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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000097-29 | EudraCT Number | ||
| 2023-505825-15-00 | Other Identifier | EU CT Number |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to <12 with LN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinded Obinutuzumab | Experimental | Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1, Day 14, Week 24, Week 26 and Week 52. Participants with a body weight of 45 kg or more will receive the 1000 mg dose. Participants with a body weight below 45 kg will receive a weight adjusted dose of 20 mg/kilogram (kg). |
|
| Placebo | Placebo Comparator | Placebo participants will receive obinutuzumab matched placebo on Day 1, Day 14, Week 24, Week 26 and Week 52. |
|
| Open-Label Obinutuzumab | Experimental | Younger participants aged 5 to <12 will receive obinutuzumab 1000 mg IV infusions on Days 1, 14, Week 24, Week 26 and Week 52. |
|
| 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, Day 14, Week 24, Week 26 and Week 52. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP) | CRR is defined as achievement of all of the following:
| Week 76 |
| Percentage of Participants with Adverse Events (PP) | Baseline to Week 76 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a CRR (AP) | Weeks 24 and 52 | |
| Percentage of Participants who Achieve CRR with Successful Prednisone Taper (AP) | Week 76 | |
| Percentage of Participants who Achieve a PRR (AP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: WA42985 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. and Canada) | global.rochegenentechtrials@roche.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University health | Recruiting | Loma Linda | California | 92354 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37678236 | Derived | Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6. |
| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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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, Day 14, Week 24, Week 26 and Week 52. |
|
| Mycophenolate Mofetil | Drug | Mycophenolate Mofetil (MMF) will be taken by home administration orally at a target dose of 1200 mg/m^2/day to a maximum of 2.5g/day from baseline (Day 1) onwards. |
|
| Acetaminophen/paracetamol | Drug | Acetaminophen 1000 mg will be administered as pre-medication prior to infusions. |
|
| Diphenhydramine hydrochloride (HCl) | Drug | Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions. |
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| Methylprednisolone | Drug | Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions. |
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| Prednisone | Drug | Oral prednisone or equivalent corticosteroid will be taken by home administration daily to a maximum dose of 60mg/day followed by a guided taper to 5mg/day or less by Week 24. |
|
| Week 76 |
| Percentage of Participants Achieving an Overall Response (CRR or PRR) (AP) | PRR is defined as: achievement of all of the following:
| Weeks 24, 52, and 76 |
| Change in UPCR (AP) | Baseline to Week 76 |
| Change in eGFR (AP) | Baseline to Week 76 |
| Time to Onset of CRR over the Course of 76 weeks (AP) | Up to Week 76 |
| Percentage of Participants who Experience Treatment Failure (AP) | Week 12 to Week 76 |
| Change in anti-dsDNA titers (AP) | Baseline to Week 76 |
| Change in C3 Complement Levels (AP) | Baseline to Week 76 |
| Change in C4 Complement Levels (AP) | Baseline to Week 76 |
| Percentage of Participants with Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 (AP) | Baseline to Week 76 |
| Serum Concentrations of Obinutuzumab (AP) | Baseline to Week 76 |
| Percentage of Participants Achieving B-cell Depletion (AP) | Baseline, Weeks 4, 24, 52 and 76 |
| Change in Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale (PedsQL)-Fatigue Total Score (AP) | Baseline to Week 76 |
| Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (AP) | Baseline to Week 76 |
| Change from Baseline in Child Health Questionnaire-Parent Form 28 (CHQ-PF28) Domain Scores (AP) | Baseline to Week 76 |
| Percentage of Participants with Anti-drug Antibodies (ADA) (AP) | Weeks 0, 24, 52 and 76 |
| Relationship Between ADA Status and Percentage of Participants Achieving a CRR (AP) | Weeks 24, 52 and 76 |
| Percentage of Participants Achieving a CRR (PP) | Week 76 |
