Efgartigimod PH20 SC for CIDP
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment option for people with CIDP, a condition that causes nerve damage and muscle weakness. It aims to observe how patients who currently rely on IVIg, a common treatment for CIDP, adjust to efgartigimod PH20 SC, a new experimental therapy. The trial seeks adults who have been using IVIg regularly and have a stable dose. Participants will stop IVIg and switch to the new treatment to determine if it helps manage their symptoms. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, if you are on IVIg, oral corticosteroids, or nonsteroidal immunosuppressive medication, you need to be on a stable dose for a certain period before joining the trial.
What is the safety track record for Efgartigimod PH20 SC?
Research has shown that efgartigimod PH20 SC is generally well-tolerated by people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). In studies, this treatment reduced the likelihood of symptoms returning. Importantly, the safety profile indicated that participants managed it well, with no major safety concerns reported. This suggests the treatment is safe for humans, providing reassurance for those considering joining a trial with this treatment.12345
Why are researchers enthusiastic about this study treatment?
Efgartigimod PH20 SC is unique because it offers a new way to manage Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), shifting from intravenous infusions, like IVIg, to a subcutaneous injection. This new delivery method could mean more convenience and comfort for patients, as it potentially allows for home administration. Additionally, efgartigimod works by targeting the neonatal Fc receptor (FcRn), which is different from many current treatments that modulate the immune system more broadly. Researchers are excited because this targeted approach might reduce side effects and improve patients' quality of life.
What evidence suggests that efgartigimod PH20 SC might be an effective treatment for CIDP?
Research has shown that efgartigimod PH20 SC, which participants in this trial will receive, effectively treats chronic inflammatory demyelinating polyneuropathy (CIDP). Studies found it reduces the likelihood of symptom recurrence compared to a placebo. It proved effective over the long term in controlling symptoms. Patients generally tolerate the treatment well, supporting its use for managing CIDP symptoms over time.12567
Are You a Good Fit for This Trial?
Adults with CIDP who are currently on a stable IVIg treatment every 3-6 weeks can join this study. They must be at least 18 years old and meet specific diagnostic criteria for CIDP. Stable doses of immunosuppressives or low-dose oral corticosteroids are allowed, but there may be other factors that could exclude them.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants transition from IVIg to efgartigimod PH20 SC treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Efgartigimod PH20 SC
Trial Overview
The trial is testing how well adults with CIDP adjust when switching from their regular IVIg treatments to a new medication called Efgartigimod PH20 SC. The study will last about 17 to 19 weeks per participant.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants start efgartigimod PH20 SC treatment after discontinuing IVIg
Find a Clinic Near You
Who Is Running the Clinical Trial?
argenx
Lead Sponsor
Tim Van Hauwermeiren
argenx
Chief Executive Officer since 2008
B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management
Dr. Peter Ulrichts
argenx
Chief Medical Officer since 2023
MD from Maastricht University, PhD in Molecular Immunology from Maastricht University
Citations
Safety, tolerability, and efficacy of subcutaneous ...
ADHERE showed the efficacy of subcutaneous efgartigimod PH20 in reducing the risk of relapse versus placebo in people with CIDP who responded to treatment.
Efficacy and Safety of Efgartigimod PH20 in Chronic ...
ADHERE demonstrated the effectiveness of efgartigimod PH20 SC in reducing the risk of relapse. Efgartigimod PH20 SC was well-tolerated; its safety profile was ...
Long-Term-Efficacy-of-Efgartigimod-PH20-SC-in-Patients- ...
efgartigimod PH20 SC results in long-term clinical efficacy in ... CIDP, chronic inflammatory demyelinating polyneuropathy; PH20 ...
Safety, tolerability, and efficacy of subcutaneous ...
Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE)
NCT04281472 | A Study to Assess the Safety and Efficacy ...
This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP. Official Title. A Phase 2 Trial ...
Safety Profile of Subcutaneous Efgartigimod PH20 From ...
Chronic Inflammatory Demyelinating Polyneuropathy. Dosing: • Weekly dosing of efgartigimod PH20 SC 1000 mg or placebo SC (ADHERE stage B only).
NCT04281472 | A Study to Assess the Safety and Efficacy ...
This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
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