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 15, 2022
  • participants needed
    90
  • sponsor
    UCB Biopharma SRL
Updated on 15 October 2021

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 on15 October 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note