Cutaneous Lupus ErythematosusPhase 3LAVENDERNCT06015737
A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
A Phase 3 study testing Anifrolumab in people with Cutaneous Lupus Erythematosus, run by AstraZeneca at 188 sites in 32 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cutaneous Lupus Erythematosus
- What is being tested?
- Anifrolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 339 participants
- Where
- 188 sitesin 32 countries
- Study dates
- 29 Jun 2024to 10 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
188 sites in 32 countries.
188 sites in 32 countries
United States34 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Aurora, Colorado, 80045
Research Site
Baltimore, Maryland, 21287
Research Site
Bloomfield Hills, Michigan, 48302
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02115-5817
Research Site
Charleston, South Carolina, 29425
Research Site
Charlotte, North Carolina, 28207
Research Site
Charlottesville, Virginia, 22903
Research Site
Chicago, Illinois, 60611
Research Site
Chicago, Illinois, 60637
Research Site
Cleveland, Ohio, 44195
Research Site
Covina, California, 91722
Research Site
Dallas, Texas, 75390-8843
Research Site
Fort Lauderdale, Florida, 33309
Research Site
Indianapolis, Indiana, 46202
Research Site
La Jolla, California, 92037
Research Site
Los Angeles, California, 90045
Research Site
Los Angeles, California, 90089
Research Site
Miami, Florida, 33174
Research Site
New Haven, Connecticut, 06519
Research Site
New York, New York, 10028
Research Site
Omaha, Nebraska, 68198-5885
Research Site
Orange, California, 92868
Research Site
Phoenix, Arizona, 85028
Research Site
Plantation, Florida, 33324
Research Site
Portland, Oregon, 97239
Research Site
Providence, Rhode Island, 02903
Research Site
Roanoke, Virginia, 24016
Research Site
Rochester, Minnesota, 55905
Research Site
Rochester, New York, 14642
Research Site
San Francisco, California, 94143
Research Site
Statesville, North Carolina, 28625
Research Site
Washington D.C., District of Columbia, 20037
Spain16 sites
Research Site
Barcelona, 08025
Research Site
Barcelona, 8035
Research Site
Castellon, 12004
Research Site
Granada, 18012
Research Site
L'Hospitalet de Llobregat, 08907
Research Site
Las Palmas de Gran Canaria, 35010
Research Site
Madrid, 28006
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Majadahonda, 28222
Research Site
Salamanca, 37007
Research Site
Seville, 41014
Research Site
Valencia, 46014
Research Site
Valencia, 46017
Research Site
Vigo, 36200
China15 sites
Research Site
Changchun, 130021
Research Site
Changsha, 410011
Research Site
Chengdu, 610021
Research Site
Chongqing, 400016
Research Site
Dongguan, 523059
Research Site
Guangzhou, 510120
Research Site
Heilongjiang, 150086
Research Site
Jinan, 250022
Research Site
Shanghai, 200025
Research Site
Shanghai, 200443
Research Site
Shenzhen, 518020
Research Site
Shenzhen, 518052
Research Site
Shenzhen, 518053
Research Site
Ürümqi, CN-830004
Research Site
Zhuzhou, 412007
Germany13 sites
Research Site
Berlin, 10117
Research Site
Bochum, 44791
Research Site
Dresden, 01307
Research Site
Erlangen, 91054
Research Site
Essen, 45147
Research Site
Freiburg im Breisgau, 79104
Research Site
Hanover, 30625
Research Site
Kiel, 24105
Research Site
Leipzig, 04103
Research Site
Mainz, 55131
Research Site
Marburg, 35043
Research Site
