Systemic Lupus ErythematosusPhase 2NCT05440422
The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD
A Phase 2 study testing anifrolumab in people with Systemic Lupus Erythematosus and Cardiovascular Disease, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
Background: People with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Cardiovascular Disease, Premature Atherosclerosis
- What is being tested?
- anifrolumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2023to 2 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-80 years
- In good general health as evidenced by medical history or diagnosed with SLE diagnosed per American College of Rheumatology 1997 revised SLE classification criteria.
- Prednisone < or equal to 10 mg/day for at least 2 weeks before screening and maintained throughout randomization (day 1)
Show all 14Show fewer
- Stable standard of care lupus therapies for at least 4 weeks before screening and maintained through randomization (day 1)
- Abnormal cardio-ankle vascular index (CAVI) (based on 2 SD above median of healthy controls based on historical data from our own patient cohorts AND/OR
- Abnormal Pulse wave velocity (PWV) using Sphygmocor. AND/OR
- Abnormal target to background ratio (TBR) in various aortic territories and total aorta using FDG PET CT scan.
- Stable medications for diabetes, hypertension and/or statins for at least the previous 3 months. Adjustments to diabetic medications may be allowed as per the discretion of PI. No changes of any other medications or immunosuppressive drugs will be allowed during
- trial. The PI will consult with DMSC members if changes to diabetic medications are being considered and the change will be documented.
- For females and males of reproductive potential: use of highly effective contraception from screening and agreement to use such a method during study participation and for an additional 16 weeks after the end of study medication administration. For the purpose of this study abstinence will be considered as an effective form of contraception.
- Subjects must confirm receipt of prior vaccination against COVID-19 and Varicella Zoster. Verbal confirmation of vaccination receipt AND detectable antibodies in serum is acceptable in the absence of vaccine records.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this
- study:
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Concurrent enrolment in another clinical study with an investigational product
- Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.
- Any of the following found at Screening:
Show all 54Show fewer
- Aspartate aminotransferase (AST) >2.5 x upper limit of normal (ULN).
- Alanine aminotransferase (ALT) >2.0 x ULN.
- Total bilirubin >ULN (unless due to Gilbert's syndrome)
- Serum creatinine >2.5 mg/dL (or >181 micromol/L)
- Urine protein/creatinine ratio >2.0 mg/mg (or >226.30 mg/mmol)
- Neutrophil count <1000/microL (or <1.0 x 109/L)
- Platelet count <25000/microL (or <25 x 109/L)
- Hemoglobin <8 g/dL (or <80 g/L), or <7 g/dL (or <70 g/L) if related to subject's SLE such as in active hemolytic anemia
- Glycosylated hemoglobin (HbA1c) >8% (or >0.08) at screening (diabetic subjects only). Patients with HbA1c >8% may be eligible for study if considered to be at low risk of infection and vascular complications at the discretion of study PI.
- Positive SARS/Flu A/B/RSV (Panther), PCR - risk-based testing, only required if patient is symptomatic or has been exposed to someone with the virus.
- Note: Abnormal screening test(s) which exclude the patient may be repeated once within 4 weeks of the Screening Visit. If the repeat test(s) does not meet the above criteria, then the patient may be included in the study and will not be considered a screen failure.
- Receipt of any of the following:
- Azathioprine >200 mg/day
- Mycophenolate mofetil > 3 g/day or mycophenolic acid >2.16 g/day
- Oral, SC, or intramuscular methotrexate >25 mg/week
- Mizoribine >150 mg/day. Leflunomide more than 20 mg and any other immunosuppressant usage at the discretion of the PI.
- Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to week 0 (day 1), whichever is greater.
- Receipt of any commercially available biologic agent within 5 half-lives prior to signing of the ICF
- Receipt of B cell depleting therapy (including but not limited to belimumab, ocrelizumab, ofatumumab, atacicept, Obinutuzumab, or rituximab), <26 weeks prior to the signing of the consent for all B-cell depleting therapy or <40 weeks prior to the signing of the ICF for atacicept.
