A Study to Evaluate the Efficacy and Safety of Subcutaneous Nomlabofusp in Subjects With Friedreich's Ataxia
← catalyst calendarNCT07778836 · readout ≤ 1,074 d
Sponsored by Larimar Therapeutics, Inc. (industry) · LRMR — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
150estimated
Sites
3
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-21
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-08-05 | estimated | When the study began enrolling |
| Primary completion | Jul 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2026-08-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Friedreich Ataxia
- Friedreich's Ataxia
Interventions
- Drug: Nomlabofusp — also filed as CTI-1601
- Drug: Placebo — also filed as CTI-1601 Placebo, Nomlabofusp Placebo
Primary outcomes
what the primary-completion date above is the date OFChange from baseline in Upright Stability Score (USS) subscale E of modified Friedreich's Ataxia Rating Scale (mFARS) at Week 72 (Region-specific)
measured Baseline, Weeks 12, 24, 36, 48, 72
Change from baseline in the total modified Friedreich's Ataxia Rating Scale (mFARS) at Week 72 (Region-specific)
measured Baseline, Weeks 12, 24, 36, 48, 72
Publications
- PMID 7786985 — cited as background
- PMID 24138436 — cited as background
- PMID 22752493 — cited as background
- PMID 20675166 — cited as background
- PMID 17056635 — cited as background
- PMID 8148458 — cited as background
- PMID 31958274 — cited as background
- PMID 3178453 — cited as background
- PMID 32746884 — cited as background
- PMID 21315377 — cited as background
- PMID 28815574 — cited as background
- PMID 26339677 — cited as background
- PMID 8962456 — cited as background
- PMID 33068037 — cited as background
- PMID 34191971 — cited as background
- PMID 18852343 — cited as background
- PMID 34985825 — cited as background
- PMID 8797541 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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