DDrare: Database of Drug Development for Rare Diseases

49. 全身性エリテマトーデス
［臨床試験数：827，薬物数：638（DrugBank：168），標的遺伝子数：108，標的パスウェイ数：191］

Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0.15mg KPG-818 dose; 0.6mg KPG-818 dose; 1 mg/kg CNTO 136; 10 mg/kg CNTO 136; 2-deoxy-2 [F-18] fluoro-2-d-glucose; 2mg KPG-818 dose; 4 mg/kg CNTO 136; 81mg aspirin; A-623; ABATACEPT; ABBV-105; ABETIMUS SODIUM; ABR-215757; ABT-199; ABT-494; AC0058TA; ACM; ACT-334441; AGS-009; AIDSVAX® B/E; AKBM-3031; ALDESLEUCHINA; ALDESLEUKIN; ALITRETINOIN; ALLOGENEIC MESENCHYMAL STROMAL CELLS DERIVED FROM THE UMBILICAL CORD; ALX-0061; ALX-0061 150 mg/mL; AMG 557; AMG 570; AMG 592; AMG 623; AMG 811; AMG592; AMG811; ANAKINRA; ANIFROLUMAB; ASF-1096 Cream 0.25%; ASF-1096 Cream 0.5%; ASF-1096 Cream 1.0%; ATACICEPT; Abatacept; Abetimus; Abetimus Sodium; Abetimus sodium; Abetimus sodium (LJP 394); Acetaminophen; Acetate; Acetylcysteine; Acido Micofenolico; Acido micofenolico; Acthar; Acthar Gel; Acthar high dose (80 U); Acthar low dose (40 U); Aldesleukin; Alfacalcidol; Alitretinoin; Allogeneic MSC (AlloMSC); Allogeneic Stem Cell Transplantation; Allogeneic bone marrow transplant; Alpha-tocopherol; Anakinra; Anifrolumab; Anifrolumab 1000 mg; Anifrolumab 300 mg; Anti BAFF (B cell activating factor); Anti LP40 antibody, subclass IgG4; Anti LP40 anticuerpo, subclase IgG4; Anti-CD19-CAR-T cells; Anti-CD20 B cell depletion with Truxima; Anti-CD28dAb; Anti-CD28dab; Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody; Anti-blood dendritic cell antigen 2; Anti-pandemic H1N1 influenza vaccine; Anti-thymocyte globulin; Aspirin; Aspirin and meloxicam; Atacicept; Atacicept 150 mg; Atacicept 75 mg; Atacicept 75 milligram (mg); Atorvastatin; Autologous EBV specific CTL infusion; Aviptadil; Azathioprine; BARICITINIB; BELIMUMAB; BENLYSTA; BENLYSTA? (belimumab); BENLYSTA™ (belimumab); BI 705564; BIIB059; BMS-188667; BMS-931699; BMS-986165; BMS-986165 Capsule; BMS-986165 Tablet; BMS-986195; BMS986195; BORTEZOMIB; BOS161721; BR-DIM; BT063; Baricitinib; Behavioral: heart health educational program; Behavioral: questionnaires; Belimumab; Belimumab 1 mg/kg; Belimumab 10 mg/kg; Belimumab 10 mg/kg plus standard therapy; Belimumab 100 mg SC; Belimumab 10mg/kg; Belimumab 200 mg SC; Belimumab 200 mg/mL; Belimumab 4 mg/kg; Belimumab Injection; Belimumab Injection [Benlysta]; Belimumab for IV; Belimumab for SC; Belimumab or benlysta; Belimumab plus Early Vaccination; Belimumab plus Late Vaccination; Benazepril; Benazepril Pill; Benlysta; Benlysta (Belimumab); Benlysta (belimumab); Benlysta 400 mg powder for concentrate for solution for infusion; Benlysta 400 mg powder for concentrate for solution for infusions; Benlysta®; Blisibimod; Blood sample; Bortezomib; Branebrutinib; Brentuximab; Brentuximab vedotin; Busulfan; CC; CC-220; CDP3194; CDP7657; CEP-33457; CFZ533; CICLOSPORIN; CICLOSPORINA; CNTO1275; CSM allogéniques issues de cordons ombilicaux ( MTI-PP); CTLA4-IgG4m (RG2077); CTLA4Ig; Calcitriol; Calcium; Campath; CellCept; Cellcept; Cenerimod; Cenerimod 0.5 mg; Cenerimod 1 mg; Cenerimod 2 mg; Cenerimod 4 mg; Cervarix; Cervarix suspensie voor