A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) (myOpportunITy1)

  • STATUS
    Recruiting
  • End date
    Aug 31, 2022
  • participants needed
    93
  • sponsor
    UCB Biopharma SRL
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Updated on 12 May 2022
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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 on12 May 2022

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 treatments 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 (<30×10^9/L) prior to Screening
Study participant has a platelet count measurement at Screening and at Baseline (Day
with an average of the two <30×10^9/L and no single count may be >35×10^9/L (using local laboratories)
Study participant has a current or history of a peripheral blood smear consistent with
Study participants may be male or female
ITP
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
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 current 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 (clear
Study participant has a history of coagulopathy disorders other than ITP
association with other medical conditions, eg, untreated H. pylori infection
leukemia, lymphoma, common variable immunodeficiency, systemic lupus erythematosus
autoimmune thyroid disease or is drug induced), participant has a multiple immune
Study participant has a clinically relevant active infection (eg, sepsis, pneumonia
cytopenia (eg, Evan's syndrome)
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 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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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