BANYANNCT07688239

The BANYAN Trial, an ALS MyMatch Trial Evaluating Safety, Biomarker Activity, and Microglial Activation of Nasal Foralumab

StatusEnrolling by Invitation

PhasePhase 2

SponsorTiziana Life Sciences LTD

Primary completionJul 2027 (estimated)

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

Notable Oct 26, 2026 Enrolling by invitation only
- Start date changed from estimate of Sep 25, 2026 to Sep 23, 2026
- Site contacts updated at 3 of 4 sites
Notable Oct 20, 2026 Start date: Jul 25, 2026 to Sep 25, 2026
- Trial sites expanded: 0 → 4 locations
- Eligibility criteria expanded, about 19 words
Jun 30, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Safety - Occurrence of serious and non-serious treatment emergent adverse events and clinically significant treatment emergent abnormalities.

Timeframe: 12 weeks and 24 weeks

Tolerability - Percentage of participant that complete 12 or 24 weeks of study treatment.

Timeframe: 12 and 24 Weeks

Secondary (3)

Immune Reconstitution Changes: change in blood Tregs and functional T cell markers on flow cytometry

Immunological gene expression changes: single cell RNA sequencing

Neurofilament light changes

Arms and interventions

ForalumabExperimental

PlaceboPlacebo comparator

Drugs: Foralumab Nasal, Placebo

Sites

4 sites in 1 country

About this trial

The goal of this clinical trial is to learn whether a nasal spray medicine called foralumab is safe and easy to tolerate in adults with amyotrophic lateral sclerosis (ALS). ALS is a disease that slowly damages the nerve cells that control movement, causing muscles to grow weaker over time. Foralumab is being studied as a possible way to calm the inflammation and immune system activity that are thought to play a role in ALS. The main questions it aims to answer are: 1. Is nasal foralumab safe for people with ALS, and how well do they tolerate it over 12 and 24 weeks of treatment? 2. Does foralumab change certain markers in the blood and spinal fluid, and lower inflammation in the brain, compared with a placebo? Researchers will compare people who take foralumab to people who take a placebo (a matching nasal spray with no medicine in it) to see how the two groups differ in safety and in these markers. About 44 adults aged 18 to 75 with ALS will take part. For the first 12 weeks, participants will be randomly assigned so that about 3 in 4 use foralumab and about 1 in 4 use the placebo. Neither the participants nor the study staff will know who is using which during this time (this is called "double-blind"). After the first 12 weeks, everyone who continues will use foralumab for the next 12 weeks. Participants will: * Spray the study treatment into both nostrils 3 times a week, on alternate days, in cycles of 2 weeks on treatment followed by 1 week off * Learn to use the nasal spray device so they or a caregiver can give most doses at home * Take part for about 8.5 months in total, which includes screening, 24 weeks of treatment, and a safety check-in about 4 weeks after the last dose * Attend some visits at the study clinic and complete others remotely by phone or video * Have study tests that may include blood samples, breathing and muscle-strength checks, and - for those who agree and at certain study centers - spinal fluid samples and brain scans to measure inflammation

Trial details

Enrollment: 44 participants (estimated)
Started: Sep 23, 2026
Study completion: Nov 2027 (estimated)
Eligibility: 18 to 75, all sexes, no healthy volunteers
Design: Interventional, randomized, quadruple blind, treatment
Oversight: Data monitoring committee, FDA-regulated drug
Conditions: Amyotrophic Lateral Sclerosis, Neuroinflammatory Diseases, ALS (Amyotrophic Lateral Sclerosis), ALS
Official title: A Phase 2a Randomized, Double-Blind Study to Evaluate the Safety, Biomarker Activity, and Microglial Activation of Nasal Foralumab in Patients With Amyotrophic Lateral Sclerosis (ALS)
First posted: Jul 7, 2026
Registry updated: Oct 28, 2026
Last verified: Oct 2026

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