A study to investigate the efficacy and safety of anifrolumab in adults with chronic and/or subacute cutaneous lupus erythematosus - LAVENDER

Study identifier:D346BC00001

ClinicalTrials.gov identifier:NCT06015737

EudraCT identifier:2021-003698-70

CTIS identifier:2023-503692-24-00

Will Be Recruiting

Official Title

A Multicenter, Randomized, Double blind, Placebo controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Antimalarial Therapy

Medical condition

Cutaneous lupus erythematosus

Phase

Phase 3

Healthy volunteers

Study drug

Sex

All

Estimated Enrollment

230

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 25 Oct 2023

Estimated Primary Completion Date: 25 Mar 2026

Estimated Study Completion Date: 16 Dec 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2023 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
- Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:
• CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.
• Combined CLASI-A score for Erythema and Scale/Hypertrophy components ≥ 7 points.
• They should have experienced inadequate response or be intolerant to anti-malarial therapy.
• In case an anti-malarial treatment was never given, they should have tried one of the following medications for CLE: topical calcineurin inhibitors, systemic glucocorticoids, or a conventional immunosuppressant.
- Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.
• No history of latent TB prior to initial Screening Visit.
•The participant must undergo an IFN-γ release assay IGRA (e.g., QFT-G test) test for TB.
- Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Females who have been or are sexually active with an intact cervix must have documentation of a cervical cancer screening as per local guidelines (Pap smear or HPV tests).
- Participants should have a COVID-19 negative PCR or antigen test result as per local policies at Screening. They should also not have had known or suspected COVID-19 exposure within 2 weeks prior to screening based on the COVID-19 questionnaire. If there is a known or suspected exposure, a participant must be negative upon retest obtained after 2 weeks and must remain asymptomatic for inclusion in the study.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
- History or evidence of suicidal ideation.
- Severe or life-threatening SLE.
- Active SLE or Sjögren’s Syndrome.
- Any active skin conditions other than CLE that may interfere with the study.
- History of recurrent infection requiring hospitalization and IV antibiotics.
- Known history of primary immunodeficiency, splenectomy, or any underlying condition that makes the participant prone to infection, or a positive result for HIV infection at Screening.
- Confirmed positive test for hepatitis B serology at screening.
- Presence of active hepatitis C infection.
- Any severe case, as defined by study guidelines, of herpes zoster infection.
- Any clinical cytomegalovirus (CMV) or Epstein-Barr virus infection that has not completely resolved.
- Any severe case, as defined by study guidelines, of herpes zoster infection at any time prior to randomization (Day 1).
- Any herpes zoster infection that has not completely resolved within 12 weeks prior to signing the informed consent form (ICF).
- Any clinical CMV or Epstein Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
- Clinically significant chronic infection within 8 weeks prior to signing the ICF or any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF.
- COVID-19 infection
• History of severe COVID-19 infection or any prior COVID-19 infection with documented long COVID-19 and/or clinically significant unresolved complications due to COVID-19 infection.
• Mild/asymptomatic COVID-19 infection within the last 6 weeks prior to first dosing.
• Confirmed or probable COVID-19 infection based on clinical symptoms and radiologic imaging within 3 months prior to Day 1.
• COVID-19 vaccine received within 30 days of randomization (Day 1).
- Participants who do not meet the study restrictions for using all biologics including anifrolumab, B- cell depleting therapies (eg, rituximab), and investigational product for CLE.
- A known history of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy.
- Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
- At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.

No locations available

Arms	Assigned Interventions
Experimental: Anifrolumab The participants will receive dose A of anifrolumab as a SC injection from Week 0/Day 1 upto and including week 51.	Combination Product: Anifrolumab Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Placebo Comparator: Placebo The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive dose A of anifrolumab up to and including Week 51.	Other: Placebo Matching placebo solution for injection in aPFS.

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]