MedTrace Logo

Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura

NCT05468320 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-12-30

Study results available
· View outcomes & findings →

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.

Conditions

  • Thrombotic Thrombocytopenic Purpura

Interventions

DRUG

Caplacizumab

Lyophilized powder for solution for injection.

DRUG

Corticosteroids

Solution for injection or Tablet

BIOLOGICAL

anti-CD20 antibody

Solution for injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2024-12-26
Completion
2024-12-26
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05468320 on ClinicalTrials.gov