Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis (IRIS)

April 25, 2024 updated by: AstraZeneca

A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

Study Overview

Status

Recruiting

Conditions

Lupus Nephritis

Intervention / Treatment

Detailed Description

This is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (consisting of MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 116 weeks, including the Screening and Follow-up. Approximately 360 participants will be randomized in a 1:1 ratio to receive anifrolumab or matching placebo throughout during the Treatment Period.

Study Type

Interventional

Enrollment (Estimated)

360

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1015ABO
    - Recruiting
    - Research Site
  - Caba, Argentina, C1425EOE
    - Recruiting
    - Research Site
  - Cordoba, Argentina, X5004AUL
    - Withdrawn
    - Research Site
  - La Plata, Argentina, 1900
    - Recruiting
    - Research Site
  - Rosario, Argentina, S2000PBJ
    - Recruiting
    - Research Site
  - San Juan, Argentina, 5400
    - Recruiting
    - Research Site
  - San Miguel de Tucuman, Argentina, X4000AXL
    - Withdrawn
    - Research Site
Belgium
- - Bruxelles, Belgium, 1200
    - Recruiting
    - Research Site
  - Leuven, Belgium, 3000
    - Recruiting
    - Research Site
  - Liège, Belgium, 4000
    - Recruiting
    - Research Site
Brazil
- - Belo Horizonte, Brazil, 30130 100
    - Not yet recruiting
    - Research Site
  - Maringá, Brazil, 87060-040
    - Not yet recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035-903
    - Not yet recruiting
    - Research Site
  - Recife, Brazil, 50740-465
    - Not yet recruiting
    - Research Site
  - Salvador, Brazil, 40150-150
    - Not yet recruiting
    - Research Site
  - Sao Jose Do Rio Preto, Brazil, 15090-000
    - Not yet recruiting
    - Research Site
  - Sao Paulo, Brazil, 05403-9000
    - Not yet recruiting
    - Research Site
  - São Paulo, Brazil, 04036-002
    - Not yet recruiting
    - Research Site
Bulgaria
- - Plovdiv, Bulgaria, 4002
    - Withdrawn
    - Research Site
  - Plovdiv, Bulgaria, 4002
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1431
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1336
    - Withdrawn
    - Research Site
  - Sofia, Bulgaria, 1680
    - Recruiting
    - Research Site
China
- - Beijing, China, 100034
    - Recruiting
    - Research Site
  - Beijing, China, 100044
    - Recruiting
    - Research Site
  - Chengdu, China, 610072
    - Recruiting
    - Research Site
  - Guangzhou, China, 510080
    - Recruiting
    - Research Site
  - Guangzhou, China, 510530
    - Recruiting
    - Research Site
  - Haikou, China, 570311
    - Recruiting
    - Research Site
  - Hangzhou, China, 310009
    - Recruiting
    - Research Site
  - Jinan, China, 250021
    - Recruiting
    - Research Site
  - Jining, China, 272011
    - Not yet recruiting
    - Research Site
  - Nanchang, China, 330006
    - Recruiting
    - Research Site
  - Nanjing, China, 210009
    - Recruiting
    - Research Site
  - Nanjing, China, 210029
    - Recruiting
    - Research Site
  - Nanning, China, 530021
    - Recruiting
    - Research Site
  - Shanghai, China, 200025
    - Recruiting
    - Research Site
  - Shanghai, China, 200040
    - Recruiting
    - Research Site
  - Shanghai, China, 201210
    - Withdrawn
    - Research Site
  - Shengyang, China, 110004
    - Recruiting
    - Research Site
  - Shenzhen, China, 518036
    - Recruiting
    - Research Site
  - Tianjin, China, 300201
    - Recruiting
    - Research Site
  - Wuhan, China, 430060
    - Recruiting
    - Research Site
  - Wuxi, China, 214023
    - Recruiting
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Zhengzhou City, China, 450000
    - Recruiting
    - Research Site
Colombia
- - Barranquilla, Colombia, 080020
    - Not yet recruiting
    - Research Site
  - Cali, Colombia, 760042
    - Not yet recruiting
    - Research Site
  - Medellin, Colombia, 050025
    - Not yet recruiting
    - Research Site
France
- - Aurillac Cedex, France, 15002
    - Recruiting
    - Research Site
  - Bordeaux Cedex, France, 33076
    - Recruiting
    - Research Site
  - Marseille, France, 13005
    - Recruiting
    - Research Site
  - Paris, France, 75013
    - Recruiting
    - Research Site
  - Paris, France, 75018
    - Recruiting
    - Research Site
  - Paris, France, 75679
    - Recruiting
    - Research Site
  - STRASBOURG Cedex, France, 67098
    - Recruiting
    - Research Site
  - Toulouse, France, 31059
    - Recruiting
    - Research Site
Germany
- - Dresden, Germany, 1307
    - Recruiting
    - Research Site
  - Düsseldorf, Germany, 40225
    - Recruiting
    - Research Site
  - Essen, Germany, 45147
    - Withdrawn
    - Research Site
  - Goettingen, Germany, 37075
    - Withdrawn
    - Research Site
  - Hannover, Germany, 30625
    - Recruiting
    - Research Site
  - Heidelberg, Germany, 69120
    - Recruiting
    - Research Site
  - Kirchheim, Germany, 73230
    - Recruiting
    - Research Site
  - Köln, Germany, 50937
    - Recruiting
    - Research Site
  - Mainz Am Rhein, Germany, 55131
    - Recruiting
    - Research Site
  - Stuttgart, Germany, 70376
    - Withdrawn
    - Research Site
Hungary
- - Budapest, Hungary, 1097
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1085
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1027
    - Withdrawn
    - Research Site
  - Debrecen, Hungary, 4032
    - Recruiting
    - Research Site
  - Pécs, Hungary, 7624
    - Recruiting
    - Research Site
India
- - Ahmedabad, India, 382421
    - Recruiting
    - Research Site
  - Ahmedabad, India, 380005
    - Recruiting
    - Research Site
  - Dehradun, India, 248001
    - Recruiting
    - Research Site
  - Delhi, India, 110029
    - Withdrawn
    - Research Site
  - Delhi, India, 110029
    - Recruiting
    - Research Site
  - Gurugram, India, 122001
    - Withdrawn
    - Research Site
  - Nadiad, India, 387001
    - Terminated
    - Research Site
  - New Delhi, India, 110017
    - Withdrawn
    - Research Site
  - New Delhi, India, 110075
    - Withdrawn
    - Research Site
  - New Delhi, India, 110070
    - Withdrawn
    - Research Site
  - Pune, India, 411001
    - Recruiting
    - Research Site
  - Secunderabad, India, 500003
    - Recruiting
    - Research Site
  - Vijayawada, India, 522002
    - Recruiting
    - Research Site
  - Visakapatnam, India, 530013
    - Recruiting
    - Research Site
Italy
- - Ancona, Italy, 60126
    - Recruiting
    - Research Site
  - Brescia, Italy, 25123
    - Recruiting
    - Research Site
  - Cona, Italy, 44124
    - Recruiting
    - Research Site
  - Monza, Italy, 20900
    - Recruiting
    - Research Site
  - Padova, Italy, 35128
    - Recruiting
    - Research Site
  - Roma, Italy, 00161
    - Recruiting
    - Research Site
  - Roma, Italy, 00152
    - Recruiting
    - Research Site
Japan
- - Bunkyo-ku, Japan, 113-8655
    - Recruiting
    - Research Site
  - Chiba-shi, Japan, 260-8712
    - Recruiting
    - Research Site
  - Chuo-ku, Japan, 104-8560
    - Recruiting
    - Research Site
  - Fukuoka-shi, Japan, 810-8563
    - Recruiting
    - Research Site
  - Gifu-shi, Japan, 500-8513
    - Recruiting
    - Research Site
  - Hiroshima-shi, Japan, 734-8551
    - Recruiting
    - Research Site
  - Izumo-shi, Japan, 693-8501
    - Recruiting
    - Research Site
  - Kita-gun, Japan, 761-0793
    - Recruiting
    - Research Site
  - Kitakyushu-shi, Japan, 807-8555
    - Recruiting
    - Research Site
  - Matsumoto-shi, Japan, 390-8621
    - Recruiting
    - Research Site
  - Nagasaki-shi, Japan, 852-8501
    - Recruiting
    - Research Site
  - Okayama, Japan, 700-8558
    - Recruiting
    - Research Site
  - Ono, Japan, 675-1392
    - Recruiting
    - Research Site
  - Osaka-shi, Japan, 545-8586
    - Recruiting
    - Research Site
  - Sagamihara-shi, Japan, 252-0375
    - Recruiting
    - Research Site
  - Sapporo-shi, Japan, 060-8648
    - Recruiting
    - Research Site
  - Sendai-shi, Japan, 980-0872
    - Recruiting
    - Research Site
  - Shinagawa-ku, Japan, 142-0054
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 160-8582
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 162-8655
    - Recruiting
    - Research Site
  - Toyoake-shi, Japan, 470-1192
    - Recruiting
    - Research Site
Malaysia
- - Batu Caves, Malaysia, 68100
    - Not yet recruiting
    - Research Site
  - Ipoh, Malaysia, 30450
    - Not yet recruiting
    - Research Site
  - Kajang, Malaysia, 43000
    - Not yet recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Not yet recruiting
    - Research Site
  - Kuantan, Malaysia, 25100
    - Not yet recruiting
    - Research Site
  - Taiping, Malaysia, 34000
    - Not yet recruiting
    - Research Site
Mexico
- - Chihuahua, Mexico, 31000
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44650
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44160
    - Recruiting
    - Research Site
  - Mexico, Mexico, 14080
    - Recruiting
    - Research Site
  - México, Mexico, 06726
    - Recruiting
    - Research Site
  - San Luis Potosi, Mexico, 78290
    - Recruiting
    - Research Site
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Recruiting
    - Research Site
Peru
- - Bellavista, Peru, CALLAO 2
    - Withdrawn
    - Research Site
  - Lima, Peru, LIMA 29
    - Recruiting
    - Research Site
  - Lima, Peru, 15036
    - Recruiting
    - Research Site
  - Lima, Peru, 15046
    - Recruiting
    - Research Site
  - Lima, Peru, LIMA 27
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15082
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15023
    - Recruiting
    - Research Site
  - Lima, Peru, L34
    - Not yet recruiting
    - Research Site
  - Piura, Peru, 20001
    - Recruiting
    - Research Site
Poland
- - Bydgoszcz, Poland, 86-605
    - Recruiting
    - Research Site
  - Nadarzyn, Poland, 05-830
    - Withdrawn
    - Research Site
  - Olsztyn, Poland, 10-561
    - Recruiting
    - Research Site
  - Opole, Poland, 46-020
    - Recruiting
    - Research Site
  - Poznań, Poland, 61-545
    - Recruiting
    - Research Site
  - Poznań, Poland, 60-355
    - Recruiting
    - Research Site
  - Rzeszów, Poland, 35-301
    - Recruiting
    - Research Site
  - Szczecin, Poland, 70-111
    - Withdrawn
    - Research Site
  - Wrocław, Poland, 50-556
    - Recruiting
    - Research Site
  - Wrocław, Poland, 51-124
    - Withdrawn
    - Research Site
  - Łódź, Poland, 92-213
    - Recruiting
    - Research Site
Russian Federation
- - Chelyabinsk, Russian Federation, 454048
    - Withdrawn
    - Research Site
  - Krasnoyarsk, Russian Federation, 660022
    - Withdrawn
    - Research Site
  - Moscow, Russian Federation, 115522
    - Terminated
    - Research Site
  - Moscow, Russian Federation, 123182
    - Withdrawn
    - Research Site
  - Novosibirsk, Russian Federation, 630090
    - Withdrawn
    - Research Site
  - Orenburg, Russian Federation, 460018
    - Withdrawn
    - Research Site
  - St. Petersburg, Russian Federation, 196066
    - Withdrawn
    - Research Site
Taiwan
- - Kaohsiung, Taiwan, 833
    - Recruiting
    - Research Site
  - New Taipei City, Taiwan, 220
    - Not yet recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 235
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 11217
    - Recruiting
    - Research Site
  - Taipei City, Taiwan, 114
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Withdrawn
    - Research Site
Thailand
- - Bangkok, Thailand, 10330
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10220
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Muang, Thailand, 50200
    - Recruiting
    - Research Site
  - Ratchathewi, Thailand, 10400
    - Recruiting
    - Research Site
Turkey
- - Ankara, Turkey
    - Recruiting
    - Research Site
  - Ankara, Turkey, 6500
    - Recruiting
    - Research Site
  - Ankara, Turkey, 06100
    - Recruiting
    - Research Site
  - Istanbul, Turkey
    - Recruiting
    - Research Site
  - Istanbul, Turkey, 34865
    - Recruiting
    - Research Site
  - Izmir, Turkey, 35965
    - Recruiting
    - Research Site
  - Kahramanmaras, Turkey, 46100
    - Recruiting
    - Research Site
  - Kayseri, Turkey, 38039
    - Recruiting
    - Research Site
  - Kocaeli, Turkey, 41380
    - Recruiting
    - Research Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Not yet recruiting
    - Research Site
- Arizona
  - Glendale, Arizona, United States, 85306
    - Recruiting
    - Research Site
- California
  - La Jolla, California, United States, 92037
    - Not yet recruiting
    - Research Site
  - Loma Linda, California, United States, 92354
    - Withdrawn
    - Research Site
  - Los Angeles, California, United States, 90095
    - Not yet recruiting
    - Research Site
  - Orange, California, United States, 92868
    - Not yet recruiting
    - Research Site
  - Upland, California, United States, 91786
    - Recruiting
    - Research Site
- Connecticut
  - New Haven, Connecticut, United States, 06519
    - Not yet recruiting
    - Research Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Withdrawn
    - Research Site
- Florida
  - Hallandale Beach, Florida, United States, 33009
    - Recruiting
    - Research Site
  - Plantation, Florida, United States, 33324
    - Recruiting
    - Research Site
  - Sun City Center, Florida, United States, 33573
    - Withdrawn
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30308
    - Not yet recruiting
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Not yet recruiting
    - Research Site
- Missouri
  - Saint Louis, Missouri, United States, 63108
    - Not yet recruiting
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89128
    - Withdrawn
    - Research Site
- New Jersey
  - Newark, New Jersey, United States, 07103
    - Recruiting
    - Research Site
  - Summit, New Jersey, United States, 07901
    - Recruiting
    - Research Site
- New Mexico
  - Las Cruces, New Mexico, United States, 88011
    - Withdrawn
    - Research Site
- New York
  - Great Neck, New York, United States, 11021
    - Not yet recruiting
    - Research Site
  - Manhasset, New York, United States, 11030
    - Recruiting
    - Research Site
  - New York, New York, United States, 10016
    - Not yet recruiting
    - Research Site
  - New York, New York, United States, 10032
    - Not yet recruiting
    - Research Site
- North Carolina
  - Winston-Salem, North Carolina, United States, 27157
    - Recruiting
    - Research Site
- Ohio
  - Middleburg Heights, Ohio, United States, 44130
    - Recruiting
    - Research Site
- Pennsylvania
  - Danville, Pennsylvania, United States, 17822
    - Not yet recruiting
    - Research Site
- Texas
  - Allen, Texas, United States, 75013
    - Recruiting
    - Research Site
  - Colleyville, Texas, United States, 76034
    - Recruiting
    - Research Site
  - Edinburg, Texas, United States, 78539
    - Recruiting
    - Research Site
  - El Paso, Texas, United States, 79902
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77054
    - Recruiting
    - Research Site
Vietnam
- - Ha Noi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Hanoi, Vietnam, 10000
    - Recruiting
    - Research Site
  - Hanoi, Vietnam, 100000
    - Terminated
    - Research Site
  - Ho Chi Minh, Vietnam, 700000
    - Recruiting
    - Research Site
  - Hochiminh, Vietnam, 70000
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol)
eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
Fulfills updated 2019 EULAR/ACR SLE classification criteria.
No signs of symptoms of active TB prior to or during screening or no treatment for latent TB

Exclusion Criteria:

A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
Evidence of hepatitis C or active hepatitis B.
Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide > 2 pulses of high-dose (≥ 0.5 g/m2) or > 4 doses of low dose (500 mg every 2 weeks) or Average MMF > 2.5 g/day (or > 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus > 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
Previous receipt of >◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
Known intolerance to ≤ 1.0 g/day of MMF.
Any history of severe COVID-19 infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anifrolumab Solution for intravenous infusion	Drug: Anifrolumab Anifrolumab intravenous infusion (IV) Other Names: Medi-546
Placebo Comparator: Placebo Solution for intravenous infusion	Drug: Placebo Placebo intravenous infusion (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group Time Frame: Week 52	CRR is defined as: UPCR ≤ 0.5 mg/mg eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20%	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in proportion of participants achieving sustained OCS reduction in anifrolumab group compared with placebo group. Time Frame: from Week 24 through Week 52	Sustained OCS reduction	from Week 24 through Week 52
Hazard Ratio (HR) of achieving sustained CRR in anifrolumab compared with placebo group Time Frame: baseline through Week 52	The endpoint for deriving the summary measure is time to sustained CRR, defined as time to achieving CRR that is sustained from that time point through the end of the time frame period.	baseline through Week 52
Difference in the mean standardized AUC for UPCR between anifrolumab and placebo participants Time Frame: baseline through Week 52	Proteinuria as measured by the cumulative UPCR	baseline through Week 52
HR to summarize the difference in the risk of hazard of renal-related event or death at any given time between anifrolumab and placebo participants Time Frame: baseline through Week 52, baseline through Week 104	The endpoint for deriving the summary measure is time to onset of renal-related event or death. Time to onset of renal event as defined as any of the following: ESKD, doubling of serum creatinine, renal worsening as evidenced by increased proteinuria and/or renal function impairment, or 4) renal disease treatment failure or death	baseline through Week 52, baseline through Week 104
Difference in proportion of participants achieving aCRR (Alternative Complete Renal Response) Time Frame: Week 52	aCRR is defined as: UPCR ≤ 0.5 mg/mg; eGFR ≥ 90 mL/min/1.73 m2 or no confirmed decrease of eGFR from baseline of ≥ 10%.	Week 52
Difference in the proportion of participants achieving CRR with sustained OCS reduction Time Frame: Week 52	CRR with sustained OCS reduction	Week 52
Difference in the proportion of participants achieving CRR Time Frame: Week 24	Early onset of CRR	Week 24
HR of achieving sustained CRR in anifrolumab compared with placebo Time Frame: baseline through Week 104	Time to sustained CRR through the time frame period	baseline through Week 104
HR of achieving 50% reduction in UPCR in anifrolumab compared to placebo group Time Frame: baseline through Week 52	The endpoint for deriving the summary measure is time from the first dose of study intervention to achieving 50% reduction in UPCR	baseline through Week 52
Difference in mean UPCR between the anifrolumab and placebo group Time Frame: Week 52	Proteinuria as measured by UPCR	Week 52
PRR (Partial Renal Response) Time Frame: Week 52	PRR defined as: UPCR: - For participants with a baseline UPCR ≤3 mg/mg: <1.0 mg/mgb eGFR: ≥ 60 mL/min/1.73 m2 or no confirmed decrease of eGFR from baseline of ≥ 20%	Week 52
Difference in change from baseline in extra-renal SLEDAI-2K total score Time Frame: baseline through Week 104	The extra-renal SLEDAI-2K score is obtained by summing the SLEDAI-2K items without including the items within the renal system organ.	baseline through Week 104
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 Time Frame: Week 52	To evaluate patient-reported HRQOL and health status	Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

July 7, 2028

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Lupus Nephritis, anifrolumab, Systemic Lupus Erythematosus, intravenous

Additional Relevant MeSH Terms

Other Study ID Numbers

D3466C00001
2021-002862-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean that all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lupus Nephritis

Imperial College London
Karolinska Institutet; Ohio State University; Dutch Working Party on Systemic... and other collaborators

Terminated

Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus Nephritis (RITUXILUP)

Systemic Lupus Erythematosus, Lupus Nephritis

United Kingdom
Sun Yat-sen University

Completed

Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis

Nephritis, Lupus

China
Peking University

Completed

Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone

Nephritis, Lupus

China
University Hospital, Grenoble
Institut de Biologie Structurale Grenoble

Completed

Anti-ficolin-3 Antibodies in Lupus Nephritis (IgFicoLupus)

Systemic Lupus Erythematosus Nephritis

France
Peking Union Medical College Hospital

Unknown

Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

Nephritis, Lupus

China
Artiva Biotherapeutics, Inc.

Recruiting

AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis

Lupus Nephritis - WHO Class IV | Lupus Nephritis - WHO Class III

United States
Kyverna Therapeutics

Recruiting

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (KYSA-3)

Lupus Nephritis | Lupus Nephritis - WHO Class IV | Lupus Nephritis - WHO Class III

Germany
Minia University

Not yet recruiting

MFERG Study of HCQ Retinopathy in Lupus Nephritis Patients: A Randomized Controlled Clinical Trial

mfERG in Lupus Nephritis

Egypt
Kyverna Therapeutics

Recruiting

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis

Lupus Nephritis | Lupus Nephritis - World Health Organization (WHO) Class III | Lupus Nephritis - WHO Class IV

United States
Centre Hospitalier Universitaire, Amiens

Completed

Detection of Annexin A2 in Systemic Lupus Erythematosus (ANLUP)

Lupus Nephritis | Systemic Lupus Erythematosus (SLE)

France

Clinical Trials on Anifrolumab

AstraZeneca

Completed

Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

China
AstraZeneca

Completed

A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects

Healthy Subjects | Pharmacokinetics | Safety

United States
AstraZeneca
PRA Health Sciences

Completed

Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus (TULIP SLE LTE)

Active Systemic Lupus Erythematosus

United States, France, Germany, Spain, Russian Federation, Peru, Taiwan, United Kingdom, Japan, Korea, Republic of, Argentina, Israel, Hungary, Bulgaria, Romania, Australia, Ukraine, Mexico, Canada, South Africa, Poland, Lithuania, ... and more
AstraZeneca
PRA Health Sciences

Completed

Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus

United States, Italy, Korea, Republic of, Peru, Taiwan, New Zealand, Germany, Israel, Hungary, Australia, Poland, United Kingdom, Romania, Ukraine, Brazil, Argentina, Chile, Colombia
AstraZeneca
Parexel

Completed

Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis (TULIP-LN1)

Lupus Nephritis

United States, Italy, Spain, Taiwan, Peru, Belgium, France, Korea, Republic of, Mexico, Germany, Australia, Hungary, Serbia, Russian Federation, United Kingdom, Poland, Argentina
Josef Smolen, Univ. Prof. Dr.

Unknown

A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)

Rheumatoid Arthritis

Austria
AstraZeneca

Active, not recruiting

Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)

Active Systemic Lupus Erythematosus

Thailand, Korea, Republic of, Philippines, China, Taiwan, Hong Kong
AstraZeneca
PRA Health Sciences

Completed

Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus

United States, France, Germany, Spain, Belgium, Russian Federation, Japan, Korea, Republic of, Argentina, Bulgaria, South Africa, Mexico, Canada, Brazil, Lithuania
MedImmune LLC

Completed

An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

Lupus Erythematosus, Systemic

United States, Korea, Republic of, Mexico, Peru, Hungary, Ukraine, Czechia, Bulgaria, Colombia, Brazil, Poland, Romania, Taiwan
AstraZeneca
Clinigen, Inc.

No longer available

Anifrolumab Early Access Program (AMANA)

Systemic Lupus Erythematosus

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis (IRIS)

A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

Study Overview

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Studies a U.S. FDA-regulated drug product

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Clinical Trials on Lupus Nephritis

Clinical Trials on Anifrolumab

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