Can a new injection tame relapsing MS?
NCT ID NCT07749157
First seen Aug 06, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This early-stage trial is testing an investigational drug called RO7845860, given as an injection under the skin, in people with relapsing multiple sclerosis (MS). The main goals are to check the drug's safety, how the body handles it, and its effects on immune cells. The study will include around 85 participants and involves multiple dose levels to find a safe and tolerable approach.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RO7845860, an investigational drug given as an injection under the skin
- What this could lead to
- If successful, this could lead to a new treatment option that helps control relapsing multiple sclerosis by targeting certain immune cells.
- What could go wrong
- This is an early, small study focused on safety and dosing, so it may not lead to an approved treatment. Possible side effects and the drug's effectiveness are not yet known.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 85 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 RMS (i.e., relapsing-remitting multiple sclerosis \[RRMS\] or a secondary progressive multiple sclerosis \[SPMS\] where patients still experience relapses) in accordance with the revised 2017 McDonald Criteria. * No relapse for 30 days prior to screening and neurologically stable with no relapse during screening. * Expanded Disability Status Scale (EDSS) score at screening (historical EDSS not older than 6 months may be used), from 0 to 6.5 inclusive. * From Part 2 onwards, 1. at least two documented clinical relapses within the last 2 years prior to screening, or 2. one documented clinical relapse in the year prior to screening or 3. one documented clinical relapse together with signs of Magnetic Resonance Imaging (MRI) activity (any T1 Gd+ and/or new or enlarging T2 lesion) between 12 and 24 months prior to screening. * Documented MRI of brain with abnormalities consistent with Multiple Sclerosis (MS) at screening. Exclusion Criteria: * History of primary progressive multiple sclerosis (PPMS) at screening. * Any of the following laboratory parameters: 1. CD4 levels below lower limit of normal (LLN) 2. Absolute neutrophil count (ANC) levels below LLN 3. Serum immunoglobulin G (IgG) levels below LLN 4. Absolute lymphocyte count \< 1000 cells per microliter (μL) 5. B-cell levels below LLN * Known presence of other neurologic disorders that may mimic MS, including but not limited to, neuromyelitis optica spectrum disease, myelin oligodendrocyte antibody associated disease, Lyme disease, untreated vitamin B-12 deficiency, cerebrovascular or spinal vascular disorders, and untreated hypothyroidism. * Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, dermatologic, psychiatric, allergic, renal or other major diseases that in the investigator's judgement, may affect interpretation of study results or participant safety. * Prior treatment with Chimeric antigen receptor (CAR) T-cell therapy, gene-therapy product, total body irradiation, bone marrow transplantation, allograft organ transplant, or hematopoietic stem cell transplant at any point. * Inability to complete an MRI scan (contraindications for MRI, including but not restricted to, pacemaker, cochlear implants, intracranial vascular clips, surgery within 6 weeks prior to screening coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc.) or contraindication to gadolinium administration.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a simple injection replace an IV for MS treatment?
- Timing of MS drug may change disease course
- MS patients switch drugs to save immune defenses
- Real-World study tracks why MS patients switch to kesimpta
- MS patients may soon get a simpler shot option