A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Primary Immune Thrombocytopenia
In brief
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).
Key facts
- Study ID
- NCT04224688
- Run by
- UCB Biopharma SRL
- People needed
- 30
- Starts
- 2020-06-03
- Expected to finish
- 2022-05-05
- Last updated by the study team
- 2023-08-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 1) 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 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 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
You may not qualify if…
- 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 association with other medical conditions eg, of untreated H. pylori infection, leukemia, lymphoma, common variable immunodeficiency, systemic lupus erythematosus, autoimmune thyroid disease or is drug induced), participant has a multiple immune cytopenia (eg, Evan's syndrome) etc.
- 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 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
Where it is running
- Tp0006 50412 — St. Petersburg, Florida, United States
- Tp0006 50243 — Boston, Massachusetts, United States
- Tp0006 40189 — Plovdiv, Bulgaria
- Tp0006 40008 — Sofia, Bulgaria
- Tp0006 20201 — Bengbu, China
- Tp0006 20189 — Changchun, China
- Tp0006 20188 — Changsha, China
- Tp0006 20186 — Changzhou, China
- Tp0006 20179 — Fuzhou, China
- Tp0006 20187 — Hangzhou, China
- Tp0006 20177 — Jinan, China
- Tp0006 20185 — Jinan, China
- Tp0006 20194 — Wuxi, China
- Tp0006 40364 — Lille, France
- Tp0006 40369 — Berlin, Germany
- Tp0006 40366 — Rostock, Germany
- Tp0006 40219 — Słupsk, Poland
- Tp0006 40223 — Warsaw, Poland
- Tp0006 20052 — Moscow, Russia
- Tp0006 20054 — Moscow, Russia
- Tp0006 20053 — Saint Petersburg, Russia
- Tp0006 40231 — Madrid, Spain
- Tp0006 40268 — Madrid, Spain
- Tp0006 40381 — Zaragoza, Spain
- Tp0006 20094 — Tainan, Taiwan
Full record on ClinicalTrials.gov
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