An Extension study of the Long-Term Safety, Tolerability, and Efficacy of DNL310 in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
Phase 1
Recruiting
- Conditions
- Mucopolysaccharidosis Type II [MPS II]MedDRA version: 20.0Level: LLTClassification code: 10056917Term: Hunter's syndrome Class: 10010331Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-503837-23-00
- Lead Sponsor
- Denali Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 99
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.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method