 2 clinical programs for the drug across several neurologic indications, including generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
Claseprubart is in Phase 3 development. Two Phase 3 trials are recruiting: EMERGE in generalized myasthenia gravis and CAPTIVATE in chronic inflammatory demyelinating polyneuropathy. Two earlier Phase 2 studies, MAGIC in generalized myasthenia gravis and a study in multifocal motor neuropathy, are active but no longer recruiting. The drug is investigational and not FDA approved.
Claseprubart is being evaluated in four registered trials. Phase 3 studies include NCT07647510 (EMERGE) in generalized myasthenia gravis and NCT06858579 (CAPTIVATE) in chronic inflammatory demyelinating polyneuropathy. Phase 2 studies include NCT06282159 (MAGIC) in generalized myasthenia gravis and NCT06537999 in multifocal motor neuropathy. All are randomized, double-blind, and placebo-controlled.
Yes. Claseprubart is also known as DNTH103, and both names refer to the same investigational small molecule from Dianthus Therapeutics. The Phase 3 CAPTIVATE trial in chronic inflammatory demyelinating polyneuropathy and the Phase 2 multifocal motor neuropathy study are listed under the DNTH103 name, while newer studies use Claseprubart.