ClinicalTrials.gov record NCT06868628
A Phase 2a Study of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)
A Phase 2a Study to Evaluate Microglial Activation, Safety, and Clinical Effects of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 2a interventional study enrolls people with Multiple System Atrophy (MSA) and includes a 6‑month observational lead‑in followed by 6 months of open‑label treatment with nasal Foralumab. Treatment is given in eight 3‑week cycles, with dosing three times per week for the first two weeks of each cycle and no dosing in the third week. The study uses PET imaging of microglial activation, clinical rating scales for MSA, brain MRI measures, and safety monitoring.
What it is studying. The study is testing the effects of intranasal Foralumab on brain microglial activation, safety, and clinical measures of MSA.
What the researchers hope to learn. Evaluate changes in microglial activation measured by TSPO PET; assess safety and tolerability of nasal Foralumab; measure clinical effects on MDS-UMSARS scores and related symptom scales; and assess changes in brain volumes by MRI.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
A Phase 2a Study of Foralumab Nasal in Patients with Multiple System Atrophy (MSA)
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Foralumab Nasal
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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).
- 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).
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
The study has a 6‑month observational lead‑in followed by a 6‑month open‑label treatment phase with intranasal Foralumab given in eight 3‑week cycles (dosing three times per week during the first two weeks of each cycle, then one week off). Participants will have brain imaging (TSPO PET with [F-18]PBR06 and MRI) at baseline and at 6 months, clinical exams including MDS‑UMSARS motor scoring, and questionnaires such as COMPASS‑31 and MSA‑QoL. Routine safety monitoring will include blood tests, ECGs (for QTc), pregnancy tests where applicable, infection screening, and checks of nasal tolerance. Vaccination timing restrictions and other screening tests (TSPO binding status, lab thresholds) apply per the study protocol.
How the study is structured. This is a single‑group, open‑label interventional study (no placebo or randomization). Participants have a 6‑month observation period, then all receive Foralumab nasal for 6 months under a fixed dosing schedule. The study compares measures taken at screening with those at month 6 using brain imaging and clinical assessments, and collects safety data.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
Important dates
- Study start
- May 19, 2025
- Primary completion
- Apr 1, 2027 (estimated)
- Study completion
- Apr 1, 2027 (estimated)
- Target enrollment
- 5 participants (estimated)
- Last updated on registry
- Jun 10, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Tiziana Life Sciences LTD
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Brigham and Women's Hospital Movement Research Team 📞 857-307-542 ✉ BWHMovementResearch@bwh.harvard.edu
Participating sites (1)
- Brigham and Women's HospitalRecruiting
Boston, Massachusetts, 02115 · United States
- BWH Movement Disorders Research Group · 857-307-542 · BWHMovementResearch@bwh.harvard.edu
- Vikram Khurana, MD, PhD
Terms used on this page · explanations by MedicalUpdates.ai
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- upper limit of normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- creatinine clearance
- A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
- QTcF
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- at Screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- PET
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- corticosteroid
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- Concomitant medication
- Other medicines a participant takes during the study. Some must be reported; some are restricted.
- standard of care
- Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
- absolute neutrophil count
- The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
- Principal Investigator
- The doctor or scientist responsible for running the study at a site or overall.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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