Anifrolumab for Skin Lupus

(LAVENDER Trial)

Recruiting at 226 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: Antimalarials

Disqualifiers: Suicidal ideation, Severe SLE, Sjögren's, 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: 1

Duration: 51 weeks

302 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called anifrolumab for individuals with cutaneous lupus erythematosus (CLE), a skin condition causing painful rashes and lesions. The goal is to determine if anifrolumab, administered as a subcutaneous injection, is safe and effective compared to a placebo (a treatment with no active drug). Participants will initially receive either anifrolumab or a placebo, and after a certain period, those on the placebo will switch to anifrolumab. The trial seeks adults with CLE that hasn't responded well to other treatments, such as antimalarials, and who do not have other active skin conditions. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have an inadequate response or intolerance to antimalarial therapy, which might imply some changes to your current treatment. It's best to discuss this with the trial coordinators.

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

Research has shown that anifrolumab has been tested for safety in people with systemic lupus erythematosus (SLE), a condition affecting the immune system. In these studies, anifrolumab was generally well-tolerated, meaning most participants did not experience serious side effects.

One study found that anifrolumab helped reduce the need for prednisone, a common drug for managing lupus symptoms, without causing major safety issues. Another study showed that side effects were similar to those seen with a placebo, suggesting that anifrolumab did not add extra risk.

Common side effects included mild reactions at the injection site and upper respiratory infections, like a cold, which were not severe for most participants. Notably, the FDA has already approved anifrolumab for treating SLE, supporting its safety.

For those considering joining a trial, these safety findings indicate that anifrolumab has been generally safe for participants in past studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for skin lupus?

Unlike the standard treatments for skin lupus, which often include corticosteroids and antimalarials, anifrolumab stands out due to its unique mechanism of action. Anifrolumab targets the type I interferon receptor, which plays a significant role in the inflammatory process of lupus. Researchers are excited about this treatment because it offers a more targeted approach, potentially leading to better control of the disease with fewer side effects compared to broader immunosuppressive therapies. Additionally, the convenience of subcutaneous injections could improve patient adherence over traditional oral or intravenous therapies.

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

Research has shown that anifrolumab works well for treating skin lupus. In people with cutaneous lupus erythematosus (CLE), anifrolumab quickly improved skin symptoms, often within the first two months. Studies also found a noticeable drop in disease activity among patients. Additionally, anifrolumab can reduce the need for prednisone, a common steroid treatment, which helps lessen side effects. In this trial, participants will receive either anifrolumab or a placebo, with some transitioning to anifrolumab after an initial period. Overall, these findings suggest that anifrolumab could be a promising option for effectively managing skin lupus symptoms. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Adults with chronic or subacute cutaneous lupus erythematosus who haven't responded well to anti-malarial therapy or other medications like topical calcineurin inhibitors, systemic glucocorticoids, or immunosuppressants. They must not have a history of tuberculosis and should test negative for COVID-19. Women must follow local cervical cancer screening guidelines.

Inclusion Criteria

Participants should have a COVID-19 negative PCR or antigen test result at Screening

I did not respond well or could not tolerate antimalarial treatment.

CLASI-A total score ≥ 10 points at Screening and confirmed at randomization

Exclusion Criteria

My lupus is severe or life-threatening.

Participants not meeting eligibility criteria based on laboratory test results at screening

History of an anaphylactic reaction to human proteins or monoclonal antibodies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment

Participants receive either anifrolumab or placebo as a subcutaneous injection

51 weeks

Weekly visits for injections

Open-label extension

Participants receive anifrolumab in an open-label treatment period

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

1 follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• Anifrolumab

Trial Overview The trial is testing the effectiveness and safety of Anifrolumab, administered under the skin, compared to a placebo in adults with cutaneous lupus erythematosus. Participants will be randomly assigned to receive either Anifrolumab or a placebo.

How Is the Trial Designed?

Group I: Anifrolumab Experimental Treatment 1 Intervention

Participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to Week 51.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo as a SC injection from Week 0/Day 1 up to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.

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

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Published Research Related to This Trial

Anifrolumab, a monoclonal antibody that inhibits the IFN-α receptor 1, has shown significant improvement in patients with refractory cutaneous lupus erythematosus (CLE) after at least 12 weeks of treatment, as evidenced by a case series of three patients.

All three patients, who had not responded adequately to standard therapies, reported improvements in symptoms and skin appearance, indicating that anifrolumab may be a promising option for those with moderate to severe CLE who have failed other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anifrolumab for treatment of refractory cutaneous lupus erythematosus. Blum, FR., Sampath, AJ., Foulke, GT.[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]

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]

Anifrolumab was effective in treating a case of systemic lupus erythematosus (SLE) with severe cutaneous manifestations that did not respond to standard treatments, showing significant improvement in skin severity after just two infusions over eight weeks.

Clinical trial data indicate that anifrolumab consistently improves skin symptoms in SLE patients, particularly with intravenous administration, suggesting it could be a valuable new treatment option for personalized therapy in SLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Response of Refractory Systemic Lupus Erythematosus Skin Manifestations to Anifrolumab-A Case-Based Review of Clinical Trial Data Suggesting a Domain-Based Therapeutic Approach. Plüß, M., Piantoni, S., Wincup, C., 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]

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 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, an anti-interferon I receptor monoclonal antibody, has shown promising results in treating refractory cutaneous lupus erythematosus (CLE) in four patients with systemic lupus erythematosus (SLE), indicating its potential efficacy in real-life settings.

The study highlights the importance of using the cutaneous lupus activity investigator's global assessment (CLA-IGA) as a useful tool for monitoring treatment efficacy in patients receiving anifrolumab for CLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anifrolumab for Moderate and Severe Muco-Cutaneous Lupus Erythematosus: A Monocentric Experience and Review of the Current Literature. Paolino, G., Ramirez, GA., Calabrese, C., et al.[2023]

Citations

1. saphnelohcp.com saphnelohcp.com/clinical-data.html

Clinical Data - SAPHNELO For HCPs Learn about the efficacy and clinical study results of SAPHNELO® (anifrolumab-fnia) intravenous injection in patients with moderate-to-severe SLE who are ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40869510/

Anifrolumab for Nonsystemic Cutaneous Lupus ... Conclusions: Anifrolumab appears effective and relatively safe in refractory NSCLE. Preliminary immunologic data suggest changes in peripheral ...

3. jrheum.org jrheum.org/content/52/Suppl_1/234.1

REAL-WORLD OUTCOMES OF ANIFROLUMAB IN ... Anifrolumab showed significant efficacy in reducing disease activity and prednisone use in SLE patients, with a good overall safety profile.

4. jaad.org jaad.org/article/S0190-9622(23)00354-7/fulltext

Rapid efficacy of anifrolumab in refractory cutaneous lupus ... Anifrolumab exposure after week 16 is also reported. Cutaneous lupus erythematosus subtypes of patients achieving complete response were both ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jvc2.590

Rapid clearance of cutaneous lesions with anifrolumab in ... We observed the rapid efficacy of anifrolumab within the first 2 months in patients with refractory cutaneous manifestations of SLE and CLE.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12278508/

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 potential risks.

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

Trial of Anifrolumab in Active Systemic Lupus Erythematosus Safety analyses included all the patients who received at least one dose of anifrolumab or placebo. Safety data were analyzed descriptively. Results. Trial ...

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 ...