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A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04221477
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Obinutuzumab Drug: MMF Drug: Prednisone Drug: Placebo Drug: Methylprednisolone Drug: Acetaminophen Drug: Diphenhydramine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)
Estimated Study Start Date : July 30, 2020
Estimated Primary Completion Date : October 6, 2023
Estimated Study Completion Date : January 7, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Obinutuzumab

Participants will be randomized into 2 groups. Group 1 will receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone. Group 2 receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, and 52 plus MMF and oral prednisone. Group 2 participants will receive a placebo infusion at their Week 50 visit.

Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80.

Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80.

Drug: Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.
Other Name: Gazyva, GA101, RO5072759

Drug: MMF
MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.

Drug: Prednisone
Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 16, prednisone will be tapered to 5 mg/day and continued until Week 80.

Drug: Methylprednisolone
Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.

Drug: Acetaminophen
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.

Drug: Diphenhydramine
Diphenhydramine 50 mg will be administered as premedication prior to infusions.

Placebo Comparator: Placebo

Placebo participants will receive obinutuzumab matched placebo at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone.

Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80.

Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80.

Drug: Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.
Other Name: Gazyva, GA101, RO5072759

Drug: MMF
MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.

Drug: Prednisone
Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 16, prednisone will be tapered to 5 mg/day and continued until Week 80.

Drug: Placebo
Placebo matching obinutuzumab will be administered by IV infusion at baseline and Weeks 0, 2, 24, 26, 50 and 52 and subsequently from Week 80 and every 6 months thereafter based on response.

Drug: Methylprednisolone
Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.

Drug: Acetaminophen
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.

Drug: Diphenhydramine
Diphenhydramine 50 mg will be administered as premedication prior to infusions.




Primary Outcome Measures :
  1. Percentage of Participants with Complete Renal Response (CRR) [ Time Frame: From baseline to Week 76 ]

Secondary Outcome Measures :
  1. Percentage of Participants Who Achieved CRR with Estimated Glomerular Filtration Rate (eGFR) criterion [ Time Frame: From baseline to Week 76 ]
  2. Percentage of Participants with Overall Renal Response (ORR), Defined as Achievement of Either Complete Renal Response (CRR) or Partial Renal Response (PRR) [ Time Frame: From baseline to Week 50 ]
  3. Change in Anti-dsDNA Titer [ Time Frame: From baseline to Week 50 ]
  4. Change in Complement C3 [ Time Frame: From baseline to Week 50 ]
  5. Change in Systematic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) [ Time Frame: From baseline to Week 76 ]
  6. Change in eGFR [ Time Frame: From baseline to Week 76 ]
  7. Time to Onset of CRR [ Time Frame: From baseline to Week 76 ]
  8. Change in Fatigue (FACIT-F) Scale [ Time Frame: From baseline to Week 76 ]
  9. Percentage of Participants with Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 [ Time Frame: From baseline to Week 76 ]
  10. Percentage of Participants with Adverse Events of Special Interest (Infusion Related Reactions, Neutropenia, Infections, Thrombocytopenia) [ Time Frame: From baseline to Week 76 ]
  11. Maximum Serum Concentration of Obinutuzumab [ Time Frame: Baseline, Week 2, 4, 12, 26, 36, 50, 52, 64, 76 and early study discontinuation ]
  12. Percentage of Participants with Anti-Drug Antibodies (ADAs) at Baseline and ADAs Post-Treatment [ Time Frame: From baseline to Week 76 ]
  13. Change from Baseline in Total Peripheral B-Cell Count [ Time Frame: Baseline, Week 4, 12, 24, 50 and 76 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diagnosis of ISN/RPS 2003 Class III or IV LN as evidenced by renal biopsy performed within 6 months. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
  • Urine protein to creatinine ratio greater than or equal to (>/=) 1 on a 24-hour collection
  • Other inclusion criteria may apply

Key Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Severe renal impairment or the need for dialysis or renal transplantation
  • Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
  • Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation
  • Known active infection of any kind or recent major episode of infection
  • Intolerance or contraindication to study therapies
  • Other exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04221477


Contacts
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Contact: Reference Study ID Number: CA41705 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04221477    
Other Study ID Numbers: CA41705
2019-004034-42 ( EudraCT Number )
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Acetaminophen
Diphenhydramine
Promethazine
Prednisone
Methylprednisolone
Obinutuzumab
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Antiemetics
Autonomic Agents
Gastrointestinal Agents