About Clinical Trials

Clinical trials are scientific studies that involve people. Most clinical trials test how effective a new potential drug, medical device, or medical technique is at improving signs or symptoms of a particular condition, OR prolonging the life of a patient with the condition. Clinical trials involve a strong collaboration between researchers, drug-makers/pharmaceutical companies, hospitals, patients, and doctors.

If you have questions about what is involved in a clinical trial, check out out clinical trial FAQ.

On Going Clinical Trials

There are several clinical trials in process right now that support research for GBS, CIDP, and variants. Please note that this information is intended to help patients be aware of all of their options; the Foundation is unable to endorse any clinical trials.

Clinical Trials for People Living with CIDP

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This biomarker study will collect blood samples before and after IVIg treatment from people with CIDP diagnosed and followed at GBS|CIDP Foundation International Center of Excellence (COE) clinics.  A network of mobile medical professionals will schedule 4 blood collection visits at the participant’s home over the course of approximately one month. The study goal is to better understand how circulating biomarkers change in response to IVIg treatment in people with CIDP with the aim of incorporating biomarkers into future interventional clinical trials.

This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

CSL Behring is conducting an open-label study to investigate the efficacy of single and multiple-dose Privigen administration in IVIG‑pretreated and IVIG-untreated pediatric subjects with chronic inflammatory demyelinating polyneuropathy (CIDP).

ClinicalTrials.gov Identifier: NCT03684018

This global multicenter study will evaluate the efficacy, safety and tolerability of BIVV020 in CIDP. BIVV020 is an investigational monoclonal antibody that targets Complement C1s and has a subcutaneous route with self-administration.

The study is seeking patients with CIDP belonging to three groups: (1) patients who are successfully treated with standard of care therapies, immunoglobulin or corticosteroids, (2) patients who have failed these therapies, or (3) patients who are naïve to these therapies, i.e. never received treatment.

The study consists of two parts: an initial 24-week treatment period (Part A), followed by an optional extension period providing up to 52 additional weeks of treatment (Part B).

For more information on this study, please visit: https://clinicaltrials.gov/ct2/show/NCT04658472

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare disease where the
body’s natural defenses, like antibodies, attack the covering of the nerves, called myelin,
and damage nerve function. While symptoms aren’t the same for everyone, CIDP can
make your arms and legs feel weak and slow your movements. The purpose of the ARISE
Study is to evaluate the safety and efficacy of an investigational medication in adults with
active CIDP.

Eligible patients will be:

  • Adults aged 18 years or older
  • Diagnosed with active CIDP
  • Either:
    • Willing to discontinue current treatment of intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and/or corticosteroids prior to study entry OR
    • Newly diagnosed with CIDP and have never been treated, or you have not taken medication for CIDP for at least 3 months prior to study entry

What can I expect if I join the study?

  • You will receive a thorough medical exam and your CIDP diagnosis will be confirmed.
  • If you qualify and are currently receiving treatment for CIDP, you will be asked to discontinue or taper off this treatment.
  • You will receive study-required medical care throughout the study by a neuromuscular neurologist.
  • All who qualify will receive the investigational medication for a portion of the study. The investigational medication will be an IV infusion.
  • If you qualify for another portion of the study, you will be randomly assigned to receive either the investigational medication or a placebo that has no active drug. You will not know which treatment you will receive.
  • If you qualify for all portions of the study and wish to continue, you can expect to spend up to 2–5 years in the study.

Participants will receive study-required medical care at no cost. Participants who qualify to receive the investigational medication will receive it at no cost. The study will not pay for other medical care or current medication(s) needed to support your daily health care routine.


Visit https://globaltrialfinder.janssen.com/trial/CR109195 and https://clinicaltrials.gov/ct2/show/NCT05327114 to learn more about this clinical study.

Clinical Trials for People Currently Experiencing GBS

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A Phase 1b Study to Evaluate the Safety, Tolerability and Drug-Drug Interactions of ANX005 and Intravenous Immunoglobulin (IVIg) in Subjects With Guillain Barré Syndrome

The international GBS Outcome Study (IGOS) is the largest and longest prospective trial designed to collect extensive data from patients afflicted with GBS in a systematic manner. The aim is to collect information from patients by intensive international collaboration. All patients are followed at standard intervals from the earliest phase of the disease up to at least one year after. At these time points all patients are clinically examined and documented according to the same protocol. The data generated from IGOS may fundamentally change how we care for patients with GBS and hasten research for more effective therapies.

The GBS|CIDP Foundation International is currently funding the IGOS trial through a research grant.

 

Clinical Trials for People Living with MMN

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The ARDA study is designed to assess the safety and effectiveness of the investigational study drug compared to a placebo for the treatment of adults living with MMN. Participants enrolled in the study will be randomly assigned by a computer to either receive the investigational drug or a placebo. Participants will have 2 out of 3 chances to receive the study drug.

The study will consist of a screening period to ensure eligibility, followed by IVIG study treatment period to confirm that the disease responds to study treatment. There is then a 4 month treatment period, followed by an optional long-term extension and a 9-month safety follow-up period. All participants will be monitored and supported by the study team.

To learn more, visit https://clinicaltrials.gov/ct2/show/NCT05225675 or email clinicaltrials@argenx.com