Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06858579 | A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE) | PHASE3 | RECRUITING | 256 | — | — | Feb 10, 2025 | Dec 31, 2030 | Jun 2, 2026 | 168 | United States, Argentina +25 |
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| Claseprubart | DRUG | IV Infusion |
| Placebo | DRUG | SC injection |
Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out. 2. Weight range between 40 kilograms (kg) and 120 kg. 3. Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: mo...