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Monoclonal Antibodies
Anifrolumab for Lupus Nephritis (IRIS Trial)
Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No signs of symptoms of active TB prior to or during screening or no treatment for latent TB
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 52, baseline through week 104
Awards & highlights
IRIS Trial Summary
This trial will test a new drug, antifrolumab, to see if it is effective and safe in treating patients with lupus nephritis.
Who is the study for?
Adults with active proliferative lupus nephritis, a kidney condition caused by systemic lupus erythematosus. Participants must have had a kidney biopsy within the last 6 months, show no signs of tuberculosis, and meet specific criteria for kidney function and protein levels in urine. Those with pure Class V lupus nephritis or severe infections like COVID-19 are excluded.Check my eligibility
What is being tested?
The trial is testing Anifrolumab's effectiveness compared to a placebo in treating active proliferative lupus nephritis. Patients will receive IV infusions of either Anifrolumab or placebo to see if there's an improvement in their condition.See study design
What are the potential side effects?
Anifrolumab may cause side effects such as increased risk of infections due to immune system suppression, infusion-related reactions (like discomfort at the injection site), potential TB reactivation, and possibly other unknown risks.
IRIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have no symptoms or treatment history for active or latent TB.
IRIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through week 52, baseline through week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 52, baseline through week 104
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group
Secondary outcome measures
Difference in change from baseline in extra-renal SLEDAI-2K total score
Difference in mean UPCR between the anifrolumab and placebo group
Difference in mean change from baseline in domains and component scores of Short Form-36 Version 2 (SF-36v2) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) total score
+10 moreSide effects data
From 2018 Phase 3 trial • 373 Patients • NCT0244689923%
Upper respiratory tract infection
16%
Nasopharyngitis
14%
Infusion related reaction
13%
Bronchitis
12%
Urinary tract infection
7%
Herpes zoster
7%
Sinusitis
6%
Cough
6%
Headache
6%
Back pain
6%
Arthralgia
4%
Nausea
2%
Pneumonia
1%
Angioedema
1%
Hypoaesthesia
1%
Cervical dysplasia
1%
Acute coronary syndrome
1%
Chilaiditi's syndrome
1%
Hypersensitivity
1%
Appendicitis
1%
Diverticulitis
1%
Gastroenteritis viral
1%
Lip squamous cell carcinoma
1%
Fall
1%
Nephrolithiasis
1%
Traumatic fracture
1%
Blood creatinine increased
1%
Osteonecrosis
1%
Systemic lupus erythematosus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anifrolumab 300 mg
Placebo
IRIS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AnifrolumabExperimental Treatment1 Intervention
Solution for intravenous infusion
Group II: PlaceboPlacebo Group1 Intervention
Solution for intravenous infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anifrolumab
2015
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,286 Previous Clinical Trials
288,619,690 Total Patients Enrolled
1 Trials studying Lupus Nephritis
147 Patients Enrolled for Lupus Nephritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have only had skin cancer or early-stage cervical cancer, which were cured.Your kidney function, as measured by a calculation called eGFR, is at least 35 mL/min/1.73 m2.You have evidence of hepatitis C or have active hepatitis B.You meet the updated 2019 criteria for diagnosing systemic lupus erythematosus (SLE).I have had a severe case of COVID-19.You had a kidney biopsy in the 6 months before joining the study or during the screening period.You have a specific type of kidney disease called lupus nephritis that is actively getting worse.The ratio of protein to creatinine in your urine is higher than 1 mg/mg (113.17 mg/mmol).I have a condition that makes me more prone to infections or I am HIV positive.You cannot tolerate taking 1.0 gram or less of MMF per day.I have had more than two experimental treatments for lupus since my diagnosis.I have no symptoms or treatment history for active or latent TB.I am currently taking medication for my lupus flare-up.You have been diagnosed with pure Class V lupus nephritis based on a kidney biopsy taken within the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Anifrolumab
- 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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