ALS (Amyotrophic Lateral Sclerosis)Phase 2BANYANNCT07688239
The BANYAN Trial, an ALS MyMatch Trial Evaluating Safety, Biomarker Activity, and Microglial Activation of Nasal Foralumab
A Phase 2 study testing Foralumab Nasal in people with ALS (Amyotrophic Lateral Sclerosis) and ALS - Amyotrophic Lateral Sclerosis, run by Tiziana Life Sciences LTD at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis), ALS - Amyotrophic Lateral Sclerosis, ALS
- What is being tested?
- Foralumab Nasal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Sep 2026to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age and ≤75 years of age with a diagnosis of symptomatic ALS by revised El Escorial Criteria (clinically possible, probable, probable lab-supported, or definite).
- Participant must be actively enrolled and must have met eligibility criteria for the Healey ALS MyMatch Common Screening Protocol (MCSP) AND determined to have met preliminary eligibility on targeted medical history and review of systems and safety laboratory results required for this trial.
- Blood neurofilament (NfL) level of greater than 40 pg/mL as measured by the MyMatch Common Screening Protocol specific NfL assay.
- Ability to provide written informed consent.
- Less than or equal to 24-months since onset of weakness or spasticity attributed to ALS.
- Slow vital capacity (SVC) of at least 65% predicted value for gender, height and age at trial screening visit.
Show all 11Show fewer
- Participant must not have taken riluzole and/or edaravone for at least 30 days, or be on a stable dose of riluzole and/or edaravone for at least 30 days prior to baseline (riluzole-naïve or edaravone-naïve participants are permitted in the study).
- Negative urine pregnancy test within 7 days prior to the first dose of study therapy for women of child-bearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active women of child-bearing potential and male participants must agree to use highly effective methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 90 days after the completion of study treatment.
- Participants must be able to travel to the study site for study visits and complete required study procedures.
- Participants who are participating in the PET or Lumbar Puncture (LP) outcomes, must be determined to be able to safely tolerate these study procedure(s) in the opinion of the study investigator AND as determined by the targeted medical history and review of systems in the MCSP. Both procedures are highly encouraged.
- Participants whose immunizations are fully up to date at Screening, according to the assessment of their primary care physician and neurologist.
Who cannot join
- Clinically significant medical condition that would pose a risk to the participant, according to the PI's judgment and examination prior to baseline.
- Active ENT disease (such as allergic rhinitis, chronic rhinitis, active sinusitis treated within the past 30 days or deemed as clinically relevant, clinically significant deviated nasal septum, nasal polyps) that might interfere with safely administering the drug nasally.
- Active clinically significant infection or immunocompromised condition.
- Treatment with chronic immunosuppressants or other immunosuppressants within the past 90 days.
- Concomitant use of investigational treatments for ALS within 5 half-lives or 30 days prior to the Baseline visit, whichever is longest (high dosage methylcobalamin permitted).
- Exposure to any gene or cell therapies under investigation for treatment of ALS.
- Inability to tolerate nasally administered medications.
- Participant reported history of any vaccines within past 14 days (prior to first dose of foralumab).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
Nova Southeastern University
Davie, Florida, 33314
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
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)
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:
Read more
- Is nasal foralumab safe for people with ALS, and how well do they tolerate it over 12 and 24 weeks of treatment?
- 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
- Being tested
- Foralumab Nasal, Placebo
- Keywords
- Lou Gehrig's Disease, Foralumab, Nasal foralumab, Anti-CD3, Anti-CD3 monoclonal antibody, Neuroinflammation
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foralumab NasalDrug
Foralumab is an anti-CD3 monoclonal antibody administered as a nasal spray. Participants will complete eight 3-week dosing cycles over the study. During each cycle, Foralumab will be administered intranasally three times per week for the first two weeks, with no administration in the third week.
PlaceboDrug
Foralumab placebo nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Participants will complete eight 3-week dosing cycles over the study. During each cycle, Foralumab placebo nasal solution will be administered intranasally three times per week for the first two weeks, with no administration in the third week.
| Study group | Role | What they receive |
|---|---|---|
| Foralumab | Experimental | Not described Receives: Drug: Foralumab Nasal |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Occurrence of serious and non-serious treatment emergent adverse events and clinically significant treatment emergent abnormalities.
The occurrence of serious (inclusive of SUSARs) and non-serious treatment emergent adverse events (TEAEs) and clinically significant treatment-emergent abnormalities in clinical, including vital signs (heart rate, blood pressure, weight) and laboratory values (reported as AEs) over both 12 (4 cycles) and 24 (8 cycles) week treatment periods in the Safety population.
Measured: 12 weeks and 24 weeks
Tolerability - Percentage of participant that complete 12 or 24 weeks of study treatment.
the percentage of nasal foralumab treated participants in the Safety population who complete four (12-weeks) or eight (24-weeks) cycles of study treatment without study drug attributed intolerable AEs or SAEs or AESIs that lead to early permanent drug discontinuation.
Measured: 12 and 24 Weeks
Secondary outcomes (3)
Immune Reconstitution Changes: change in blood Tregs and functional T cell markers on flow cytometry
Evaluate immune reconstitution changes from baseline following 4 cycles of foralumab 50 μg dosage treatment compared to placebo, as measured by blood Treg number and functional T cell markers including CD4+ T cell subset profiles on flow cytometry
Measured: 12 weeks
Immunological gene expression changes: single cell RNA sequencing
Evaluate immune reconstitution changes from baseline following 4 cycles of foralumab 50 μg dosage treatment compared to placebo, as measured by blood Treg number and functional T cell markers including CD4+ T cell subset profiles on flow cytometry
Measured: 12 weeks
Neurofilament light changes
evaluate plasma and CSF neurofilament light (pNfL) changes from baseline following 4 cycles of foralumab 50 μg dosage treatment compared to placebo.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start23 Sep 2026
- Primary completionJul 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS (Amyotrophic Lateral Sclerosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tiziana Life Sciences LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688239
- Sponsor's protocol ID
- TILS-ALS-01
- Acronym
- BANYAN
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07688239
- Acronym / sponsor ID
- BANYAN / TILS-ALS-01
- Keywords
- Lou Gehrig's Disease, Foralumab, Nasal foralumab, Anti-CD3, Anti-CD3 monoclonal antibody, Neuroinflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Tiziana Life Sciences LTDIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is nasal foralumab safe for people with ALS, and how well do they tolerate it over 12 and 24 weeks of treatment?
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foralumab | Experimental | Drug: Foralumab Nasal |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults ≥18 years of age and ≤75 years of age with a diagnosis of symptomatic ALS by revised El Escorial Criteria (clinically possible, probable, probable lab-supported, or definite).
- Participant must be actively enrolled and must have met eligibility criteria for the Healey ALS MyMatch Common Screening Protocol (MCSP) AND determined to have met preliminary eligibility on targeted medical history and review of systems and safety laboratory results required for this trial.
- Blood neurofilament (NfL) level of greater than 40 pg/mL as measured by the MyMatch Common Screening Protocol specific NfL assay.
- Ability to provide written informed consent.
- Less than or equal to 24-months since onset of weakness or spasticity attributed to ALS.
Key exclusion criteria (8 listed)
- Clinically significant medical condition that would pose a risk to the participant, according to the PI's judgment and examination prior to baseline.
- Active ENT disease (such as allergic rhinitis, chronic rhinitis, active sinusitis treated within the past 30 days or deemed as clinically relevant, clinically significant deviated nasal septum, nasal polyps) that might interfere with safely administering the drug nasally.
- Active clinically significant infection or immunocompromised condition.
- Treatment with chronic immunosuppressants or other immunosuppressants within the past 90 days.
- Concomitant use of investigational treatments for ALS within 5 half-lives or 30 days prior to the Baseline visit, whichever is longest (high dosage methylcobalamin permitted).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foralumab NasalForalumab is an anti-CD3 monoclonal antibody administered as a nasal spray. Participants will complete eight 3-week dosing cycles over the study. During each cycle, Foralumab will be administered intranasally three times per week for the first two weeks, with no administration in the third week. | Drug | Foralumab |
| PlaceboForalumab placebo nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Participants will complete eight 3-week dosing cycles over the study. During each cycle, Foralumab placebo nasal solution will be administered intranasally three times per week for the first two weeks, with no administration in the third week. | Drug | Placebo |
Primary outcome
Safety - Occurrence of serious and non-serious treatment emergent adverse events and clinically significant treatment emergent abnormalities.
Time frame: 12 weeks and 24 weeks
The occurrence of serious (inclusive of SUSARs) and non-serious treatment emergent adverse events (TEAEs) and clinically significant treatment-emergent abnormalities in clinical, including vital signs (heart rate, blood pressure, weight) and laboratory values (reported as AEs) over both 12 (4 cycles) and 24 (8 cycles) week treatment periods in the Safety population.
Tolerability - Percentage of participant that complete 12 or 24 weeks of study treatment.
Time frame: 12 and 24 Weeks
the percentage of nasal foralumab treated participants in the Safety population who complete four (12-weeks) or eight (24-weeks) cycles of study treatment without study drug attributed intolerable AEs or SAEs or AESIs that lead to early permanent drug discontinuation.
3 secondary outcomes
Immune Reconstitution Changes: change in blood Tregs and functional T cell markers on flow cytometry
Time frame: 12 weeks
Immunological gene expression changes: single cell RNA sequencing
Time frame: 12 weeks
Neurofilament light changes
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Foralumab Nasal in people with ALS (Amyotrophic Lateral Sclerosis) and ALS - Amyotrophic Lateral Sclerosis, run by Tiziana Life Sciences LTD at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Occurrence of serious and non-serious treatment emergent adverse events and clinically significant treatment emergent abnormalities. (time frame: 12 weeks and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.