A Randomized, Phase 3, Open-label Study to Investigate Pharmacokinetics, Safety, and Efficacy of Subcutaneous Compared to Intravenous Frexalimab in Adult Participants With Multiple Sclerosis

Plain English Summary

Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis is a Phase 3 clinical trial sponsored by Sanofi studying Multiple Sclerosis. Tests the effectiveness and safety of Frexalimab given subcutaneously compared to intravenously in adults with Multiple Sclerosis. For adults aged 18-60 with Multiple Sclerosis, diagnosed within the last 5 years. Participation involves 17-11 clinic visits over 12 months, with follow-ups for up to 6 months. Alternative treatments include oral medications and other injectable therapies. The trial aims to enroll 160 participants.

Official Summary

This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment. The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months. The number of scheduled visits (Parts A and B) will be 17 or 11 for participants receiving frexalimab SC or IV, respectively, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible if 18-60, diagnosed with Multiple Sclerosis, and meet specific criteria. Not eligible if diagnosed with primary progressive MS, have recent infections, or have certain medical conditions. Age range: 18-60 years. Health requirements: No primary progressive MS, no recent infections, no significant medical conditions. This trial is studying Multiple Sclerosis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

Measures include blood levels and adverse events, helping patients understand the drug's impact and safety. The specific primary outcome measures are: Area under the curve over the interval W20 to W24(part A) (Until Week 24); Trough concentration at steady state(part A) (Until Week 24). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill the gap in understanding the effectiveness of Frexalimab in different administration methods for Multiple Sclerosis. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Multiple Sclerosis, where improved treatment options are needed.

Investor Insight

Market size for MS treatments is large, with few direct competitors, and a high probability of approval. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor about your eligibility and the benefits of participating in the study. Participation involves regular clinic visits and blood tests. This trial is currently recruiting participants. The trial is being conducted at 10 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 160 participants

Interventions

• DRUG: Frexalimab — Pharmaceutical form:Solution for injection-Route of administration:SC injection
• DRUG: Frexalimab — Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion
• DRUG: MRI contrast-enhancing preparations — Route of administration:IV injection

Primary Outcomes

• Area under the curve over the interval W20 to W24(part A) (Until Week 24)
• Trough concentration at steady state(part A) (Until Week 24)

Secondary Outcomes

• Frexalimab plasma concentrations over time(part A) (Until Week 24)
• Pharmacokinetic parameters: Cmax(part A) (Until Week 24)
• Pharmacokinetic parameters: Tmax(part A) (Until Week 24)
• Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, and potentially clinically significant abnormality(PCSA) in laboratory tests, and vital signs during the study period (Until Week 96)
• Incidence of ADAs over time(part A) (Until Week 96)

Full Eligibility Criteria

Inclusion Criteria:

The participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the inclusion criteria of the applicable group:

Group A (RMS)

* The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
* The participant must have been diagnosed with RMS in accordance with the 2017 revised McDonald criteria.
* The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (Screening Visit).
* The participant must have at least 1 of the following prior to screening:

  * 1 documented relapse within the previous year OR
  * 2 documented relapses within the previous 2 years, OR
  * 1 documented Gd enhancing lesion on an MRI scan within the previous year. Group B (nrSPMS)
* Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria
* The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.
* The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013.
* The participant must have documented evidence of disability progression observed during the 12 months before screening.
* The participant must have an absence of clinical relapses for at least 24 months.
* The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit).

Participants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply:

\- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria.
* The participant has a history of infection or may be at risk for infection:
* Fever within 28 days of the Screening Visit
* Presence of psychiatric disturbance or substance abuse
* History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment.
* Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN at screening or a history of primary hypogammaglobulinemia.
* A history or presence of disease that can mimic MS symptoms.
* The participant has a contraindication for MRI.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial Locations

• North Central Neurology Associates- Site Number : 8401100, Cullman, Alabama, United States
• Alabama Neurology Associates- Site Number : 8400115, Homewood, Alabama, United States
• Perseverance Research Center- Site Number : 8400138, Scottsdale, Arizona, United States
• Private Practice - Dr. Regina Berkovich- Site Number : 8400005, West Hollywood, California, United States
• Neurology of Central Florida- Site Number : 8400147, Altamonte Springs, Florida, United States
• Aqualane Clinical Research- Site Number : 8400026, Naples, Florida, United States
• Neurology Associates of Ormond Beach- Site Number : 8400086, Ormond Beach, Florida, United States
• Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002, Charlotte, North Carolina, United States
• Raleigh Neurology Associates- Site Number : 8400014, Raleigh, North Carolina, United States
• Hope Neurology- Site Number : 8400019, Knoxville, Tennessee, United States

Frequently Asked Questions

Related Conditions

• Multiple Sclerosis
• Neurology
• Autoimmune Diseases
• Inflammation
• Immune System Disorders
• Neurodegenerative Diseases
• Central Nervous System Disorders
• Immunotherapy

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