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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-Naive (all criteria a-c must be met): a) Participants without previous treatment for CIDP or participants who received immunoglobulins (IVIg or SCIg) or corticosteroids but were stopped for reasons other than lack of response or side effects. b) Not treated with immunoglobulins (IVIg or SCIg) or corticosteroids for at least 6 months prior to screening. c) INCAT score: 2-9 (a score of 2 should be exclusively from leg disability component of INCAT).

Documented definite or probable diagnosis of CIDP (typical CIDP, pure motor CIDP, or Lewis-Sumner Syndrome) according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) Task Force first revision.

Must not have

Treatment (any time) with highly immunosuppressive/chemotherapeutic medications with sustained effects, eg, mitoxantrone, alemtuzumab, cladribine.

Poorly controlled diabetes (HbA1c >7%).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24 up to week 76

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I have been diagnosed with CIDP according to EFNS/PNS guidelines.

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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.

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I can't take immunoglobulins or corticosteroids because of side effects.

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I can't take immunoglobulins or corticosteroids because of side effects.

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I have taken a pregnancy test recently and it was negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken strong immune-suppressing drugs like mitoxantrone.

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My diabetes is not well-controlled (HbA1c over 7%).

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I have been diagnosed with systemic lupus erythematosus (SLE).

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I have undergone total lymphoid irradiation or bone marrow transplantation.

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I haven't used any complement system inhibitors recently.

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My tests show IgG4 autoantibodies against specific nerve proteins.

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I have not had, nor am I planning to have, any major surgery that could affect the trial.

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I have not had plasma exchange treatment in the last 3 months.

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I haven't taken rituximab or ocrelizumab in the last 6 months or until my B-cell counts normalized, whichever took longer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24 up to week 76

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 15Eligibility criteria met