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

  • STATUS
    Recruiting
  • End date
    Aug 5, 2022
  • participants needed
    90
  • sponsor
    UCB Biopharma SRL
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Updated on 5 December 2021
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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).

Details
Condition Primary Immune Thrombocytopenia
Treatment Placebo, Rozanolixizumab
Clinical Study IdentifierNCT04200456
SponsorUCB Biopharma SRL
Last Modified on5 December 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Study participant must be 18 years of age at the time of the Screening Visit
Study participant has a diagnosis of persistent (>3 months duration) or chronic (>12 months duration) primary immune thrombocytopenia (ITP) at the Screening Visit
Study participant has a documented intolerance or insufficient response to two or more appropriate standard of care ITP medications prior to Screening
Study participants must have prior history of a response to a previous ITP therapy
If taking allowed drugs, study participant must be on stable doses during defined time periods prior to Baseline (Day 1)
Study participant has a documented history of low platelet count (<30x10^9/L) prior to Screening
Study participant has a platelet count measurement at Screening and at Baseline (Day
with an average of the two <30x10^9/L and no single count may be >35x10^9/L (using local laboratories)
Study participant has a current or history of a peripheral blood smear consistent with ITP
Study participants may be male or female
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 or not planning to get pregnant during the participation in the study, not breastfeeding, and at least one of the following conditions applies
Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow
the contraceptive guidance during the Treatment Period and for at least 3
months after the dose of study treatment

Exclusion Criteria

Participant has a history of arterial or venous thromboembolism (eg, stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires anticoagulant treatment
Study participant has clinically significant bleeding that warrants immediate platelet adjustment (eg, menorrhagia with significant drop in hemoglobin)
Study participant has a known hypersensitivity to any components of the study medication or any other anti-neonatal Fc receptor (FcRn) medications
Study participant has evidence of a secondary cause of immune thrombocytopenia (eg, past medical history of untreated H. pylori infection, leukemia, lymphoma, common variable immunodeficiency, systemic lupus erythematosus, autoimmune thyroid disease or drug induced), participant has a multiple immune cytopenia (eg, Evan's syndrome)
Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP)
Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI)
Study participant has a history of a major organ transplant or hematopoietic stem cell/marrow transplant
Study participant has experienced intracranial bleed in the last 6 months prior to the Screening Visit
Study participant has a history of coagulopathy disorders other than ITP
Study participant has a Karnofsky Performance Status rating <60% at the Screening Visit
Study participant with current or medical history of immunoglobulin A (IgA) deficiency, or a measurement of IgA <50 mg/dL at the Screening Visit
Study participant has undergone a splenectomy in the 2 years prior to the Baseline Visit
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