injectie; Chloroquine; Cholecalciferol; Cholecalciferol and C. Xanthorrhiza; Ciclosporin; Ciclosporina; Clofarabine; Clopidogrel; Combination Product: Belimumab; Conjugated equine estrogens; Conjugated equine estrogens 0.625 mg/d + MPA 5 mg/d/10d; Continuation of azathioprine; Corn starch; Corticosteroids; Corticosteroids (prednisone or prednisolone); Creatine; Crestor; Csa; Cumulative corticosteroid exposure; Curcumin; Curcumin supplement; Cyclophosphamide; Cyclophosphamide-prednisone-azathioprine; Cyclosporin; Cyclosporin A; Cyclosporine; Cyclosporine A; Cymbalta; Cytarabine; D-glucose; DELTACORTENE*20CPR 5MG; DHA; DHEA; DZP; Dapagliflozin; Dapirolizumab pegol; Dapirolizumab pegol (DZP); Dehydroepiandrosterone; Dehydroepiandrosterone (DHEA); Device: Belimumab autoinjector; Device: Doppler ultrasound; Device: Flash glucose monitoring system; Device: bone densitometry; Device: fan beam CT scan; Device: flow-mediated dilation of the brachial artery; Dihydroartemisinin; Dihydroartemisinin tablet; Dimethylfumarat; Diphenhydramine; Dipyridamole; Docosahexaenoic acid; Drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom; ELSUBRUTINIB; EPA; EPA and DHA supplementation; EPRATUZUMAB; ERL080A; Edratide; Edratide Acetate; Eicosapentaenoic acid; Elsubrutinib; Enteric-Coated Mycophenolate Sodium; Epatuzumab; Epratuzumab; Epratuzumab 100 mg; Epratuzumab 1200 mg; Epratuzumab 400 mg; Epratuzumab 600 mg; Epratuzumab iv; Epratuzumab sc; Estradiol; Ethinyl estradiol; Ethylhydrogenfumarat, Calciumsalz; Ethylhydrogenfumarat, Magnesiumsalz; Ethylhydrogenfumarat, Zinksalz; Evobrutinib; Extended release dipyridamole 200mg/aspirin 25mg; Ezetimibe; Ezetimibe+Simvastatin Drug Combination; Faslodex; Filgrastim; Fish Oil; Fish oil; Fludarabine; Fludarabine phosphate; Fluzone; Focetria (Monovalent MF59-Adjuvanted vaccine); Folate; FolateScan (Technetium Tc 99mEC20); Folic acid; Forigerimod; Fostamatinib; Fostamatinib Disodium (R935788); Fumaderm®; Fumaderm® initial; G-CSF; GC+HCQ; GDC-0853; GDC-0853 RO7010939; GL701; GSK1550188; GSK1550188 1mg/kg or 10mg/kg; GSK1550188 IV; GSK1550188 SC; GSK2586184; GSK2586184 100 mg; GSK2586184 200 mg; GSK2586184 400 mg; GSK2586184 50 mg; GSK2586184 800mg single and repeat dose; GSK2586184 new formulation; GSK2586184 standard formulation; Gardasil; Genetic: Polymorphism Analysis; Glucose; Gold; Group A SLE prospective study; Growth colony stimulating factor (G-CSF); H.P. Acthar Gel; HCQ; HGS1006; HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA; HLL2; HLL2 (Epratuzumab); HLL2 (trivial name or chemical description); HLL2,IMMU-103; HPV prophylactic vaccine Gardasil; HYDROXYCHLOROQUINE; Hematopoietic stem cell transplantation; High Dietary Sodium; High Dose Mesenchymal Stem Cells (MSCs); Hiomega-3 supplement of Naturalis® company -; HrIL-2 active; Human papillomavirus vaccination (Gardasil); Human umbilical cord derived MSC transplantation for SLE; Hydroxychloroquine; Hydroxychloroquine (Z0188); Hydroxychloroquine high; Hydroxychloroquine or Chloroquine; Hydroxychloroquine reduced; ICI 182,780 (Faslodex); ICP-022; IFN-K; IFN-Kinoid; IFN-Kinoid Drug Substance; IFN-a 2b