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A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

NCT04200456 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-03-18

Study results available
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Summary

The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).

Conditions

  • Primary Immune Thrombocytopenia

Interventions

DRUG

Rozanolixizumab

Study participants receive rozanolixizumab by subcutaneous infusion at pre-specified time points.

OTHER

Placebo

Study participants receive placebo by subcutaneous infusion at pre-specified time points.

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2022-03-21
Completion
2022-04-27
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • France
  • Georgia
  • Greece
  • Hungary
  • Italy
  • Japan
  • Moldova
  • Poland
  • Romania
  • Russia
  • South Korea
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT04200456 on ClinicalTrials.gov