CompletedPhase 2

A Study of NIDO-361 in Patients With SBMA

Denmark, Italy, South Korea54 participantsStarted 2024-03-01

Plain-language summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of NIDO-361 in adult patients with Spinal and Bulbar Muscular Atrophy (SBMA).

Who can participate

Age range18 Years – 70 Years

SexMALE

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Inclusion Criteria: * Ambulatory male * Documented SBMA diagnosis confirmed by DNA genetic testing * Able to complete six-minute walk test (6MWT) Exclusion Criteria: * Clinically significant cardiovascular, endocrine, hepatic, renal, pulmonary, gastrointestinal, neurologic, immunologic, malignant, metabolic, psychiatric, or other condition that, in the opinion of the Investigator, precludes the participant's safe participation in the study or would interfere with the study assessments * Inability to undergo MRI (mild sedation may be allowed)

What they're measuring

Analysis of Thigh and Total Lean Muscle Volume (LMV) [A+B+C]

Timeframe: Baseline, Day 180, Days 360-374 (Last Visit)

Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

Timeframe: Through study completion, an average of 1 year

Number of Participants Discontinuing Study Drug and Number of Participants' Deaths

Timeframe: Through study completion, an average of 1 year

Total Number of Mild, Moderate, and Severe Adverse Events (AEs) Across All Participants

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT06411912

SponsorNido Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-22

Results submitted2026-01-20

View on ClinicalTrials.gov More Spinal and Bulbar Muscular Atrophy trials