- Receipt of any of the following: (a) Intra-articular, intramuscular or IV corticosteroids within 4 weeks prior to Day 1 (b) Any live or attenuated vaccine within 8 weeks prior to signing the ICF (administration of killed vaccines is acceptable)
- History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months based on screening or at baseline.
- Recent cardiac or stroke event (with in the last year prior to week 0 (day 1))
- Active SLE disease with SLEDAI 2K >6 at the time of screening.
- Active severe or unstable neuropsychiatric SLE including, but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex:
- That would make the subject unable to fully understand the ICF OR
- Where, in the opinion of the Principal Investigator (PI), protocol specified SOC is insufficient and utilization of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and/or high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated
- Active severe SLE-driven renal disease where, in the opinion of the PI, protocol specified standard of care (SOC) is insufficient and utilization of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and/or high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.
- History of or current diagnosis of catastrophic or severe anti-phospholipid syndrome within 1 year prior to signing the ICF. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 3 months is acceptable.
- Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at screening. Subjects refusing HIV testing during the screening period will not be eligible for study participation.
- Confirmed positive test for hepatitis B serology for:
- Hepatitis B surface antigen (HBsAg), OR
- Hepatitis B core antibody (HBcAb)
- If positive for HBcAb, hepatitis B virus (HBV) DNA will be checked. If HBV DNA is detected above the lower limit of quantitation (LLOQ) at screening subject will be excluded
- Note: Subjects who are only HBcAb positive at screening will be tested every month for HBV DNA. To remain eligible for the study, the subject s HBV DNA levels must remain below the LLOQ as per the central laboratory.
- Positive test for hepatitis C antibody along with detectable Hepatitis C viral RNA.
- Any severe herpes infection at any time prior to Week 0 (Day 1), including, but not limited to, disseminated herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years) or ophthalmic herpes (ever)
- Any herpes zoster, cytomegalovirus (CMV) or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
- Any of the following:
- Clinically significant chronic infection (i.e., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to week 0 (day1) (chronic nail infections are allowed)
- Any infection requiring hospitalization or treatment with IV antibiotics not completed at least 4 weeks prior to week 0 (day1)
- Any infection requiring oral antimicrobials (including antivirals) within 2 weeks prior to Day 1, except if taking antivirals/antimicrobials prophylactically.
- History of cancer, apart from:
- Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy >=3 months prior to Week 0 (Day 1)
- Cervical cancer in situ treated with apparent success with curative therapy >=1 year prior to Week 0 (Day 1).
- Pregnancy or lactation or intend to become pregnant anytime from initiation of Screening until completion of study.
- Spontaneous or induced abortion, still or live birth, or pregnancy <= 4 weeks prior to week 0 (day1)
- Known allergic reactions to any component of the investigational product formulation or history of anaphylaxis to any human gamma globulin therapy.
- Tested positive for COVID-19 infection on the day of screening or up to 21 days prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus
Background:
People with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus.
Read more
Objective:
To test whether a drug (anifrolumab) can improve blood vessel function and reduce blood vessel inflammation in people with SLE.
Eligibility:
People aged 18 to 80 years with SLE.
Design:
Participants will undergo screening. They will have a physical exam. They will have blood and urine tests. They will have a test of their heart function and a chest X-ray. They will answer questions about their SLE symptoms.
Participants will visit the clinic 9 times in 8 months. After screening, visits will be 4 weeks apart. Each visit may take up to 4 hours.
Participants will receive infusions from a tube attached to a needle inserted into a vein in the arm (IV). Some will receive anifrolumab. Others will receive a placebo treatment. They will not know which one they are getting.
At some visits they will have additional tests:
CAVI (cardio-ankle vascular index) tests blood vessel function. Participants will lie still for 20 minutes. Small electrodes will be placed on both wrists with stickers. A microphone will be placed on their chest. Blood pressure cuffs will be wrapped around their ankles and arms.
FDG-PET/CT is an imaging procedure. Participants will receive a substance through an IV line. They will lie on a table for 110 minutes while a machine captures images of their body.
