A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

Conditions

• Secondary Progressive Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Foralumab — DRUG
  Foralumab nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Each Unidose device contains 0.13 mL foralumab placebo nasal solution, sufficient for administration to a single nare. Two Aptar Unidose devices will be used for a single dose (one device per nare). Each Unidose device contains foralumab nasal solution, supplied at either 25 μg foralumab or 50 μg foralumab, sufficient for administration into a single nare.
• Placebo — OTHER
  Foralumab placebo nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Each Unidose device contains 0.13 mL foralumab placebo nasal solution, sufficient for administration to a single nare. Two Aptar Unidose devices will be used for a single dose (one device per nare).

Study Details

Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases. The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS). The primary objectives that this study aims to answer are: 1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo 2. To investigate the effect of foralumab relative to placebo on the change from baseline \[18F\]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment.

Key Dates

First listed

Mar 5, 2024

Start date

Nov 15, 2023

Status verified

Jun 2026

Primary completion

Sep 30, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

54 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nasal Foralumab 50 μg
  Each patient will receive nasal foralumab 50 μg per dosing day (25 μg per nostril).
• Experimental: Nasal Foralumab 100 μg
  Each patient will receive nasal foralumab 100 μg per dosing day (50 μg per nostril).
• Placebo Comparator: Nasal placebo (acetate buffer)
  Each patient will receive placebo on each dosing day in divided doses, in each nostril.

Primary Outcome Measure

The number of patients with adverse event (AE) reports. [ Time Frame: Throughout the study, an average of 12 weeks (3 months). ]

Locations (7)

Find similar trials in North Haven, CT

Related Studies

• Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
  PHASE3 · Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Palo Alto, California
• A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
  PHASE3 · Recruiting · Zenas BioPharma (USA), LLC · Phoenix, Arizona