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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

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.
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.
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.

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

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
64 Previous Clinical Trials
9,970 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
~85 spots leftby Mar 2027
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