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New treatment option for Non-Active Secondary Progressive Multiple Sclerosis
Official title Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis
ClinicalTrials.gov ID: NCT06890923
What this study is testing
What is Foralumab TZLS-401 100 µg?
Foralumab TZLS-401 100 µg is an investigational medicine, being studied as a potential treatment for non-active secondary progressive multiple sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Only subjects that have completed TILS-021, a Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients are eligible to be enrolled in TILS-022. TILS-022 is a 6-month open-label extension study with an opportunity for dose to be escalated based on the subject's clinical status.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people must have enrolled in and successfully completed TILS-021 within the preceding 90 days, including End of Treatment and End of Study...
- Screening clinical laboratory studies are within the normal ranges or within the parameters specified below, and clinically acceptable in the opinion...
- Adequate hematologic parameters without ongoing transfusion support:
- Hemoglobin (Hb) ≥ 9 g/dL
- Platelets ≥ 100 x 109 cells/L
You likely can't join if
- people that terminated TILS-021 early as defined as not undergoing an End of Treatment visit.
- people that terminated TILS-021 early as defined as not undergoing an End of Study visit.
- people that terminated TILS-021 due to any adverse events.
- Corticosteroid use (oral or intravenous) within the last 60 days or anticipated need for such treatment during the study period.
- Current use or use within 30 days prior to the Screening Visit of interferon, glatiramer acetate, fingolimod, siponimod, dimethyl fumarate...
- Patient in whom the need to start or stop other pharmacologic treatment for MS is expected during the time of the study or the need for initiation of...
See the full eligibility criteria
Who can join
- people must have enrolled in and successfully completed TILS-021 within the preceding 90 days, including End of Treatment and End of Study assessments.
- Screening clinical laboratory studies are within the normal ranges or within the parameters specified below, and clinically acceptable in the opinion of the Investigator. Exceptions must be approved by the Clinical...
- 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 ≤ 1.5 times the ULN unless due to Gilbert's disease.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times ULN.
- Negative urine pregnancy test within 7 days prior to the first dose of study therapy for women of childbearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been...
- Sexually active women of childbearing potential and male patients must agree to use two effective methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptives; tubal ligation; intra-uterine...
- Immunizations are current and up to date as adjusted for disease status and prior/current treatments and documented by the subject's treating neurologist.
- Ability and willingness to provide written informed consent.
What rules you out
- people that terminated TILS-021 early as defined as not undergoing an End of Treatment visit.
- people that terminated TILS-021 early as defined as not undergoing an End of Study visit.
- people that terminated TILS-021 due to any adverse events.
- Corticosteroid use (oral or intravenous) within the last 60 days or anticipated need for such treatment during the study period.
- Current use or use within 30 days prior to the Screening Visit of interferon, glatiramer acetate, fingolimod, siponimod, dimethyl fumarate, ponesimod, ozanimod, cyclosporin, methotrexate, azathioprine, mycophenolate...
- Patient in whom the need to start or stop other pharmacologic treatment for MS is expected during the time of the study or the need for initiation of B cell depleting therapies (e.g.: ocrelizumab, ofatumumab...
- Use of B cell depleting therapies (e.g.: ocrelizumab, ofatumumab, ublituximab, rituximab) at any time during study TILS-021 or after the patient has completed TILS-021 is not permitted.
- people with any previous exposure to alemtuzumab, cyclophosphamide, cladribine, mitoxantrone, or daclizumab.
- Prior use of autologous hematopoietic stem cell transplantation or stem cell therapy.
- Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 60 days.
- Active COVID-19 disease; according to FDA guidelines.
- Female patient who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during the study. Female patients of childbearing age will undergo a serum pregnancy test at Screening, but prior to receiving...
- Any history of malignancy or active malignancy. This includes any skin cancers at any time.
- Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, or type 1 diabetes.
- Patients with a history of gadolinium allergy/contraindications or any other contraindications to MRI, such as metal implants, chronic renal disease and an eGRF of \<30 mL/minute or claustrophobia. Or who are unable to...
- Known positivity for human immunodeficiency virus, hepatitis B virus surface antigen (HBsAg), or hepatitis C virus or tuberculosis at Screening. If the subject has a history of positivity for any of these diseases, they...
- Any nasal pathology such as clinically significant deviated septum, nasal polyps, chronic rhinitis, or a history of sinusitis diagnosed or treated in the past 12 months.
- Clinically significant cardiac condition or ECG abnormality at Screening or by history. An ECG will be done prior to each dosing cycle and patients will be excluded or treatment discontinued for any significant ECG...
- Any other medical 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.
- Other than nasal foralumab, receipt of an investigational drug/biological product in the past 30 days of Screening, or concurrent receipt of an investigational drug during this study, other than the product under study.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.