TerminatedPhase 3

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

Stopped: Strategic Business Decision; Not a safety decision

United States, Bulgaria, France33 participantsStarted 2020-01-31

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. A male participant must agree to use contraception during the Treatment Period and for at least 3 months after the final dose of study treatment and refrain from donating sperm during this period
✓. A female participant is eligible to participate if she is not pregnant as confirmed by a negative serum pregnancy test and not planning to get pregnant during the participation in the study, not breastfeeding, and at least one of the following conditions applies:

What they're measuring

Percentage of Participants With Durable Clinically Meaningful Platelet Response of ≥50x10^9/L, for at Least 8 Out of 12 Weeks During the Last 12 Weeks

Timeframe: During the last 12 weeks (Week 13 to Week 25)

Trial details

NCT IDNCT04200456

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-21

Results submitted2023-05-15

View on ClinicalTrials.gov More Primary Immune Thrombocytopenia trials