Kinoid Drug Substance; IFN-a2b Kinoid; IFNa-Kinoid; IL-2; IL-6R nanobody; ILT-101; IMMU-103; IMMUNOGLOBULIN G; INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED); INTERLEUKIN 2; INTERLEUKIN-2; IPP - 201101; IPP-201101; IPP-201101, P140; Ianalumab; Ibandronate; Ibandronate+alfacalcidol+calcium; Immune ablation and hematopoietic stem cell support.; Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer; Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate); Individualized dose of rituximab; Infliximab; Influenz virus surface antigens; Influvac; Interleukin 2; Interleukin-2; Intravenous immunoglobulin; Iscalimab; Itolizumab; Itolizumab [Bmab 600]; JBT-101; JNJ-55920839; JNJ-56022473; KINERET; KPG-818; KZR-616; Kineret; L04AA26; LA294; LJP 394; LJP394; LY2127399; LY3009104; LY3361237; LY3471851; Laquinimod; Leflunomide; Lenalidomide; Levothyroxine; Lisinopril; Lisinopril Pills; Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol); Low Dietary Sodium; Low Dose Mesenchymal Stem Cells (MSCs); Low-dose Aldesleukin (Proleukin®); Lulizumab Pegol; Lulizumab pegol; Lupuzor; LymphoStat-B; LymphoStat-B TM; LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®; M2951; M2951 (Other Name: Evobrutinib); M5049; MEDI 545; MEDI-545; MEDI-545 600; MEDI-546; MEDI-570 0.03 MG; MEDI-570 0.1 MG; MEDI-570 0.3 MG; MEDI-570 1 MG; MICOFENOLICO ACIDO; MMF; MONITOR; MPA; MRA 003 US; MSC treatment; MSC2364447C; MT-1303 High dose; MT-1303 Low dose; MTX; MYCOPHENOLIC ACID; MYFORTIC*50CPR RIV 360MG; MabThera; MabThera (Rituximab); Medi-546; Medroxyprogesterone; Melatonin; Meloxicam; Memantine; Mesenchymal Stromal Cells; Mesenchymal stem cells; Mesna; Metformin; Methotrexate; Methotrexate and folic acid; Methyl prednisolone; Methylprednisolone; Methylprednisolone sodium succinate; Micofenolico acido; Milatuzumab; Milnacipran; Mizoribine; Modafinil; Moxifloxacin; Multivitamin; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofetil; Mycophenolate mofetil (MMF); Mycophenolate motetil; Mycophenolic acid; Myfortic; N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide; N-acetylcysteine; NNC 0151-0000-0000; NNC0114-0006; NOX-E36; Nelfinavir; Nicotinamide; Nivolumab; Norethindrone; Normal Saline; Null; ORENCIA; ORENCIA 125 mg solution for injection in pre-filled syringe; Ocrelizumab; Olive; Olive Oil; Olive oil; Olumiant; Omacor; Omega-3; Oral Prednisone 5mg; Oral prednisolone; Orencia; Ortho-Novum 777; Ortho-novum; Other: Blood drawing only Group C; Other: Coaching Sessions; Other: Concomitant Medication; Other: Drug free; Other: Fitbit Activity Monitor; Other: GSK2586184 single dose taken with food; Other: GSK2586184 single dose taken without food; Other: Group B SLE one blood donation; Other: ISA 51 VG; Other: Pharmacokinetic analysis; Other: SLE treatment; Other: Smartphone Application; Other: Standard of Care; Other: Standard therapy; Other: Standard treatment according to the Clinical protocols; Other: Ultrasonography assessment; Other: corn starch; Other: immunologic technique; Other: laboratory biomarker analysis; Oxygen; Ozone; P 140; PAH; PF-04236921; PF-06700841; PF-06700841 15 mg; PF-06700841 