Study 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.
Eligible Conditions
- Lupus
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 20 Secondary · Reporting Duration: Up to approximately 6 years
Baseline
Percentage of Participants with Anti-drug Antibodies (ADAs) at Baseline
Week 54
Serum Concentration of Obinutuzumab
Week 52
Percentage of Participants who Achieve Sustained Corticosteroid Control
Percentage of Participants who Achieve Sustained SRI(4) Response
Percentage of Participants who Achieve a Sustained SRI(4) Response
Week 52
Change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain Domain Scale
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale
Change in SF-36 v2 Physical Component Summary Scale
Time to First BILAG Flare
Time to First BILAG Flare over 52 Weeks
Year 6
Percentage of Participants with Adverse Events
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Year 6
Percentage of Participants with ADAs During the Study
Week 24
Percentage of Participants who Achieve SRI(4) at Week 24
Week 52
Percentage of Participants who Achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52
Percentage of Participants who Achieve Clinical SRI(4) at Week 52
Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS) at Week 52
Percentage of Participants who Achieve SRI(4) at Week 52 on Low-dose Corticosteroids
Percentage of Participants who Achieve SRI(6) at Week 52
Percentage of Participants who Achieve SRI(8) at Week 52
Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
CLB+OB
63%Neutropenia
53%Infusion related reaction
30%Nausea
25%Thrombocytopenia
25%Anaemia
24%Pyrexia
17%Fatigue
15%Asthenia
13%Dyspnoea
12%Cough
12%Constipation
12%Vomiting
11%Headache
10%Diarrhea
10%Arthralgia
10%Back pain
9%Chills
9%Pain in extremity
8%Epistaxis
7%Anxiety
7%Oedema peripheral
6%Vision blurred
6%Upper respiratory tract infection
6%Urinary tract infection
6%Dizziness
6%Hyperglycaemia
6%Tremor
6%Febrile neutropenia
6%Muscle spasms
5%Abdominal pain
5%Oral herpes
5%Hypotension
5%Weight decreased
4%Pneumonia
4%Decreased appetite
4%Insomnia
4%Tumour lysis syndrome
4%Lacrimation increased
4%Hypertension
3%Cellulitis
3%Herpes zoster
3%Gastrooesophageal reflux disease
3%Musculoskeletal pain
3%Pruritus
3%Palpitations
3%Nasopharyngitis
3%Fall
3%Myalgia
3%Oropharyngeal pain
3%Dry eye
2%Peripheral swelling
2%Hypokalaemia
2%Sepsis
2%Dyspepsia
2%Conjunctivitis
2%Bronchitis
2%Productive cough
2%Rash maculo-papular
1%Hyponatraemia
1%Acute myocardial infarction
1%Pericarditis constrictive
1%Gastroenteritis
1%Accidental overdose
1%Craniocerebral injury
1%Chronic lymphocytic leukaemia
1%Essential thrombocythaemia
1%Kaposi's sarcoma
1%Keratoacanthoma
1%Loss of consciousness
1%Acute kidney injury
1%Urinary retention
1%Respiratory failure
1%Venous thrombosis limb
1%Spontaneous haematoma
1%Stomatitis
1%Hip fracture
1%Dehydration
1%Neuroendocrine carcinoma of the skin
1%Prostate Cancer
1%Seizure
1%Acute respiratory failure
1%Pulmonary embolism
1%Cataract
1%Blood creatine increased
1%Respiratory tract infection
1%Contusion
1%Depression
1%Rash
1%Myocardial ischaemia
1%Cholecystitis
1%Small intestinal obstruction
1%Vascular device infection
1%Pharyngitis
1%Concussion
1%Osteonecrosis of jaw
1%Osteolysis
Trial Design
2 Treatment Groups
Obinutuzumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
200 Total Participants · 2 Treatment Groups
Primary Treatment: Obinutuzumab · Has Placebo Group · Phase 3
ObinutuzumabExperimental Group · 4 Interventions: Obinutuzumab, Methylprednisolone, Acetaminophen/Paracetamol, Diphenhydramine hydrochloride · Intervention Types: Drug, Drug, Drug, Drug
PlaceboPlaceboComparator Group · 4 Interventions: Methylprednisolone, Placebo, Acetaminophen/Paracetamol, Diphenhydramine hydrochloride · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
FDA approved
Methylprednisolone
FDA approved
Acetaminophen
FDA approved
Diphenhydramine
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 6 years
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,361 Previous Clinical Trials
1,067,883 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,148 Previous Clinical Trials
875,973 Total Patients Enrolled
Eligibility Criteria
Age 18 - 75 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Low complement levels are associated with an increased risk of developing autoimmune hepatitis.
You have active disease on Day 1.
You are currently receiving at least 1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants.
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Conditions
Cancer Related
Treatments