TerminatedPhase 3

A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Stopped: Strategic Business Decision; Not a safety decision

United States, China, Georgia43 participantsStarted 2021-01-06

Plain-language summary

The purpose of this study is to assess the long-term safety, tolerability and clinical efficacy of treatment with rozanolixizumab.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 urine 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:

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: From Baseline to end of Safety Follow-Up Period (up to Week 60)

Percentage of Participants With TEAEs Leading to Permanent Withdrawal of Rozanolixizumab (ie, Study Discontinuation)

Timeframe: From Baseline to end of Safety Follow-Up Period (up to Week 60)

NCT IDNCT04596995

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-21

Results submitted2023-12-20