25mg; PF-06700841 30 mg; PF-06700841 45 mg; PF-06700841 5mg; PF-06700841-15; PF-06835375; PREDNISONA; PREDNISONE; Paquinimod; Paquinimod (ABR-215757); Phosphate; Phosphate-buffered saline; Pioglitazone; Pitavastatin; Placebo; Plaquenil; Pneumovax; Pooled mesenchymal stem cell; Prasterone; Prasterone (GL701); Pravastatin; Prednisolone; Prednisolone/prednisone; Prednisona; Prednisone; Prednisone acetate; Prednisone discontinuation; Premarin and Provera; Prevenar® and Pneumo23®; Procedure: Autologous CD34+HPC transplantation (HSCT); Procedure: Autologous Peripheral Blood Stem Cell Transplantation; Procedure: CD34+ Peripheral Blood Stem Cell Reinfusion; Procedure: Computed Tomography; Procedure: Leukapheresis; Procedure: MRI, Venipuncture; Procedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT); Procedure: Plasmapheresis; Procedure: Positron Emission Tomography; Procedure: Reduced Intensity Allogeneic Transplant; Procedure: autologous hematopoietic stem cell transplantation; Proleukin; Quinipril; R-salbutamol; R-salbutamol sulphate; R932333; RANKL/OPG ratio; RAYOS; RC18 160 mg plus standard therapy; RC18 240 mg plus standard therapy; RC18 80 mg plus standard therapy; RECOMBINANT FACTOR FC FUSION PROTEIN; RIQUENT; RITUXIMAB; RO 496-4913; RO7010939/F13; ROSUVASTATIN CALCIUM; RSLV-132; Rabbit; Rabbit anti-thymocyte globulin; Rabbit antithymocyte globulin; Radiation: Fluorine F 18 Clofarabine; Radiation: Total body irradiation; Ramipril; Rapamycin; Raptiva; Recombinant zoster vaccine; Remicade; RhuMAb 2H7; RhuMAb IFNalpha; Rigerimod; Riquent; Rituxan (rituximab); Rituximab; Rivaroxaban; Ro 106-1443; Rontalizumab; Rosuvastatin; Royal jelly; SAR113244; SBI-087; SC belimumab 200 mg; SM101; SM934; SOLU-MEDROL; SQ Fludarabine; STELARA®; Salbutamol; Sifalimumab; Sifalimumab 1,200 mg; Sifalimumab 200 mg; Sifalimumab 600 mg; Simvastatin; Sirolimus; Solu-Medrol; Solu-medrol; Soluble Fc receptor; Soluble Fc-gamma receptor IIb; Standard dose of rituximab; Standard of Care; Standard therapy; Standard therapy (Excluding Immunosuppressants); Standard therapy (Including Immunosuppressants); Stelara; Steroid Drug; Steroid Taper; Subcuvia; Sugar pill; Sulfamethoxazole; Sulfate; Switch to Myfortic; TAB08; TACI-Fc5; TAK-079; TRU-015; TV-4710; Tabalumab; Tabalumab Auto-Injector; Tabalumab Prefilled Syringe; Tacrolimus; Thalidomide; The generic name is warfarin and many producers will be involved; Tocopherol; Tocopherol acetate; Toctino; Toctino®; Tofacitinib; Tofacitinib citrate; Trade Name Xarelto; Trade name Xarelto; Trimethoprim; Trimethoprim-Sulfamethoxazole; Triptorelin; Triptorelin pamoate; Truxima; UPADACITINIB; USTEKINUMAB; Upadacitinib; Urine sample; Ustekinumab; Ustekinumab (approximately 6 mg/kg); Ustekinumab 90 mg; Ustekinumab 90 milligram (mg); Ustekinumab IV; Ustekinumab SC; VAY736; VIB7734; VIP; Vaccination; Vaccine; Velcade; Velcade®; Versus hydroxychloroquine; Vitamin D; Vitamin D 25(OH)D; Vitamin D3; Vitamin D3 400 IU; Vitamin D3 6000 IU; Vitamins: B6, B12, and folate; Vobarilizumab; Warfarin; Warfarin Sodium; Warfarin sodium; Xarelto; XmAb5871; Zishenqing; Zostavax; Zostavax vaccine

