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Monoclonal Antibodies

efgartigimod PH20 SC in stage B for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (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 during the randomized placebo-controlled stage b
Awards & highlights

ADHERE Trial Summary

This trial is testing a new drug to treat CIDP, a disease that causes weakness and numbness in the arms and legs.

Eligible Conditions
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

ADHERE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 weeks during the randomized placebo-controlled stage b
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 weeks during the randomized placebo-controlled stage b for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stage A: Percentage of patients with confirmed evidence of clinical improvement(ECI)
Stage B: Time to first adjusted INCAT deterioration compared to Stage B baseline
Secondary outcome measures
Stage A: Change from Stage A baseline over time in I-RODS disability scores
Stage A: Change from Stage A baseline over time in Medical Research Council (MRC) Sum score
Stage A: Change from Stage A baseline over time in TUG score
+23 more

ADHERE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: efgartigimod PH20 SCExperimental Treatment1 Intervention
patients receiving efgartigimod PH20 SC in both stage A as stage B
Group II: PlaceboPlacebo Group2 Interventions
patients receiving efgartigimod PH20 SC during stage A and receiving placebo in stage B
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
efgartigimod PH20 SC in stage B
2020
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
60 Previous Clinical Trials
8,910 Total Patients Enrolled
1 Trials studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy
226 Patients Enrolled for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Frequently Asked Questions

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

Are there any remaining slots available in this research trial?

"Affirmative. Evidence from clinicaltrials.gov shows that this trial, which launched on April 15th 2020 is still recruiting participants. It requires 360 patients to be drawn from 36 different medical centres around the country."

Answered by AI

Is there a notable concentration of this experiment taking place in Canada?

"A variety of 36 sites are currently running this trial, such as Investigator site 35 in Philadelphia, Investigator site 48 in Cincinnati and Investigator site 184 in Burlington. Additionally, there are a host of other locations also involved."

Answered by AI

How many participants are currently enrolled in this trial?

"Affirmative, the information hosted on clinicaltrials.gov corroborates that this trial is actively seeking participants. It was first listed on April 15th 2020 and has had its details recently revised as of November 16th 2022. 360 subjects are needed between 36 sites to complete the study."

Answered by AI

Has efgartigimod PH20 SC been given the green light by the FDA for use in stage B?

"Our team at Power gave efgartigimod PH20 SC a safety score of 2 in stage B. This is due to the fact that Phase 2 trials have data supporting their security, but lack information on efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
Investigator site 0010014
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the 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 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/NCT04281472.
~72 spots leftby Apr 2025
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