About this trial
The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).
Eligibility criteria
Qualifiers
Must have given written informed consent before any study-related activities are carried out.
Weight range between 40 kilograms (kg) and 120 kg.
Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.
CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.
Disqualifiers
Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.
Known evidence of central demyelination or known history of myelopathy.
History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety/efficacy or study procedures.
Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.
Trial design
Treatments tested in this trial
- Claseprubart
- Claseprubart
- Placebo