Read the detailed description
Study Description:
This is a double-blind placebo-controlled study to characterize whether blocking type I IFN receptor signaling with anifrolumab will lead to improvements in vascular function, decreases in vascular inflammation and modulation of biomarkers of vascular risk in patients with systemic lupus erythematosus (SLE).
Objectives:
Primary Objective: To assess the role of anifrolumab in modulating vascular function and vascular inflammation in SLE patients with mild to moderate disease activity as determined by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K <= 6.
Secondary Objectives: To assess the role of anifrolumab in modulating biomarkers of cardiovascular risk in SLE patients with mild to moderate disease activity as determined by SLEDAI 2K. 6. Assess safety and tolerability of short-term use of anifrolumab.
Endpoints:
Primary:
- Change from Baseline (Week 0) to Week 28 in cardio-ankle vascular index (CAVI).
- Change from Baseline to Week 28 in pulse wave velocity (PWV) using Sphygmocor.
- Change from Baseline to Week 28 in vascular inflammation as measured by target to background ratio (TBR) in various aortic territories and total aorta using FDG PET CT scans.
Secondary:
Changes over time in biomarkers of cardiovascular risk/immune dysregulation and metabolic dysfunction previously described in SLE. These biomarkers include but not limited to lipoprotein profiles and high-density lipoprotein cholesterol efflux capacity, immune cell types, endothelial progenitor cells, circulating neutrophil extracellular traps, serum cytokines, acute phase reactants, insulin resistance, transcriptomic analysis of peripheral immune cells.
Tertiary:
Safety, as assessed by severity and incidence of adverse events and the change over time from baseline in laboratory variables.
- Being tested
- anifrolumab, Placebo
- Keywords
- Vascular Inflammation, Interferons, Vascular Function
- Medical subject headings
- Lupus Erythematosus, Systemic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anifrolumabDrug
This is a double blind placebo-controlled study to characterize whether blocking type I IFN receptor signaling with anifrolumab will lead to improvements in vascular function, decreases in vascular inflammation and modulation of biomarkers of vascular risk in patients with SLE.
PlaceboOther
non-active substance comprised of 25 mM histidine/histidine-HCl, 50 mM lysine-HCl, 130 mM trehalose, and 0.05% (w/v) polysorbate 80, with a pH of 5.9.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Active comparator | anifrolumab Receives: Drug: anifrolumab |
| Patient placebo | Placebo comparator | placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
role of anifrolumab
1.Change from Baseline (Week 0) to Week 28 in cardio-ankle vascular index (CAVI). 2. Change from Baseline to Week 28 in pulse wave velocity (PWV) using Sphygmocor. 3. Change from Baseline to Week 28 in vascular inflammation as measured by target to background ratio (TBR) in various aortic territories and total aorta using FDG PET CT scans.
Measured: 8 months
Secondary outcomes (1)
Role of anifrolumab
in modulating biomarkers of cardiovascular risk in SLE patients with mild to moderate disease activity as determined by SLEDAI 2K= 6. Assess safety and tolerability of short-term use of anifrolumab
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start7 Dec 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion2 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mariana J Kaplan, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440422
- Sponsor's protocol ID
- 10000682
- Other IDs
- 000682-AR
- Status last verified
- 16 Sep 2026
- First submitted
- 29 Jun 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The protocol is silent on sharing IPD.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05440422
- Acronym / sponsor ID
- 10000682
- Keywords
- Vascular Inflammation, Interferons, Vascular Function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 2 Aug 2027 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
People with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus.
Objective:
To test whether a drug (anifrolumab) can improve blood vessel function and reduce blood vessel inflammation in people with SLE.
Eligibility:
People aged 18 to 80 years with SLE.
Design:
Participants will undergo screening. They will have a physical exam. They will have blood and urine tests. They will have a test of their heart function and a chest X-ray. They will answer questions about their SLE symptoms.
Participants will visit the clinic 9 times in 8 months. After screening, visits will be 4 weeks apart. Each visit may take up to 4 hours.
Participants will receive infusions from a tube attached to a needle inserted into a vein in the arm (IV). Some will receive anifrolumab. Others will receive a placebo treatment. They will not know which one they are getting.
