A Phase 1b/2 Study to Evaluate NB-4746 in Participants with Amyotrophic Lateral Sclerosis
Research type
Research Study
Full title
A Phase 1b/2 Study to Evaluate NB-4746 in Participants with Amyotrophic Lateral Sclerosis
IRAS ID
1013368
Contact name
Lahar Mehta
Contact email
Sponsor organisation
Nura Bio Inc
Clinicaltrials.gov Identifier
Research summary
The purpose of this trial is to learn about the effects of NB-4746 compared with placebo in people with amyotrophic lateral sclerosis (ALS). ALS is a nervous system disease that affects the cells in the brain and spinal cord that control muscle movement leading to symptoms like muscle twitching, weakness in an arm or leg, and trouble swallowing. NB-4746 is an oral molecule given in a capsule that may protect nerve cells from damage.
About 80 participants are expected to take part. Participants must be 18 years or older, and of any sex and race.
People can take part in this trial if they:
have ALS confirmed by the trial doctors using different tests.
have had symptoms of ALS (weakness) within 48 months of taking part in this trial for Part A of the trial and within 24 months of taking part in the trial for Part B.
have not received treatment for ALS or on a stable dose of an approved treatment for ALS.
can slowly exhale a volume of air at least 60% of what is expected for the
participant’s sex, height and age.
Before treatment, trial doctors will check the participants’ health to ensure they can take part (up to 2 months). This trial has 2 parts. Part A is completed before Part B begins.
Part A: Participants will be randomly placed into 1 of the 3 groups (1 month):
Group 1: Low dose NB-4746, twice daily
Group 2: High dose NB-4746, twice daily
Group 3: Placebo, twice daily
Part B: Participants will be randomly placed into 1 of the 2 groups (12 weeks):
Group 1: NB-4746 at a dose determined by Part A, twice daily
Group 2: Placebo, twice daily
After Part A or B, participants may choose to enter an open-label extension where everyone receives NB-4746 for up to 1 year. Trial doctors and participants will know which treatment the participants will receive. Participants will attend a final visit after their last dose so trial doctors can check their overall health.
This study will be conducted at NHS sites across the UK.REC name
Wales REC 5
REC reference
26/WA/0085
Date of REC Opinion
11 May 2026
REC opinion
Further Information Favourable Opinion