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2016-000625-39-BG (EUCTR)	17/05/2017	08/03/2017	A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	575	Phase 3	United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
2	JPRN-JapicCTI-173544	26/4/2017	23/03/2017	TULIP SLE LTE	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus	Active Systemic Lupus Erythematosus	Intervention name : Anifrolumab INN of the intervention : anifrolumab Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses	AstraZeneca	NULL	complete	18		BOTH	50	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Oceania
3	NCT02962960 (ClinicalTrials.gov)	February 14, 2017	23/9/2016	A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations	A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations.	Systemic Lupus Erythematosus	Drug: Anifrolumab;Drug: Placebo	AstraZeneca	NULL	Completed	18 Years	70 Years	All	36	Phase 2	United States;Hungary;Korea, Republic of;Poland
4	EUCTR2016-003246-93-PL (EUCTR)	26/01/2017	13/12/2016	The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms.	A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations	Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: ANIFROLUMAB Other descriptive name: Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer	Astrazeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	32	Phase 2	United States;Hungary;Poland;Korea, Republic of
5	EUCTR2016-000625-39-DE (EUCTR)	13/12/2016	05/07/2016	A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	575	Phase 3	United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2016-003246-93-HU (EUCTR)	06/12/2016	19/10/2016	The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms.	A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations	Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Astrazeneca AB	NULL	Not Recruiting			Female: yes Male: yes	32	Phase 2	United States;Hungary;Poland;Korea, Republic of
7	EUCTR2016-000625-39-LT (EUCTR)	03/11/2016	17/08/2016	A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	575	Phase 3	United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan
8	EUCTR2016-000625-39-ES (EUCTR)	24/08/2016	15/07/2016	A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE	Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	575	Phase 3	United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
9	EUCTR2016-000625-39-HU (EUCTR)	18/08/2016	23/06/2016	A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	575	Phase 3	United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
10	NCT02794285 (ClinicalTrials.gov)	June 30, 2016	6/6/2016	Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.	Active Systemic Lupus Erythematosus	Biological: Anifrolumab;Drug: Placebo	AstraZeneca	PRA Health Sciences	Active, not recruiting	18 Years	70 Years	All	559	Phase 3	United States;Argentina;Australia;Bulgaria;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Belgium;Brazil;Czech Republic;Czechia;Italy;New Zealand;Singapore
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2014-004632-19-BG (EUCTR)	11/12/2015	27/10/2015	A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
12	EUCTR2014-004633-96-RO (EUCTR)	26/11/2015	08/10/2015	A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
13	EUCTR2014-004632-19-DE (EUCTR)	12/11/2015	06/08/2015	A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;South Africa;Germany;Korea, Republic of
14	EUCTR2014-004633-96-DE (EUCTR)	12/11/2015	28/05/2015	A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab INN or Proposed INN: Anifrolumab Product Name: Anifrolumab INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Brazil;Poland;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of
