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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB7665 4 mg/kg | Experimental | Participants in this arm received 5 subcutaneous (sc) doses of UCB7665 (rozanolixizumab) 4 milligram per kilograms (mg/kg) at 1-week intervals. |
|
| UCB7665 7 mg/kg | Experimental | Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals. |
|
| UCB7665 10 mg/kg | Experimental | Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals. |
|
| UCB7665 15 mg/kg | Experimental | Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg. |
|
| UCB7665 20 mg/kg | Experimental | Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB7665 | Drug |
Subcutaneous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study | 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. | 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) |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tp0001 1101 | Adelaide | Australia | ||||
| Tp0001 1302 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32886753 | Result | 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. | |
| 30130439 |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
The study included a Screening Period (1 to 28 days), a Dosing Period of 1 to 4 weeks, and an Observation Period of 8 weeks. Participant Flow refers to the Safety Set.
The study started to enroll patients in March 2016 and concluded in February 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | UCB7665 7 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2017 | May 15, 2023 |
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|
| 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 |
| 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. |
Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals.
| FG002 | UCB7665 10 mg/kg | Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals. |
| FG003 | UCB7665 15 mg/kg | Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg. |
| FG004 | UCB7665 20 mg/kg | Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to the Safety Set which consisted of all study participants who had received at least 1 infusion (full or partial infusion) of rozanolixizumab and was used for the analysis of safety data.
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| ID | Title | Description |
|---|---|---|
| BG000 | UCB7665 4 mg/kg | Participants in this arm received 5 sc doses of UCB7665 (rozanolixizumab) 4 mg/kg at 1-week intervals. |
| BG001 | UCB7665 7 mg/kg | Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals. |
| BG002 | UCB7665 10 mg/kg | Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals. |
| BG003 | UCB7665 15 mg/kg | Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg. |
| BG004 | UCB7665 20 mg/kg | Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg. |
| BG005 | Total Title |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study | 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. | The Safety Set (SS) consisted of all study participants who had received at least 1 infusion (full or partial infusion) of rozanolixizumab and was used for the analysis of safety data. | Posted | Number | percentage of participants | 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) |
|
|
|
Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UCB7665 4 mg/kg (SS) | Participants in this arm received 5 sc doses of UCB7665 (rozanolixizumab) 4 mg/kg at 1-week intervals. Participants formed the Safety Set (SS). | 0 | 15 | 1 | 15 | 11 | 15 |
| EG001 | UCB7665 7 mg/kg (SS) | Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals. Participants formed the SS. | 0 | 15 | 0 | 15 | 9 | 15 |
| EG002 | UCB7665 10 mg/kg (SS) | Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals. Participants formed the SS. | 0 | 12 | 1 | 12 | 7 | 12 |
| EG003 | UCB7665 15 mg/kg (SS) | Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg. Participants formed the SS. | 0 | 12 | 2 | 12 | 10 | 12 |
| EG004 | UCB7665 20 mg/kg (SS) | Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg. Participants formed the SS. | 0 | 12 | 0 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA21.1 | Non-systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Angina bullosa haemorrhagica | Gastrointestinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Infusion site oedema | General disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA21.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA21.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA21.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA21.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA21.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA21.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA21.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA21.1 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA21.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA21.1 | Non-systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA21.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA21.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA21.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA21.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA21.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA21.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2019 | May 15, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627812 | rozanolixizumab |
Not provided
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| White |
|