Ripertamab for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy

ConditionChronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorZhongming Qiu

About this trial

The goal of this clinical trial is to learn if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy. It will also learn about the safety of ripertamab. The main questions it aims to answer are:

Does ripertamab reduce the risk of recurrence in patients? What medical problems do participants have when taking ripertamab? Researchers will compare ripertamab to a placebo (a look-alike substance that contains no drug) to see if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy.

Participants will:

A single intravenous infusion of drug ABC or placebo. Visit the clinic for checkups and tests during W1, W2, W4, W8, W12 Keep a diary of their symptoms and the number of times they undergo rescue therapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand the requirements of the trial, provide written informed consent (including consent to use and disclose health information related to the study), and willing and able to comply with the trial protocol procedures (including required trial visits);

Aged 18 years or older at the time of signing the informed consent form;

Diagnosed with definite CIDP according to the 2021 EFNS/PNS criteria;

CIDP Disease Activity Status (CDAS) score of ≥2 at screening;

Disqualifiers

Pure sensory atypical CIDP (defined by EFNS/PNS criteria);

Polyneuropathy due to other causes, including but not limited to: multifocal motor neuropathy, monoclonal gammopathy of undetermined significance caused by anti-myelin-associated glycoprotein immunoglobulin M antibodies, hereditary demyelinating neuropathy, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes syndrome, lumbosacral radiculoplexus neuropathy, polyneuropathy most likely caused by diabetes, polyneuropathy most likely caused by systemic disease, polyneuropathy caused by drugs or toxins;

Any disease that can better explain the patient's symptoms and signs;

History of any myelopathy or evidence of central demyelination;

Trial design

Design model

Parallel

Treatments tested in this trial

ripertamab
Drug
On Day 1 of the treatment period, an intravenous infusion of Ripertamab at a dose of 375 mg/m² body surface area will be administered.
Placebo
Drug
On Day 1 of the treatment period, an intravenous infusion of Placebo at a dose of 375 mg/m² body surface area will be administered.

Treatment groups

175 Participants

are divided into 2 treatment groups

Group A: Treatment groupExperimental treatment 1 intervention

Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

The time to first increase of ≥1 point in the aINCAT score compared to baseline.

Time frame

Within 24 weeks

Locations

This trial has no locations.

Sponsors and contacts

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

Zhongming Qiu

Lead sponsor

Xinqiao Hospital of Chongqing

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: