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Multiple System AtrophyPhase 2NCT06868628

A Phase 2a Study of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)

A Phase 2 study testing Foralumab Nasal in people with Multiple System Atrophy, run by Tiziana Life Sciences LTD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A Phase 2a Study of Foralumab Nasal in Patients with Multiple System Atrophy (MSA) Read more about this study

Who is it for?
Ages 30 to 85 years
Conditions the study is for
Multiple System Atrophy
What is being tested?
Foralumab Nasal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
19 May 2025to 1 Apr 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 30 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with a clinical diagnosis of Clinically Established or Clinically Probable Multiple System Atrophy in accordance with 2022 MDS diagnostic criteria.
  • Age 30 to 85 years, at the time of signing the informed consent.
  • Stable dopaminergic treatment for at least 4 weeks before enrollment.
  • Adequate hematologic parameters without ongoing transfusion support: Hemoglobin (Hb) ≥ 9 g/dL; Platelets ≥ 100 x 109 cells/L.
  • Creatinine ≤ 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 mL/minute x 1.73 m2 per the Cockcroft-Gault formula.
  • Total bilirubin ≤ 2 times the upper limit of normal (ULN) unless due to Gilbert's disease.
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  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN.
  • QT interval corrected for rate (QTcF) ≤ 470 msec for women and ≤ 450 msec for men on the ECG obtained at Screening.
  • Negative urine pregnancy test within 7 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), 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 WCBP and male patients 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.
  • Patients whose immunizations are fully up to date at the Screening, according to the assessment of their primary care physician and neurologist.
  • Ability to provide written informed consent.

Who cannot join

  • Diagnosis or suspicion of other cause for Parkinsonism or a known alternate neurologic diagnosis.
  • Female patient who is pregnant, lactating, breastfeeding, or planning to become pregnant during study.
  • Individuals with claustrophobia who cannot tolerate the study procedures
  • Non-MRI-compatible implanted devices.
  • Low-affinity binders for translocator protein (TSPO) PET ligands.
  • Systemic corticosteroid treatment in the past four weeks (excluding nasal or local treatment).
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  • Individuals with significant cognitive impairment (i.e., MoCA score less than or equal to 20).
  • Brain MRI indicative of significant abnormalities that interfere with PET-MRI co-registration (i.e., large prior hemorrhage or multiple infarcts).
  • Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina, or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV or hereditary long QT syndrome.
  • Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, except for antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care.
  • Patients who test positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) or positive Epstein-Barr virus (EBV) IgM at the Screening Visit.
  • Past medical history of a hematologic or solid malignancy.
  • Treatment with chronic immunosuppressives such as interferon, glatiramer acetate, fingolimod, Siponimod, dimethyl fumarate, or natalizumab within the past 90 days.
  • Inability to tolerate nasally administered medications.
  • Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 30 days, or anticipated need during the study.
  • Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past 8 months.
  • Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren's Syndrome, asthma, or type 1 diabetes.
  • Neutropenia or an absolute neutrophil count of < 1,000 cells/mL or other indicators of severe immunosuppression.
  • Severe lymphopenia or an absolute lymphocyte count of < 500 cells/mL
  • Patients with a history of gadolinium allergy.
  • A recent clinically significant active infection requiring treatment with antibiotics or other anti-infective agents within the past 15 days.
  • Any other medical or surgical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results.
  • Unable or unwilling to comply with protocol requirements.
  • Active COVID-19 disease.
  • COVID-19 vaccine within past 10 days or any other vaccine within past 7 days (at dosing).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brigham and Women's Hospital Movement Research Team contact

857-307-542

BWHMovementResearch@bwh.harvard.edu

United States1 site, 1 recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    BWH Movement Disorders Research Group, 857-307-542, BWHMovementResearch@bwh.harvard.edu

    Vikram Khurana, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2a Study to Evaluate Microglial Activation, Safety, and Clinical Effects of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)

A Phase 2a Study of Foralumab Nasal in Patients with Multiple System Atrophy (MSA)

Being tested
Foralumab Nasal
Medical subject headings
Multiple System Atrophy

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.

Study groups in NCT06868628
Study groupRoleWhat they receive
Foralumab NasalExperimentalThis study includes a 6-month observational lead-in phase followed by a 6-month open-label treatment phase with Foralumab Nasal.
Receives: Drug: Foralumab Nasal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Screening to Month 6 in the total MDS-UMSARS score

    Measured: From Screening to Month 6

  2. Change in TSPO activity as measured by [F-18]PBR06 retention calculated over whole brain and within key regions of interest (ROIs) at 6 months as compared to screening

    Measured: From Screening to Month 6

Secondary outcomes (9)

  1. Change from Screening to Month 6 in MDS-UMSARS Part III (motor examination) score

    Measured: From Screening to Month 6

  2. Proportion of patients with ≥30% improvement in MDS-UMSARS total score at Month 6

    Measured: From Screening to Month 6

  3. Change from Screening to Month 6 in COMPASS-31 total score

    Measured: From Screening to Month 6

  4. Change from Screening to Month 6 in MSA-QoL summary index score

    Measured: From Screening to Month 6

  5. Percent whole brain volume change (PWBVC) between screening and 6 months

    Measured: From Screening to Month 6

  6. Percent putamen volume change (PPVC) between screening and 6 months

    Measured: From Screening to Month 6

  7. Percent cerebellar volume change (PCVC) between screening and 6 months

    Measured: From Screening to Month 6

  8. Percent pontine volume change (PPoVC) between screening and 6 months

    Measured: From Screening to Month 6

  9. Percent midbrain volume change (PMVC) between screening and 6 months

    Measured: From Screening to Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start19 May 2025
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06868628
Sponsor's protocol ID
TILS-025
Status last verified
Jun 2026
First submitted
6 Mar 2025
Last updated
10 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wenning GK, Stankovic I, Vignatelli L, Fanciulli A, Calandra-Buonaura G, Seppi K, Palma JA, Meissner WG, Krismer F, Berg D, Cortelli P, Freeman R, Halliday G, Hoglinger G, Lang A, Ling H, Litvan I, Low P, Miki Y, Panicker J, Pellecchia MT, Quinn N, Sakakibara R, Stamelou M, Tolosa E, Tsuji S, Warner T, Poewe W, Kaufmann H. The Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy. Mov Disord. 2022 Jun;37(6):1131-1148. doi: 10.1002/mds.29005. Epub 2022 Apr 21.

    PubMed 35445419

  • Singhal T, Cicero S, Rissanen E, Ficke J, Kukreja P, Vaquerano S, Glanz B, Dubey S, Sticka W, Seaver K, Kijewski M, Callen AM, Chu R, Carter K, Silbersweig D, Chitnis T, Bakshi R, Weiner HL. Glial Activity Load on PET Reveals Persistent "Smoldering" Inflammation in MS Despite Disease-Modifying Treatment: 18 F-PBR06 Study. Clin Nucl Med. 2024 Jun 1;49(6):491-499. doi: 10.1097/RLU.0000000000005201. Epub 2024 Apr 17.

    PubMed 38630948

  • Singhal T, O'Connor K, Dubey S, Pan H, Chu R, Hurwitz S, Cicero S, Tauhid S, Silbersweig D, Stern E, Kijewski M, DiCarli M, Weiner HL, Bakshi R. Gray matter microglial activation in relapsing vs progressive MS: A [F-18]PBR06-PET study. Neurol Neuroimmunol Neuroinflamm. 2019 Jul 1;6(5):e587. doi: 10.1212/NXI.0000000000000587. eCollection 2019 Sep.

    PubMed 31355321

  • Shahnawaz M, Mukherjee A, Pritzkow S, Mendez N, Rabadia P, Liu X, Hu B, Schmeichel A, Singer W, Wu G, Tsai AL, Shirani H, Nilsson KPR, Low PA, Soto C. Discriminating alpha-synuclein strains in Parkinson's disease and multiple system atrophy. Nature. 2020 Feb;578(7794):273-277. doi: 10.1038/s41586-020-1984-7. Epub 2020 Feb 5.

    PubMed 32025029

  • Owen DR, Yeo AJ, Gunn RN, Song K, Wadsworth G, Lewis A, Rhodes C, Pulford DJ, Bennacef I, Parker CA, StJean PL, Cardon LR, Mooser VE, Matthews PM, Rabiner EA, Rubio JP. An 18-kDa translocator protein (TSPO) polymorphism explains differences in binding affinity of the PET radioligand PBR28. J Cereb Blood Flow Metab. 2012 Jan;32(1):1-5. doi: 10.1038/jcbfm.2011.147. Epub 2011 Oct 19.

    PubMed 22008728

  • Ndayisaba A, Pitaro AT, Willett AS, Jones KA, de Gusmao CM, Olsen AL, Kim J, Rissanen E, Woods JK, Srinivasan SR, Nagy A, Nagy A, Mesidor M, Cicero S, Patel V, Oakley DH, Tuncali I, Taglieri-Noble K, Clark EC, Paulson J, Krolewski RC, Ho GP, Hung AY, Wills AM, Hayes MT, Macmore JP, Warren L, Bower PG, Langer CB, Kellerman LR, Humphreys CW, Glanz BI, Dielubanza EJ, Frosch MP, Freeman RL, Gibbons CH, Stefanova N, Chitnis T, Weiner HL, Scherzer CR, Scholz SW, Vuzman D, Cox LM, Wenning G, Schmahmann JD, Gupta AS, Novak P, Young GS, Feany MB, Singhal T, Khurana V. Clinical Trial-Ready Patient Cohorts for Multiple System Atrophy: Coupling Biospecimen and iPSC Banking to Longitudinal Deep-Phenotyping. Cerebellum. 2024 Feb;23(1):31-51. doi: 10.1007/s12311-022-01471-8. Epub 2022 Oct 3.

    PubMed 36190676

  • Moreira TG, Matos KTF, De Paula GS, Santana TMM, Da Mata RG, Pansera FC, Cortina AS, Spinola MG, Baecher-Allan CM, Keppeke GD, Jacob J, Palejwala V, Chen K, Izzy S, Healey BC, Rezende RM, Dedivitis RA, Shailubhai K, Weiner HL. Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study. Front Immunol. 2021 Aug 12;12:709861. doi: 10.3389/fimmu.2021.709861. eCollection 2021.

