Primary Progressive Multiple SclerosisPhase 1NCT05029609
Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS
A Phase 1 study testing Intranasal Foralumab Solution in people with Primary Progressive Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by Tiziana Life Sciences LTD.
Trial summary
The primary objective is to establish the safety of administration of intranasal Foralumab in non-active primary and secondary progressive Multiple Sclerosis (MS) patients in a multiple ascending dose format in escalating doses for 14 consecutive days. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Multiple Sclerosis
- What is being tested?
- Intranasal Foralumab Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of MS (according to the 2010 McDonald criteria).
- Age 25-70 years.
- Clinical diagnosis of non-active primary and secondary MS
- MRI imaging consistent with a diagnosis of MS at any time point.
- Score on the Expanded Disability Status Scale (EDSS) of 2.5-6.5
- Adequate hematologic parameters without ongoing transfusion support:
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- 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, or < 5 times ULN for patients with liver metastases
- QT interval corrected for rate (QTcF) ≤ 470 msec for women and ≤ 450 msec for men on the ECG obtained at Screening
- Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP)
- 13. Ability to provide written informed consent.
Who cannot join
- Corticosteroid use (oral or intravenous) within the last 30 days.
- Current use or use in the prior 6 months of MS immunotherapy, interferon, glatiramer acetate, fingolimod, siponimod, dimethyl fumarate or natalizumab or any other chronic immunosuppressive medication
- Inability to tolerate intranasally administered medications
- Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 30 days.
- Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past 12 months.
- Active COVID-19 disease; according to FDA guidelines
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- Female patient who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during study.
- Female patients of childbearing age will undergo a pregnancy test and be excluded from the study if positive.
- Active malignancy within 5 years.
- Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, or type 1 diabetes
- Neutropenia (<500 neutrophils/mL) or other severe immunosuppression
- Unable or unwilling to comply with protocol requirements.
- Patients with a history of gadolinium allergy.
- Screening labs outside of the normal range; EBV IgM positive subjects with clinical signs will not receive study drug.
- 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 (See Appendix B) 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
- Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
- 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
About this study
Official title: A Phase 1b, Double-Blind, Randomized, Placebo Controlled, Multiple Ascending Dose Study of the Safety, Tolerability and Immune Effects of the Intranasal Anti-CD3 Monoclonal Antibody Foralumab in Primary and Secondary Progressive MS
The primary objective is to establish the safety of administration of intranasal Foralumab in non-active primary and secondary progressive Multiple Sclerosis (MS) patients in a multiple ascending dose format in escalating doses for 14 consecutive days.
Read the detailed description
This is a Phase 1b double blind, randomized, placebo controlled, dose escalating study evaluating multiple doses of Foralumab via intranasal administration for 14 days in patients with MS.
Up to 55 untreated primary and secondary progressive MS patients will be enrolled, to obtain a total of 48 completed subjects (9 active, 3 placebos per group), allowing for dropouts.
- Conditions
- Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Multiple Sclerosis
- Being tested
- Intranasal Foralumab Solution, Placebo
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Foralumab SolutionDrug
The Aptar Unidose device will be used to deliver foralumab nasal solution intranasally. Foralumab nasal solution is prepackaged in a Type 1 glass vial inside the Unidose device.
PlaceboDrug
The placebo nasal solution is the acetate buffer vehicle used for foralumab nasal solution. It will be handled in a manner identical to active drug.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Group A will receive nasal Foralumab Dose 1 daily for 14 days (n=9) or placebo (n=3) Receives: Drug: Intranasal Foralumab Solution; Drug: Placebo |
| Group B | Other | Group B will receive nasal Foralumab Dose 2 tiw for 14 days (n=9) or placebo (n=3) Receives: Drug: Intranasal Foralumab Solution; Drug: Placebo |
| Group C | Other | Group C will receive nasal Foralumab Dose 3 daily for 14 days (n=9) or placebo (n=3) Receives: Drug: Intranasal Foralumab Solution; Drug: Placebo |
| Group D | Other | Group D will receive nasal Foralumab Dose 4 daily for 14 days (n=9) or placebo (n=3) Receives: Drug: Intranasal Foralumab Solution; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the safety of intranasal foralumab in non-active primary and secondary progressive MS in escalating doses for 14 consecutive days
Analyses through review of adverse events categorized and graded via CTCAE.
