Trials / Terminated
TerminatedNCT04200456
A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- UCB Biopharma SRL · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-01-31
- Primary completion
- 2022-03-21
- Completion
- 2022-04-27
- First posted
- 2019-12-16
- Last updated
- 2025-03-18
- Results posted
- 2023-08-08
Locations
29 sites across 16 countries: United States, Bulgaria, France, Georgia, Greece, Hungary, Italy, Japan, Moldova, Poland, Romania, Russia, South Korea, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04200456. Inclusion in this directory is not an endorsement.