A Phase 3 interventional study of Tralesinidase alfa (TA) in MPS IIIB, sponsored by Spruce Biosciences. Not yet recruiting. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Spruce Biosciences · Phase 3, Interventional, and Treatment
The primary objectives of this study are to evaluate the effects of Tralesinidase Alfa (TA) on cognition
58 studies on the registry are indexed under Mucopolysaccharidosis III; 16 are open to participants now.
This study's planned enrollment of 14 is above the median of 12 across 33 interventional studies indexed under Mucopolysaccharidosis III.
Browse Mucopolysaccharidosis III studies →Spruce Biosciences is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Has a diagnosis of MPS IIIB confirmed by deficient NAGLU enzyme activity during screening.
Has nonattenuated severe MPS IIIB by the Genotype and Clinical Assessment Committee.
Is ≥1 and ≤5 years of age with BSID-III-C raw score of \<70. Is male or female as identified at birth.
Exclusion Criteria:
Genotyped for a known MPS IIIB variant associated with an attenuated phenotype or has a sibling with a known attenuated phenotype.
Has another neurological illness that may have caused cognitive decline (e.g., trauma, meningitis, or hemorrhage) before study entry.
Has received stem cell, gene therapy, or enzyme replacement therapy for MPS IIIB.
Drug: Tralesinidase alfa (TA)
TA study drug is a sterile solution for ICV infusion.
Change from Baseline in Bayley Scales of Infant and Toddler Development, Third Edition, Cognition Domain (BSID-III-C) Raw Score
The BSID-III-C is a standardized tool that evaluates cognitive development in young children, capturing skills such as processing speed, problem solving, and play. Raw scores are used to sensitively measure individual change over time, independent of age. Assessments are administered by a trained, blinded rater and reviewed by a central blinded rater. The endpoint is the difference in mean change from baseline in BSID-III-C raw score between the tralesinidase alfa and control arms at Week 260
Time frame: Baseline to Week 260 (approximately 5 years)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Aug 2033, 80 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tralesinidase alfa
Spruce Biosciences