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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005760-57 | EudraCT Number | ||
| 2023-504774-38-00 | Other Identifier | EU CT Number |
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This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obinutuzumab | Experimental | Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26. |
|
| Placebo | Placebo Comparator | Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52 | SRI(4) requires reduction from baseline of >=4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), no new systems or organs affected, as defined by >=1 new British Isles Lupus Assessment Group (BILAG) A or >=2 new BILAG B items compared with baseline using BILAG-2004, and no worsening from baseline of >=0.30 points on a 3-point Physician's Global Assessment Visual Analogue Scale (PGA-VAS). | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve SRI(6) at Week 52 | SRI(6) requires reduction from baseline of >=6 points in the SLEDAI-2K, no new systems or organs affected, as defined by >=1 new BILAG A or >=2 new BILAG B items compared with baseline using BILAG-2004, and no worsening from baseline of >=0.30 points on a 3-point PGA-VAS. | Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| Unity Health - White County Medical Center- Rheumatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41789864 | Derived | Furie RA, Dall'Era M, Vital EM, Garg JP, Irazoque Palazuelos F, Zuta Santillan AE, Ravelo-Hernandez J, Santiago MB, Zazueta Montiel B, Botha S, Leszczynski P, de Souza VA, Sicsik SA, Bellatin L, Naidoo A, Amoura Z, D'Agostino MA, Kumar S, Workeneh B, Rae J, Mao HA, Erblang F, Meier O, Maller JC, Askanase AD; ALLEGORY Trial Investigators. Efficacy and Safety of Obinutuzumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2026 Mar 6. doi: 10.1056/NEJMoa2516150. Online ahead of print. |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Placebo | Drug | Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26. |
|
| Acetaminophen/Paracetamol | Drug | Acetaminophen 650-1000 mg will be administered as premedication prior to infusions. |
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| Diphenhydramine hydrochloride | Drug | Diphenhydramine 50 mg will be administered as premedication prior to infusions. |
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| Methylprednisolone | Drug | Methylprednisolone 80 mg IV will be administered as premedication prior to infusions. |
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| Percentage of Participants Entering the Study on Prednisone >= 10 mg/day (or equivalent) who Achieve Sustained Corticosteroid Control | No treatment with prednisone >=7.5 mg/day (or equivalent) and no receipt of intravenous, intramuscular, or intra-articular corticosteroids. | From Week 40 to Week 52 |
| Time to First BILAG Flare over 52 Weeks | Flare is defined as the occurrence of >=1 new BILAG A or >=2 new BILAG B manifestations from the previous visit | From baseline to Week 52 |
| Percentage of Participants who Achieve a Sustained SRI(4) Response | Achievement of SRI(4) at all study visits from Week 40 through Week 52. | From Week 40 to Week 52 |
| Percentage of Participants who Achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52 | Reduction of all baseline BILAG-2004 A items to B/C/D and baseline BILAG-2004 B items to C/D; no new systems or organs affected, as defined by >=1 new BILAG A or >=2 new BILAG B items compared with baseline; no net increase in SLEDAI-2K score from baseline; and no worsening from baseline of >=0.30 points on a 3-point PGA-VAS. | Week 52 |
| Percentage of Participants who Achieve SRI(8) at Week 52 | Week 52 |
| Percentage of Participants who Achieve SRI(4) at Week 24 | Week 24 |
| Percentage of Participants who Achieve Clinical SRI(4) at Week 52 | Week 52 |
| Percentage of Participants who Achieve SRI(4) at Week 52 on Low-dose Corticosteroids | Week 52 |
| Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS) at Week 52 | Week 52 |
| Percentage of Participants who Achieve Definition of Remission in SLE (DORIS) at Week 52 | Week 52 |
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale | From baseline to Week 24 and from baseline to Week 52 |
| Change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain Domain Scale | From baseline to Week 24 and from baseline to Week 52 |
| Change in SF-36 v2 Physical Component Summary Scale | From baseline to Week 24 and from baseline to Week 52 |
| Change in Active Joint Count (Swollen plus Tender) | From baseline to Week 24 and from baseline to Week 52 |
| Percentage of Participants who Achieve a >= 50% Reduction in Active Joint Counts (Swollen plus Tender) at Each Study Visit | From baseline to Week 52 |
| Percentage of Participants who Achieve a >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity (CLASI) Total Activity Score at each Study Visit, among Participants with CLASI Total Activity Score >=10 at Baseline | From baseline to Week 52 |
| Percentage of Participants who Achieve Sustained Corticosteroid Control | From Week 40 through Week 52 |
| Cumulative Corticosteroid use (in Equivalent Milligrams of Prednisone) | From baseline to Week 52 |
| Annualized flare rate through Week 52 | At Week 52 |
