Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia

Conditions

• X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ER004 — BIOLOGICAL
  Intra-amniotic route 100 mg/kg of estimated fetal weight per injection. 3 injections, approximately 3 weeks apart starting from gestational week 26

Study Details

This is an open-label, prospective, genotype-match controlled for primary estimand, non randomized, multicenter, international Phase 2 clinical trial designed to investigate the efficacy and safety of ER004 administered intraamniotically as a treatment for unborn XLHED male subjects.

Key Dates

Start date

Apr 26, 2022

Status verified

Apr 2025

Primary completion

Feb 28, 2027

Completion

Dec 31, 2032

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ER004
  Human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor binding domain fusion protein.

Primary Outcome Measure

Mean sweat volume [ Time Frame: at 6 months of age (corrected age for subjects born at < 37 weeks) ]

Central Contacts

• Agnes Jaulent
  +41 22 794 4004
  [email protected]
• Marlène Guiraud
  +33 5 34 50 60 00
  [email protected]

Locations (2)

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