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A Phase 2, multicenter, open-label, non-randomized, proof-of-concept study evaluating the efficacy, safety, and tolerability of SAR445088 in adults with chronic inflammatory demyelinating polyneuropathy (CIDP)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512345-16-00
Acronym
PDY16744
Enrollment
56
Registered
2024-06-24
Start date
2021-10-13
Completion date
2025-10-01
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic inflammatory demyelinating polyradiculoneuropathy

Brief summary

Part A, SOC-Treated: Percentage of participants relapsing after withdrawal of SOC and during the SAR445088 treatment period, Part A, SOC-Refractory (initial and low dose group) and SOC-Naïve: Percentage of participants responding during the SAR445088 treatment period, Part B: Number of participants reported with adverse events

Detailed description

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, Part B, SOC-Treated (initial dose group): Percentage of participants relapse-free during the treatment extension period, Part B, SOC-Refractory (initial and low dose group) and SOC-Naive: Percentage of participants with sustained response during the treatment extension period, Part B: Long-term immunogenicity

Interventions

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part A, SOC-Treated: Percentage of participants relapsing after withdrawal of SOC and during the SAR445088 treatment period, Part A, SOC-Refractory (initial and low dose group) and SOC-Naïve: Percentage of participants responding during the SAR445088 treatment period, Part B: Number of participants reported with adverse events

Secondary

MeasureTime frame
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, Part B, SOC-Treated (initial dose group): Percentage of participants relapse-free during the treatment extension period, Part B, SOC-Refractory (initial and low dose group) and SOC-Naive: Percentage of participants with sustained response during the treatment extension period, Part B: Long-term immunogenicity

Countries

France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026