Trials / Terminated
TerminatedNCT04224688
A Study to Assess 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
- 30 (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
- 2020-06-03
- Primary completion
- 2022-04-25
- Completion
- 2022-05-05
- First posted
- 2020-01-13
- Last updated
- 2023-08-08
- Results posted
- 2023-08-08
Locations
29 sites across 11 countries: United States, Bulgaria, China, France, Germany, Poland, Russia, Spain, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04224688. Inclusion in this directory is not an endorsement.