Trial · NCT06075537
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
NCT06075537, Phase 2, Phase 3, Enrolling by invitation, Denali Therapeutics Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT06075537. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06075537
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT06075537
- Status
- Enrolling by invitation
- Phases
- Phase 2, Phase 3
- Enrollment
- 99 participants, estimated
- Lead sponsor
- Denali Therapeutics Inc.
- Conditions
- Mucopolysaccharidosis II
- Interventions
- tividenofusp alfa
- First posted
- 2023-10-10
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and intensity of treatment-emergent adverse events (TEAEs) | 5 years | |
| Primary | Clinically significant changes in urine total glycosaminoglycan (GAG) concentrations throughout the treatment period | 5 years | |
| Primary | Incidence and intensity of infusion-related reactions (IRRs) | 5 years | The intensity of IRRs will be assessed following each infusion of DNL310 using the categories of Mild, Moderate and Severe. IRRs will be summarized overall as well as stratified by intensity. |
| Secondary | Percentage change from baseline in cerebrospinal fluid (CSF) heparan sulfate (HS) concentration | 5 years | |
| Secondary | Change from baseline in the Vineland-3 Adaptive Behavior Scale | 5 years | |
| Secondary | Change from baseline in the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) cognitive raw score | 5 years | |
| Secondary | Change from baseline in distance walked (meters) in the Six-Minute Walk Test (6MWT) | 5 years | |
| Secondary | Percent change from baseline in the sum of urine HS and dermatan sulfate (DS) concentrations | 5 years | |
| Secondary | Liver volume within the normal range (normal vs abnormal) as measured by MRI | 5 years | |
| Secondary | Spleen volume within the normal range (normal vs abnormal) as measured by MRI | 5 years |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06075537
GET https://conductscience.org/api/trials/v1/NCT06075537/registered