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Monoclonal Antibodies

Obinutuzumab for Lupus Nephritis (POSTERITY Trial)

Phase 2

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who are age 12 to <18 years at the time of randomization

Participants who are age 5 to <12 years (younger participant cohort) at the time of randomization once recruitment is open

Must not have

Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia

History of serious recurrent or chronic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 24, 52, and 76

Summary

This trial will study whether the drug obinutuzumab is safe and effective in treating adolescent patients with lupus nephritis.

Who is the study for?

Adolescents aged 12-17 with active Class III or IV Lupus Nephritis (LN) and children aged 5-11 for safety assessment can join this trial. They must have a biopsy confirming LN, meet specific criteria for protein in urine, and have received certain treatments for LN within the last year. Those with isolated Class V disease, severe other diseases, recent cancers, uncontrolled CNS SLE symptoms, drug abuse history or current infections cannot participate.

What is being tested?

The study is testing Obinutuzumab's effectiveness and safety in treating Lupus Nephritis in adolescents compared to a placebo. It includes medications like Prednisone and Mycophenolate Mofetil as part of treatment regimens. The trial also assesses how the body processes Obinutuzumab in younger children.

What are the potential side effects?

Possible side effects include reactions to infusion such as fever or chills; low blood cell counts leading to increased infection risk; potential liver issues indicated by blood tests; allergic reactions; and gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 17 years old.

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I am between 5 and 11 years old.

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I have been diagnosed with SLE as per the SLICC 2012 criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe brain-related lupus symptoms like vision loss, uncontrolled seizures, confusion, or difficulty moving.

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I have a history of serious, recurring infections.

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I cannot tolerate or am not allowed to have the study's treatments.

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I have not had any cancer except for treated skin cancer in the last 5 years.

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My kidney biopsy shows I only have chronic damage, with no active disease.

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I have a quickly worsening kidney condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 24, 52, and 76

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 24, 52, and 76

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 24, 52, and 76 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP)

Secondary study objectives

Percentage of Participants Achieving an Overall Response (CRR or PRR) (AP)

Percentage of Participants Achieving an Overall Response (PP)

Side effects data

From 2019 Phase 3 trial • 229 Patients • NCT02264574

44%

Neutropenia

35%

Thrombocytopenia

35%

Diarrhea

29%

Cough

24%

Arthralgia

23%

Infusion related reaction

19%

Fatigue

19%

Back pain

19%

Hypertension

17%

Anaemia

17%

Constipation

17%

Pyrexia

16%

Upper respiratory tract infection

15%

Rash maculo-papular

14%

Muscle spasms

14%

Atrial fibrillation

13%

Hyperuricaemia

13%

Nausea

13%

Nasopharyngitis

12%

Insomnia

12%

Urinary tract infection

12%

Oedema peripheral

11%

Conjunctivitis

11%

Asthenia

11%

Pneumonia

11%

Dyspnoea

11%

Vomiting

11%

Pain in extremity

11%

Dizziness

10%

Cataract

10%

Decreased appetite

Spontaneous haematoma

Anxiety

Fall

Rash

Headache

Iron deficiency

Abdominal pain

Dyspepsia

Vision blurred

Pruritus

Bronchitis

Lacrimation increased

Respiratory tract infection

Blood creatine increased

Productive cough

Oropharyngeal pain

Gastrooesophageal reflux disease

Hypokalaemia

Dry eye

Chills

Myalgia

Depression

Dry Skin

Ecchymosis

Onychoclasis

Palpitations

Stomatitis

Peripheral swelling

Epistaxis

Herpes zoster

Increased tendency to bruise

Hyperglycaemia

Musculoskeletal pain

Haematuria

Petechiae

Cellulitis

Contusion

Tremor

Febrile neutropenia

Adenocarcinoma of colon

Acute coronary syndrome

Gastroenteritis

Weight decreased

Septic shock

Femur fracture

Osteoarthritis

Transient ischaemic attack

Cardiac arrest

Angina pectoris

Death

Cerebrovascular accident

Acute kidney injury

Renal failure

Bronchopulmonary aspergillosis

Gastritis

Ischaemic stroke

Compartment syndrome

Respiratory failure

Colorectal cancer

Peripheral ischaemia

Inclusion body myositis

Invasive ductal breast carcinoma

Uterine prolapse

Pleural effusion

Haemoptysis

Myelodysplastic syndrome

Oesophageal rupture

Bronchitis chronic

Colorectal cancer metastatic

Concussion

Cardiac failure congestive

Arthritis

Malignant melanoma

Non-small cell lung cancer

Bacterial sepsis

Leukopenia

Acute myocardial infarction

Pericarditis

Stress cardiomyopathy

Goitre

Haemorrhoids

Impaired gastric emptying

Proctitis

Small intestinal obstruction

Catheter site haematoma

Multi-organ disorder

Cholelithiasis

Abscess

Bursitis infective staphylococcal

Erysipelas

Escherichia sepsis

Escherichia urinary tract infection

Infective aneurysm

Listeria sepsis

Lower respiratory tract infection

Pneumocystis jirovecii pneumonia

Pneumonia bacterial

Pneumonia klebsiella

Prostate infection

Sinusitis fungal

Urosepsis

Jaw fracture

Pubis fracture

Rib fracture

Spinal compression fracture

Thoracic vertebral fracture

Traumatic haematoma

Upper limb fracture

Diabetes mellitus inadequate control

Adenocarcinoma gastric

Basal cell carcinoma

Benign renal neoplasm

Squamous cell carcinoma

Syncope

Acute psychosis

Complete Suicide

Soft tissue infection

Osteoma

Atrial tachycardia

Retinal detachment

Herpes Zoster

Oral herpes

Pharyngitis

Streptococcal bacteraemia

Cardiac failure

Myocardial infarction

Sudden Death

Incisional hernia

Hypercalcaemia

Hypomagnesaemia

Aplastic anaemia

Inguinal hernia

Large intestine polyp

Cerebral ischaemia

Depressed level of consciousness

Confusional state

Nephrolithiasis

Urinary retention

Benign prostatic hyperplasia

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

IBR+OB

CLB+OB

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Open-Label ObinutuzumabExperimental Treatment6 Interventions

Younger participants aged 5 to \<12 will receive obinutuzumab 1000 mg IV infusions on Days 1, 14, Week 24, Week 26 and Week 52.

Group II: Blinded ObinutuzumabExperimental Treatment6 Interventions

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).

Group III: PlaceboPlacebo Group6 Interventions

Placebo participants will receive obinutuzumab matched placebo on Day 1, Day 14, Week 24, Week 26 and Week 52.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Obinutuzumab

2014