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New combo therapy aims to hit MS early and hard

NCT ID NCT07517185

Disease control Sponsor: Uppsala University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether giving two strong medications one after the other—rituximab then cladribine—is safe and works well for people with relapsing-remitting multiple sclerosis (MS). Sixty adults aged 18 to 50 with active MS within the last year will receive the treatment and be monitored for 2 years. The main goal is to check for serious side effects, while also tracking brain scans, relapses, and disability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of RRMS according to the 2017 revised McDonald criteria, * With disease activity within the preceding year in the form of: a clinical relapse, and/or evidence of ≥2 T2 lesions on MRI scan, and or presence of gadolinium enhancing lesions on an MRI scan, * Age 18 - 50 years (inclusive) of age, * Disease duration ≤10 years (since MS diagnosis), * EDSS 0 - 5.5 (inclusive), * Signed informed consent. Exclusion Criteria: * Diagnosis of progressive MS, * Previous use of rituximab (or any other B-cell depleting monoclonal antibody) and/or cladribine, * Pregnant or lactating women, * Unwilling to use contraception during the treatment period and the first year after completing the treatment course, * Patients having contraindication for or otherwise not compliant with MRI investigations, * Simultaneous treatment with other immunosuppressive drugs, * Infection with human immunodeficiency virus (HIV), * Active, severe infections (e.g. hepatitis or tuberculosis), * Severe cardiac disorder, * Moderate or severe renal impairment (eGFR \<60). * Active malignancy, * No prior exposure to varicella virus, * Vaccination within 4 weeks of first dose of study medication, * Severe psychiatric condition.

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing-remitting multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centralsjukhuset Karlstad, Neurologi och Rehabiliteringskliniken

    NOT_YET_RECRUITING

    Karlstad, 651 85, Sweden

  • Falu Lasarett, Neurologen

    NOT_YET_RECRUITING

    Falun, 79182, Sweden

  • Gävle sjukhus, Neurologmottagningen

    NOT_YET_RECRUITING

    Gävle, 80324, Sweden

  • Uppsala University Hospital

    RECRUITING

    Uppsala, 75185, Sweden

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