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NCT05468320 · ClinicalTrials.gov registry record · Phase 3
Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
NCT05468320 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 51 participants.
The verdict
NCT05468320, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
Study Summary
This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary endpoint of remission in male and female participants aged 18 to 80 years with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The anticipated study duration per participant without a recurrence while on therapy is maximum 24 weeks (ie, approximately 1 day for screening + maximum 12 weeks of treatment for the presenting episode + 12 weeks of follow-up). Participants will have daily assessments during hospitalization and weekly visits for assessments during ongoing treatment with caplacizumab and IST. There will be 3 outpatient visits for assessments during the follow-up period. There will be two additional follow-up visits for participants who do not have ADAMTS13 activity levels of ≥50% at the time of caplacizumab discontinuation.
Interventions
- DRUG Corticosteroids
- DRUG Caplacizumab
- BIOLOGICAL anti-CD20 antibody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2022-11-21 |
| Est. Completion | 2024-12-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05468320
The ClinicalTrials.gov registry entry for NCT05468320 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Corticosteroids is the first listed.
NCT05468320 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05468320 about?
NCT05468320 is a clinical study titled "Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura". This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary endpoint of remission in male and female participants aged 18 to 80 years ...
What is the current status of trial NCT05468320?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2022-11-21. Estimated completion is 2024-12-26.
What interventions are being tested in trial NCT05468320?
The interventions under investigation include: Corticosteroids (DRUG), Caplacizumab (DRUG), anti-CD20 antibody (BIOLOGICAL).
Who is sponsoring clinical trial NCT05468320?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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