WHO ICTRP trial
Study to determine effectiveness and safety of DNL310 vs Idursulfase in…
EUCTR2021-005200-35-DE · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2021-005200-35-DE |
|---|---|
| Public title | Study to determine effectiveness and safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Hunter Syndrome |
| Scientific title | A Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II |
| Primary sponsor | Denali Therapeutics Inc. |
| Registry | EU Clinical Trials Register |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Czechia;Spain;Turkey;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Netherlands;Germany;Sweden |
| Conditions | Mucopolysaccharidosis Type II [MPS II];Therapeutic area: Diseases [C] - Nervous System Diseases [C10] |
| Interventions | Product Name: DNL310 Product Code: DNL310 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: DNL310 Current Sponsor code: DNL310 Drug Substance. Also referred to as: ETV:IDS Drug Substance or ETV-IDS Drug… |
| Registration date | Apr 27, 2022 |
| Target size | 54 |
| Secondary IDs | DNLI-E-0007 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: