DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

What is the Purpose of this Study?

The purpose of this study is to evaluate safety and effectiveness of an experimental drug called DNTH103 for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) when compared to a placebo (inactive substance). Participants are those who have or possibly have CIDP, a condition in which the body’s immune system mistakenly attacks and damages the protective covering of nerves (called myelin) throughout the body. This damage disrupts the normal communication between the nerves and muscles, leading to weakness, numbness, pain, and tingling sensations. The most common form of CIDP typically affects both sides of the body, particularly the lower limbs (e.g. legs) and upper limbs (e.g. hands & wrists), leading to movement and balance problems. Study procedures include administration of the experimental medication or placebo, questionnaires, evaluations, electrocardiograms, and blood samples. Participants will receive DNTH103 in the first part of the study (Part A). If the patient’s CIDP improves, they may qualify for the second part of the study (Part B), during which they will receive DNTH103 or placebo. Researchers believe that DNTH103 may decrease or prevent the injury (caused by CIDP) to the nerves that control the muscles.


Eligibility

  • 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: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.
  • 4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DNTH103 IN ADULTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY

Study Details
Disease Type/Condition

Other

Principal Investigator

Lewis, Richard

Age Group

Adult

Phase

III

IRB Number

STUDY00003941

ClinicalTrials.gov ID

NCT06858579

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Lewis, Richard

Age Group

Adult

Phase

III

IRB Number

DNTH103-CIDP-301

ClinicalTrials.gov ID

NCT06858579

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org