Anifrolumab for Lupus

(NAIVE Trial)

Not currently recruiting at 4 trial locations

Overseen By Cristina Arriens, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Oklahoma Medical Research Foundation

Must be taking: Standard care immunosuppressants

Must not be taking: Cytotoxic agents, Biologic agents

Disqualifiers: Pregnancy, Cancer, Severe infections, others

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effects of anifrolumab, a medication that may reduce disease activity in people with Systemic Lupus Erythematosus (SLE), a condition where the immune system mistakenly attacks healthy tissue. Researchers seek to understand how anifrolumab affects disease symptoms, the immune system, and the body’s response to the flu vaccine. Participants will receive either anifrolumab alongside their usual lupus treatments or just their usual treatments, with all receiving a flu shot. The trial seeks individuals with moderate to severe lupus symptoms who have been managing their condition with stable doses of medication. As an Early Phase 1 trial, this research focuses on understanding how anifrolumab works in people, offering participants a chance to be among the first to receive this treatment.

Do I have to stop taking my current medications for the trial?

You may continue taking your current medications if they are part of the standard care for lupus, such as prednisone, antimalarials, or certain immunosuppressants, as long as they have been stable for a specified period before the trial. However, you cannot take certain other medications like cytotoxic agents or marketed biologic agents within two months before the trial.

Is there any evidence suggesting that anifrolumab is likely to be safe for humans?

Research has shown that anifrolumab is generally safe for people with systemic lupus erythematosus (SLE). In one study, patients who took anifrolumab for about a year did not experience any unexpected side effects. However, like many treatments, some individuals did encounter serious infections because anifrolumab can affect the immune system's ability to fight them. Awareness of this risk is important.

Real-world data also support these findings. While known side effects exist, no new safety concerns have emerged. The FDA has already approved anifrolumab for treating moderate to severe lupus, which supports its safety in humans. However, anyone considering joining a trial should discuss potential risks with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for lupus, like corticosteroids and immunosuppressants, aim to broadly dampen the immune system. But anifrolumab works differently, targeting a specific part of the immune system called the type I interferon pathway, which plays a key role in lupus. Researchers are excited about anifrolumab because it offers a more targeted approach, potentially reducing disease activity with fewer side effects compared to traditional treatments. By honing in on this specific pathway, anifrolumab could provide a more effective and safer option for people with lupus.

What evidence suggests that anifrolumab might be an effective treatment for lupus?

Research has shown that anifrolumab holds promise for treating moderate to severe systemic lupus erythematosus (SLE). In this trial, participants will receive either anifrolumab added to standard care or standard care alone. Studies have found that anifrolumab can significantly reduce disease activity, particularly in skin and joint symptoms. Patients have reported a clear decrease in overall symptoms, confirming its potential effectiveness. Additionally, anifrolumab has a manageable safety profile, with generally mild and controllable side effects. These findings suggest that anifrolumab could be a valuable addition to SLE treatment options. ^{1 6 7 8 9}

Who Is on the Research Team?

Joan T Merrill, M.D.

Principal Investigator

Member

Cristina Arriens, M.D.

Principal Investigator

Clinical Assistant Member

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with moderate to severely active Systemic Lupus Erythematosus (SLE), as indicated by specific disease activity scores. Participants may be on stable doses of certain lupus medications, including steroids and antimalarials. Women must use two forms of contraception, men must use condoms, and participants cannot be pregnant or have had recent severe infections or cancer.

Inclusion Criteria

Testing for Inclusion in the Study for those in the anifrolumab arm

Meets all of the following tuberculosis criteria

I will use a condom during sex from the start of the trial until 12 weeks after the last dose.

Exclusion Criteria

History of cancer, apart from

I haven't taken any restricted medications recently.

I have kidney inflammation and recent tests show stable kidney function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anifrolumab in addition to standard of care treatments, or only standard of care treatments. All participants receive the influenza vaccine two weeks after baseline.

16 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including disease activity, gene/cytokine expression, and autoantibody production.

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anifrolumab
• Standard of Care

Trial Overview The study tests the effects of anifrolumab in addition to standard lupus care versus standard care alone on SLE disease activity and response to the flu vaccine. It involves 20 patients: half will receive anifrolumab plus standard treatments; the other half will only get standard treatments. All participants will be vaccinated against influenza.

How Is the Trial Designed?

Group I: Anifrolumab plus Standard of Care Experimental Treatment 1 Intervention

Anifrolumab will be added to Standard of Care Treatments for SLE

Group II: Standard of Care Placebo Group 1 Intervention

Standard of Care Treatments for SLE

Anifrolumab is already approved in United States, European Union for the following indications:

Approved in United States as Saphnelo for:

• Moderate to severe systemic lupus erythematosus (SLE)

Approved in European Union as Saphnelo for:

• Moderate to severe systemic lupus erythematosus (SLE)

Who Is Running the Clinical Trial?

Oklahoma Medical Research Foundation

Lead Sponsor

Trials

24

Recruited

8,400+

Piedmont Heart Institute, Inc., Atlanta, GA

Industry Sponsor

Trials

5

Recruited

1,800+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11299632/

Evaluation of the Efficacy and Safety of Anifrolumab in ... Anifrolumab shows great promise as a treatment for moderate-to-severe SLE, providing significant efficacy together with a manageable safety profile.

2. jrheum.org jrheum.org/content/52/Suppl_1/254

REAL-WORLD EFFICACY AND SAFETY DATA OF ... ANI showed promising results, reducing overall and organ-specific disease activity, confirming its efficacy in cutaneous and joint manifestations.

3. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2025/SAPHNELO-self-administration-TULIP-SC-Phase-III-trial-meets-primary-endpoint-in-patients-with-systemic-lupus-erythematosus-based-on-an-interim-analysis.html

SAPHNELO self-administration TULIP-SC Phase III trial ... Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02446899

NCT02446899 | Efficacy and Safety of Anifrolumab ... The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in adult participants with ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1912196

Trial of Anifrolumab in Active Systemic Lupus Erythematosus Results. A total of 362 patients received the randomized intervention: 180 received anifrolumab and 182 received placebo. The percentage of patients who had a ...

6. saphnelo.com saphnelo.com/safety

Safety | SAPHNELO® (anifrolumab-fnia) Injection for ... SAPHNELO may cause serious side effects, including: Serious infections: SAPHNELO can lower the ability of your immune system to fight infections.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40691805/

Post-marketing safety signals of anifrolumab in systemic ... This study provides valuable safety data on the real-world application of anifrolumab, confirming known AEs and revealing additional ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/761123s000lbl.pdf

SAPHNELO (anifrolumab-fnia) injection, for intravenous use The safety of SAPHNELO was assessed through 52 weeks in patients with moderate to severe SLE who received anifrolumab-fnia 300 mg by intravenous infusion every ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496725039196

ABS0626 SAFETY AND EFFICACY DATA OF ... Anifrolumab, a monoclonal antibody targeting the type I interferon receptor, represents a new target therapy for SLE.