| Percentage of Participants Achieving an Overall Response (PP) | PRR is defined as achievement of all of the following:
| Week 76 |
| Percentage of Participants who Achieve CRR with Successful Prednisone Taper (PP) | Week 76 |
| Change in eGFR (PP) | Baseline to Week 76 |
| Percentage of Participants Achieving B-cell Depletion (PP) | Baseline, Weeks 4, 24, 52 and 76 |
| Percentage of Participants with ADAs (PP) | Weeks 0, 24, 52 and 76 |
| Change in anti-dsDNA titers (PP) | Baseline to Week 76 |
| UCSF Benioff Childrens Hospital |
| Recruiting |
| San Francisco |
| California |
| 94158 |
| United States |
| Children's Hospital Colorado, Anchutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
| Emory Children's Center | Recruiting | Atlanta | Georgia | 30322 | United States |
| Indiana University Health University Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Louisiana State University | Recruiting | Shreveport | Louisiana | 71103 | United States |
| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Cohen Children's Medical Center of New York | Recruiting | Queens | New York | 11042 | United States |
| Cincinnati Childrens Hospital | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Chldren?s Hospital of Philadelphia | Withdrawn | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Arthritis Center | Withdrawn | El Paso | Texas | 79902 | United States |
| Ser Servicos Especializados Em Reumatologia | Recruiting | Salvador | Estado de Bahia | 40150-150 | Brazil |
| Centro de Pesquisa São Lucas | Recruiting | Campinas | São Paulo | 13060-904 | Brazil |
| Hospital das Clinicas - FMUSP | Recruiting | São Paulo | São Paulo | 05403-000 | Brazil |
| Universidade Federal de Sao Paulo - UNIFES | Active, not recruiting | São Paulo | 04024-002 | Brazil |
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
| Hospital Sainte-Justine | Recruiting | Montreal | Quebec | H3T 1C5 | Canada |
| CH de Bicêtre | Recruiting | Le Kremlin-Bicêtre | 94275 | France |
| Hôpital Robert Debré | Recruiting | Paris | 75019 | France |
| Hop Necker Enfants Malades | Recruiting | Paris | 75743 | France |
| CHU de Toulouse - Hôpital des Enfants | Recruiting | Toulouse | 31000 | France |
| Ospedale Pediatrico Bambino Gesu | Recruiting | Rome | Lazio | 00165 | Italy |
| IRCCS G. Gaslini | Recruiting | Genoa | Liguria | 16148 | Italy |
| Clinica Pediatrica II De Marchi | Recruiting | Milan | Lombardy | 20122 | Italy |
| CREA Hospital Mexico Americano | Recruiting | Guadalajara | Jalisco | 44620 | Mexico |
| Clinstile S.A de C.V. | Recruiting | Mexico City | Mexico CITY (federal District) | 06700 | Mexico |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez | Recruiting | Monterrey | Nuevo León | 64460 | Mexico |
| Instituto de Ginecología y Reproducción | Active, not recruiting | Lima | Peru |
| Clinica El Golf | Active, not recruiting | San Isidro | L27 Lima | Peru |
| Uniwersyteckie Centrum Kliniczne | Recruiting | Gdansk | 80-294 | Poland |
| Szpital Specjalistyczny dla Dzieci i Doroslych | Withdrawn | Torun | 87-100 | Poland |
| Saint-Petersburg State | Withdrawn | St-peterburg | Sankt-Peterburg | 194100 | Russia |
| Red Cross War Memorial Children?s Hospital | Withdrawn | Cape Town | 7700 | South Africa |
| Groote Schuur Hospital | Withdrawn | Cape Town | 7925 | South Africa |
| Panaroma Medical Center | Recruiting | Panorama | 7500 | South Africa |
| Hospital Sant Joan De Deu | Recruiting | Esplugas de Llobregat | Barcelona | 08950 | Spain |
| Hospital Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hospital de La Paz | Recruiting | Madrid | 28046 | Spain |
| Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica | Recruiting | Valencia | 46026 | Spain |
| Royal Hospital For Children | Withdrawn | Glasgow | G51 4TF | United Kingdom |
| Alder Hey Childrens Hospital | Recruiting | Liverpool | L12 2AP | United Kingdom |
| Great Ormond Street Hospital for Children | Recruiting | London | WC1N 3JH | United Kingdom |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| 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 |
| D009173 | Mycophenolic Acid |
| D000082 | Acetaminophen |
| D004155 | Diphenhydramine |
| D008775 | Methylprednisolone |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| 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 |
| D011244 | Pregnadienediols |
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