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Contact Information:

Dr Gavin Giovannoni
+44 (0)20 7882 8954
g.giovannoni@qmul.ac.uk


Dr Allan Poma
+1 857 2730413
allen.poma@zenasbio.com


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Be Part of Research - Trial Details - A phase II Study of obexelimab in patients with relapsing multiple sclerosis
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A phase II Study of obexelimab in patients with relapsing multiple sclerosis

Recruiting

Open to: All Genders

Age: Adult

London Basildon Harlow Leicester Swansea Chelmsford Colchester Westcliff-on-sea Croydon

Medical Conditions

Relapsing multiple sclerosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Multiple sclerosis (MS) is a potentially disabling autoimmune disease that affects the central nervous system (brain and spinal cord). B cells play an important role in the autoimmune disease mechanism. Obexelimab, an experimental study drug, is an antibody developed for the treatment of such autoimmune disorders. The drug acts by binding to the B cell surface and decreases B cell activity. The purpose of this study is to evaluate the safety and effectiveness of obexelimab, on MS.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

06 Aug 2024 31 Mar 2025

In Part A, obexelimab or placebo as subcutaneous injections, will be administered at random. Two-thirds of the patients will receive obexelimab and one-third will receive a placebo, once weekly for 12 weeks. After week 12, all patients will receive obexelimab in Part B, for an additional 12 weeks.


Patients ≥ 18 to ≤ 60 years of age with a diagnosis of relapsing-remitting or secondary progressive with relapses (RMS)

You can take part if:



You may not be able to take part if:


1. Primary progressive MS or secondary progressive MS without relapses2. Meet criteria for neuromyelitis optica spectrum disorder3. Relapse in the 30 days prior to randomization4. ≥ 10 years disease duration from the onset with patient’s EDSS ≤ 2.0 (patient-reported is adequate in absence of written medical record)5. Has > 20 Gd+ lesions on brain MRI at screening6. Prior use of B cell–depleting agents7. Prior use of other biologic immunomodulatory agents ≤ 6 months before randomization8. Has received systemic corticosteroids or adrenocorticotropic hormone within 1 month (30 days) before screening MRI9. Has received dimethyl fumarate within 1 month before randomization10. Has received treatment with B-interferons or glatiramer acetate within 1 month before randomization11. Has received treatment with intravenous immunoglobulins, plasmaphereses, sphingosine-1-phosphate treatments, or natalizumab (patients who stop getting infusions within 6 months before randomization should be ruled out for progressive multifocal leukoencephalopathy) within 2 months before randomization12. Has received azathioprine or methotrexate within 6 months before randomization13. Has received treatment with teriflunomide within 3 months to randomization (unless elimination procedure was done)14. Has received cladribine, cyclophosphamide, alemtuzumab, or mitoxantrone within 2 years before randomization15. Has received lymphoid irradiation or stem cell transplantation16. Has received an investigational treatment or direct medical intervention on another clinical study within 12 weeks or < 5 half-lives of the investigational treatment, whichever is longer, before randomization17. Has received a live vaccine or live therapeutic infectious agent within the 4 weeks before randomization 18. History of drug or alcohol abuse in the previous 12 months before screening in the opinion of the investigator19. Acute hepatitis B infection (hepatitis B surface antigen-positive), active hepatitis C virus, or HIV infection. Patients will be excluded from the study if they have a positive test for active hepatitis B by detecting (a) hepatitis B surface antigen or (b) hepatitis B core antibody. In Japan, patients will be excluded if there is detection of (a) hepatitis B surface antigen, (b) hepatitis B surface antibody, or (c) hepatitis B core antibody. Patients with active, chronic or uncured HBV will be excluded.20. Evidence of active tuberculosis (TB) or at high risk for TB as shown by at least one of the following:20.1. Documented history of active TB or latent TB, unless completion of treatment according to local guidelines20.2. Positive, indeterminate, or invalid interferon-gamma release assay results at screening, unless treatment is documented. Patients with an indeterminate test result can repeat the test once either centrally or locally, but if the repeat test is also indeterminate, the patient is excluded20.3. Signs or symptoms that could represent active TB20.4. Chest radiograph, computed tomography, or MRI that suggests possible diagnosis of TB21. Malignancy within 5 years except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin22. Hematology or clinical chemistry parameters that meet any of the following criteria at screening:22.1. White blood cell count < 3.5 × 10^3/μL22.2. Absolute neutrophil count < 1.5 × 10^3/μL22.3. Elevated serum creatinine > 2.5 × upper limit of normal (ULN) OR estimated creatinine clearance < 40 mL/min calculated by the Cockcroft-Gault formula at screening22.4. Hemoglobin < 10 g/dL22.4. Platelet count < 75 × 10^3/μL23. Abnormal liver function tests meeting any of the following criteria:23.1. Alanine aminotransferase > 2 × ULN23.2. Aspartate aminotransferase > 2 × ULN23.3. Total bilirubin > 1.5 × ULN24. History or evidence of a clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, oncologic, renal, hepatic, metabolic, hematologic, psychiatric, active infection) other than RMS that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion25. Any known allergy to mAb therapy26. Hypersensitivity to dextran or components of dextran or any component of the study drug and placebo, including excipients27. Inability to comply with MRI scanning or MRI contrast administration