15	EUCTR2014-004633-96-PL (EUCTR)	14/10/2015	05/08/2015	A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2014-004632-19-CZ (EUCTR)	23/09/2015	28/07/2015	A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
17	EUCTR2014-004632-19-ES (EUCTR)	21/09/2015	24/06/2015	A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
18	EUCTR2014-004633-96-IT (EUCTR)	16/09/2015	21/01/2020	A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - NA	Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ASTRAZENECA AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
19	EUCTR2014-004632-19-BE (EUCTR)	07/09/2015	23/06/2015	A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
20	EUCTR2014-004633-96-HU (EUCTR)	02/09/2015	29/06/2015	A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2014-004632-19-LT (EUCTR)	20/08/2015	19/06/2015	A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
22	EUCTR2014-004633-96-GB (EUCTR)	16/07/2015	08/05/2015	A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
23	NCT02446899 (ClinicalTrials.gov)	July 9, 2015	14/5/2015	Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus	Active Systemic Lupus Erythematosus	Biological: Anifrolumab;Drug: Placebo	AstraZeneca	PRA Health Sciences	Completed	18 Years	70 Years	All	373	Phase 3	United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Russian Federation;South Africa;Spain;Czech Republic;Czechia;Singapore
24	NCT02446912 (ClinicalTrials.gov)	June 9, 2015	14/5/2015	Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus	Active Systemic Lupus Erythematosus	Biological: Anifrolumab;Drug: Placebo	AstraZeneca	PRA Health Sciences	Completed	18 Years	70 Years	All	460	Phase 3	United States;Argentina;Australia;Brazil;Chile;Colombia;Germany;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Taiwan;Ukraine;United Kingdom
25	EUCTR2012-004619-30-HU (EUCTR)	27/08/2013	28/06/2013	A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus	A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: anifrolumab Product Code: Medi-546 INN or Proposed INN: anifrolumab Product Name: anifrolumab Product Code: Medi-546 INN or Proposed INN: anifrolumab	MedImmune, LLC, a wholly owned subsidiary of AstraZeneca	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Taiwan;Ukraine;Colombia;Hungary;Czech Republic;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	NCT01753193 (ClinicalTrials.gov)	March 28, 2013	17/12/2012	An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults	A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Biological: Anifrolumab	MedImmune LLC	NULL	Completed	18 Years	68 Years	All	218	Phase 2	United States;Brazil;Bulgaria;Colombia;Czechia;Hungary;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Czech Republic
27	NCT01438489 (ClinicalTrials.gov)	January 2012	9/9/2011	A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus	A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Biological: Anifrolumab 300 mg;Biological: Anifrolumab 1000 mg;Other: Placebo	MedImmune LLC	NULL	Completed	18 Years	65 Years	All	626	Phase 2	United States;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;India;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Hong Kong
28	JPRN-JapicCTI-153064		11/11/2015	TULIP	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus	Active Systemic Lupus Erythematosus	Intervention name : anifrolumab INN of the intervention : anifrolumab Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses Control intervention name : Placebo Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses	AstraZeneca	NULL	complete	18	70	BOTH		Phase 3	NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-000625-39-BG
(EUCTR)

