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Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP

Study acronym: LTS
StatusEnrolling by Invitation
PhasePhase 3
SponsorSanofi
Started
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Record History

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  1. Study sites: 60 to 62
  2. Trial sites expanded: 49 → 59 locations
  3. Study sites: 49 to 59
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 6 entries
  4. Study sites: 47 to 49v16
  5. Study sites: 45 to 47v15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 44 to 45v14
  2. Site details revised at 1 of 44 sitesv13
  3. Study sites: 43 to 44v12
  4. Study sites: 41 to 43v11
  5. Study sites: 39 to 41v10
  6. Study sites: 36 to 39v9
  7. Study sites: 35 to 36v8
  8. Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 33 to 35
    • Eligibility criteria expanded, about 20 words
    v7
  9. Study sites: 30 to 33v6
  10. Study sites: 29 to 30v5
  11. Study sites: 28 to 29v4
  12. Study sites: 3 to 28v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoint revised
    • Study sites: 0 to 3
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
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.
Trial Details
NCT Number NCT06859099
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Polyneuropathy, Inflammatory Demyelinating, Chronic
Related terms Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov