A Study on the Safety and Efficacy of Riliprubart in Participants with Chronic Inflammatory Demyelinating Polyneuropathy Who Are Not Responding to Standard Treatments
Zusammenfassung der Studie
The aim of this study is to find out whether a new medication called Riliprubart works in people with CIDP whose condition has not improved under standard treatments. The study will also ensure that Riliprubart is safe for the individuals receiving it.
(BASEC)
Untersuchte Intervention
This study investigates Riliprubart. It is a type of medication that prevents a specific part of the body's immune system from being overly active. A placebo (dummy medication) will also be used in the study. The placebo looks like the medication being studied – however, it contains no active ingredient. Therefore, it is also called a 'dummy medication.' In the first part of the study, it will be determined how well Riliprubart improves disability compared to a placebo treatment. In the second part, it will be assessed how well Riliprubart works to improve disability in the long term.
(BASEC)
Untersuchte Krankheit(en)
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare condition in which the body's immune system attacks the myelin that surrounds and protects the nerves. People with CIDP typically suffer from muscle weakness, making it difficult for them to walk. They may also experience strange sensations such as tingling, numbness, or coordination difficulties. This often leads to increasing disability, which may require physical therapy, special devices like braces, or even a wheelchair.
(BASEC)
I 02. The participant must have CIDP or possible CIDP criteria. I 03. The participant must be refractory (non-responsive) to either immunoglobulin therapy or corticosteroid therapy. I 05. All permitted immunosuppressants (azathioprine, ciclosporin, or mycophenolate mofetil) must have been taken at a stable dose for ≥6 months before screening. I 06. The participant may receive low-dose oral corticosteroids, but only if they have been taken at a stable dose for ≥3 months before screening. I 08. The participant must have documented vaccinations against encapsulated bacterial pathogens [Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae] within 5 years prior to screening or have the vaccinations initiated at least 14 days before the first dose of the investigational product. (BASEC)
Ausschlusskriterien
E 01. Polyneuropathy of other causes. E 03. Any other neurological or systemic disease that may cause symptoms and signs that could interfere with treatment or outcome assessment. E 04. Poorly controlled diabetes (HbA1c > 7%). E 05. Severe infections. E 12. The participant has received immunoglobulins (IVIg or SCIg) within 8 weeks prior to screening. E 13. Treatment with plasma exchange within 8 weeks prior to screening. (BASEC)
Studienstandort
Bern
(BASEC)
Sponsor
Sanofi-aventis (suisse) sa 3, Route de Montfleury 1214 Vernier
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Hanka Klaus
+49 (0)30 2575 2442
CSU-CTA-EK@cluttersanofi.comSanofi-aventis (suisse) sa 3, Route de Montfleury 1214 Vernier
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
27.08.2024
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
A Phase 3, double-blind, placebo-controlled study evaluating efficacy and safety of riliprubart in participants with refractory chronic inflammatory demyelinating polyneuropathy (BASEC)
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Untersuchte Krankheit(en)
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Ergebnisse der Studie
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