← Back to Search

Monoclonal Antibodies

SAR445088 for Chronic Inflammatory Demyelinating Polyneuropathy

Phase 2
Waitlist Available
Research Sponsored by Bioverativ, a Sanofi company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
SOC-Treated (all criteria a-c must be met): a) Documented evidence of objective response to SOC, with clinically meaningful improvement. Clinically meaningful improvement is defined as one of the following: ≥1-point decrease in adjusted INCAT score, ≥4 points increase in RODS total score, ≥3 points increase in MRC Sum score, ≥8 kilopascal improvement in mean grip strength (one hand), or an equivalent improvement based on information documented in medical records and per the PI's judgement. b) Must be on stable SOC therapy, defined as no change greater than 10% in frequency or dose of immunoglobulin therapy or corticosteroids within 8 weeks prior to screening, remaining at stable SOC therapy until the time of first SAR445088 dosing. c) Evidence of clinically meaningful deterioration on interruption or dose reduction of SOC therapy within 24 months prior to screening, determined by clinical examination or medical records. Clinically meaningful deterioration is defined as one of the following: ≥1-point increase in adjusted INCAT score, decrease in RODS total score ≥4 points, decrease in MRC Sum score ≥3, mean grip strength worsening of ≥8 kilopascals (one hand), or an equivalent deterioration based on information from medical records and at the PI's judgement.
b) Patient has not received immunoglobulins (IVIg or SCIg) within 12 weeks prior to screening. c) Certain immunosuppressant drugs are allowed in this group if taken for ≥6 months and at a stable dose for ≥3 months prior to screening: azathioprine, methotrexate, mycophenolate mofetil and cyclosporine. Oral corticosteroids are allowed if on a stable dose of <20 mg/day of prednisone (or equivalent dose for other oral corticosteroids) for ≥3 months prior to screening. d) INCAT score: 2-9 (a score of 2 should be exclusively from leg disability component of INCAT).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24 up to week 76
Awards & highlights

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.

