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Sahlgrenska University Hospital | Gothia Forum - Clinical Trial Center

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A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With LOPD

Amicus Therapeutics logo

Amicus Therapeutics

Status and phase

Active, not recruiting
Phase 3

Conditions

Pompe Disease (Late-onset)

Treatments

Drug: AT2221
Biological: ATB200

Study type

Interventional

Funder types

Industry

Identifiers

NCT04138277
ATB200-07

Details and patient eligibility

About

This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.

Full description

This is an open label extension study for subjects who completed the ATB200-03 study. The subjects will stay in this study until regulatory approval or marketing authorization and/or commercialization in the participating subject's country.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  1. Subject must have completed Study ATB200-03.

Exclusion Criteria

  1. Subject plans to receive gene therapy or participate in another interventional study for Pompe disease.
  2. Subject, if female, is pregnant or breastfeeding.
  3. Subject, whether male or female, is planning to conceive a child during the study.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

110 participants in 1 patient group

ATB200/AT2221
Experimental group
Description:
Participants received ATB200 co-administered with AT2221 capsule (Miglustat)
Treatment:
Biological: ATB200
Drug: AT2221

Trial contacts and locations

60

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Data sourced from clinicaltrials.gov

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