Trial · NCT06859099
Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP
NCT06859099, Phase 3, Enrolling by invitation, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP. Trials, record NCT06859099. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06859099
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP
- NCT number
- NCT06859099
- Status
- Enrolling by invitation
- Phases
- Phase 3
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Sanofi
- Conditions
- Polyneuropathy, Inflammatory Demyelinating, Chronic
- Interventions
- Riliprubart Prefilled Pen (PFP)
- First posted
- 2025-03-05
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Up to End of Study (approx. 4 years) | adverse events: AEs, serious adverse events: SAEs, adverse events of special interest: AESIs, electrocardiograms: ECGs |
| Secondary | Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156) | From first dose of riliprubart in parent study to end of treatment (up to approx. 7 years) | 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. |
| Secondary | Percentage of participants experiencing improvement from baseline | From Baseline to 3 years | 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 |
| Secondary | Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time | From Baseline to 3 years | |
| Secondary | Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time | From Baseline to 3 years | |
| Secondary | Change from baseline in grip strength (kilopascals; dominant hand) over time | From Baseline to 3 years | |
| Secondary | Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time | From Baseline to 3 years |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06859099
GET https://conductscience.org/api/trials/v1/NCT06859099/registered