Efgartigimod PH20 SC for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Chronic Inflammatory Demyelinating PolyradiculoneuropathyEfgartigimod PH20 SC - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 19 Secondary · Reporting Duration: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study

Week 48
Change from baseline over time in BPI SF
Change from baseline over time in EQ-5D-5L
Change from baseline over time in HADS
Change from baseline over time in RT-FSS
Change from baseline over time in TSQM-9
Change from baseline over time of I-RODS disability scores
Change from baseline over time of TUG score
Change from baseline over time of mean grip strength
Change from baseline over time of the MRC Sum score
Change from baseline over time of the adjusted INCAT score
Changes from baseline over time of serum IgG levels (total)
Incidence of treatment-emergent adverse events and serious adverse events
Percentage of patients performing self-administration over time
Percentage of patients with treatment administered by caregiver over time.
Percentage of patients without clinical deterioration over time, defined by adjusted INCAT deterioration ≥1 point compared to baseline.
Up to 51 weeks
Changes from baseline over time of serum IgG levels
Efgartigimod serum concentrations
Efgartigimod serum concentrations over time during the trial
Percentage of patients with and titers of binding antibodies towards efgartigimod and/or rHuPH20 and the presence of neutralizing antibodies against efgartigimod and titers of NAb against rHuPH20.
Percentage of patients with titers of binding antibodies towards efgartigimod and the presence of neutralizing antibodies against efgartigimod.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

efgartigimod PH20 SC
1 of 1

Experimental Treatment

360 Total Participants · 1 Treatment Group

Primary Treatment: Efgartigimod PH20 SC · No Placebo Group · Phase 2

efgartigimod PH20 SC
Biological
Experimental Group · 1 Intervention: Efgartigimod PH20 SC · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study

Who is running the clinical trial?

argenxLead Sponsor
43 Previous Clinical Trials
6,811 Total Patients Enrolled
1 Trials studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy
360 Patients Enrolled for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are of childbearing potential and have a negative urine pregnancy test at baseline before IMP administration.

Who else is applying?

How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%