Study on the Effects of Riliprubart for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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What is this study about?

This clinical trial is focused on studying a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a rare neurological disorder that causes progressive weakness and impaired sensory function in the legs and arms. The study is testing a new treatment called riliprubart, also known by its code name SAR445088. This treatment is given as a solution for injection under the skin, known as subcutaneous use.

The purpose of the study is to evaluate how effective, safe, and tolerable riliprubart is for adults with CIDP. The study is divided into two parts. In the first part, the focus is on how well riliprubart works in three groups of CIDP patients: those who are currently receiving standard treatments, those who do not respond well to standard treatments, and those who have not yet received standard treatments. The second part of the study looks at the long-term safety and tolerability of riliprubart in these patients.

Participants in the study will receive riliprubart and will be monitored for any changes in their condition and any side effects they may experience. The study will also track the number of participants who respond to the treatment and those who experience any adverse events. This research aims to provide more information about riliprubart as a potential treatment option for people living with CIDP.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP), and previous treatment history.

Participants must have documented vaccinations against certain bacterial infections and agree to use effective birth control methods if applicable.

2 initial assessment

An initial assessment is conducted to evaluate the current health status and establish a baseline for future comparisons.

This includes a review of medical history and any previous treatments for CIDP.

3 treatment phase a

Participants receive the study medication, riliprubart, administered as a solution for injection under the skin.

The focus is on evaluating the effectiveness of the medication in different subgroups of CIDP patients: those treated with standard care, those who did not respond to standard care, and those who have not received standard care.

4 monitoring and evaluation

Regular monitoring is conducted to assess the response to the medication and any side effects.

Participants are evaluated for improvements or relapses in their condition, and any adverse events are recorded.

5 treatment phase b

The long-term safety and tolerability of riliprubart are assessed.

Participants continue to receive the medication, and their health is monitored over an extended period.

6 final assessment

A final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

The study aims to determine the percentage of participants who respond to the treatment and those who remain relapse-free.

Who Can Join the Study?

Must be an adult, at least 18 years old.
Must have a confirmed diagnosis of CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy), which is a condition affecting the nerves.
Must belong to one of these groups:
- SOC-Treated: Currently receiving standard treatment and have shown improvement, but also experienced worsening when treatment was reduced or stopped.
- SOC-Refractory: Did not improve with standard treatment or cannot continue it due to side effects. Must not have received certain treatments recently and have a specific score on a disability scale.
- SOC-Naïve: Have not been treated for CIDP before or stopped treatment for reasons other than lack of response or side effects. Must not have received certain treatments recently and have a specific score on a disability scale.
Must have received certain vaccinations within the last 5 years or at least 14 days before starting the study.
Female participants must use two methods of birth control and agree not to donate eggs during the study and for a period after.
Female participants must have a negative pregnancy test before starting the study.
Male participants with partners who can become pregnant must use two methods of birth control during the study and agree not to donate sperm for a period after.
Must be able to provide signed consent to participate in the study.

Who Cannot Join the Study?

Patients who have other serious health conditions that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have an allergy to the study medication.
Patients who have a condition that affects their immune system.
Patients who are unable to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Universitaetsmedizin Goettingen	Goettingen	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France
Ayxrcynynm Pxbahcyr Hkxdsthi Dk Mrvurxszu	Marseille	France
Ucspfelxdknutapkgkzrn Dxmebchfclj Arg	Duesseldorf	Germany
Eyooqnr Unlbiftccotn Mjpgszi Cbjdzqk Ryimluhpq (xudxxsa Mtl	Rotterdam	The Netherlands
Haghfxos Dx Lb Sdgml Couc I Ssoz Pxq	Barcelona	Spain
Hjhmtvoc Vwce dgwhbhhr	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	13.10.2021
Germany	Not recruiting	13.10.2021
Italy	Not recruiting	13.10.2021
Poland	Not recruiting	13.10.2021
Spain	Not recruiting	13.10.2021
The Netherlands	Not recruiting	13.10.2021

Trial locations

Investigated drugs:

Riliprubart

SAR445088 is a medication being studied for its effectiveness, safety, and tolerability in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). This study aims to understand how well this medication works in different groups of patients, including those who have been treated with standard care, those who do not respond to standard care, and those who have not received any standard care. The study also looks at the long-term safety and how well patients can tolerate the medication.

Chronic Inflammatory Demyelinating Polyradiculoneuropathy – This is a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. It is caused by damage to the myelin sheath, the protective covering of the nerves. The disease progresses slowly, often over several months, and can lead to significant disability if untreated. Symptoms may include tingling or numbness, muscle weakness, and loss of reflexes. The condition can vary greatly in severity and duration among individuals. It is considered a rare disease and can affect people of any age, though it is more common in adults.

Trial ID:

2024-512345-16-00

Protocol code:

PDY16744

NCT ID:

NCT04658472

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Riliprubart for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?