Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia

Study Overview
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Brief Summary
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The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia.

Official Title
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A Multicenter, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia

Conditions
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Thrombocytopenia

Intervention / Treatment
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* Drug: UCB7665


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a diagnosis of primary immune thrombocytopenia (ITP) for a minimum of 3 months prior to Screening Visit Subject has a platelet count <30x10^9/L at Screening and <35x10^9/L at Baseline (Visit 2) Subject has a current or history of a peripheral blood smear consistent with ITP Subject has responded to previous ITP therapy (according to the judgment of the investigator) Exclusion Criteria: Subject has an immunoglobulin G (IgG) level <=6g/L at Screening Visit Subject has a partial thromboplastin time (PTT) >=1.5x upper limit of normal (ULN) or International Normalized Ratio (INR) >=1.5 at Screening Visit Subject has renal and/or liver impairment defined as: Serum creatinine level of >=1.4 mg/dL for females and >=1.5 mg/dL for males at Screening Visit Subject has planned an elective surgical procedure in the coming 6 months Subject has evidence of a secondary cause of primary immune thrombocytopenia purpura Subject has a history of clinically relevant ongoing chronic infections Subject has a family history of primary immunodeficiency Subject has a clinically relevant active infection or has had a serious infection within 6 weeks prior to the first dose of IMP Subject has a history of known inflammatory bowel disease, diverticular disease, and gastric or esophageal ulceration Subject has experienced gastrointestinal bleed in the last 6 months prior to Screening Visit and/or has current gastritis or esophagitis Subject has a medical history of thrombosis Subject has a history of coagulopathy disorders other than ITP Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP Subject has had prior treatment with rituximab in the 6 months prior to the Baseline Visit Subject has not completed the washout period for the immunosuppressants, biologics and other therapies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UCB7665 dose 1<br>Subjects in this Arm will receive 5 subcutaneous (sc) doses of UCB7665 at 1-week intervals | Drug: UCB7665<br>* Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion<br>|
| Experimental: UCB7665 dose 2<br>Subjects in this Arm will receive 3 subcutaneous (sc) doses of UCB7665 dose 2 at 1-week intervals | Drug: UCB7665<br>* Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion<br>|
| Experimental: UCB7665 dose 3<br>Subjects in this Arm will receive 2 subcutaneous (sc) doses of UCB7665 dose 3 at 1-week intervals | Drug: UCB7665<br>* Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion<br>|
| Experimental: UCB7665 dose 4<br>Subjects in this Arm will receive 1 subcutaneous (sc) dose of UCB7665 dose 4 | Drug: UCB7665<br>* Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion<br>|
| Experimental: UCB7665 dose 5<br>Subjects in this Arm will receive 1 subcutaneous (sc) dose of UCB7665 dose 5 | Drug: UCB7665<br>* Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects experiencing at least one Treatment Emergent Event (TEAE) during the study | TEAEs are defined as Adverse Events starting after the time of first Investigational Medicinal Product (IMP) administration up to and including 8 weeks after the final dose. | From Visit 2 (Week 1) until End of Study Visit or Early Termination (up to 12 weeks after the first IMP administration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ITP