Subcutaneous Anifrolumab for Lupus

(Tulip SC Trial)

Recruiting at 135 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: DMARDs, Glucocorticoids, Antimalarials

Disqualifiers: Severe neuropsychiatric SLE, Severe renal disease, Recurrent infections, HIV, Hepatitis, Cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

367 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing an injectable medication called anifrolumab in adults with moderate-to-severe lupus who haven't fully responded to standard treatments. Anifrolumab works by reducing the immune system's attack on the body to help lessen lupus symptoms. It has been approved for the treatment of moderate to severe systemic lupus erythematosus (SLE) based on evidence from various studies.

Will I have to stop taking my current medications?

The trial requires that you stay on your current stable background standard therapy, which may include DMARDs, glucocorticoids, or anti-malarials, either alone or in combination.

What data supports the effectiveness of the drug Anifrolumab for treating lupus?

Anifrolumab has been shown to help more patients with lupus achieve remission or a low disease activity state compared to a placebo, according to phase 3 trials. It can also reduce the need for corticosteroids and improve symptoms like skin and joint issues, with a safety profile similar to other treatments. ^{1 2 3 4 5}

Is subcutaneous Anifrolumab safe for humans?

Anifrolumab has been studied in clinical trials for lupus, showing a generally similar safety profile to placebo, with serious side effects occurring in 8-16% of patients. However, there is an increased risk of certain viral infections, like herpes zoster, in those taking Anifrolumab compared to placebo. ^{1 3 4 5 6}

What makes the drug Anifrolumab unique for treating lupus?

Anifrolumab is unique because it is a first-in-class drug that specifically targets and blocks type 1 interferons, which play a key role in lupus. Unlike other treatments, it can reduce the need for corticosteroids and improve skin and joint symptoms with a generally acceptable safety profile. ^{1 3 4 5 7}

Eligibility Criteria

Adults with moderate-to-severe Systemic Lupus Erythematosus (SLE) who've had it for at least 24 weeks and are on stable SLE medications can join. They need a certain level of disease activity and positive tests for specific lupus antibodies. People with severe, unstable SLE, recent serious infections or hospitalizations, immune deficiencies including HIV, hepatitis B or C, certain cancers, or those treated with high-dose steroids recently cannot participate.

Inclusion Criteria

My lupus is severely affecting at least one organ.

My lupus affects at least two organ systems moderately.

I have severe lupus affecting at least one organ.

Exclusion Criteria

I have severe kidney problems due to lupus.

I have not been hospitalized for an infection needing IV treatment in the last 3 years.

I've been hospitalized 3+ times for the same infection in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a fixed subcutaneous dose of anifrolumab or placebo administered once weekly

52 weeks

Weekly visits for subcutaneous administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment with anifrolumab for up to 52 weeks

52 weeks

Treatment Details

Interventions

• Anifrolumab

Trial Overview The trial is testing Anifrolumab given under the skin to see if it's effective and safe in adults with SLE who aren't getting better with standard treatments. Participants will either receive Anifrolumab or a placebo without knowing which one they're getting to compare results fairly.

Participant Groups

Group I: Anifrolumab Experimental Treatment 1 Intervention

Solution for injection in aPFS

Group II: Placebo Placebo Group 1 Intervention

Solution for injection in aPFS

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?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Iqvia Pty Ltd

Industry Sponsor

Trials

120

Recruited

177,000+

Ari Bousbib

Iqvia Pty Ltd

Chief Executive Officer since 2016

MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris

Jeffrey Spaeder

Iqvia Pty Ltd

Chief Medical Officer

MD

Findings from Research

Anifrolumab is a monoclonal antibody that targets the type 1 interferon receptor and has been approved in the USA for treating moderate to severe systemic lupus erythematosus (SLE) in adults, marking a significant advancement in autoimmune disorder therapies.