At some visits they will have additional tests:
CAVI (cardio-ankle vascular index) tests blood vessel function. Participants will lie still for 20 minutes. Small electrodes will be placed on both wrists with stickers. A microphone will be placed on their chest. Blood pressure cuffs will be wrapped around their ankles and arms.
FDG-PET/CT is an imaging procedure. Participants will receive a substance through an IV line. They will lie on a table for 110 minutes while a machine captures images of their body.
Detailed description
Study Description:
This is a double-blind placebo-controlled study to characterize whether blocking type I IFN receptor signaling with anifrolumab will lead to improvements in vascular function, decreases in vascular inflammation and modulation of biomarkers of vascular risk in patients with systemic lupus erythematosus (SLE).
Objectives:
Primary Objective: To assess the role of anifrolumab in modulating vascular function and vascular inflammation in SLE patients with mild to moderate disease activity as determined by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K <= 6.
Secondary Objectives: To assess the role of anifrolumab in modulating biomarkers of cardiovascular risk in SLE patients with mild to moderate disease activity as determined by SLEDAI 2K. 6. Assess safety and tolerability of short-term use of anifrolumab.
Endpoints:
Primary:
- Change from Baseline (Week 0) to Week 28 in cardio-ankle vascular index (CAVI).
- Change from Baseline to Week 28 in pulse wave velocity (PWV) using Sphygmocor.
- Change from Baseline to Week 28 in vascular inflammation as measured by target to background ratio (TBR) in various aortic territories and total aorta using FDG PET CT scans.
Secondary:
Changes over time in biomarkers of cardiovascular risk/immune dysregulation and metabolic dysfunction previously described in SLE. These biomarkers include but not limited to lipoprotein profiles and high-density lipoprotein cholesterol efflux capacity, immune cell types, endothelial progenitor cells, circulating neutrophil extracellular traps, serum cytokines, acute phase reactants, insulin resistance, transcriptomic analysis of peripheral immune cells.
Tertiary:
Safety, as assessed by severity and incidence of adverse events and the change over time from baseline in laboratory variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Active comparator | Drug: anifrolumabanifrolumab |
| Patient placebo | Placebo comparator | Other: Placeboplacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-80 years
- In good general health as evidenced by medical history or diagnosed with SLE diagnosed per American College of Rheumatology 1997 revised SLE classification criteria.
Key exclusion criteria (54 listed)
- An individual who meets any of the following criteria will be excluded from participation in this
- Note: Abnormal screening test(s) which exclude the patient may be repeated once within 4 weeks of the Screening Visit. If the repeat test(s) does not meet the above criteria, then the patient may be included in the study and will not be considered a screen failure.
- Note: Subjects who are only HBcAb positive at screening will be tested every month for HBV DNA. To remain eligible for the study, the subject s HBV DNA levels must remain below the LLOQ as per the central laboratory.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anifrolumabThis is a double blind placebo-controlled study to characterize whether blocking type I IFN receptor signaling with anifrolumab will lead to improvements in vascular function, decreases in vascular inflammation and modulation of biomarkers of vascular risk in patients with SLE. | Drug | Patient |
| Placebonon-active substance comprised of 25 mM histidine/histidine-HCl, 50 mM lysine-HCl, 130 mM trehalose, and 0.05% (w/v) polysorbate 80, with a pH of 5.9. | Other | Patient placebo |
Primary outcome
role of anifrolumab
Time frame: 8 months
1.Change from Baseline (Week 0) to Week 28 in cardio-ankle vascular index (CAVI). 2. Change from Baseline to Week 28 in pulse wave velocity (PWV) using Sphygmocor. 3. Change from Baseline to Week 28 in vascular inflammation as measured by target to background ratio (TBR) in various aortic territories and total aorta using FDG PET CT scans.
1 secondary outcome
Role of anifrolumab
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The protocol is silent on sharing IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariana J Kaplan, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anifrolumab in people with Systemic Lupus Erythematosus and Cardiovascular Disease, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lubna K Hooda, R.N. ((301) 480-1391, lubna.hooda@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
role of anifrolumab (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.