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Monoclonal Antibodies

Efgartigimod SC for CIDP (ADHERE+ Trial)

Phase 2
Waitlist Available
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Awards & highlights

ADHERE+ Trial Summary

This trial is to see if a medication is safe and effective for people with a disease that causes weakness and numbness.

Who is the study for?
This trial is for adults with CIDP, an autoimmune disorder affecting nerves. Participants must have been part of a prior efgartigimod study or treatment and deteriorated during that time. They should understand the trial's demands, consent in writing, follow procedures, and use contraception if applicable. Pregnant women or those with serious diseases or recent major surgeries are excluded.Check my eligibility
What is being tested?
The study tests long-term safety and effectiveness of Efgartigimod PH20 SC (a drug given under the skin) in adults with CIDP. It includes patients stabilized on this medication from a previous phase II trial and explores less frequent dosing options within a sub-study.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones for medications like Efgartigimod may include injection site reactions, possible allergic responses to ingredients, general discomforts such as headaches or nausea, fatigue, and potential immune system impacts.

ADHERE+ Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events and serious adverse events
Secondary outcome measures
Change from baseline over time in BPI SF
Change from baseline over time in EQ-5D-5L
Change from baseline over time in HADS
+13 more

ADHERE+ Trial Design

1Treatment groups
Experimental Treatment
Group I: efgartigimod PH20 SCExperimental Treatment1 Intervention
Patients treated with efgartigimod PH20 SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efgartigimod PH20 SC
2020
Completed Phase 3
~210

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
60 Previous Clinical Trials
9,044 Total Patients Enrolled
1 Trials studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy
360 Patients Enrolled for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Media Library

Efgartigimod PH20 SC (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04280718 — Phase 2
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Research Study Groups: efgartigimod PH20 SC
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Clinical Trial 2023: Efgartigimod PH20 SC Highlights & Side Effects. Trial Name: NCT04280718 — Phase 2
Efgartigimod PH20 SC (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04280718 — Phase 2
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patient Testimony for trial: Trial Name: NCT04280718 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many total people are enrolled in this trial?

"The sponsor, argenx, needs to enroll 360 eligible patients at different clinical sites, such as Investigator site 27 in Boca Raton, California and Investigator site 42 in Carlsbad, Iowa."

Answered by AI

Are there any legal restrictions on Efgartigimod PH20 SC?

"Efgartigimod PH20 SC is currently in Phase 2 of clinical trials. While there is some evidence supporting its safety, more data is needed to verify the efficacy of this medication."

Answered by AI

Are there several sites running this trial in Canada?

"Currently, this clinical trial is taking place in Boca Raton, Carlsbad, and Iowa City. However, there are 18 other sites where this trial is being conducted. To limit travel time and strain, please choose the location nearest you."

Answered by AI

What prior research has there been on Efgartigimod PH20 SC?

"Efgartigimod PH20 SC was first researched in 2020 at a location called Investigator Site 3800006. There have been 9 completed trials since then, with 4 more active ones currently underway--many of which are based in Boca Raton, California."

Answered by AI

Are there still opportunities for people to participate in this research project?

"That is correct, the information on clinicaltrials.gov does show that this study is actively looking for patients to enroll. The original posting date was September 18th 2020, with the most recent edit being June 9th 2022. In total, 360 individuals are needed across 18 different locations."

Answered by AI

Has this type of trial been conducted before?

"To date, 4 studies regarding Efgartigimod PH20 SC are ongoing in 32 metropolitan areas and 39 countries. The initial study was conducted in 2020 and completed Phase 3 drug approval that same year. This research project, which argenx sponsored, included 101 patients total. In the years since 2020, 9 more trials have concluded."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Kansas
North Carolina
Other
New Jersey
What site did they apply to?
Investigator site 77
Investigator site 0010003
Other
Investigator site 26
How many prior treatments have patients received?
0
1
2
3+

Why did patients apply to this trial?

I am hoping this trial will help my condition. I have tried Mutiple other remedies, and nothing works to improve my conditions.
PatientReceived 2+ prior treatments
I have had CIDP for almost 30 years and I have done all the customary treatments for CIDP with little/ no improvement.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long is the trial? How long do screening visits take? How often are the faucet visits and their duration?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
2020. "A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04280718.
All > Chronic Inflammatory Demyelinating Polyneuropathy > Cidp
~100 spots leftby Mar 2027
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