    PubMed 34475873

  • Meissner WG, Remy P, Giordana C, Maltete D, Derkinderen P, Houeto JL, Anheim M, Benatru I, Boraud T, Brefel-Courbon C, Carriere N, Catala H, Colin O, Corvol JC, Damier P, Dellapina E, Devos D, Drapier S, Fabbri M, Ferrier V, Foubert-Samier A, Frismand-Kryloff S, Georget A, Germain C, Grimaldi S, Hardy C, Hopes L, Krystkowiak P, Laurens B, Lefaucheur R, Mariani LL, Marques A, Marse C, Ory-Magne F, Rigalleau V, Salhi H, Saubion A, Stott SRW, Thalamas C, Thiriez C, Tir M, Wyse RK, Benard A, Rascol O; LIXIPARK Study Group. Trial of Lixisenatide in Early Parkinson's Disease. N Engl J Med. 2024 Apr 4;390(13):1176-1185. doi: 10.1056/NEJMoa2312323.

    PubMed 38598572

  • Lopes JR, Zhang X, Mayrink J, Tatematsu BK, Guo L, LeServe DS, Abou-El-Hassan H, Rong F, Dalton MJ, Oliveira MG, Lanser TB, Liu L, Butovsky O, Rezende RM, Weiner HL. Nasal administration of anti-CD3 monoclonal antibody ameliorates disease in a mouse model of Alzheimer's disease. Proc Natl Acad Sci U S A. 2023 Sep 12;120(37):e2309221120. doi: 10.1073/pnas.2309221120. Epub 2023 Sep 5.

    PubMed 37669383

  • Lavisse S, Goutal S, Wimberley C, Tonietto M, Bottlaender M, Gervais P, Kuhnast B, Peyronneau MA, Barret O, Lagarde J, Sarazin M, Hantraye P, Thiriez C, Remy P. Increased microglial activation in patients with Parkinson disease using [18F]-DPA714 TSPO PET imaging. Parkinsonism Relat Disord. 2021 Jan;82:29-36. doi: 10.1016/j.parkreldis.2020.11.011. Epub 2020 Nov 17.

    PubMed 33242662

  • Kuzkina A, Bargar C, Schmitt D, Rossle J, Wang W, Schubert AL, Tatsuoka C, Gunzler SA, Zou WQ, Volkmann J, Sommer C, Doppler K, Chen SG. Diagnostic value of skin RT-QuIC in Parkinson's disease: a two-laboratory study. NPJ Parkinsons Dis. 2021 Nov 15;7(1):99. doi: 10.1038/s41531-021-00242-2.

    PubMed 34782640

  • Jucaite A, Cselenyi Z, Kreisl WC, Rabiner EA, Varrone A, Carson RE, Rinne JO, Savage A, Schou M, Johnstrom P, Svenningsson P, Rascol O, Meissner WG, Barone P, Seppi K, Kaufmann H, Wenning GK, Poewe W, Farde L. Glia Imaging Differentiates Multiple System Atrophy from Parkinson's Disease: A Positron Emission Tomography Study with [11 C]PBR28 and Machine Learning Analysis. Mov Disord. 2022 Jan;37(1):119-129. doi: 10.1002/mds.28814. Epub 2021 Oct 5.

    PubMed 34609758

  • Ishizawa K, Komori T, Sasaki S, Arai N, Mizutani T, Hirose T. Microglial activation parallels system degeneration in multiple system atrophy. J Neuropathol Exp Neurol. 2004 Jan;63(1):43-52. doi: 10.1093/jnen/63.1.43.

    PubMed 14748560

  • Gilman S, Wenning GK, Low PA, Brooks DJ, Mathias CJ, Trojanowski JQ, Wood NW, Colosimo C, Durr A, Fowler CJ, Kaufmann H, Klockgether T, Lees A, Poewe W, Quinn N, Revesz T, Robertson D, Sandroni P, Seppi K, Vidailhet M. Second consensus statement on the diagnosis of multiple system atrophy. Neurology. 2008 Aug 26;71(9):670-6. doi: 10.1212/01.wnl.0000324625.00404.15.

    PubMed 18725592

  • Fujimura Y, Zoghbi SS, Simeon FG, Taku A, Pike VW, Innis RB, Fujita M. Quantification of translocator protein (18 kDa) in the human brain with PET and a novel radioligand, (18)F-PBR06. J Nucl Med. 2009 Jul;50(7):1047-53. doi: 10.2967/jnumed.108.060186. Epub 2009 Jun 12.

    PubMed 19525468

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Foralumab Nasal in people with Multiple System Atrophy, run by Tiziana Life Sciences LTD at 1 site 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 25 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Contact Brigham and Women's Hospital Movement Research Team (857-307-542, BWHMovementResearch@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Screening to Month 6 in the total MDS-UMSARS score (time frame: From Screening to Month 6). 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?

On the ClinicalTrials.gov record for NCT06868628, which also lists 18 linked publications.

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 10 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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