A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
LAVENDER
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.
2 other identifiers
interventional
306
31 countries
183
Brief Summary
This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with chronic and/or subacute cutaneous lupus erythematosus (CLE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2024
Typical duration for phase_3
183 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
August 29, 2023
CompletedStudy Start
First participant enrolled
June 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 11, 2027
May 1, 2026
April 1, 2026
2.5 years
August 1, 2023
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score
The CLASI is a validated index used for assessing the cutaneous lesions of SLE. It consists of 2 separate scores: i) activity of the disease, and ii) measure of damage. The CLASI instrument will be used at each study visit to capture individual skin manifestation scores. CLASI-70 responder (Yes/No) is defined as a participant who achieves a 70% reduction relative to baseline in CLASI-A score. Otherwise, the participant is considered a non-responder.
At Week 24
Secondary Outcomes (15)
Change from baseline in total CLASI-A score
At Week 24
Number of participants with CLASI-70 response
At Week 12
Number of participants with ≥ 7-point reduction from baseline in CLASI-A total score
At Week 12
Number of participants with CLASI-50 response
At Week 12 and Week 24
Number of participants who are sustained CLASI-70 responders
Up to Week 52
- +10 more secondary outcomes
Other Outcomes (1)
Number of participants with adverse events
Screening (up to and including 42 days before Day 1) until Safety Follow-up Period (12 weeks from Week 52/EDV)
Study Arms (2)
Anifrolumab
EXPERIMENTALParticipants will receive anifrolumab as a SC injection from Week 0/Day 1 up to Week 51.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Eligibility Criteria
You may qualify if:
- 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.
- Inadequate response or intolerant to antimalarial therapy.
- 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.
- Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
You may not qualify if:
- History or evidence of suicidal ideation.
- Severe or life-threatening Systemic lupus erythematosus (SLE).
- Active SLE or Sjögren's Syndrome.
- Any active skin conditions other than CLE that may interfere with the study.
- History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS).
- History of recurrent infection requiring hospitalization and IV antibiotics.
- COVID-19 infection.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (188)
Research Site
Phoenix, Arizona, 85028, United States
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Covina, California, 91722, United States
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La Jolla, California, 92037, United States
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Los Angeles, California, 90045, United States
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Los Angeles, California, 90089, United States
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Orange, California, 92868, United States
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San Francisco, California, 94143, United States
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Aurora, Colorado, 80045, United States
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New Haven, Connecticut, 06519, United States
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Washington D.C., District of Columbia, 20037, United States
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Fort Lauderdale, Florida, 33309, United States
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Miami, Florida, 33174, United States
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Plantation, Florida, 33324, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60637, United States
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Indianapolis, Indiana, 46202, United States
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Baltimore, Maryland, 21287, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02115-5817, United States
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Ann Arbor, Michigan, 48109, United States
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Bloomfield Hills, Michigan, 48302, United States
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Rochester, Minnesota, 55905, United States
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Omaha, Nebraska, 68198-5885, United States
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New York, New York, 10028, United States
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Rochester, New York, 14642, United States
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Charlotte, North Carolina, 28207, United States
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Statesville, North Carolina, 28625, United States
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Cleveland, Ohio, 44195, United States
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Portland, Oregon, 97239, United States
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Providence, Rhode Island, 02903, United States
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Charleston, South Carolina, 29425, United States
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Dallas, Texas, 75390-8843, United States
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Charlottesville, Virginia, 22903, United States
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Roanoke, Virginia, 24016, United States
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Ciudad de Buenos Aires, 1221, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5004BAL, Argentina
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Quilmes, 1878, Argentina
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San Miguel, 1663, Argentina
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Kogarah, 3168, Australia
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Melbourne, 3004, Australia
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Mitcham, 3132, Australia
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Westmead, 2145, Australia
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Woolloongabba, 04102, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Vienna, 1130, Austria
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Belo Horizonte, 30150-221, Brazil
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Porto Alegre, 90035903, Brazil
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Rio de Janeiro, 22470-220, Brazil
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Salvador, 40150-150, Brazil
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São Paulo, 05403-000, Brazil
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Sofia, 1463, Bulgaria
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Sofia, 1528, Bulgaria
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Sofia, 1784, Bulgaria
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Vancouver, British Columbia, V5Z 1M9, Canada
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Hamilton, Ontario, L8N 3Z5, Canada
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Toronto, Ontario, M5T 2S8, Canada
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Osorno, 200025, Chile
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Santiago, 130021, Chile
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Santiago, 7500571, Chile
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Changchun, 130021, China
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Changsha, 410011, China
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Chengdu, 610021, China
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Chongqing, 400016, China
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Dongguan, 523059, China
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Guangzhou, 510120, China
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Heilongjiang, 150086, China
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Jinan, 250022, China
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Shanghai, 200025, China
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Shanghai, 200443, China
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Shenzhen, 518020, China