Who is the study for?
Adults over 18 with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) who are either untreated, have not responded well to standard treatments, or cannot continue those treatments due to side effects. Participants must be able to consent and women of childbearing age must use effective contraception.Check my eligibility
What is being tested?
The trial is testing SAR445088 for CIDP patients. It's given via IV or SC injections. The study has two parts: Part A tests the drug's effectiveness in different subpopulations; Part B looks at long-term safety and how well it works over time.See study design
What are the potential side effects?
While specific side effects of SAR445088 aren't listed, similar drugs may cause injection site reactions, increased risk of infections, potential allergic reactions, fatigue, headache, and possible immune system impacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition did not improve after 12 weeks of standard treatment.
Select...
I am either new to treatment, have had standard treatment, or my condition didn't improve with standard treatment.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with CIDP according to EFNS/PNS guidelines.
Select...
I agree to use a condom and another effective birth control method.
Select...
I have been vaccinated against certain bacterial infections within the last 5 years or started vaccinations at least 14 days before my first dose.
Select...
I agree not to donate sperm during and up to a year after the treatment.
Select...
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.
Select...
I can't take immunoglobulins or corticosteroids because of side effects.
Select...
I can't take immunoglobulins or corticosteroids because of side effects.
Select...
This criterion is not applicable on its own.
Select...
I have taken a pregnancy test recently and it was negative.
Select...
I agree to use two forms of birth control and not donate eggs until 52 weeks and 30 days after my last study dose.
Select...
I am able to understand and sign the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24 up to week 76
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 up to week 76 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A, SOC-Refractory (initial and low dose group) and SOC-Naive: Percentage of participants responding during the SAR445088 treatment period
Part A, SOC-Treated: Percentage of participants relapsing after withdrawal of SOC and during the SAR445088 treatment period
Part B: Number of participants reported with adverse events
Secondary outcome measures
Part A: Number of participants reported with adverse events
Part A: Number of participants with incidence and titer of anti-SAR445088 antibodies (ADA)
Part A: Percentage of participants in the SOC-Treated group improving during the overlap treatment period
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: SOC-Treated Low DoseExperimental Treatment2 Interventions
Part A: Eligible participants will receive SAR445088 for 24 weeks. Weeks 1-12 (overlap period): Participants will be given SAR445088 with superimposing effects SOC therapy; Weeks 13-24: SAR445088. Participants who do not enroll into Part B will attend a final safety follow-up visit that will take place 22 weeks after Week 24 (~Week 46). Part B: Participants who successfully complete Part A, will be reassessed for continued eligibility, will be given the option of rolling into Part B, and continue receiving SAR445088 for 52 weeks. At the end of the Part B treatment period, participants will attend a safety follow-up visit that will take place 22 weeks after the last SAR445088 dose (~week 98) if they do not continue in Part C. Part C: Participants from Part B who enter Part C will continue receiving SAR445088 until end of study. Participants who discontinue at any time in Part C will attend a safety follow-up visit that will take place 22 weeks after the last SAR445088 dose.
Group II: SOC-Treated Initial DoseExperimental Treatment2 Interventions
Part A: Eligible participants will receive SAR445088 for 24 weeks. Weeks 1-12 (overlap period): Participants will be given SAR445088 with superimposing effects of SOC therapy; Weeks 13-24: SAR445088 given. Participants who do not enroll into Part B will attend final safety follow-up visit at 22 weeks after Week 24 (~Week 46). Part B: Participants who successfully complete Part A, will be reassessed for continuing eligibility and will be given option of rolling into Part B, and continue receiving SAR445088 for 52 weeks. At the end of the Part B treatment period, participants will be asked to attend a safety follow-up visit that will take place 22 weeks after the last SAR445088 dose (~week 98) if they do not continue in Part C. Part C: Participants from Part B who enter Part C will continue receiving SAR445088 until end of study. Participants who discontinue at any time during Part C will be asked to attend a safety follow-up visit at 22 weeks after the last SAR445088 dose.
Group III: SOC-Refractory Low DoseExperimental Treatment2 Interventions
Part A: Eligible participants will receive SAR445088 for 24 weeks. Participants who do not enroll into Part B will be asked to attend a final safety follow-up visit that will take place 22 weeks after Week 24 (approximately at Week 46). Part B: Participants who successfully complete Part A, will be reassessed for continued eligibility and will be given the option to roll into Part B, where they will continue receiving SAR445088 for an additional 52 weeks. At the end of the Part B treatment period, participants will be asked to attend a safety follow-up visit that will take place 22 weeks after the last SAR445088 dose (approximately week 98) if they do not continue in Part C. Part C: Participants from Part B who enter Part C will continue receiving SAR445088 until the end of study. Participants who discontinue at any time during Part C will be asked to attend a safety follow-up visit that will take place 22 weeks after the last SAR445088 dose.
Group IV: SOC-Refractory Initial DoseExperimental Treatment2 Interventions
Part A: Eligible participants will receive SAR445088 for 24 weeks. Participants who do not enroll into Part B will be asked to attend a final safety follow-up visit that will take place 22 weeks after Week 24 (approximately (~)at Week 46). Part B: Participants who successfully complete Part A, will be reassessed for continuing eligibility and will be given the option of rolling into Part B, where they will continue receiving SAR445088 for an additional 52 weeks. At the end of the Part B treatment period, participants will be asked to attend a safety follow-up visit that will take place 22 weeks after the last SAR445088 dose (approximately week 98) if they will not continue in Part C. Part C: Participants from Part B who enter Part C will continue receiving SAR445088 until the end of study. Participants who discontinue at any time during Part C will be asked to attend a safety follow-up visit that will take place 22 weeks after the last SAR445088 dose.
Group V: SOC-NaiveExperimental Treatment2 Interventions
Part A: Eligible participants will receive SAR445088 for 24 weeks. Participants who do not enroll into Part B will be asked to attend a final safety follow-up visit that will take place 22 weeks after Week 24 (approximately at Week 46). Part B: Participants who successfully complete Part A, will be reassessed for continuing eligibility and will be given the option of rolling into Part B, where they will continue receiving SAR445088 for an additional 52 weeks. At the end of the Part B treatment period, participants will be asked to attend a safety follow-up visit that will take place 22 weeks after last SAR445088 dose (approximately week 98) if they do not continue in Part C. Part C: Participants from Part B who enter Part C will continue receiving SAR445088 until the end of study. Participants who discontinue at any time during Part C will be asked to attend a safety follow-up visit that will take place 22 weeks after last SAR445088 dose.

Find a Location

Who is running the clinical trial?

Bioverativ, a Sanofi companyLead Sponsor
17 Previous Clinical Trials
926 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,845 Total Patients Enrolled

Media Library

BIVV020 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04658472 — Phase 2
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Research Study Groups: SOC-Treated Initial Dose, SOC-Treated Low Dose, SOC-Refractory Initial Dose, SOC-Refractory Low Dose, SOC-Naive
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Clinical Trial 2023: BIVV020 Highlights & Side Effects. Trial Name: NCT04658472 — Phase 2
BIVV020 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04658472 — Phase 2
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patient Testimony for trial: Trial Name: NCT04658472 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

Who else is applying?

How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
Kansas
Texas
New Jersey
What site did they apply to?
University of California, Irvine
Columbia University-Site Number:8400005
University of Kansas Medical Center-Site Number:8400003
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I am hoping this trial will help me and others feel better.
PatientReceived no prior treatments
~35 spots leftby Aug 2025