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This is a randomised Phase III, double-blind, multicentre, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and Soliris® in subjects with PNH.
Subjects will be randomised in a 1:1 ratio to either treatment sequence. Subjects randomly assigned to treatment with SB12 or Soliris® will receive 600 mg of eculizumab IV every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks until Week 52. Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® and subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence I | Experimental | Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® at Week 26 |
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| Treatment Sequence II | Experimental | Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB12 (proposed eculizumab biosimilar) | Drug | 600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lactate Dehydrogenase (U/L) at Week 26 | Week 26 | |
| Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52 | From Week 14 to Week 26 and from Week 40 to Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortis Memorial Research Institute | Gurgaon | Haryana | 122002 | India | ||
| Post Graduate Institute of Medical Education and Research (PGIMER) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Soliris to SB12 | Subjects randomly assigned to treatment with Soliris received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter. |
| FG001 | SB12 to Soliris |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 27, 2020 |
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| Soliris (eculizumab) | Drug | 600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter |
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| Chandigarh |
| India |
| Apollo Hospitals International Limited | Chennai | India |
| Amrita Institute of Medical Sciences and Research Centre | Kochi | India |
| Nil Ratan Sircar Medical College and Hospital | Kolkata | India |
| Hospital Ampang | Ampang | Malaysia |
| Hospital Sultanah Aminah | Johor Bahru | Malaysia |
| Queen Elizabeth Hospital - Kota Kinabalu | Kota Kinabalu | Malaysia |
| Hospital Tengku Ampuan Afzan | Kuantan | Malaysia |
| Hospital Pulau Pinang | Pulau Pinang | Malaysia |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Tlalpan | Mexico |
| Colentina Clinical Hospital | Bucharest | Romania |
| Emergency University Hospital | Bucharest | Romania |
| Prof Dr I Chiricuta Institute of Oncology | Cluj-Napoca | Romania |
| Filantropia Municipal Clinical Hospital | Craiova | Romania |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Tri-Service General Hospital | Taipei | Taiwan |
| Chang Gung Memorial Hospital | Taoyuan | Taiwan |
| Chulalongkorn University | Bangkok | Thailand |
| Srinagarind Hospital | Nai Muang | Thailand |
| Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov | Vinnytsia | Vinnytsia Oblast | 21018 | Ukraine |
| Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council | Cherkasy | 18009 | Ukraine |
| Communal Non-profit Enterprise Regional Center of Oncology | Kharkiv | Ukraine |
| Poltava Regional Clinical Hospital n.a. M.V. Sklifosovskyi | Poltava | Ukraine |
Subjects randomly assigned to treatment with SB12 received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter. |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Soliris to SB12 | Subjects randomly assigned to treatment with Soliris received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter. Subjects who were randomized to initially receive Soliris were switched to receive SB12 at Week 26. |
| BG001 | SB12 to Soliris | Subjects randomly assigned to treatment with SB12 received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter. Subjects who were randomized to initially receive SB12 were switched to receive Soliris at Week 26. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Lactate Dehydrogenase (U/L) at Week 26 | Per-Protocol Set for LDH at a Single Time Point | Posted | Least Squares Mean | Standard Deviation | U/L | Week 26 |
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| Primary | Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52 | Per-Protocol Set for AUEC of LDH | Posted | Geometric Least Squares Mean | Standard Deviation | U/L | From Week 14 to Week 26 and from Week 40 to Week 52 |
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From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
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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 | SB12 | SB12 treated group | 0 | 47 | 3 | 47 | 18 | 47 |
| EG001 | Soliris | Soliris treated group | 1 | 47 | 2 | 47 | 11 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hand fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Haemolysis | Blood and lymphatic system disorders | Systematic Assessment |
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| Infusion site hypersensitivity | General disorders | Systematic Assessment |
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| Portal vein thrombosis | Hepatobiliary disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Wound infection bacterial | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Corona virus infection | Infections and infestations | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Haemoglobinuria | Renal and urinary disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Samsung Bioepis Co., Ltd | +82-32-728-0371 | sbregistry@samsung.com |
| Sep 14, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006457 | Hemoglobinuria, Paroxysmal |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| C034730 | zwittergent 3-12 |
| C481642 | eculizumab |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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