Measured: 14 days
Secondary outcomes (1)
Change in Expanded Disability Status Scale (EDSS) at Day 45
The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems. Lower score indicates that the subject is doing better.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study startOct 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Withdrawn due to business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Progressive Multiple SclerosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a Phase 1b double blind, randomized, placebo controlled, dose escalating study evaluating multiple doses of Foralumab via intranasal administration for 14 days in patients with MS.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
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
- NCT05029609
- Sponsor's protocol ID
- TILS-015
- Status last verified
- Feb 2022
- First submitted
- 27 Aug 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Double-Blind, Randomized, Placebo Controlled, Multiple Ascending Dose Study of the Safety, Tolerability and Immune Effects of the Intranasal Anti-CD3 Monoclonal Antibody Foralumab in Primary and Secondary Progressive MS
- ClinicalTrials.gov ID
- NCT05029609
- Acronym / sponsor ID
- TILS-015
- Conditions
- Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tiziana Life Sciences LTDIndustry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 31 Aug 2021 (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 primary objective is to establish the safety of administration of intranasal Foralumab in non-active primary and secondary progressive Multiple Sclerosis (MS) patients in a multiple ascending dose format in escalating doses for 14 consecutive days.
Detailed description
This is a Phase 1b double blind, randomized, placebo controlled, dose escalating study evaluating multiple doses of Foralumab via intranasal administration for 14 days in patients with MS.
Up to 55 untreated primary and secondary progressive MS patients will be enrolled, to obtain a total of 48 completed subjects (9 active, 3 placebos per group), allowing for dropouts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a Phase 1b double blind, randomized, placebo controlled, dose escalating study evaluating multiple doses of Foralumab via intranasal administration for 14 days in patients with MS.
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Drug: Intranasal Foralumab Solution, Drug: PlaceboGroup A will receive nasal Foralumab Dose 1 daily for 14 days (n=9) or placebo (n=3) |
| Group B | Other | Drug: Intranasal Foralumab Solution, Drug: PlaceboGroup B will receive nasal Foralumab Dose 2 tiw for 14 days (n=9) or placebo (n=3) |
| Group C | Other | Drug: Intranasal Foralumab Solution, Drug: PlaceboGroup C will receive nasal Foralumab Dose 3 daily for 14 days (n=9) or placebo (n=3) |
| Group D | Other | Drug: Intranasal Foralumab Solution, Drug: PlaceboGroup D will receive nasal Foralumab Dose 4 daily for 14 days (n=9) or placebo (n=3) |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Confirmed diagnosis of MS (according to the 2010 McDonald criteria).
- Age 25-70 years.
- Clinical diagnosis of non-active primary and secondary MS
- MRI imaging consistent with a diagnosis of MS at any time point.
- Score on the Expanded Disability Status Scale (EDSS) of 2.5-6.5
Key exclusion criteria (18 listed)
- Corticosteroid use (oral or intravenous) within the last 30 days.
- Current use or use in the prior 6 months of MS immunotherapy, interferon, glatiramer acetate, fingolimod, siponimod, dimethyl fumarate or natalizumab or any other chronic immunosuppressive medication
- Inability to tolerate intranasally administered medications
- Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 30 days.
- Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past 12 months.
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 |
|---|---|---|
| Intranasal Foralumab SolutionThe Aptar Unidose device will be used to deliver foralumab nasal solution intranasally. Foralumab nasal solution is prepackaged in a Type 1 glass vial inside the Unidose device. | Drug | Group A, Group B, Group C, Group D |
| PlaceboThe placebo nasal solution is the acetate buffer vehicle used for foralumab nasal solution. It will be handled in a manner identical to active drug. | Drug | Group A, Group B, Group C, Group D |
Primary outcome
To establish the safety of intranasal foralumab in non-active primary and secondary progressive MS in escalating doses for 14 consecutive days
Time frame: 14 days
Analyses through review of adverse events categorized and graded via CTCAE.
1 secondary outcome
Change in Expanded Disability Status Scale (EDSS) at Day 45
Time frame: 45 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intranasal Foralumab Solution in people with Primary Progressive Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by Tiziana Life Sciences LTD.
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 15 inclusion and 18 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: withdrawn, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To establish the safety of intranasal foralumab in non-active primary and secondary progressive MS in escalating doses for 14 consecutive days (time frame: 14 days). 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 3 Mar 2022.