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal London Hospital
    Whitechapel
    London
    E1 1BB
  • Basildon University Hospital
    Nethermayne
    Basildon
    SS16 5NL
  • Princess Alexandra Hospital
    Hamstel Road
    Harlow
    CM20 1QX
  • Leicester General Hospital
    Gwendolen Road
    Leicester
    LE5 4PW
  • Morriston Hospital
    Heol Maes Eglwys Cwmrhydyceirw
    Swansea
    SA6 6NL
  • Broomfield Hospital
    Court Road Broomfield
    Chelmsford
    CM1 7ET
  • Colchester General Hospital
    Colchester District General Hosp. Charter Way Turner Road
    Colchester
    CO4 5JL
  • Southend University Hospital
    Prittlewell Chase
    Westcliff-on-sea
    SS0 0RY
  • Queens Hospital
    Queens Road
    Croydon
    CR9 2PQ

Taking part in this study may or may not help to treat the patient’s MS, however, the data collected may help doctors learn more about the study drug and whether it provides any benefit to patients with MS, which in turn may help future patients with MS.
Participants might have side effects related to the study drug and procedures while taking part in the study. Everyone taking part in the study will be watched for side effects; however, the study team do not know all the side effects that the study drug may have on the participant. These effects may be mild or serious. In some cases, these effects might be long-lasting, permanent, and may even be life-threatening. Participants should call the study doctor when they think they are having any problems.
The sponsor recognises that weekly IP administration is quite intensive, therefore the burden of this has been mitigated for visits where no clinic attendance is required by protocol, by allowing the option of home IP administration either via self, caregiver or utilisation of home care vendor services (Firma). IP administration is the only study procedure that Firma would be undertaking if required.
There have been 198 healthy volunteers and patients with autoimmune diseases treated with various doses of obexelimab as either intravenous infusion (158 patients) or subcutaneous injection (40 patients). Approximately 40 additional patients have been dosed with either obexelimab or placebo in patients with IgG4-RD and warm autoimmune hemolytic anaemia. Obexelimab affects the immune system and may cause serious infections. Obexelimab has side effects at the site of drug injection with the most common being bruising and redness. Most of these side effects were mild and lasted less than a day.
When obexelimab was given by intravenous infusion, there were serious cases of infusion reactions and non-serious abdominal discomfort including nausea, vomiting, and diarrhoea. These side effects have not been observed for obexelimab given as a subcutaneous injection.
Other common side effects included:
• Headache 8%
• Injection site bruising 8%
• Dizziness 5%
• Back pain 5%
• Injection site redness 5%
These events were mostly mild and temporary.
• Injection site reactions: pain, redness, swelling, itching, or bruising at the site of the study drug injection.
• Blood sampling: Having blood taken from a vein may cause some pain, redness, or bruising at the injection site. An infection at the injection site is possible but rare.
• ECG: The ECG procedure may cause some mild discomfort during the placement and removal of the leads to and from the skin. The skin may become a little red or irritated. May also experience local irritation, redness, or burning in the areas where the leads are attached.
• MRI scan: There are risks from an MRI if participants are pregnant or have one of the following: an artificial heart valve, pacemaker, metal plate, pins, or other metallic objects in their body (including gunshot or shrapnel). Participants may also become anxious from lying in a tight space without moving. The MRI scan does not cause any pain and does not expose participants to X-ray radiation. For some MRI scans, participants may receive a contrast dye, given via vein using a small needle or plastic tube. Participants may feel local warmth or pain in the area where the dye is injected. The most common contrast material used for MRIs is gadolinium. Side effects from the dye may include nausea, vomiting, or headache. Participants will not be given the MRI contrast dye if they have abnormal kidney function. People with severe kidney insufficiency or chronic liver disease experiencing kidney insufficiency may develop a severe disease, called nephrogenic systemic fibrosis, from gadolinium. Nephrogenic systemic fibrosis triggers thickening of the skin, organs, and other tissues. The exact cause is unclear, and there is no effective treatment. Serious allergic reactions that may be life-threatening are very rare. Participants will be asked questions and may undergo tests to ensure that the MRI scan is safe for them.
• Chest X-ray: Chest X-rays involve exposure to a very small amount of ionising radiation. Ionising radiation can cause cancer many years or decades after the exposure. Participants are advised of the inherent risks in the ICF.
• Lumbar Puncture: Use of atraumatic or non-cutting lumbar puncture needles and screening techniques (ultrasound) may be used to reduce the risk of a post-lumbar puncture headache.
• Unforeseeable risks: Since obexelimab is an experimental study drug, there may be other risks that are unknown at this time. Participants are advised to seek medical assistance right away.
• Reproductive risks; The effects of obexelimab on human eggs, unborn children (including miscarriage), or nursing infants are not known at this time. Participants will not be eligible for participation if they are planning on becoming pregnant if they are pregnant, or if they are nursing.

Dr Gavin Giovannoni
+44 (0)20 7882 8954
g.giovannoni@qmul.ac.uk


Dr Allan Poma
+1 857 2730413
allen.poma@zenasbio.com



The study is sponsored by Zenas BioPharma (USA) LLC and funded by Zenas Biopharma.




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Read full details for Trial ID: ISRCTN78327800

Or CPMS 61107

Last updated 16 January 2025

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