Active Not Recruiting PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT04093349

A Gene Transfer Study for Late-Onset Pompe Disease (RESOLUTE)

Phase 1/2, Dose-escalation Study to Evaluate the Safety, Tolerability and Efficacy of a Single Intravenous Infusion of SPK-3006 in Adults With Late-onset Pompe Disease

Sponsor: Spark Therapeutics, Inc.

Conditions Acid Maltase Deficiency Glycogen Storage Disease Type 2 Glycogen Storage Disease Type II LOPD Lysosomal Storage Diseases Pompe Disease Pompe Disease (Late-onset)

Interventions SPK-3006

Updated 20 times since 2019 Last updated: Nov 25, 2024 Started: Oct 1, 2020 Primary completion: Apr 30, 2032 Completion: Apr 30, 2032

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04093349, this PHASE1/PHASE2 trial focuses on Acid Maltase Deficiency and Glycogen Storage Disease Type 2 and remains ongoing. Sponsored by Spark Therapeutics, Inc., it has been updated 20 times since 2020, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

20 versions recorded

Sep 2025 — Present [monthly]

Active Not Recruiting PHASE1/PHASE2
Dec 2024 — Sep 2025 [monthly]

Active Not Recruiting PHASE1/PHASE2
Sep 2024 — Dec 2024 [monthly]

Active Not Recruiting PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Apr 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE1_PHASE2

▶ Show 15 earlier versions

Dec 2023 — Apr 2024 [monthly]

Active Not Recruiting PHASE1_PHASE2
Sep 2023 — Dec 2023 [monthly]

Active Not Recruiting PHASE1_PHASE2
Sep 2022 — Sep 2023 [monthly]

Active Not Recruiting PHASE1_PHASE2

Status: Recruiting → Active Not Recruiting
Jul 2022 — Sep 2022 [monthly]

Recruiting PHASE1_PHASE2
Mar 2022 — Jul 2022 [monthly]

Recruiting PHASE1_PHASE2
Feb 2022 — Mar 2022 [monthly]

Recruiting PHASE1_PHASE2
Sep 2021 — Feb 2022 [monthly]

Recruiting PHASE1_PHASE2
Jun 2021 — Sep 2021 [monthly]

Recruiting PHASE1_PHASE2
Jan 2021 — Jun 2021 [monthly]

Recruiting PHASE1_PHASE2
Dec 2020 — Jan 2021 [monthly]

Recruiting PHASE1_PHASE2
Sep 2020 — Dec 2020 [monthly]

Recruiting PHASE1_PHASE2

Status: Suspended → Recruiting
Jun 2020 — Sep 2020 [monthly]

Suspended PHASE1_PHASE2

Status: Recruiting → Suspended
Mar 2020 — Jun 2020 [monthly]

Recruiting PHASE1_PHASE2

Status: Not Yet Recruiting → Recruiting
Jan 2020 — Mar 2020 [monthly]

Not Yet Recruiting PHASE1_PHASE2
Oct 2019 — Jan 2020 [monthly]

Not Yet Recruiting PHASE1_PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Spark Therapeutics, Inc.

Data source: Spark Therapeutics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Angers, France , Atlanta, United States , Birmingham, United Kingdom , Copenhagen, Denmark , Fairfax, United States , Garches, France , Kansas City, United States , Lille, France , London, United Kingdom , Marseille, France and 19 more locations