Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Riliprubart Prefilled Pen (PFP), Riliprubart Prefilled Pen, SAR445088
Riliprubart · 5 trials · 4 indications
adverse events: AEs, serious adverse events: SAEs, adverse events of special interest: AESIs, electrocardiograms: ECGs
A response is defined as decrease of ≥1 point from baseline in adjusted INCAT disability score at Week 24
Lasting response is defined as a decrease of ≥1 point in adjusted INCAT disability score
Lasting response is defined as a decrease of ≥1 point in adjusted INCAT disability score at week 48 versus baseline.
A response is defined as a decrease of ≥1 point in adjusted INCAT disability score at Week 48 versus week 24.
Relapse will be defined as ≥1-point increase in adjusted Inflammatory neuropathy cause and treatment (INCAT) disability score. The Investigator/rater will evaluate the level of impairment in participants? arms and legs each on a scale of 0 (least impaired) to 5 (most impaired), in the context of a neurological examination, and will record the added scores (range 0 to 10) per the INCAT reporting instructions. A low score reflects no or minimal disability eg, no arm dysfunction or walking normally, whereas higher scores indicate more disability eg, wheelchair bound or no purposeful arm movement.
Response will be defined as ≥1-point decrease in adjusted INCAT disability score. The Investigator/rater will evaluate the level of impairment in participants? arms and legs each on a scale of 0 (least impaired) to 5 (most impaired), in the context of a neurological examination, and will record the added scores (range 0 to 10) per the INCAT reporting instructions. A low score reflects no or minimal disability eg, no arm dysfunction or walking normally, whereas higher scores indicate more disability eg, wheelchair bound or no purposeful arm movement.
Number of participants reported with adverse events during 76 weeks of treatment and 22 weeks of follow-up.
A naive participant was a participant who did not use sutimlimab prior to enrollment. A switcher was a participant who used sutimlimab prior to enrollment. A naive participant was a responder if the platelet count was \>=50 × 10\^9/liter (L) at \>=50 percent (%) of scheduled visits, or for participants with baseline platelet count \<15 × 10\^9/L, a \>=20 × 10\^9/L increase in platelet count from baseline at \>=50% of scheduled visits, without receiving rescue immune thrombocytopenia (ITP) therapy. A switcher was a responder if the maintenance platelet count was \>=30 × 10\^9/L at \>=50% of scheduled visits, without receiving rescue ITP therapy.
| Arm | Type | Description |
|---|---|---|
| riliprubart | EXPERIMENTAL | Participants receive subcutaneous injection with a riliprubart prefilled pen (PFP) |
| Riliprubart Arm | EXPERIMENTAL | Riliprubart + Placebo IVIg for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks |
| IVIg Arm | ACTIVE_COMPARATOR | IVIg (IVIg continuation) + Placebo riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks |
| Placebo Arm | PLACEBO_COMPARATOR | Placebo for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks |
| SOC-Refractory Initial Dose | EXPERIMENTAL | 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. |
| SOC-Refractory Low Dose | EXPERIMENTAL | 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. |
| SOC-Treated Initial Dose | EXPERIMENTAL | 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. |
| SOC-Naive | EXPERIMENTAL | 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. |
| SOC-Treated Low Dose | EXPERIMENTAL | 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. |
| SAR445088 | EXPERIMENTAL | Participants received SAR445088 (BIVV020). |
| Name | Type | Description |
|---|---|---|
| Riliprubart Prefilled Pen (PFP) | DRUG | Pharmaceutical form: Solution Route of administration: Subcutaneous injection |
| riliprubart | DRUG | Pharmaceutical form: Solution Route of administration: IV solution |
| Placebo | DRUG | Pharmaceutical form: Solution Route of administration: IV solution |
| IVIg | DRUG | Pharmaceutical form: Concentrate for solution for infusion (or any other formulation approved locally) Route of administration: IV solution |
| SAR445088 (IV) | DRUG | Pharmaceutical form: Solution for Injection Route of Administration: Intravenous (IV) |
| SAR445088 (SC) | DRUG | Pharmaceutical form: Solution for Injection Route of Administration: Subcutaneous (SC) |
| SAR445088 (BIVV020) | DRUG | Pharmaceutical form:solution for injection |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participants with chronic inflammatory demyelinating polyneuropathy (CIDP) currently receiving riliprubart who completed treatment in Part B of Study PDY16744, Study EFC17236, ...
Riliprubart is an investigational small molecule being developed by Sanofi for chronic inflammatory demyelinating polyneuropathy, or CIDP. It is in Phase 3 clinical development and has received an orphan drug designation from the FDA. It is not yet approved for any indication.
Riliprubart is being studied for the treatment of chronic inflammatory demyelinating polyneuropathy, a neurological condition affecting peripheral nerves. The clinical program includes patients who have not responded to usual treatments as well as those receiving standard therapy such as intravenous immunoglobulin.
Riliprubart is developed by Sanofi, which trades under the ticker SNY. Sanofi is running the Phase 3 clinical program for the drug in chronic inflammatory demyelinating polyneuropathy across multiple countries worldwide.
Riliprubart is in Phase 3 clinical development. Two active Phase 3 trials are ongoing, and a third Phase 3 study is active but not recruiting. The drug is investigational and has not been approved by the FDA.
Riliprubart is being evaluated in three Phase 3 trials: NCT06290141, which compares it with intravenous immunoglobulin in CIDP; NCT06290128, which studies patients for whom usual treatments do not work; and NCT06859099, a long-term safety and efficacy study. All are randomized, double-blind, and active-controlled.
Yes. Riliprubart Prefilled Pen, sometimes abbreviated PFP, is an alternative name for riliprubart. Both refer to the same Sanofi investigational drug being studied in Phase 3 trials for chronic inflammatory demyelinating polyneuropathy.