460 Participants Needed

Anifrolumab for Skin Lupus

(LAVENDER Trial)

Recruiting at 193 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must be taking: Antimalarials
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).

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 anifrolumab safe for humans?

Anifrolumab has been studied for safety in people with systemic lupus erythematosus (SLE), showing a generally similar safety profile to placebo, though with a higher incidence of herpes zoster (shingles) infections. Serious adverse events occurred in 8-16% of patients taking anifrolumab compared to 16-19% with placebo.12345

What makes the drug Anifrolumab unique for treating skin lupus?

Anifrolumab is unique because it specifically targets and blocks the type 1 interferon receptor, which plays a key role in the development of skin lupus. This makes it different from other treatments that do not target this pathway, offering a new option for patients who have not responded to standard therapies.12456

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

Research shows that Anifrolumab, a drug that blocks a specific protein involved in inflammation, has helped patients with skin lupus who did not respond to other treatments. In studies, patients experienced significant improvement in their skin condition after using Anifrolumab.16789

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
See 4 more

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
See 5 more

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?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Stage 2: AnifrolumabExperimental Treatment1 Intervention
Group II: Stage 1: AnifrolumabExperimental Treatment1 Intervention
Group III: Stage 2: PlaceboPlacebo Group1 Intervention
Group IV: Stage 1: PlaceboPlacebo Group1 Intervention

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

🇺🇸
Approved in United States as Saphnelo for:
🇪🇺
Approved in European Union as Saphnelo for:

Find a Clinic Near You

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 profile image

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 profile image

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 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.
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]
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.
Belimumab or anifrolumab for systemic lupus erythematosus? A risk-benefit assessment.Kirou, KA., Dall Era, M., Aranow, C., et al.[2022]
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.
Anifrolumab for treatment of refractory cutaneous lupus erythematosus.Blum, FR., Sampath, AJ., Foulke, GT.[2022]

Citations

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. [2023]
Belimumab or anifrolumab for systemic lupus erythematosus? A risk-benefit assessment. [2022]
Anifrolumab for treatment of refractory cutaneous lupus erythematosus. [2022]
Viewpoint on anifrolumab in patients with systemic lupus erythematosus and a high unmet need in clinical practice. [2023]
Anifrolumab for Moderate and Severe Muco-Cutaneous Lupus Erythematosus: A Monocentric Experience and Review of the Current Literature. [2023]
Evaluation of anifrolumab safety in systemic lupus erythematosus: A meta-analysis and systematic review. [2022]
Anifrolumab: First Approval. [2022]
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]
Anifrolumab in systemic lupus erythematosus. [2023]
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