Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Riliprubart Prefilled Pen (PFP), Riliprubart Prefilled Pen
Riliprubart · 2 trials · 3 indications
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/Peripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (20...
Riliprubart is an investigational small molecule being developed for chronic inflammatory demyelinating polyneuropathy (CIDP), also known as chronic inflammatory demyelinating polyradiculoneuropathy. It is being studied in adults aged 18 years and older whose usual treatments do not work, as well as in comparison to standard intravenous immunoglobulin (IVIg) therapy.
Riliprubart is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 3 clinical development for chronic inflammatory demyelinating polyneuropathy (CIDP).
Riliprubart is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. It has received orphan drug designation from the FDA for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
Riliprubart is being studied in three Phase 3 trials. NCT06290128 is an active, not recruiting study in CIDP patients for whom usual treatments do not work. NCT06290141 is recruiting and compares Riliprubart to IVIg. NCT06859099 is an enrolling-by-invitation long-term safety and efficacy study. All trials are randomized, double-blind, and placebo-controlled.
Yes, Riliprubart is also known as Riliprubart Prefilled Pen (PFP) or Riliprubart Prefilled Pen. These names refer to the same drug product, which is being developed by Sanofi for chronic inflammatory demyelinating polyneuropathy (CIDP).
The Riliprubart Phase 3 program includes trials with enrollment of 109, 160, and 300 participants across multiple countries including the United States, Canada, Japan, and European nations. The trials are randomized, double-blind, and placebo-controlled, with a minimum participant age of 18 years.