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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 5 years
Awards & highlights
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2023 Phase 3 trial • 207 Patients • NCT0468707231%
Blood urine present
25%
Ecchymosis
25%
Petechiae
23%
Haematuria
16%
Contusion
15%
Epistaxis
14%
Mouth haemorrhage
13%
COVID-19
12%
Headache
11%
Purpura
10%
Gingival bleeding
10%
Injection site haemorrhage
9%
Upper respiratory tract infection
9%
Injection site bruising
7%
Injection site reaction
7%
Anaemia
7%
Oral blood blister
7%
Injection site erythema
6%
Urinary tract infection
6%
Fatigue
6%
Injection site pain
6%
Dizziness
5%
Diarrhoea
5%
Injection site rash
5%
Hyperuricaemia
5%
Haematoma
5%
Hypertension
2%
Arthralgia
2%
Vessel puncture site haemorrhage
2%
C-reactive protein increased
2%
Dyspepsia
1%
Abdominal distension
1%
COVID-19 pneumonia
1%
Meningitis aseptic
1%
Haematochezia
1%
Immune thrombocytopenia
1%
Amaurosis fugax
1%
Vitreous haemorrhage
1%
Melaena
1%
Cholecystitis acute
1%
Urosepsis
1%
Haemoglobin decreased
1%
Cerebral infarction
1%
Intermenstrual bleeding
1%
Thrombocytopenia
1%
Heavy menstrual bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
Efgartigimod PH20 SC
Placebo PH20 SC
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
71 Previous Clinical Trials
10,851 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your condition got worse during the previous stage of the trial and you can be treated with efgartigimod PH20 SC.I do not have any serious health issues or recent major surgeries that could affect the trial.I am a woman who can have children, not pregnant, and using birth control.I have been treated with efgartigimod PH20 SC or participated in its trials.
Research Study Groups:
This trial has the following groups:- Group 1: efgartigimod PH20 SC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patient Testimony for trial: Trial Name: NCT04280718 — Phase 2
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