Your session is about to expire
← Back to Search
Protein Replacement Therapy
ER004 for Hypohidrotic Ectodermal Dysplasia (EDELIFE Trial)
Phase 2
Recruiting
Led By Holm Schneider, MD
Research Sponsored by EspeRare Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male fetal subject with confirmed diagnosis of XLHED
Adult mother with confirmed pregnancy no later than week 23+6 and genetically confirmed as carrier of an EDA mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3, 12, 18, 24, 36, 48, 60 months of age
Awards & highlights
EDELIFE Trial Summary
This trial is investigating if a new treatment is effective and safe for unborn babies with a certain genetic condition.
Who is the study for?
This trial is for unborn male babies with X-linked Hypohidrotic Ectodermal Dysplasia (XLHED), diagnosed via genetic testing. The mother must be an adult, confirmed pregnant up to week 23+6, and a carrier of the EDA mutation. Relatives aged 6 months to 75 years with XLHED can also join. Exclusions include other serious medical conditions, maternal infections or conditions increasing preterm birth risk, known hypersensitivity to certain drugs, significant additional fetal anomalies, and previous treatment with ER004.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of ER004 given intraamniotically (into the amniotic fluid) as a potential treatment for XLHED in unborn males. It's an open-label Phase 2 study without randomization but includes genotype-matched controls for primary estimand evaluation across multiple international centers.See study design
What are the potential side effects?
While specific side effects are not listed here, typical concerns may include reactions at the injection site within the womb or systemic effects on both mother and fetus due to drug exposure during pregnancy.
EDELIFE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My unborn son has been diagnosed with XLHED.
Select...
I am pregnant, not past 23 weeks and 6 days, and carry an EDA mutation.
Select...
I am a male relative with the same genetic mutation, aged between 6 months and 75 years, and have not been treated.
EDELIFE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3, 12, 18, 24, 36, 48, 60 months of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3, 12, 18, 24, 36, 48, 60 months of age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Assessment of eczema
Dental development
Incidence of TEAEs (treatment-emergent adverse events)
+10 moreEDELIFE Trial Design
1Treatment groups
Experimental Treatment
Group I: ER004Experimental Treatment1 Intervention
Human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor binding domain fusion protein.
Find a Location
Who is running the clinical trial?
Iqvia Pty LtdIndustry Sponsor
107 Previous Clinical Trials
170,048 Total Patients Enrolled
IQVIA (clinical CRO)UNKNOWN
Pierre Fabre Medicament (co-sponsor)UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My unborn son has been diagnosed with XLHED.You are allergic to pilocarpine or similar medications that work like pilocarpine.I do not have conditions affecting my tooth development other than XLHED.You have an ongoing infection that could harm the baby during pregnancy or after birth.I am pregnant, not past 23 weeks and 6 days, and carry an EDA mutation.I am a male relative with the same genetic mutation, aged between 6 months and 75 years, and have not been treated.If the mother has any medical condition that makes it more likely for the baby to be born early or for the mother to have serious problems during pregnancy.You have another significant physical abnormality that could cause serious health problems or increase the risk of a baby not surviving or being born too early.My mother has a documented HIV infection.I have never been treated with the study drug before.I carry a specific genetic mutation related to EDA.You have a condition related to pregnancy that increases the risk of early birth or harm to the mother, baby, or newborn.
Research Study Groups:
This trial has the following groups:- Group 1: ER004
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this experiment still in progress?
"Affirmative. The clinical trials website states that this investigation was initially posted on April 26th, 2022 and is currently looking for 20 test subjects from a single centre."
Answered by AI
How hazardous is ER004 for those using it therapeutically?
"The safety of ER004 received a rating of 2 since it is currently in Phase 2 testing, which suggests that there are some data validating its security but none yet confirming its effectiveness."
Answered by AI
How many people have taken part in this experiment?
"Affirmative. According to the information provided on clinicaltrials.gov, this medical trial is actively recruiting patients with an initial posting date of April 26th 2022 and a most recent update occurring October 27th 2022. The study requires 20 participants from one site in total."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger