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NCT04658472 · ClinicalTrials.gov registry record · Phase 2
Proof-of-concept Study for SAR445088 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Phase 2 study, sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT04658472: Completed Phase 2 study, sponsored by Bioverativ, a Sanofi company.
NCT04658472 is a Phase 2 study that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04658472, a Phase 2 study, has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study Summary
Primary Objectives: * Part A: Efficacy of SAR445088 across three subpopulations of CIDP patients: standard of care (SOC)-Treated, SOC-Refractory and SOC-Naive * Part B:Long-term safety and tolerability of SAR445088 in CIDP Secondary Objectives: * Part A: * Safety and tolerability of SAR445088 in CIDP * Immunogenicity of SAR445088 * Efficacy of SAR445088 with overlapping SOC (SOC-Treated group) * Part B: * Durability of efficacy during long-term treatment with SAR445088 in CIDP * Long-term immunogenicity of SAR445088 in CIDP
Primary Outcome
Relapse will be defined as ≥1-point increase in adjusted Inflammatory neuropathy cause and treatment (INCAT) disability score. The Investigator/rater will evaluate the level of impairment in participants? arms and legs each on a scale of 0 (least impaired) to 5 (most impaired), in the context of a neurological examination, and will record the added scores (range 0 to 10) per the INCAT reporting instructions. A low score reflects no or minimal disability eg, no arm dysfunction or walking normally
Interventions
- DRUG SAR445088 (IV)
- DRUG SAR445088 (SC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2021-04-28 |
| Est. Completion | 2025-10-01 |
| Phase | Phase 2 |
What the finished NCT04658472 record still lists
NCT04658472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which SAR445088 (IV) is the first listed.
NCT04658472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04658472 about?
NCT04658472 is a clinical study titled "Proof-of-concept Study for SAR445088 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)". Primary Objectives: * Part A: Efficacy of SAR445088 across three subpopulations of CIDP patients: standard of care (SOC)-Treated, SOC-Refractory and SOC-Naive * Part B:Long-term safety and tolerability of SAR445088 in CIDP Secondary Objectives: * Part A: * Safety and tolerability of SAR445088 ...
What is the current status of trial NCT04658472?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2021-04-28. Estimated completion is 2025-10-01.
What interventions are being tested in trial NCT04658472?
The interventions under investigation include: SAR445088 (IV) (DRUG), SAR445088 (SC) (DRUG).
Who is sponsoring clinical trial NCT04658472?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04658472's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,255 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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