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Monoclonal Antibodies

Stage 1: Anifrolumab for Cutaneous Lupus Erythematosus (LAVENDER Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection reflected in chest radiograph or a chest CT scan result

Participants must have a confirmed diagnosis of CLE clinically and histologically

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening (up to and including 42 days before day 1) until safety follow-up period (13 weeks from week 52/ edv)

Awards & highlights

LAVENDER Trial Summary

"This trial will test if an injection called anifrolumab is better than a placebo for treating skin lupus in adults."

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects of Anifrolumab may include respiratory tract infections, herpes zoster, headaches, infusion-related reactions (like pain at injection site), and potential increased risk of infection.

LAVENDER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have never had tuberculosis, as confirmed by chest scans.

Select...

My CLE diagnosis is confirmed by clinical and tissue examination.

LAVENDER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening (up to and including 42 days before day 1) until safety follow-up period (13 weeks from week 52/ edv)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening (up to and including 42 days before day 1) until safety follow-up period (13 weeks from week 52/ edv)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (up to and including 42 days before day 1) until safety follow-up period (13 weeks from week 52/ edv) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Stage 1 and Stage 2 (European Union [EU]/Rest of the World [ROW]: Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score

Stage 1 and Stage 2 (United States [US]): Number of participants with Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R) erythema score of 0 or 1 and at least a 2- point reduction relative to baseline

Secondary outcome measures

Stage 1 and Stage 2 (EU/ROW): Number of participants with CLASI-70 response

Stage 1 and Stage 2 (EU/ROW): Percent change from baseline in total CLASI-A erythema score

Stage 1 and Stage 2 (EU/ROW): Percent change from baseline in total CLASI-A scale/hypertrophy score

+13 more

Other outcome measures

Stage 1 and Stage 2 (US, EU and ROW): Number of participants with adverse events

Side effects data

From 2018 Phase 3 trial • 373 Patients • NCT02446899

23%

Upper respiratory tract infection

16%

Nasopharyngitis

14%

Infusion related reaction

13%

Bronchitis

12%

Urinary tract infection

Herpes zoster

Sinusitis

Cough

Headache

Back pain

Arthralgia

Nausea

Pneumonia

Angioedema

Hypoaesthesia

Cervical dysplasia

Acute coronary syndrome

Chilaiditi's syndrome

Hypersensitivity

Appendicitis

Diverticulitis

Gastroenteritis viral

Lip squamous cell carcinoma

Fall

Nephrolithiasis

Traumatic fracture

Blood creatinine increased

Osteonecrosis

Systemic lupus erythematosus

100%

80%

60%

40%

20%

Study treatment Arm

Anifrolumab 300 mg

Placebo

LAVENDER Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Stage 2: AnifrolumabExperimental Treatment1 Intervention

The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.

Group II: Stage 1: AnifrolumabExperimental Treatment1 Intervention

The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.

Group III: Stage 1: PlaceboPlacebo Group1 Intervention

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

Group IV: Stage 2: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anifrolumab

2015

Completed Phase 3

~1990

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

ParexelIndustry Sponsor

304 Previous Clinical Trials

100,692 Total Patients Enrolled

AstraZenecaLead Sponsor

4,274 Previous Clinical Trials

288,612,904 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 75 and above being sought for participation in this medical study?

"To be considered for participation in this research study, individuals must be at least 18 years old but no older than 70."

Answered by AI

In how many different geographical areas can patients access this clinical trial?

"At present, patient enrollment is ongoing at 61 different trial sites. These locations include Lyon Cedex 03, Berlin, Florence, and various other cities across the globe. Opting for a nearby facility can reduce travel requirements when enrolling in the study."

Answered by AI

Are participants currently being enrolled for this research study?

"According to clinicaltrials.gov, recruitment for this particular study is currently closed. The trial was initially posted on May 9th, 2024 and last updated on April 22nd, 2024. Although this specific trial is not recruiting participants now, there are a total of 164 other trials actively seeking patients at present."

Answered by AI

Has Stage 1: Anifrolumab received approval by the FDA?

"As part of this Phase 3 trial, our team at Power has rated the safety of Anifrolumab in Stage 1 as a 3. This score indicates that there is existing data supporting its effectiveness and numerous rounds of data confirming its safety."

Answered by AI

What specific criteria should be considered when selecting participants for this research endeavor?

"The study seeks to enroll 460 individuals aged between 18 and 70 diagnosed with cutaneous lupus erythematosus. Eligible participants must have shown an inadequate response or intolerance to anti-malarial therapy; in cases where this treatment was not administered, patients should have trialed topical calcineurin inhibitors, systemic glucocorticoids, or conventional immunosuppressants for CLE. Additionally, candidates must exhibit no evidence of current or prior tuberculosis infection based on medical history and radiographic findings. A negative result from the IFN-γ release assay IGRA test is mandatory for TB screening."

Answered by AI

What are the main goals and purposes of this investigation?

"The primary objective of this clinical investigation, to be assessed at the Week 24 juncture, is as follows: For Stages 1 and 2 in Europe (EU) and other regions around the world (ROW), the focus will be on determining the number of individuals achieving a notable decrease of at least 70% from baseline in their Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score. Supplementary objectives encompass for Stages 1 and 2 specifically within the United States: assessing how many participants reach a CLA-IGA-R OMC grade of zero."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

2024. "A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06015737.

All > Systemic Lupus Erythematosus > Lupus