NCT02547922 (TULIP-LN1) is a Phase 2 clinical trial of Anifrolumab in Lupus Nephritis, sponsored by AstraZeneca.

Who is sponsoring NCT02547922?

NCT02547922 is sponsored by AstraZeneca.

What drugs are being tested in NCT02547922?

Interventions in NCT02547922: Anifrolumab, Placebo.

What condition does NCT02547922 study?

NCT02547922 studies Lupus Nephritis.

Is NCT02547922 still recruiting?

NCT02547922 is currently completed. Last updated 24 November 2021.

Are results published for NCT02547922?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-11-24 · How we verify

NCT02547922: TULIP-LN1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 24 November 2021

What this trial tests

Phase 2 trial testing Anifrolumab in Lupus Nephritis in 147 participants. Completed in 18 January 2021.

Timeline

4 November 2015

Primary endpoint
26 November 2019

18 January 2021

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	147
Start date	4 November 2015
Primary completion	26 November 2019
Estimated completion	18 January 2021
Sites	80 locations across France, Italy, Russia, Peru, Belgium, Serbia, Taiwan, United Kingdom

Drugs / interventions tested

Anifrolumab (ANIFROLUMAB) — full drug profile →
Placebo

Conditions studied

Lupus Nephritis — all drugs for Lupus Nephritis →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 70, any sex, with Lupus Nephritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR) Primary · From Week 1 (Baseline) up to Week 52

To evaluate the efficacy of anifrolumab plus SOC (combination of mycophenolate mofetil and corticosteroids) compared with placebo plus SOC in subjects with active proliferative lupus nephritis (LN). Geometric mean ratio of 24-hour UPCR at week 52 over baseline. Values \<1 indicate improvement from baseline.

Group	Value	95% CI
Anifrolumab - Basic Regimen	0.326	0.190 – 0.561
Anifrolumab - Intensified Regimen	0.285	0.177 – 0.457
All Anifrolumab	0.305	0.198 – 0.468
Placebo	0.296	0.175 – 0.499

Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR) Secondary · Week 52

CRR was defined as meeting all of the following: * Estimated glomerular filtration rate (eGFR) is ≥60 mL/min/1.73 m\^2 or no confirmed decrease of eGFR from baseline of ≥20% * 24-hour UPCR ≤ 0.7 mg/mg * No discontinuation of investigational product (IP) or use of restricted medication beyond the protocol allowed threshold before assessment * eGFR was based on Modification of Diet in Renal Disease (MDRD) formula. Subjects treated with restricted medication beyond the protocol allowed threshold, or discontinuing study treatment for other reasons, were regarded as non-responders.

Responder

Group	Value	95% CI
Anifrolumab - Basic Regimen	16.3
Anifrolumab - Intensified Regimen	45.5
All Anifrolumab	31.0
Placebo	31.1

Non-responder

Group	Value	95% CI
Anifrolumab - Basic Regimen	83.7
Anifrolumab - Intensified Regimen	54.5
All Anifrolumab	69.0
Placebo	68.9

Number of Subjects With Adverse Events Secondary · From screening (Day-30 to -1) period until the follow-up period (Week 112)

To assess AEs (non-serious, serious and adverse event of special interest (AESI)) as variables of safety and tolerability of anifrolimab. The AESIs are serious infections, including non-opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, TB (including latent TB), influenza, vasculitis (non-SLE), and MACE (including stroke, acute coronary syndrome, myocardial infarction, or cardiovascular death). Study period: During treatment and follow-up data are presented.

Subjects with any AE- During treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	43
Anifrolumab - Intensified Regimen	47
All Anifrolumab	90
Placebo	44

Subjects with any acute AE- During treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	11
Anifrolumab - Intensified Regimen	15
All Anifrolumab	26
Placebo	14

Any AE with outcome of death- During treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	0
Anifrolumab - Intensified Regimen	0
All Anifrolumab	0
Placebo	0

Any SAE (including events with- outcome of death)- During treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	10
Anifrolumab - Intensified Regimen	9
All Anifrolumab	19
Placebo	8

Any AE leading to discontinuation of investigational product- During treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	5
Anifrolumab - Intensified Regimen	6
All Anifrolumab	11
Placebo	5

Any AE related to investigational product (investigator assessment)- During treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	24
Anifrolumab - Intensified Regimen	13
All Anifrolumab	37
Placebo	16

Any AE of severe intensity- During treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	6
Anifrolumab - Intensified Regimen	7
All Anifrolumab	13
Placebo	8

Any AESI- During treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	12
Anifrolumab - Intensified Regimen	12
All Anifrolumab	24
Placebo	8

Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) Secondary · Baseline, treatment and follow up (an average of 60 weeks)

The C-SSRS was used to assess the suicidal ideation and behavior and suicide attempts on a graded scale from 1 to 5. 1 indicates as low suicidal and 5 as high suicidal behavior.

Suicidal attempts: Baseline

Group	Value	95% CI
Anifrolumab - Basic Regimen	0
Anifrolumab - Intensified Regimen	0
All Anifrolumab	0
Placebo	0

Suicidal attempts: Treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	0
Anifrolumab - Intensified Regimen	0
All Anifrolumab	0
Placebo	0

Suicidal attempts: Follow up

Group	Value	95% CI
Anifrolumab - Basic Regimen	0
Anifrolumab - Intensified Regimen	0
All Anifrolumab	0
Placebo	0

Suicidal behaviour: Baseline

Group	Value	95% CI
Anifrolumab - Basic Regimen	0
Anifrolumab - Intensified Regimen	0
All Anifrolumab	0
Placebo	0

Suicidal behaviour: Treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	0
Anifrolumab - Intensified Regimen	0
All Anifrolumab	0
Placebo	0

Suicidal behaviour: Follow up

Group	Value	95% CI
Anifrolumab - Basic Regimen	0
Anifrolumab - Intensified Regimen	0
All Anifrolumab	0
Placebo	0

Suicidal ideation: Baseline

Group	Value	95% CI
Anifrolumab - Basic Regimen	0
Anifrolumab - Intensified Regimen	2
All Anifrolumab	2
Placebo	4

Suicidal ideation: Treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	0
Anifrolumab - Intensified Regimen	0
All Anifrolumab	0
Placebo	2

Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) Secondary · Baseline, Week 12, Week 24, Week 36, Week 52, Week 60

PHQ-8 is a 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQ-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms.

Baseline

Group	Value	95% CI
Anifrolumab - Basic Regimen	5.1	± 4.34
Anifrolumab - Intensified Regimen	4.3	± 4.05
All Anifrolumab	4.6	± 4.18
Placebo	5.8	± 4.54

Week 12

Group	Value	95% CI
Anifrolumab - Basic Regimen	3.4	± 3.88
Anifrolumab - Intensified Regimen	3.1	± 3.56
All Anifrolumab	3.2	± 3.68
Placebo	5.1	± 4.84

Week 24

Group	Value	95% CI
Anifrolumab - Basic Regimen	2.7	± 2.41
Anifrolumab - Intensified Regimen	2.5	± 3.18
All Anifrolumab	2.6	± 2.86
Placebo	4.9	± 5.10

Week 36

Group	Value	95% CI
Anifrolumab - Basic Regimen	3.3	± 4.04
Anifrolumab - Intensified Regimen	2.5	± 3.22
All Anifrolumab	2.8	± 3.63
Placebo	3.5	± 2.73

Week 52

Group	Value	95% CI
Anifrolumab - Basic Regimen	2.3	± 3.44
Anifrolumab - Intensified Regimen	3.4	± 5.24
All Anifrolumab	2.9	± 4.51
Placebo	4.2	± 3.30

Week 60

Group	Value	95% CI
Anifrolumab - Basic Regimen	3.3	± 4.80
Anifrolumab - Intensified Regimen	5.6	± 7.01
All Anifrolumab	4.6	± 6.06
Placebo	4.6	± 2.07

Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument Secondary · From baseline up to week 112

Flare will be defined as any one criterion present in either the Mild/Moderate Flare and/or Severe Flare categories. New or worsened manifestation should only be reported for manifestations of SLE. The SLEDAI-2K score range is 0 to 105 with higher scores representing increased disease activity. Mild/ Moderate flare defined as change in non-renal components of the SLEDAI-2K instrument score of ≥3 but \<7 points compared to previous visit. Severe Flare defined as change in non-renal components of the SLEDAI-2K instrument score by ≥7 points compared to previous visit. The flare rate per subject

Mild/moderate: All flares

Group	Value	95% CI
Anifrolumab - Basic Regimen	0.019
Anifrolumab - Intensified Regimen	0.016
All Anifrolumab	0.017
Placebo	0.016

Mild/moderate: On-treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	0.017
Anifrolumab - Intensified Regimen	0.012
All Anifrolumab	0.014
Placebo	0.010

Mild/moderate: Off-treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	0.002
Anifrolumab - Intensified Regimen	0.003
All Anifrolumab	0.003
Placebo	0.006

Severe: All flares

Group	Value	95% CI
Anifrolumab - Basic Regimen	0.007
Anifrolumab - Intensified Regimen	0.001
All Anifrolumab	0.003
Placebo	0.006

Severe: On-treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	0.004
Anifrolumab - Intensified Regimen	0.00
All Anifrolumab	0.002
Placebo	0.004

Severe: Off-treatment

Group	Value	95% CI
Anifrolumab - Basic Regimen	0.003
Anifrolumab - Intensified Regimen	0.001
All Anifrolumab	0.002
Placebo	0.002

Adverse events — posted to ClinicalTrials.gov

Time frame: From screening (Day-30 to -1) period until follow-up (Week 112).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Anifrolumab - Basic Regimen- Treatment Period

Serious: 10/45 (22%)

Deaths: 0/45

Anifrolumab - Intensified Regimen- Treatment Period

Serious: 9/51 (18%)

Deaths: 0/51

All Anifrolumab- Treatment Period

Serious: 19/96 (20%)

Deaths: 0/96

Placebo- Treatment Period

Serious: 8/49 (16%)

Deaths: 0/49

Anifrolumab - Basic Regimen- Follow up

Serious: 3/45 (7%)

Deaths: 1/45

Anifrolumab - Intensified Regimen- Follow up

Serious: 0/51 (0%)

Deaths: 0/51

All Anifrolumab- Follow up

Serious: 3/96 (3%)

Deaths: 1/96

Placebo- Follow up

Serious: 3/49 (6%)

Deaths: 0/49

Serious adverse events (31 terms)

Reaction	System	Anifrolumab - Basic Regime…	Anifrolumab - Intensified …	All Anifrolumab- Treatment…	Placebo- Treatment Period	Anifrolumab - Basic Regime…	Anifrolumab - Intensified …	All Anifrolumab- Follow up	Placebo- Follow up
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—
Lupus nephritis	Renal and urinary disorders	—	—	—	—	—	—	—	—
Abscess bacterial	Infections and infestations	—	—	—	—	—	—	—	—
Pyelonephritis acute	Infections and infestations	—	—	—	—	—	—	—	—
Varicella zoster pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Atypical pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Histoplasmosis disseminated	Infections and infestations	—	—	—	—	—	—	—	—
Meningitis	Infections and infestations	—	—	—	—	—	—	—	—
Otitis externa bacterial	Infections and infestations	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Lupus endocarditis	Cardiac disorders	—	—	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—
Nephrotic syndrome	Renal and urinary disorders	—	—	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—

Other adverse events (21 terms — click to expand)

Reaction	System	Anifrolumab - Basic Regime…	Anifrolumab - Intensified …	All Anifrolumab- Treatment…	Placebo- Treatment Period	Anifrolumab - Basic Regime…	Anifrolumab - Intensified …	All Anifrolumab- Follow up	Placebo- Follow up
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—	—	—	—
Herpes simplex	Infections and infestations	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Herpes zoster, Influenza, Lupus nephritis, Abscess bacterial, Pyelonephritis acute, Varicella zoster pneumonia, Atypical pneumonia, Histoplasmosis disseminated.

Data from ClinicalTrials.gov NCT02547922 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Update on Lupus Nephritis.
Almaani S, Meara A, Rovin BH. · · 2017 · cited 605× · PMID 27821390 · DOI 10.2215/cjn.05780616
Immunological pathogenesis and treatment of systemic lupus erythematosus.
Pan L, Lu MP, Wang JH, Xu M, et al · · 2020 · cited 268× · PMID 30796732 · DOI 10.1007/s12519-019-00229-3
Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis.
Jayne D, Rovin B, Mysler EF, Furie RA, et al · · 2022 · cited 137× · PMID 35144924 · DOI 10.1136/annrheumdis-2021-221478
Evolving understanding of autoimmune mechanisms and new therapeutic strategies of autoimmune disorders.
Song Y, Li J, Wu Y. · · 2024 · cited 109× · PMID 39362875 · DOI 10.1038/s41392-024-01952-8
Plasmacytoid dendritic cell biology and its role in immune-mediated diseases.
Ye Y, Gaugler B, Mohty M, Malard F. · · 2020 · cited 107× · PMID 32489664 · DOI 10.1002/cti2.1139
Type I interferonopathies in pediatric rheumatology.
Volpi S, Picco P, Caorsi R, Candotti F, et al · · 2016 · cited 93× · PMID 27260006 · DOI 10.1186/s12969-016-0094-4
Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0
Current and Emerging Therapies for Lupus Nephritis.
Parikh SV, Rovin BH. · · 2016 · cited 68× · PMID 27283496 · DOI 10.1681/asn.2016040415

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02547922 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 24 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02547922.

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