| Percentage of Participants with Adverse Events | From baseline to approximately 6 years |
| Percentage of Participants with Adverse Events of Special Interest (AESIs) | From baseline to approximately 6 years |
| Serum Concentration of Obinutuzumab | Double blind period: At Weeks 2, 4, 12, 24, 26, 36, 52 and at early study discontinuation visit; Open label period: At Weeks 54, 56, 58, 66, 78, 90, 104 and at early study discontinuation visit |
| Percentage of Participants with Anti-drug Antibodies (ADAs) at Baseline | Baseline |
| Percentage of Participants with ADAs During the Study | Up to approximately 6 years |
| Searcy |
| Arkansas |
| 72143 |
| United States |
| Providence Medical Foundation | Fullerton | California | 92835 | United States |
| Arthritis & Rheumatism | Aventura | Florida | 33180 | United States |
| Great Lakes Center of Rheumatology | Lansing | Michigan | 48911 | United States |
| Clinical Research Institute of Michigan, LLC | Troy | Michigan | 48047 | United States |
| Northwell Health Division of Rheumatology | Great Neck | New York | 11021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Joint & Muscle Research Institute | Charlotte | North Carolina | 28204 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43212 | United States |
| Paramount Medical Research & Consulting, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | 76034 | United States |
| Texas Arthritis Center | El Paso | Texas | 79902 | United States |
| Prolato Clinical Research Center | Houston | Texas | 77054 | United States |
| Organizacion Medica de Investigacion | Buenos Aires | C1015ABO | Argentina |
| DOM Centro de Reumatología | Buenos Aires | C1111AAJ | Argentina |
| Centro de Investigaciones Médicas Tucuman | San Miguel | T4000AXL | Argentina |
| Ser Servicos Especializados Em Reumatologia | Salvador | Estado de Bahia | 40150-150 | Brazil |
| Hospital das Clinicas - UFMG | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Santa Casa de Misericordia | Belo Horizonte | Minas Gerais | 30150-221 | Brazil |
| Centro Mineiro de Pesquisa - CMIP | Juiz de Fora | Minas Gerais | 36010-570 | Brazil |
| Centro de Estudos em Terapias Inovadoras ? CETI | Curtiba | Paraná | 80030-110 | Brazil |
| Hospital das Clinicas - FMUSP Ribeirao Preto | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
| Centro Multidisciplinar de Estudos Clínicos - CEMEC*X* | São Bernardo do Campo | São Paulo | 09715-090 | Brazil |
| Revmatologicky Ustav | Prague | 128 50 | Czechia |
| Ch Pitie Salpetriere | Paris | 75651 | France |
| Policlinico Universitario Agostino Gemelli | Rome | Lazio | 00168 | Italy |
| IRCCS S. Raffaele | Milan | Lombardy | 20132 | Italy |
| A.O. Universitaria Pisana | Pisa | Tuscany | 56126 | Italy |
| Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna | Cona (Ferrara) | Veneto | 44124 | Italy |
| Uni Di Padova | Padova | Veneto | 35128 | Italy |
| Centro de Investigacion Alberto Bazzoni S.A. de C.V. | Torreón | Coahuila | 27000 | Mexico |
| Unidad de Reumatologia Rehabilitacion Integral | Mexicali | Estado de Baja California | 21100 | Mexico |
| Centro de Investigación y Tratamiento Reumatológico S.C. | Mexico City | Mexico CITY (federal District) | 11850 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | 64460 | Mexico |
| Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI) | Culiacán | Sinaloa | 80000 | Mexico |
| Middlemore Hospital | Auckland | 2025 | New Zealand |
| Wellington Hospital | Wellington | 0621 | New Zealand |
| Hogar Clínica San Juan de Dios | Arequipa | 04000 | Peru |
| Clínica San Juan Bautista CSJB | Lima | 15431 | Peru |
| Instituto de Ginecología y Reproducción | Lima | Peru |
| Clinica El Golf | San Isidro | L27 Lima | Peru |
| Clinica San Antonio;Investigaciones Trujillo S.A.C. | Trujillo | 13008 | Peru |
| Szpital Uniwersytecki | Bydgoszcz | 85-168 | Poland |
| Medyczne Centrum Hetmanska | Poznan | 60-218 | Poland |
| Prywatna Praktyka Lekarska | Poznan | 61-397 | Poland |
| Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM | Poznan | 61-545 | Poland |
| MICS Centrum Medyczne Warszawa | Warsaw | 00-874 | Poland |
| Rheuma Medicus Zaklad Opieki Zdrowotnej | Warsaw | 02-118 | Poland |
| REUMATOP Grzegorz Rozumek, Karin Pistorius Spó?ka Jawna | Wroc?aw | 52-210 | Poland |
| Republican clinical hospital named after G.G. Kuvatov | Ufa | Bashkortostan Republic | 450005 | Russia |
| Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova | Moscow | Moscow Oblast | 115522 | Russia |
| FGBU ?Federal Medical and Research Center named after V.A.Almazov? Russian Ministry of Health | Saint Petersburg | Sankt-Peterburg | 197341 | Russia |
| Panorama Medical Center | Cape Town | 7500 | South Africa |
| Winelands Medical Research | Cape Town | 7600 | South Africa |
| Emmed Research | Pretoria | 0002 | South Africa |
| Dr Asokan Naidoo | Umhlanga | 4319 | South Africa |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Addenbrooke'S Hospital | Cambridge | CB2 2QQ | United Kingdom |
| Chapel Allerton Hospital | Leeds | LS1 3EX | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C543332 | obinutuzumab |
| D000082 | Acetaminophen |
| D004155 | Diphenhydramine |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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