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Shenzhen, 518052, China
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Shenzhen, 518053, China
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Ürümqi, CN-830004, China
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Zhuzhou, 412007, China
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Barranquilla, 080020, Colombia
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Bogotá, 110221, Colombia
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Aarhus, 641-8510, Denmark
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Copenhagen, 2100, Denmark
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Bois-Guillaume, 76031, France
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Dijon, 21000, France
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Lyon, 69437, France
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Montivilliers, 76290, France
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Nantes, 44000, France
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Paris, 75010, France
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Paris, 75013, France
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Paris, 75014, France
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Paris, 75970, France
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Poitiers, 86000, FR, France
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Toulouse, 31059, France
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Berlin, 10117, Germany
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Bochum, 44791, Germany
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Dresden, 01307, Germany
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Erlangen, 91054, Germany
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Essen, 45147, Germany
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Freiburg im Breisgau, 79104, Germany
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Hanover, 30625, Germany
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Kiel, 24105, Germany
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Leipzig, 04103, Germany
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Mainz, 55131, Germany
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Marburg, 35043, Germany
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Regensburg, 93053, Germany
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Wuppertal, 42283, Germany
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Athens, 12462, Greece
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Athens, 16121, Greece
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Brescia, 25123, Italy
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Cona, 44124, Italy
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Florence, 50121, Italy
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Milan, 20132, Italy
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Naples, 80138, Italy
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Reggio Emilia, 42123, Italy
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Roma, 00144, Italy
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Rome, 00168, Italy
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Chūōku, 104-8560, Japan
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Fukuoka, 812-8582, Japan
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Kanazawa, 920-8641, Japan
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Kita-gun, 761-0793, Japan
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Nagoya, 457-8510, Japan
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Nagoya, 467-8602, Japan
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tabashi City, 173-8606, Japan
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Wakayama, 641-8510, Japan
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Yokohama, 232-0024, Japan
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Guadalajara, 44340, Mexico
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Guadalajara, 44610, Mexico
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Mexico City, 07760, Mexico
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Veracruz, 91910, Mexico
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Breda, 4818 CK, Netherlands
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Rotterdam, 3015 GD, Netherlands
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Papatoetoe, 2025, New Zealand
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Iloilo City, 5000, Philippines
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Lipa, 4217, Philippines
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Manila, 1000, Philippines
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Katowice, 40-851, Poland
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Kielce, 25-316, Poland
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Ossy, 40-027, Poland
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Rzeszów, 35-055, Poland
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Warsaw, 02-637, Poland
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Braga, 4710-243, Portugal
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Lisbon, 1649-035, Portugal
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Porto, 4099-001, Portugal
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Bucharest, 020125, Romania
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Iași, 700291, Romania
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Belgrade, 11000, Serbia
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Kragujevac, 34000, Serbia
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Košice, 04001, Slovakia
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Piešťany, 92101, Slovakia
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Cape Town, 7500, South Africa
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Johannesburg, 2193, South Africa
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Seoul, 03080, South Korea
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Seoul, 06591, South Korea
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Seoul, 06973, South Korea
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Barcelona, 08025, Spain
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Barcelona, 8035, Spain
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Castellon, 12004, Spain
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Granada, 18012, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Las Palmas de Gran Canaria, 35010, Spain
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Madrid, 28006, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Majadahonda, 28222, Spain
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Salamanca, 37007, Spain
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Seville, 41014, Spain
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Valencia, 46014, Spain
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Valencia, 46017, Spain
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Vigo, 36200, Spain
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Kaohsiung City, 83301, Taiwan
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Taichung, 404, Taiwan
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Taipei, 10449, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Khlong Luang, 12120, Thailand
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Khon Kaen, 40002, Thailand
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Cordaleo, 35575, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Samsun, 55270, Turkey (Türkiye)
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Cambridge, CB2 0QQ, United Kingdom
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Leeds, LS2 9JT, United Kingdom
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London, NW1 2PG, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE1 7EH, United Kingdom
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London, SE5 9RS, United Kingdom
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Newcastle upon Tyne, NE1 4LP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2023
First Posted
August 29, 2023
Study Start
June 29, 2024
Primary Completion (Estimated)
December 11, 2026
Study Completion (Estimated)
August 11, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.