Health Trials

A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

ConditionChronic Inflammatory Demyelinating Polyneuropathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDianthus Therapeutics

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Claseprubart

    Drug

    IV Infusion

  • Claseprubart

    Drug

    SC injection

  • Placebo

    Drug

    SC injection

Treatment groups

256 Participants
are divided into 4 treatment groups
Group A: Claseprubart (Part A)Experimental treatment 1 intervention
Group B: Claseprubart (Part B)Experimental treatment 1 intervention
Group C: Placebo (Part B)Placebo comparator 1 intervention
Group D: Claseprubart (Optional OLE)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT)

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.

Time frame
Part B baseline to Part B end of treatment period (up to Week 52)

Secondary outcomes

1

Part B: Time to Decrease of ≥ 4 Points (Centile Metric) in Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score

The I-RODS score ranges from 0-100, with lower scores indicating the greatest degree of disability.

Time frame
Part B baseline to Part B end of treatment period (up to Week 52)
2

Part B: Time to Decrease of ≥ 8 kilopascal (kPa) in Grip Strength in the Dominant Hand

This is measured with a handheld device called a vigorimeter.

Time frame
Part B baseline to Part B end of treatment period (up to Week 52)
3

Part B: Percentage of Participants who Relapse as Assessed by the Adjusted INCAT

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.

Time frame
Part B baseline to end of treatment period for Part B (up to Week 52)
4

Parts A and B: Change in I-RODS Score (Centile Metric)

The I-RODS score ranges from 0-100, with lower scores indicating the greatest degree of disability.

Time frame
Part A baseline up to Part A end of treatment period (up to Week 13); Part A baseline to Part B end of treatment period (up to Part B Week 52)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dianthus Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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