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Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS

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

NCT05029609•Tiziana Life Sciences LTD

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

25 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Confirmed diagnosis of MS (according to the 2010 McDonald criteria).
•2. Age 25-70 years.
•3. Clinical diagnosis of non-active primary and secondary MS
•4. MRI imaging consistent with a diagnosis of MS at any time point.
•5. Score on the Expanded Disability Status Scale (EDSS) of 2.5-6.5
•6. Adequate hematologic parameters without ongoing transfusion support:
•* Hemoglobin (Hb) ≥ 9 g/dL
•* Platelets ≥ 100 x 109 cells/L
•7. 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
+5 more criteria

Exclusion Criteria

•1. Corticosteroid use (oral or intravenous) within the last 30 days.
•2. 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
•3. Inability to tolerate intranasally administered medications
•4. Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 30 days.
•5. Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past 12 months.
•6. Active COVID-19 disease; according to FDA guidelines
•7. Female patient who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during study.
•8. Female patients of childbearing age will undergo a pregnancy test and be excluded from the study if positive.
•9. Active malignancy within 5 years.
•10. Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, or type 1 diabetes
+8 more criteria

Key Dates

Start Date

October 1, 2021

Primary Completion Date

November 1, 2022

Completion Date

December 1, 2022

Last Updated

March 3, 2022

Conditions

Primary Progressive Multiple SclerosisSecondary Progressive Multiple SclerosisMultiple Sclerosis

Interventions

Intranasal Foralumab Solution

DRUG

Placebo

DRUG

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

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RECRUITINGNA

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Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Intermittent Hypoxia in Persons With Multiple Sclerosis

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