Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
- Registration Number
- NCT02718716
- Lead Sponsor
- UCB Biopharma SRL
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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)
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description UCB7665 7 mg/kg UCB7665 Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals. UCB7665 4 mg/kg UCB7665 Participants in this arm received 5 subcutaneous (sc) doses of UCB7665 (rozanolixizumab) 4 milligram per kilograms (mg/kg) at 1-week intervals. UCB7665 10 mg/kg UCB7665 Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals. UCB7665 20 mg/kg UCB7665 Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg. UCB7665 15 mg/kg UCB7665 Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg.
- Primary Outcome Measures
Name Time Method Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study From Visit 2 (Week 1) until End of Study Visit or Early Termination (up to 12 weeks after the first investigational medicinal product (IMP) administration) TEAEs were 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Tp0001 601
🇲🇩Chisinau, Moldova, Republic of
Tp0001 1301
🇧🇬Sofia, Bulgaria
Tp0001 703
🇵🇱Gdańsk, Poland
Tp0001 705
🇵🇱Warsaw, Poland
Tp0001 1201
🇬🇪Tbilisi, Georgia
Tp0001 702
🇵🇱Bialystok, Poland
Tp0001 704
🇵🇱Poznan, Poland
Tp0001 1302
🇧🇬Pleven, Bulgaria
Tp0001 1101
🇦🇺Adelaide, Australia
Tp0001 403
🇩🇪Dusseldorf, Germany
Tp0001 404
🇩🇪Muenchen, Germany
Tp0001 506
🇮🇹Torino, Italy
Tp0001 503
🇮🇹Udine, Italy
Tp0001 505
🇮🇹Vicenza, Italy
Tp0001 701
🇵🇱Lodz, Poland
Tp0001 802
🇷🇴Brasov, Romania
Tp0001 801
🇷🇴Bucharest, Romania
Tp0001 901
🇪🇸Valencia, Spain
Tp0001 1001
🇬🇧London, United Kingdom
Tp0001 902
🇪🇸Madrid, Spain
Tp0001 803
🇷🇴Craiova, Romania
Tp0001 903
🇪🇸Madrid, Spain
Tp0001 1003
🇬🇧London, United Kingdom
Tp0001 1004
🇬🇧Truro, United Kingdom
Tp0001 203
🇨🇿Olomouc, Czechia
Tp0001 201
🇨🇿Praha 10, Czechia
Tp0001 401
🇩🇪Berlin, Germany
Tp0001 502
🇮🇹Firenze, Italy
Tp0001 1002
🇬🇧London, United Kingdom