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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 years for reporting.

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 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
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%
Inclusion body myositis
1%
Uterine prolapse
1%
Colorectal cancer
1%
Non-small cell lung cancer
1%
Haemoptysis
1%
Arthritis
1%
Leukopenia
1%
Compartment syndrome
1%
Bronchitis chronic
1%
Bronchopulmonary aspergillosis
1%
Respiratory failure
1%
Invasive ductal breast carcinoma
1%
Oesophageal rupture
1%
Peripheral ischaemia
1%
Ischaemic stroke
1%
Myelodysplastic syndrome
1%
Concussion
1%
Colorectal cancer metastatic
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

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,090,986 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,630 Total Patients Enrolled

Media Library

Obinutuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04963296 — Phase 3
Lupus Research Study Groups: Obinutuzumab, Placebo
Lupus Clinical Trial 2023: Obinutuzumab Highlights & Side Effects. Trial Name: NCT04963296 — Phase 3
Obinutuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04963296 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I sign up for this clinical test?

"Eligible patients must have a diagnosis of libman-sacks disease and be between 18-75 years old. Currently, the medical trial is looking to enroll 200 individuals."

Answered by AI

Is this a clinical study that only elderly people can participate in?

"This particular clinical trial only accepts patients aged 18-75. However, there are 82 other trials catering to a younger demographic and 400 for elderly patients."

Answered by AI

How many hospitals are participating in this research project?

"This study has locations in Fullerton, Columbus, Denver, and 16 other sites."

Answered by AI

For what purpose is Obinutuzumab most often prescribed?

"Obinutuzumab is most often used as a nephrotic syndrome treatment, but it has also been known to help patients with conditions like whiplash syndrome and ophthalmia."

Answered by AI

Could you please tell me what other research has been done on Obinutuzumab?

"The first study into obinutuzumab was conducted in 2003 at Penn State Hershey Cancer Institute. As of now, there have been a total of 19234 completed studies with 354 trials still ongoing. Fullerton, California has a significant number of these live trials taking place."

Answered by AI

Can people with the required qualifications join this clinical trial?

"From what is published on clinicaltrials.gov, it appears that this study is still looking for participants. The trial was first announced on October 26th 2021 and the most recent update was November 4th 2022."

Answered by AI

What is the FDA's official stance on Obinutuzumab?

"Obinutuzumab is classified as a 3 on our Power team's safety scale. This is due to the fact that this drug has gone through Phase 3 trials, providing some evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

Who else is applying?

What site did they apply to?
Precision Comprehensive Clinical Research Solutions
What portion of applicants met pre-screening criteria?
Met criteria
~110 spots leftby Nov 2025