What side effects are associated with this type of intervention?

Common side effects of treatments for Lupus, particularly anti-CD20 monoclonal antibodies like Obinutuzumab and Rituximab, include infusion reactions (fever, chills, rigors), increased risk of infections due to immunosuppression, and serum-sickness-like reactions. Rarely, severe conditions such as progressive multifocal leukoencephalopathy (PML) may occur.

What prior FDA approvals exist?

The FDA has approved several treatments for Lupus, including biologic agents that target B cells. Belimumab (Benlysta) is a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS) and is approved for systemic lupus erythematosus (SLE). Rituximab, another anti-CD20 monoclonal antibody, has been used off-label for Lupus, although it is not specifically FDA-approved for this indication. These treatments, like Obinutuzumab, aim to reduce the activity of B cells, which play a significant role in the pathogenesis of Lupus.

What other types of research exist?

Promising alternatives to Obinutuzumab for Lupus patients include Rituximab, which targets CD20 and has been used in various autoimmune conditions, and Epratuzumab, a CD22-targeted monoclonal antibody that has shown B cell-specific immunologic activity in SLE patients. Additionally, Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), is another effective option for treating SLE.

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Monoclonal Antibodies

Obinutuzumab for Lupus (ALLEGORY Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

High disease activity on Day 1, based on SLEDAI-2K (score >=8) and PGA (score >=1.0 on a 0 to 3 VAS)

Current receipt of >=1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants

Must not have

Known active infection of any kind or recent major episode of infection

Presence of significant lupus-associated renal disease and/or renal impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 40 to week 52

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called obinutuzumab in people with active lupus who have specific antibodies in their blood. These patients are already on standard treatments but need more help. The medication works by reducing harmful immune cells that cause inflammation and damage.

Who is the study for?

This trial is for people with active, autoantibody-positive systemic lupus erythematosus (SLE) who have high disease activity despite standard treatments. Participants must meet specific criteria including low complement levels and positive ANA or anti-dsDNA/anti-Sm antibodies. They should not have severe kidney issues related to lupus, be pregnant or breastfeeding, or have used certain excluded therapies recently.

What is being tested?

The study tests the effectiveness and safety of Obinutuzumab compared to a placebo in SLE patients on standard care. It's a parallel-group, double-blind trial meaning neither participants nor researchers know who gets the real drug versus placebo during the study.

What are the potential side effects?

Possible side effects include reactions at the injection site, allergic reactions to medication components like acetaminophen/paracetamol or diphenhydramine hydrochloride, and potential steroid-related effects from methylprednisolone.

Eligibility Criteria

Inclusion Criteria

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

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My lupus is highly active, with a SLEDAI score of 8 or more and a PGA score of 1 or more.

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I am currently taking medication for lupus at a stable dose.

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My lupus is very active, affecting multiple organs with high scores on health assessments.

Exclusion Criteria

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

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I do not have any current infections or recent serious infections.

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I have kidney problems due to lupus.

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I cannot tolerate or am advised against the study's treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 40 to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 40 to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 40 to week 52 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 Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52

Secondary study objectives

Percentage of Participants Entering the Study on Prednisone >= 10 mg/day (or equivalent) who Achieve Sustained Corticosteroid Control

Percentage of Participants who Achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52

Percentage of Participants who Achieve SRI(6) at Week 52

+2 more

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

Oesophageal rupture

Respiratory failure

Compartment syndrome

Invasive ductal breast carcinoma

Colorectal cancer

Malignant melanoma

Non-small cell lung cancer

Uterine prolapse

Bronchitis chronic

Peripheral ischaemia

Myelodysplastic syndrome

Haemoptysis

Pleural effusion

Bronchopulmonary aspergillosis

Cardiac failure congestive

Gastritis

Concussion

Arthritis

Inclusion body myositis

Colorectal cancer metastatic

Ischaemic stroke

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ObinutuzumabExperimental Treatment4 Interventions

Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26.

Group II: PlaceboPlacebo Group4 Interventions

Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diphenhydramine hydrochloride

2006

Completed Phase 1

~40

Methylprednisolone

2015

Completed Phase 4

~2280

Obinutuzumab

2014

Completed Phase 3

~3470

Acetaminophen/Paracetamol

2008

Completed Phase 3

~170

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Lupus, such as Obinutuzumab, work by targeting B cells and autoantibodies, which play a crucial role in the disease's pathology. Obinutuzumab is an anti-CD20 monoclonal antibody that depletes B cells, reducing the production of autoantibodies that attack the body's own tissues. This mechanism is vital for Lupus patients because it helps control the immune system's overactivity, thereby reducing inflammation and preventing organ damage. Other treatments, like rituximab, also target CD20 on B cells, while therapies like cyclophosphamide suppress the overall immune response. These treatments are essential for managing Lupus symptoms and improving patients' quality of life.

Targeting B cells and autoantibodies in the therapy of autoimmune diseases.