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Monoclonal Antibodies
Obinutuzumab for Lupus (ALLEGORY Trial)
Phase 3
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 years
Awards & highlights
ALLEGORY Trial Summary
This trial will compare the effects of a new drug, obinutuzumab, to a placebo in people with active SLE. The trial will be double-blind, meaning neither the participants nor the researchers will know who is receiving the real drug or the placebo.
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.Check my eligibility
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.See study design
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.
ALLEGORY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lupus is highly active, with a SLEDAI score of 8 or more and a PGA score of 1 or more.
Select...
I am currently taking medication for lupus at a stable dose.
Select...
My lupus is very active, affecting multiple organs with high scores on health assessments.
ALLEGORY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52
Secondary outcome measures
Annualized flare rate through Week 52
Change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain Domain Scale
Change in Active Joint Count (Swollen plus Tender)
+22 moreSide effects data
From 2019 Phase 3 trial • 229 Patients • NCT0226457444%
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
9%
Spontaneous haematoma
9%
Anxiety
9%
Fall
9%
Rash
8%
Iron deficiency
8%
Headache
8%
Abdominal pain
8%
Dyspepsia
8%
Vision blurred
8%
Pruritus
7%
Bronchitis
7%
Lacrimation increased
7%
Respiratory tract infection
7%
Blood creatine increased
7%
Productive cough
7%
Oropharyngeal pain
7%
Gastrooesophageal reflux disease
6%
Hypokalaemia
6%
Dry eye
6%
Chills
6%
Myalgia
6%
Depression
6%
Dry Skin
6%
Ecchymosis
6%
Onychoclasis
6%
Palpitations
6%
Stomatitis
6%
Peripheral swelling
6%
Epistaxis
5%
Herpes zoster
5%
Increased tendency to bruise
5%
Hyperglycaemia
5%
Musculoskeletal pain
5%
Haematuria
5%
Petechiae
5%
Cellulitis
5%
Contusion
4%
Tremor
4%
Febrile neutropenia
3%
Acute coronary syndrome
3%
Adenocarcinoma of colon
3%
Gastroenteritis
3%
Weight decreased
2%
Septic shock
2%
Femur fracture
2%
Osteoarthritis
2%
Transient ischaemic attack
2%
Cardiac arrest
2%
Angina pectoris
2%
Death
2%
Cerebrovascular accident
2%
Acute kidney injury
2%
Renal failure
1%
Acute myocardial infarction
1%
Haemoptysis
1%
Inclusion body myositis
1%
Uterine prolapse
1%
Colorectal cancer
1%
Non-small cell lung cancer
1%
Arthritis
1%
Leukopenia
1%
Compartment syndrome
1%
Bronchitis chronic
1%
Colorectal cancer metastatic
1%
Ischaemic stroke
1%
Bronchopulmonary aspergillosis
1%
Respiratory failure
1%
Invasive ductal breast carcinoma
1%
Oesophageal rupture
1%
Peripheral ischaemia
1%
Myelodysplastic syndrome
1%
Concussion
1%
Malignant melanoma
1%
Pleural effusion
1%
Cardiac failure congestive
1%
Gastritis
1%
Bacterial sepsis
1%
Pericarditis
1%
Stress cardiomyopathy
1%
Goitre
1%
Haemorrhoids
1%
Impaired gastric emptying
1%
Proctitis
1%
Small intestinal obstruction
1%
Catheter site haematoma
1%
Multi-organ disorder
1%
Cholelithiasis
1%
Abscess
1%
Bursitis infective staphylococcal
1%
Erysipelas
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Infective aneurysm
1%
Listeria sepsis
1%
Lower respiratory tract infection
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia bacterial
1%
Pneumonia klebsiella
1%
Prostate infection
1%
Sinusitis fungal
1%
Urosepsis
1%
Jaw fracture
1%
Pubis fracture
1%
Rib fracture
1%
Spinal compression fracture
1%
Thoracic vertebral fracture
1%
Traumatic haematoma
1%
Upper limb fracture
1%
Diabetes mellitus inadequate control
1%
Adenocarcinoma gastric
1%
Basal cell carcinoma
1%
Benign renal neoplasm
1%
Squamous cell carcinoma
1%
Syncope
1%
Acute psychosis
1%
Complete Suicide
1%
Soft tissue infection
1%
Osteoma
1%
Atrial tachycardia
1%
Retinal detachment
1%
Herpes Zoster
1%
Oral herpes
1%
Pharyngitis
1%
Streptococcal bacteraemia
1%
Cardiac failure
1%
Myocardial infarction
1%
Sudden Death
1%
Incisional hernia
1%
Hypercalcaemia
1%
Hypomagnesaemia
1%
Aplastic anaemia
1%
Inguinal hernia
1%
Large intestine polyp
1%
Cerebral ischaemia
1%
Depressed level of consciousness
1%
Confusional state
1%
Nephrolithiasis
1%
Urinary retention
1%
Benign prostatic hyperplasia
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
IBR+OB
CLB+OB
ALLEGORY 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
Obinutuzumab
2015
Completed Phase 3
~3250
Acetaminophen/Paracetamol
2008
Completed Phase 3
~170
Diphenhydramine hydrochloride
2006
Completed Phase 1
~40
Methylprednisolone
2015
Completed Phase 4
~2280
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.
Targeting B cells and autoantibodies in the therapy of autoimmune diseases.
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,092 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,736 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lupus is highly active, with a SLEDAI score of 8 or more and a PGA score of 1 or more.I am currently taking medication for lupus at a stable dose.I haven't taken specific immune therapies or certain medications in the months before my screening.I do not have any severe illnesses that would stop me from joining the study.I have been diagnosed with lupus for at least 12 weeks.I do not have any current infections or recent serious infections.My lupus is very active, affecting multiple organs with high scores on health assessments.I have kidney problems due to lupus.I cannot tolerate or am advised against the study's treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Obinutuzumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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