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SAR445088 for Chronic Inflammatory Demyelinating Polyneuropathy
Study Summary
This trial is testing the efficacy and safety of SAR445088 in CIDP patients. There are three groups of patients: those who are currently being treated with the standard of care (SOC-Treated), those who are refractory to SOC (SOC-Refractory), and those who have never been treated with SOC (SOC-Naive). The secondary objectives are to assess the long-term safety and tolerability of SAR445088 in CIDP patients, as well as the durability of its efficacy over time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My condition did not improve after 12 weeks of standard treatment.I haven't been hospitalized for serious infections in the last 30 days and don't have any active infections needing treatment.I am either new to treatment, have had standard treatment, or my condition didn't improve with standard treatment.I am 18 years old or older.I have been diagnosed with CIDP according to EFNS/PNS guidelines.I agree to use a condom and another effective birth control method.I haven't taken strong immune or cancer drugs in the last 6 months.I have conditions that could lead to heavy bleeding or higher infection risk.I have not taken strong immune-suppressing drugs like mitoxantrone.I have been vaccinated against certain bacterial infections within the last 5 years or started vaccinations at least 14 days before my first dose.I agree not to donate sperm during and up to a year after the treatment.I am using two forms of birth control and will not donate eggs for up to 82 weeks after my last study dose.My current treatment for my condition has not improved my symptoms after 12 weeks.I do not have any neurological or systemic diseases that could affect my treatment results.a) You have shown a positive response to the standard treatment you are currently receiving, with noticeable improvements in your condition based on specific measurements and assessments.
b) Your current treatment has remained stable for at least 8 weeks prior to screening, with no significant changes in medication frequency or dosage.
c) There is evidence that interrupting or reducing your current treatment has led to a noticeable decline in your condition within the past 24 months, based on clinical examination or medical records.b) You haven't received immunoglobulins (IVIg or SCIg) in the past 12 weeks.
c) If you're taking certain medications like azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, or oral corticosteroids, you can still participate if you've been on a stable dose for at least 3 months.
d) Your INCAT score, which measures disability, should be between 2 and 9, with any score of 2 only being from leg disability.To be eligible for this study, you must meet the following criteria:
a) You have not been treated before for CIDP (a nerve disorder) or if you have received immunoglobulins or corticosteroids in the past, it was not stopped because it didn't work or caused side effects.
b) You have not received immunoglobulins or corticosteroids for at least 6 months before screening.
c) Your INCAT score (a measure of disability) is between 2 and 9. If your score is 2, it should be only due to problems with your legs.My diabetes is not well-controlled (HbA1c over 7%).I can't take immunoglobulins or corticosteroids because of side effects.I can't take immunoglobulins or corticosteroids because of side effects.I am not allergic to SAR445088 or similar medications.I have been diagnosed with systemic lupus erythematosus (SLE).My CIDP symptoms worsened within 6 weeks after a vaccination.I have a type of nerve damage not caused by the trial's treatment.I have undergone total lymphoid irradiation or bone marrow transplantation.I haven't used any complement system inhibitors recently.This criterion is not applicable on its own.My tests show IgG4 autoantibodies against specific nerve proteins.I have taken a pregnancy test recently and it was negative.I agree to use two forms of birth control and not donate eggs until 52 weeks and 30 days after my last study dose.I have not had, nor am I planning to have, any major surgery that could affect the trial.I have not had plasma exchange treatment in the last 3 months.I haven't taken rituximab or ocrelizumab in the last 6 months or until my B-cell counts normalized, whichever took longer.This criterion does not apply to me.I am in one of the groups: treated, refractory, or new to standard cancer care.I am able to understand and sign the consent form.I can't take immunoglobulins or corticosteroids because of side effects.
- Group 1: SOC-Treated Initial Dose
- Group 2: SOC-Treated Low Dose
- Group 3: SOC-Refractory Initial Dose
- Group 4: SOC-Refractory Low Dose
- Group 5: SOC-Naive
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
When might we see BIVV020 on the market?
"BIVV020 falls into the Phase 2 category, meaning that while there is some evidence suggesting it is safe, there is no data to support its efficacy. We've given it a score of 2."
Are we still looking for enrollees for this experiment?
"Indeed, this clinical trial is still recruiting patients. The information on clinicaltrials.gov shows that the study was first posted on 4/28/2021 and was last edited on 10/27/2022."
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