The drug is currently being evaluated in ongoing clinical studies and is under regulatory review in the EU and Japan, indicating its potential for broader use in managing SLE and related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anifrolumab: First Approval. Deeks, ED.[2022]

Anifrolumab, a type I interferon receptor antagonist, has been shown in phase 3 trials to help a higher percentage of systemic lupus erythematosus (SLE) patients achieve remission and the Lupus Low Disease Activity State (LLDAS) compared to placebo, addressing a significant unmet need in this patient population.

This treatment option is particularly relevant for patients who struggle to reach or maintain LLDAS with standard care, as it may help reduce organ damage and improve overall outcomes in SLE management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Viewpoint on anifrolumab in patients with systemic lupus erythematosus and a high unmet need in clinical practice. Tanaka, Y.[2023]

Anifrolumab, a monoclonal antibody targeting the type I interferon receptor, has shown significant efficacy in treating moderately to severely active systemic lupus erythematosus (SLE), with over 16% improvement compared to placebo in response rates after 52 weeks in phase 3 studies (TULIP-1 and TULIP-2).

The safety profile of anifrolumab is comparable to placebo, although there is a higher incidence of herpes zoster in patients receiving the treatment (up to 7% vs. 2% for placebo), indicating that while effective, monitoring for this specific side effect is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anifrolumab, a monoclonal antibody to the type I interferon receptor subunit 1, for the treatment of systemic lupus erythematosus: an overview from clinical trials. Tanaka, Y., Tummala, R.[2021]

Belimumab and anifrolumab are two targeted biological drugs approved for treating systemic lupus erythematosus (SLE), with belimumab primarily affecting adaptive immune responses and anifrolumab potentially causing organ-specific effects due to its action on the IFNAR1 receptor.

Safety data indicate that anifrolumab may increase the risk of certain viral infections, while belimumab appears to have a more favorable safety profile, suggesting that careful patient selection and monitoring are essential to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belimumab or anifrolumab for systemic lupus erythematosus? A risk-benefit assessment. Kirou, KA., Dall Era, M., Aranow, C., et al.[2022]

Anifrolumab, a new type 1 interferon inhibitor, has been approved by the FDA for treating systemic lupus erythematosus and can be used alongside standard therapies like hydroxychloroquine and corticosteroids.

Clinical trials (MUSE, TULIP-1, and TULIP-2) show that anifrolumab not only reduces lupus disease activity, particularly in skin and musculoskeletal symptoms, but also helps lower the need for corticosteroids, all while maintaining a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anifrolumab in systemic lupus erythematosus. Loncharich, MF., Robertson, I.[2023]

In the TULIP-LN trial involving 147 patients with active lupus nephritis, the intensified regimen of anifrolumab (900 mg followed by 300 mg) showed a higher rate of complete renal response at Week 104 compared to the basic regimen and placebo (27.3% vs 18.6% and 17.8%).

The safety profile of anifrolumab remained consistent over two years, with 72% of patients reporting at least one adverse event, but serious adverse events were relatively low, suggesting that anifrolumab is a tolerable treatment option for lupus nephritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. Jayne, D., Rovin, B., Mysler, E., et al.[2023]

Anifrolumab, a treatment for systemic lupus erythematosus (SLE), was found to have a lower incidence of serious adverse events compared to placebo in a meta-analysis of 1160 patients from four randomized controlled trials, indicating good safety.

Common adverse events associated with anifrolumab included upper respiratory infections and herpes zoster, but overall, it is considered a well-tolerated option for patients with moderate to severe SLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of anifrolumab safety in systemic lupus erythematosus: A meta-analysis and systematic review. Liu, Z., Cheng, R., Liu, Y.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Anifrolumab: First Approval. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Viewpoint on anifrolumab in patients with systemic lupus erythematosus and a high unmet need in clinical practice. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Anifrolumab, a monoclonal antibody to the type I interferon receptor subunit 1, for the treatment of systemic lupus erythematosus: an overview from clinical trials. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Belimumab or anifrolumab for systemic lupus erythematosus? A risk-benefit assessment. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

Anifrolumab in systemic lupus erythematosus. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of anifrolumab safety in systemic lupus erythematosus: A meta-analysis and systematic review. [2022]