17/05/2017

08/03/2017

A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

575

Phase 3

United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand

JPRN-JapicCTI-173544

26/4/2017

23/03/2017

TULIP SLE LTE

Active Systemic Lupus Erythematosus

Intervention name : Anifrolumab
INN of the intervention : anifrolumab
Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses

AstraZeneca

NULL

complete

BOTH

Phase 3

Japan, Asia except Japan, North America, South America, Europe, Oceania

NCT02962960
(ClinicalTrials.gov)

February 14, 2017

23/9/2016

A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations.

Systemic Lupus Erythematosus

Drug: Anifrolumab;Drug: Placebo

AstraZeneca

NULL

Completed

18 Years

70 Years

All

Phase 2

United States;Hungary;Korea, Republic of;Poland

EUCTR2016-003246-93-PL
(EUCTR)

26/01/2017

13/12/2016

The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms.

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations

Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer

Astrazeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Hungary;Poland;Korea, Republic of

EUCTR2016-000625-39-DE
(EUCTR)

13/12/2016

05/07/2016

A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

575

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-003246-93-HU
(EUCTR)

06/12/2016

19/10/2016

Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Astrazeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Poland;Korea, Republic of

EUCTR2016-000625-39-LT
(EUCTR)

03/11/2016

17/08/2016

A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus

Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

575

Phase 3

United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan

EUCTR2016-000625-39-ES
(EUCTR)

24/08/2016

15/07/2016

A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

575

Phase 3

EUCTR2016-000625-39-HU
(EUCTR)

18/08/2016

23/06/2016

A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus

Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

575

Phase 3

United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand

NCT02794285
(ClinicalTrials.gov)

June 30, 2016

6/6/2016

Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus

Biological: Anifrolumab;Drug: Placebo

AstraZeneca

PRA Health Sciences

Active, not recruiting

18 Years

70 Years

All

559

Phase 3

United States;Argentina;Australia;Bulgaria;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Belgium;Brazil;Czech Republic;Czechia;Italy;New Zealand;Singapore

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-004632-19-BG
(EUCTR)

11/12/2015

27/10/2015

A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of

EUCTR2014-004633-96-RO
(EUCTR)

26/11/2015

08/10/2015

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of

EUCTR2014-004632-19-DE
(EUCTR)

12/11/2015

06/08/2015

A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;South Africa;Germany;Korea, Republic of

EUCTR2014-004633-96-DE
(EUCTR)

12/11/2015

28/05/2015

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Brazil;Poland;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of

EUCTR2014-004633-96-PL
(EUCTR)

14/10/2015

05/08/2015

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-004632-19-CZ
(EUCTR)

23/09/2015

28/07/2015

A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of

EUCTR2014-004632-19-ES
(EUCTR)

21/09/2015

24/06/2015

A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of

EUCTR2014-004633-96-IT
(EUCTR)

16/09/2015

21/01/2020

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - NA

Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

ASTRAZENECA AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of

EUCTR2014-004632-19-BE
(EUCTR)

07/09/2015

23/06/2015

A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of

EUCTR2014-004633-96-HU
(EUCTR)

02/09/2015

29/06/2015

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-004632-19-LT
(EUCTR)

20/08/2015

19/06/2015

A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of

EUCTR2014-004633-96-GB
(EUCTR)

16/07/2015

08/05/2015

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of

NCT02446899
(ClinicalTrials.gov)

July 9, 2015

14/5/2015

Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus

Biological: Anifrolumab;Drug: Placebo

AstraZeneca

PRA Health Sciences

Completed

18 Years

70 Years

All

373

Phase 3

United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Russian Federation;South Africa;Spain;Czech Republic;Czechia;Singapore

NCT02446912
(ClinicalTrials.gov)

June 9, 2015

14/5/2015

Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus

Biological: Anifrolumab;Drug: Placebo

AstraZeneca

PRA Health Sciences

Completed

18 Years

70 Years

All

460

Phase 3

United States;Argentina;Australia;Brazil;Chile;Colombia;Germany;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Taiwan;Ukraine;United Kingdom

EUCTR2012-004619-30-HU
(EUCTR)

27/08/2013

28/06/2013

A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus

A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab

MedImmune, LLC, a wholly owned subsidiary of AstraZeneca

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Taiwan;Ukraine;Colombia;Hungary;Czech Republic;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01753193
(ClinicalTrials.gov)

March 28, 2013

17/12/2012

An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Biological: Anifrolumab

MedImmune LLC

NULL

Completed

18 Years

68 Years

All

218

Phase 2

United States;Brazil;Bulgaria;Colombia;Czechia;Hungary;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Czech Republic

NCT01438489
(ClinicalTrials.gov)

January 2012

9/9/2011

A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Biological: Anifrolumab 300 mg;Biological: Anifrolumab 1000 mg;Other: Placebo

MedImmune LLC

NULL

Completed

18 Years

65 Years

All

626

Phase 2

United States;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;India;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Hong Kong

JPRN-JapicCTI-153064

11/11/2015

TULIP

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus

Intervention name : anifrolumab
INN of the intervention : anifrolumab
Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses

AstraZeneca

NULL

complete

BOTH

Phase 3

NULL