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.

List of 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

ADVANCE CIDP 1 Clinical Study

CIDP Treatment Trial, Now Enrolling Patients Worldwide!
Announcing a new study to investigate a potential new medication for CIDP patients. The ADVANCE-CIDPTM 1 Study is looking at a potential new treatment (an investigational medication) for patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). It will assess if the investigational medication could help to prevent muscle weakness in the upper and lower limbs. The investigational medication is an immunoglobulin (made from proteins found in the body called antibodies) and is given as an infusion under the skin every 2, 3, or 4 weeks.

About the study

The study is currently looking for 170 patients at approximately 90 study centers worldwide.

If you take part, you may be involved in the study for up to 14 months. The study is now enrolling. Requirements include:

  • Must be 18 years of age or older
  • Must have been diagnosed with CIDP
  • Must have been receiving treatment with immunoglobulin infusions at a stable dose, every 2–6 weeks, for at least 12 weeks (3 months)

Please visit clinicaltrials.gov and search for study identifier NCT02955355 for more information, including a list of participating countries and study centers:

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

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