An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
Launched by DENALI THERAPEUTICS INC. · Oct 3, 2023
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • For participants from Study DNLI-E-0002 only: Completed at least through the Week 49 visit in Study DNLI-E-0002 and did not discontinue study intervention early
- • For participants from Study DNLI-E-0007 only: Completed the treatment period of 96 weeks in Cohort A for nMPS II participants and 48 weeks in Cohort B for nnMPS II participants
- Key Exclusion Criteria:
- • Unstable or poorly controlled medical condition(s) or significant medical or psychological comorbidity or comorbidities that, in the opinion of the investigator, would interfere with safe participation in the trial or interpretation of study assessments
About Denali Therapeutics Inc.
Denali Therapeutics Inc. is a biotechnology company focused on developing innovative therapies for neurodegenerative diseases, including Alzheimer's disease and Parkinson's disease. With a commitment to advancing scientific discovery, Denali leverages its proprietary platform to design and optimize biologic and small molecule treatments that target underlying disease mechanisms. The company is dedicated to improving patient outcomes through rigorous clinical trials and collaborations with leading research institutions, aiming to transform the landscape of neurodegenerative disease treatment and enhance the quality of life for patients and their families.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Toronto, Ontario, Canada
Cincinnati, Ohio, United States
Edegem, Antwerpen, Belgium
Hamburg, , Germany
Jette, , Belgium
Prague, , Czechia
Montréal, Quebec, Canada
Chapel Hill, North Carolina, United States
Montréal, , Canada
Rotterdam, , Netherlands
Edmonton, Alberta, Canada
Rotterdam, , Netherlands
Chapel Hill, North Carolina, United States
Prague, , Czechia
Lille, , France
Barcelona, , Spain
Hochheim, , Germany
Patients applied
Trial Officials
Jose Alcantara Rodriguez, PharmD
Study Director
Denali Therapeutics
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported