NCT02962960

A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations

Completed Phase 2 Results posted Last updated 12 January 2023

What this trial tests

Phase 2 trial testing Anifrolumab in Systemic Lupus Erythematosus in 36 participants. Completed in 17 December 2018.

Timeline

14 February 2017

Primary endpoint
22 January 2018

17 December 2018

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	36
Start date	14 February 2017
Primary completion	22 January 2018
Estimated completion	17 December 2018
Sites	14 locations across Poland, United States, Hungary, South Korea

Drugs / interventions tested

• Anifrolumab (ANIFROLUMAB) — full drug profile →
• Placebo

Conditions studied

• Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 70, any sex, with Systemic Lupus Erythematosus. 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.

Maximum Concentration of Anifrolumab in Serum After First Dose Primary · Week 0

Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment.

Group	Value	95% CI
Anifrolumab - Lower Dose	14.058	± 49.8151
Anifrolumab - Higher Dose	28.115	± 74.4916

Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab Primary · Week 12

Steady-state serum through concentration (Ctrough) is based on sample collected at Week 12 prior to dosing of study treatment (predose).

Group	Value	95% CI
Anifrolumab - Lower Dose	15.618	± 81.3595
Anifrolumab - Higher Dose	16.926	± 9205.6677

21-gene Type 1 IFN Signature Score (Fold-change) Primary · Week 12

21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control.

Group	Value	95% CI
Anifrolumab - Lower Dose	3.2	± 3.69
Anifrolumab - Higher Dose	3.5	± 5.73
Placebo Comparator	14.3	± 6.68

21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change) Primary · Week 12

21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. For each individual participant and assessment, the level of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control, as the median of 100-(((baseline-Week 12)/baseline)\*100) for the 21 genes. At a population level, the results are presented as mean the above.

Group	Value	95% CI
Anifrolumab - Lower Dose	77.5	± 24.16
Anifrolumab - Higher Dose	80.5	± 36.65
Placebo Comparator	15.1	± 49.63

Number of Participants With Antidrug Antibody (ADA) Secondary · Baseline to Week 52

Post-baseline ADA incidence based on the number of participants with Antidrug antibody (ADA)

Group	Value	95% CI
Anifrolumab - Lower Dose	1
Anifrolumab - Higher Dose	1
Placebo Comparator	0

Number of Participants With Neutralizing Antibodies (nAb) Secondary · Baseline to Week 52

Incidence of detectable nAb in post-baseline ADA positive participants.

Group	Value	95% CI
Anifrolumab - Lower Dose	0
Anifrolumab - Higher Dose	0
Placebo Comparator	0

Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) Secondary · Baseline to Week 52

Number of participants with any AEs (Adverse events), any SAEs (serious adverse events), and any adverse events of special interest (AESI) are summarized. More details are reported in the Adverse Events section.

Any adverse event

Group	Value	95% CI
Anifrolumab - Lower Dose	12
Anifrolumab - Higher Dose	11
Placebo Comparator	7

Any serious adverse event

Group	Value	95% CI
Anifrolumab - Lower Dose	4
Anifrolumab - Higher Dose	2
Placebo Comparator	0

Any adverse event of special interest

Group	Value	95% CI
Anifrolumab - Lower Dose	5
Anifrolumab - Higher Dose	1
Placebo Comparator	1

Change From Baseline for Vital Signs Secondary · Baseline to Week 60

Change from baseline for vital signs.

Systolic Blood Pressure (mmHg) - Week 12

Group	Value	95% CI
Anifrolumab - Lower Dose	-4.1	± 12.08
Anifrolumab - Higher Dose	3	± 6.63
Placebo Comparator to Lower Dose	-5.8	± 13.99
Placebo Comparator to Higher Dose	7.3	± 8.96

Systolic Blood Pressure (mmHg) - Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	2.1	± 10.96
Anifrolumab - Higher Dose	-1.7	± 12.96
Placebo Comparator to Lower Dose	3.4	± 8.53
Placebo Comparator to Higher Dose	12.5	± 19.36

Systolic Blood Pressure (mmHg) - Week 60

Group	Value	95% CI
Anifrolumab - Lower Dose	4.1	± 19.70
Anifrolumab - Higher Dose	-2.8	± 14.91
Placebo Comparator to Lower Dose	12.2	± 8.61
Placebo Comparator to Higher Dose	4.5	± 7.14

Diastolic Blood Pressure (mmHg) - Week 12

Group	Value	95% CI
Anifrolumab - Lower Dose	-2.0	± 10.02
Anifrolumab - Higher Dose	2.4	± 6.71
Placebo Comparator to Lower Dose	-3.8	± 6.50
Placebo Comparator to Higher Dose	4.3	± 4.35

Diastolic Blood Pressure (mmHg) - Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	0.1	± 6.87
Anifrolumab - Higher Dose	2.9	± 7.54
Placebo Comparator to Lower Dose	-0.4	± 7.13
Placebo Comparator to Higher Dose	6.8	± 5.38

Diastolic Blood Pressure (mmHg) - Week 60

Group	Value	95% CI
Anifrolumab - Lower Dose	3.6	± 12.23
Anifrolumab - Higher Dose	-0.8	± 6.86
Placebo Comparator to Lower Dose	-1.0	± 8.22
Placebo Comparator to Higher Dose	8.8	± 6.29

Change From Baseline for Physical Examination Secondary · Baseline to Week 60

Physical examination is reported as change from baseline in body weight.

Week 12

Group	Value	95% CI
Anifrolumab - Lower Dose	-1.81	± 2.674
Anifrolumab - Higher Dose	1.37	± 3.113
Placebo Comparator to Lower Dose	0.7	± 1.889
Placebo Comparator to Higher Dose	0.98	± 2.904

Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	-2.83	± 4.683
Anifrolumab - Higher Dose	2.52	± 6.495
Placebo Comparator to Lower Dose	0.30	± 3.338
Placebo Comparator to Higher Dose	3.90	± 5.608

Week 60

Group	Value	95% CI
Anifrolumab - Lower Dose	-1.81	± 3.858
Anifrolumab - Higher Dose	2.93	± 6.463
Placebo Comparator to Lower Dose	1.06	± 4.020
Placebo Comparator to Higher Dose	3.60	± 5.300

Change From Baseline for 12-lead ECG Secondary · Baseline to Week 52

The 12-lead ECG measurements were assessed by the investigators, and reported as normal, abnormal (not clinically significant \[NCS\]), abnormal (clinically significant \[CS\]), or not done.

Normal baseline - Normal Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	7
Anifrolumab - Higher Dose	10
Placebo Comparator to Lower Dose	5
Placebo Comparator to Higher Dose	3

Normal baseline - Abnormal (NCS) Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	1
Anifrolumab - Higher Dose	1
Placebo Comparator to Lower Dose	0
Placebo Comparator to Higher Dose	0

Normal baseline - not done Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	1
Anifrolumab - Higher Dose	2
Placebo Comparator to Lower Dose	0
Placebo Comparator to Higher Dose	0

Abnormal (NCS) baseline - Normal Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	2
Anifrolumab - Higher Dose	0
Placebo Comparator to Lower Dose	0
Placebo Comparator to Higher Dose	1

Abnormal (NCS) baseline - Abnormal (NCS) Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	1
Anifrolumab - Higher Dose	0
Placebo Comparator to Lower Dose	0
Placebo Comparator to Higher Dose	0

Abnormal (NCS) baseline - not done Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	2
Anifrolumab - Higher Dose	0
Placebo Comparator to Lower Dose	0
Placebo Comparator to Higher Dose	0

Not done baseline - Normal Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	0
Anifrolumab - Higher Dose	0
Placebo Comparator to Lower Dose	0
Placebo Comparator to Higher Dose	0

Not done baseline - Abnormal (NCS) Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	0
Anifrolumab - Higher Dose	0
Placebo Comparator to Lower Dose	0
Placebo Comparator to Higher Dose	0

Value of Haemoglobin Blood Test to Detect Change From Baseline Secondary · Baseline to Week 60

Change from baseline in haemoglobin blood tests are reported.

Haemoglobin - Week 12

Group	Value	95% CI
Anifrolumab - Lower Dose	-0.2	± 9.07
Anifrolumab - Higher Dose	0.7	± 7.4
Placebo Comparator to Lower Dose	-0.5	± 7.14
Placebo Comparator to Higher Dose	4.8	± 5.91

Haemoglobin - Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	-1.1	± 13.92
Anifrolumab - Higher Dose	0.1	± 11.65
Placebo Comparator to Lower Dose	-4.8	± 3.83
Placebo Comparator to Higher Dose	7	± 5.94

Haemoglobin - Week 60

Group	Value	95% CI
Anifrolumab - Lower Dose	0.8	± 12.97
Anifrolumab - Higher Dose	0	± 10.43
Placebo Comparator to Lower Dose	-5.4	± 5.68
Placebo Comparator to Higher Dose	5.8	± 6.85

Value of Haematology Blood Tests to Detect Change From Baseline Secondary · Baseline to Week 60

Change from baseline in haematology blood tests (leucocytes \[particle concentration\], platelets \[particle concentration\]) are reported.

Leucocytes - Week 12

Group	Value	95% CI
Anifrolumab - Lower Dose	0.491	± 1.5806
Anifrolumab - Higher Dose	3.165	± 2.2706
Placebo Comparator to Lower Dose	0.867	± 1.0999
Placebo Comparator to Higher Dose	1.96	± 1.9487

Leucocytes - Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	1.041	± 1.5794
Anifrolumab - Higher Dose	2.457	± 2.3891
Placebo Comparator to Lower Dose	0.236	± 1.0107
Placebo Comparator to Higher Dose	0.080	± 1.4798

Leucocytes - Week 60

Group	Value	95% CI
Anifrolumab - Lower Dose	-0.012	± 1.5489
Anifrolumab - Higher Dose	1.474	± 1.6490
Placebo Comparator to Lower Dose	0.776	± 2.1779
Placebo Comparator to Higher Dose	1.23	± 1.6687

Platelets - Week 12

Group	Value	95% CI
Anifrolumab - Lower Dose	7.8	± 65.28
Anifrolumab - Higher Dose	45.2	± 67.41
Placebo Comparator to Lower Dose	10.3	± 24.54
Placebo Comparator to Higher Dose	17.0	± 42.58

Platelets - Week 52

Group	Value	95% CI
Anifrolumab - Lower Dose	28.0	± 74.28
Anifrolumab - Higher Dose	46.1	± 74.91
Placebo Comparator to Lower Dose	6.6	± 64.24
Placebo Comparator to Higher Dose	-2.0	± 33.85

Platelets - Week 60

Group	Value	95% CI
Anifrolumab - Lower Dose	-19.1	± 53.48
Anifrolumab - Higher Dose	39.0	± 60.33
Placebo Comparator to Lower Dose	24.4	± 65.73
Placebo Comparator to Higher Dose	-2.8	± 28.43

Adverse events — posted to ClinicalTrials.gov

Time frame: 52 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Anifrolumab - Lower Dose

Serious: 4/14 (29%)

Deaths: 0/14

Anifrolumab - Higher Dose

Serious: 2/13 (15%)

Deaths: 0/13

Placebo Comparator

Serious: 0/9 (0%)

Deaths: 0/9

Serious adverse events (6 terms)

Reaction	System	Anifrolumab - Lower Dose	Anifrolumab - Higher Dose	Placebo Comparator
Herpes Zoster	Infections and infestations	—	—	—
Otitis Media Acute	Infections and infestations	—	—	—
Transient Ischaemic Attack	Nervous system disorders	—	—	—
Mouth Ulceration	Gastrointestinal disorders	—	—	—
Systemic Lupus Erythematosus	Musculoskeletal and connective tissue disorders	—	—	—
Lupus Nephritis	Renal and urinary disorders	—	—	—

Other adverse events (69 terms — click to expand)

Reaction	System	Anifrolumab - Lower Dose	Anifrolumab - Higher Dose	Placebo Comparator
Upper Respiratory Tract Infection	Infections and infestations	—	—	—
Bronchitis	Infections and infestations	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Herpes Zoster	Infections and infestations	—	—	—
Headache	Nervous system disorders	—	—	—
Sciatica	Nervous system disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—
Abscess Limb	Infections and infestations	—	—	—
Acute Sinusitis	Infections and infestations	—	—	—
Conjunctivitis	Infections and infestations	—	—	—
Conjunctivitis Viral	Infections and infestations	—	—	—
Influenza	Infections and infestations	—	—	—
Labyrinthitis	Infections and infestations	—	—	—
Laryngitis	Infections and infestations	—	—	—
Pharyngitis	Infections and infestations	—	—	—
Sinusitis	Infections and infestations	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Hypersensitivity	Immune system disorders	—	—	—
Anxiety	Psychiatric disorders	—	—	—
Panic Attack	Psychiatric disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—
Migraine	Nervous system disorders	—	—	—
Syncope	Nervous system disorders	—	—	—
Chalazion	Eye disorders	—	—	—
Myopia	Eye disorders	—	—	—
Uveitis	Eye disorders	—	—	—
Atrial Fibrillation	Cardiac disorders	—	—	—
Palpitations	Cardiac disorders	—	—	—
Pericardial Cyst	Cardiac disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—
Nasal Inflammation	Respiratory, thoracic and mediastinal disorders	—	—	—
Nasal Septum Perforation	Respiratory, thoracic and mediastinal disorders	—	—	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—	—	—
Productive Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—

Most-reported serious reactions: Herpes Zoster, Otitis Media Acute, Transient Ischaemic Attack, Mouth Ulceration, Systemic Lupus Erythematosus, Lupus Nephritis.

Data from ClinicalTrials.gov NCT02962960 adverse events section.

Sponsor's own description

This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result and active skin manifestations while receiving Standard of Care (SOC) treatment. In addition, the efficacy of anifrolumab on SLE skin manifestations will be characterized.

Publications & conference data

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

1. Spotlight on anifrolumab and its potential for the treatment of moderate-to-severe systemic lupus erythematosus: evidence to date.
   Felten R, Scher F, Sagez F, Chasset F, et al · · 2019 · cited 37× · PMID 31190735 · DOI 10.2147/dddt.s170969
2. Safety, tolerability and pharmacokinetics of subcutaneous and intravenous anifrolumab in healthy volunteers.
   Tummala R, Rouse T, Berglind A, Santiago L. · · 2018 · cited 20× · PMID 29644080 · DOI 10.1136/lupus-2017-000252
3. Pharmacokinetics, pharmacodynamics, and safety of subcutaneous anifrolumab in patients with systemic lupus erythematosus, active skin disease, and high type I interferon gene signature: a multicentre, randomised, double-blind, placebo-controlled, phase 2 study.
   Bruce IN, Nami A, Schwetje E, Pierson ME, et al · · 2021 · cited 16× · PMID 38279367 · DOI 10.1016/s2665-9913(20)30342-8
4. Type I interferon antagonists in clinical development for lupus.
   Paredes JL, Niewold TB. · · 2020 · cited 16× · PMID 32700979 · DOI 10.1080/13543784.2020.1797677
5. Evaluation of anifrolumab safety in systemic lupus erythematosus: A meta-analysis and systematic review.
   Liu Z, Cheng R, Liu Y. · · 2022 · cited 11× · PMID 36211347 · DOI 10.3389/fimmu.2022.996662
6. Interferon Inhibition in SLE: From Bench to Bedside.
   Deligeorgakis D, Skouvaklidou E, Adamichou C. · · 2024 · cited 3× · PMID 39193183 · DOI 10.31138/mjr.010324.iis
7. Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
   Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497
8. Comparative effectiveness and safety of biologics and targeted small-molecule therapies plus stable background therapy in systemic lupus erythematosus: a systematic review and network meta-analysis.
   Li W, Zhao Y, Shu S, Li R, et al · · 2026 · PMID 42170175 · DOI 10.3389/fimmu.2026.1739946