Actively Recruiting

Phase 3
Age: 0Years - 1Year
All Genders
NCT07473973

ENERGY 2: Evaluation of the Efficacy and Safety of INZ-701 in Infants With ENPP1 Deficiency

Led by Inozyme Pharma · Updated on 2026-03-18

12

Participants Needed

8

Research Sites

188 weeks

Total Duration

On this page

Sponsors

I

Inozyme Pharma

Lead Sponsor

B

BioMarin Pharmaceutical

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary purpose of ENERGY 2 (Study INZ701-105) is to assess the efficacy and safety of INZ-701 in infants with ENPP1 Deficiency.

CONDITIONS

Official Title

ENERGY 2: Evaluation of the Efficacy and Safety of INZ-701 in Infants With ENPP1 Deficiency

Who Can Participate

Age: 0Years - 1Year
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infant aged 60; 1 year at the time of enrollment.
  • Confirmed diagnosis of ENPP1 deficiency through genetic testing.
  • Clinical features consistent with generalized arterial calcification of infancy (GACI), such as vascular calcification or cardiac involvement.
  • Medically stable to participate in a 52-week treatment study.
  • Written informed consent provided by a parent or legal guardian.
Not Eligible

You will not qualify if you...

  • Receiving end-of-life or hospice care.
  • Prior treatment with INZ-701, unless received through an approved expanded access program.
  • Concurrent participation in another interventional clinical trial.
  • Planned major surgery during the study period that would interfere with study participation.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Hospital Universitario Pedro Ernesto/Rio de Janeiro

Rio de Janeiro, Brazil, 20551-030

Actively Recruiting

2

Hopital Necker - Enfants Malades

Paris, France, 75015

Actively Recruiting

3

Gyermekgyogyaszat, DE

Debrecen, Hungary

Actively Recruiting

4

Azienda Ospedaliera Universitaria Meyer

Florence, Italy, 50139

Actively Recruiting

5

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia, 12713

Actively Recruiting

6

Hospital Sant Joan de Deu Edificio Consultas Externas. Unitat de Recerca

Barcelona, Esplugues de Llobregat, Spain, 08950

Actively Recruiting

7

Umraniye Traiing and Research Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

8

Royal Manchester Children's Hospital

Manchester, United Kingdom, M13 9WL

Actively Recruiting

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Research Team

T

Trial Specialist

CONTACT

M

Medical Director, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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