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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1311-1432 | Other Identifier | WHO ICTRP | |
| 2024-517032-22-00 | Registry Identifier | CTIS |
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This study is a Phase 3 extension, global, multicenter open-label study. The purpose of this study is to evaluate long-term safety and efficacy of riliprubart in adult participants with chronic inflammatory demyelinating polyneuropathy (CIDP) who have completed Part B in 1 of 3 parent studies (PDY16744, EFC17236, or EFC18156) and wish to continue treatment with riliprubart. Up to approximately 300 participants will be enrolled to continue receiving treatment with riliprubart. The duration of participation for each participant will be up to approximately 4 years, including posttreatment follow-up. The treatment duration will be up to approximately 3 years. A participant who discontinues riliprubart treatment at any time during the study will be followed for safety for a minimum of 55 weeks after the last dose of riliprubart received.
This is a single-arm study. All participants transitioning to Study LTS17261 will receive riliprubart weekly for up to 3 years, or until commercialization of riliprubart for the treatment of CIDP or termination of the riliprubart clinical development program for the treatment of CIDP, or the local availability of other options for long-term treatment with riliprubart, whichever comes first.
The total number of study visits will be 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| riliprubart | Experimental | Participants receive subcutaneous injection with a riliprubart prefilled pen (PFP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riliprubart Prefilled Pen (PFP) | Drug | Pharmaceutical form: Solution Route of administration: Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants having any AEs, SAEs, adverse events leading to treatment discontinuation, AESIs, and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, ECGs, and vital signs during the study period | adverse events: AEs, serious adverse events: SAEs, adverse events of special interest: AESIs, electrocardiograms: ECGs | Up to End of Study (approx. 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156) | To estimate the relapse-free rate, time to first relapse, defined as time from first dose of riliprubart in the parent study to the first relapse since riliprubart initiation, will be derived for each participant. Relapse since riliprubart initiation is defined as increase of 1 point or more in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score relative to the visit for the first dose of riliprubart in the parent study. |
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Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Neurology Associates- Site Number : 8400019 | Homewood | Alabama | 35209 | United States | ||
| University of Kansas Medical Center- Site Number : 8400010 |
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| Label | URL |
|---|---|
| LTS17261 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| From first dose of riliprubart in parent study to end of treatment (up to approx. 7 years) |
| Percentage of participants experiencing improvement from baseline | Improvement is defined as a decrease of 1 point or more in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score relative to baseline of the current study, Study LTS17261 | From Baseline to 3 years |
| Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time | From Baseline to 3 years |
| Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time | From Baseline to 3 years |
| Change from baseline in grip strength (kilopascals; dominant hand) over time | From Baseline to 3 years |
| Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time | From Baseline to 3 years |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022 | Philadelphia | Pennsylvania | 19104 | United States |
| Investigational Site Number : 0320003 | Buenos Aires | 1221 | Argentina |
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760004 | Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| Investigational Site Number : 1240001 | Gatineau | Quebec | J8Y 1W2 | Canada |
| Investigational Site Number : 1240002 | Québec | Quebec | G1E 7G9 | Canada |
| Investigational Site Number : 1520003 | Lo Barnechea | Reg Metropolitana de Santiago | 7691236 | Chile |
| Investigational Site Number : 1520002 | Santiago | Reg Metropolitana de Santiago | 8207257 | Chile |
| Investigational Site Number : 1560013 | Beijing | 100034 | China |
| Investigational Site Number : 1560005 | Beijing | 100053 | China |
| Investigational Site Number : 1560011 | Chengdu | 610072 | China |
| Investigational Site Number : 1560002 | Fuzhou | 350001 | China |
| Investigational Site Number : 1560012 | Guangzhou | 510000 | China |
| Investigational Site Number : 1560001 | Shanghai | 200040 | China |
| Investigational Site Number : 1560003 | Wuhan | 430030 | China |
| Investigational Site Number : 1560006 | Wuhan | 430060 | China |
| Investigational Site Number : 2030004 | Brno | 625 00 | Czechia |
| Investigational Site Number : 2030001 | Prague | 128 08 | Czechia |
| Investigational Site Number : 2080002 | Aarhus | 8200 | Denmark |
| Investigational Site Number : 2500007 | Bordeaux | 33076 | France |
| Investigational Site Number : 2500001 | Le Kremlin-Bicêtre | 94270 | France |
| Investigational Site Number : 2500002 | Marseille | 13885 | France |
| Investigational Site Number : 2500004 | Paris | 75013 | France |
| Investigational Site Number : 2760002 | Göttingen | 37075 | Germany |
| Investigational Site Number : 2760004 | Tübingen | 72076 | Germany |
| Investigational Site Number : 3800003 | Genoa | Genova | 16132 | Italy |
| Investigational Site Number : 3800001 | Milan | Milano | 20132 | Italy |
| Investigational Site Number : 3800004 | Rozzano | Milano | 20089 | Italy |
| Investigational Site Number : 3800002 | Rome | Roma | 00168 | Italy |
| Investigational Site Number : 3800005 | Pavia | 27100 | Italy |
| Investigational Site Number : 3800007 | Pisa | 56126 | Italy |
| Investigational Site Number : 3920012 | Higashi-Matsuyama | Saitama | 355-0005 | Japan |
| Investigational Site Number : 3920011 | Bunkyo-Ku | Tokyo | 113-8510 | Japan |
| Investigational Site Number : 2500005 | Toyama | 939-2716 | Japan |
| Investigational Site Number : 5280001 | Amsterdam | 1105 AZ | Netherlands |
| Investigational Site Number : 6160001 | Lublin | Lublin Voivodeship | 20-954 | Poland |
| Investigational Site Number : 6200004 | Lisbon | 1150-199 | Portugal |
| Investigational Site Number : 6880001 | Belgrade | 11000 | Serbia |
| Investigational Site Number : 4100003 | Seoul | Seoul-teukbyeolsi | 02841 | South Korea |
| Investigational Site Number : 7240001 | Barcelona | Catalunya [Cataluña] | 08041 | Spain |
| Investigational Site Number : 7240004 | Majadahonda | Madrid | 28222 | Spain |
| Investigational Site Number : 7240002 | Barcelona | 08035 | Spain |
| Investigational Site Number : 7240008 | Málaga | 29010 | Spain |
| Investigational Site Number : 7240003 | Valencia | 46026 | Spain |
| Investigational Site Number : 7520001 | Stockholm | 113 65 | Sweden |
| Investigational Site Number : 7920003 | Konya | 42075 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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