Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
NCT ID: NCT02718716
Last Updated: 2024-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2016-03-02
2019-02-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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UCB7665 4 mg/kg
Participants in this arm received 5 subcutaneous (sc) doses of UCB7665 (rozanolixizumab) 4 milligram per kilograms (mg/kg) at 1-week intervals.
UCB7665
* Intervention Type: Biological/Vaccine
* Pharmaceutical Form: Powder for solution for infusion
* Concentration: 100 mg/ml - Route of Administration:
Subcutaneous infusion
UCB7665 7 mg/kg
Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals.
UCB7665
* Intervention Type: Biological/Vaccine
* Pharmaceutical Form: Powder for solution for infusion
* Concentration: 100 mg/ml - Route of Administration:
Subcutaneous infusion
UCB7665 10 mg/kg
Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals.
UCB7665
* Intervention Type: Biological/Vaccine
* Pharmaceutical Form: Powder for solution for infusion
* Concentration: 100 mg/ml - Route of Administration:
Subcutaneous infusion
UCB7665 15 mg/kg
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg.
UCB7665
* Intervention Type: Biological/Vaccine
* Pharmaceutical Form: Powder for solution for infusion
* Concentration: 100 mg/ml - Route of Administration:
Subcutaneous infusion
UCB7665 20 mg/kg
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg.
UCB7665
* Intervention Type: Biological/Vaccine
* Pharmaceutical Form: Powder for solution for infusion
* Concentration: 100 mg/ml - Route of Administration:
Subcutaneous infusion
Interventions
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UCB7665
* Intervention Type: Biological/Vaccine
* Pharmaceutical Form: Powder for solution for infusion
* Concentration: 100 mg/ml - Route of Administration:
Subcutaneous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
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Tp0001 1101
Adelaide, , Australia
Tp0001 1302
Pleven, , Bulgaria
Tp0001 1301
Sofia, , Bulgaria
Tp0001 203
Olomouc, , Czechia
Tp0001 201
Prague, , Czechia
Tp0001 1201
Tbilisi, , Georgia
Tp0001 401
Berlin, , Germany
Tp0001 403
Düsseldorf, , Germany
Tp0001 404
München, , Germany
Tp0001 502
Florence, , Italy
Tp0001 506
Torino, , Italy
Tp0001 503
Udine, , Italy
Tp0001 505
Vicenza, , Italy
Tp0001 601
Chisinau, , Moldova
Tp0001 702
Bialystok, , Poland
Tp0001 703
Gdansk, , Poland
Tp0001 701
Lodz, , Poland
Tp0001 704
Poznan, , Poland
Tp0001 705
Warsaw, , Poland
Tp0001 802
Brasov, , Romania
Tp0001 801
Bucharest, , Romania
Tp0001 803
Craiova, , Romania
Tp0001 902
Madrid, , Spain
Tp0001 903
Madrid, , Spain
Tp0001 901
Valencia, , Spain
Tp0001 1001
London, , United Kingdom
Tp0001 1002
London, , United Kingdom
Tp0001 1003
London, , United Kingdom
Tp0001 1004
Truro, , United Kingdom
Countries
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References
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Robak T, Kazmierczak M, Jarque I, Musteata V, Trelinski J, Cooper N, Kiessling P, Massow U, Woltering F, Snipes R, Ke J, Langdon G, Bussel JB, Jolles S. Phase 2 multiple-dose study of an FcRn inhibitor, rozanolixizumab, in patients with primary immune thrombocytopenia. Blood Adv. 2020 Sep 8;4(17):4136-4146. doi: 10.1182/bloodadvances.2020002003.
Smith B, Kiessling A, Lledo-Garcia R, Dixon KL, Christodoulou L, Catley MC, Atherfold P, D'Hooghe LE, Finney H, Greenslade K, Hailu H, Kevorkian L, Lightwood D, Meier C, Munro R, Qureshi O, Sarkar K, Shaw SP, Tewari R, Turner A, Tyson K, West S, Shaw S, Brennan FR. Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration. MAbs. 2018 Oct;10(7):1111-1130. doi: 10.1080/19420862.2018.1505464. Epub 2018 Sep 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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TP0001
Identifier Type: -
Identifier Source: org_study_id
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