Regensburg, 93053
Research Site
Wuppertal, 42283
France11 sites
Research Site
Bois-Guillaume, 76031
Research Site
Dijon, 21000
Research Site
Lyon, 69437
Research Site
Montivilliers, 76290
Research Site
Nantes, 44000
Research Site
Paris, 75010
Research Site
Paris, 75013
Research Site
Paris, 75014
Research Site
Paris, 75970
Research Site
Poitiers, 86000, FR
Research Site
Toulouse, 31059
Japan9 sites
Research Site
Chūōku, 104-8560
Research Site
Fukuoka, 812-8582
Research Site
Kanazawa, 920-8641
Research Site
Kita-gun, 761-0793
Research Site
Nagoya, 457-8510
Research Site
Nagoya, 467-8602
Research Site
tabashi City, 173-8606
Research Site
Wakayama, 641-8510
Research Site
Yokohama, 232-0024
Italy8 sites
Research Site
Brescia, 25123
Research Site
Cona, 44124
Research Site
Florence, 50121
Research Site
Milan, 20132
Research Site
Naples, 80138
Research Site
Reggio Emilia, 42123
Research Site
Roma, 00144
Research Site
Rome, 00168
United Kingdom7 sites
Research Site
Cambridge, CB2 0QQ
Research Site
Leeds, LS2 9JT
Research Site
London, NW1 2PG
Research Site
London, NW3 2QG
Research Site
London, SE1 7EH
Research Site
London, SE5 9RS
Research Site
Newcastle upon Tyne, NE1 4LP
Argentina5 sites
Research Site
Ciudad de Buenos Aires, 1221
Research Site
Córdoba, 5000
Research Site
Córdoba, X5004BAL
Research Site
Quilmes, 1878
Research Site
San Miguel, 1663
Australia5 sites
Research Site
Kogarah, 3168
Research Site
Melbourne, 3004
Research Site
Mitcham, 3132
Research Site
Westmead, 2145
Research Site
Woolloongabba, 04102
Brazil5 sites
Research Site
Belo Horizonte, 30150-221
Research Site
Porto Alegre, 90035903
Research Site
Rio de Janeiro, 22470-220
Research Site
Salvador, 40150-150
Research Site
São Paulo, 05403-000
Poland5 sites
Research Site
Katowice, 40-851
Research Site
Kielce, 25-316
Research Site
Ossy, 40-027
Research Site
Rzeszów, 35-055
Research Site
Warsaw, 02-637
Thailand5 sites
Research Site
Bangkok, 10330
Research Site
Bangkok, 10700
Research Site
Hat Yai, 90110
Research Site
Khlong Luang, 12120
Research Site
Khon Kaen, 40002
Austria4 sites
Research Site
Graz, 8036
Research Site
Innsbruck, 6020
Research Site
Linz, 4020
Research Site
Vienna, 1130
Mexico4 sites
Research Site
Guadalajara, 44340
Research Site
Guadalajara, 44610
Research Site
Mexico City, 07760
Research Site
Veracruz, 91910
Turkey (Türkiye)4 sites
Research Site
Cordaleo, 35575
Research Site
Istanbul, 34098
Research Site
Kayseri, 38039
Research Site
Samsun, 55270
Bulgaria3 sites
Research Site
Sofia, 1463
Research Site
Sofia, 1528
Research Site
Sofia, 1784
Canada3 sites
Research Site
Hamilton, Ontario, L8N 3Z5
Research Site
Toronto, Ontario, M5T 2S8
Research Site
Vancouver, British Columbia, V5Z 1M9
Chile3 sites
Research Site
Osorno, 200025
Research Site
Santiago, 130021
Research Site
Santiago, 7500571
Philippines3 sites
Research Site
Iloilo City, 5000
Research Site
Lipa, 4217
Research Site
Manila, 1000
Portugal3 sites
Research Site
Braga, 4710-243
Research Site
Lisbon, 1649-035
Research Site
Porto, 4099-001
South Korea3 sites
Research Site
Seoul, 03080
Research Site
Seoul, 06591
Research Site
Seoul, 06973
Taiwan3 sites
Research Site
Kaohsiung City, 83301
Research Site
Taichung, 404
Research Site
Taipei, 10449
Colombia2 sites
Research Site
Barranquilla, 080020
Research Site
Bogotá, 110221
Netherlands2 sites
Research Site
Breda, 4818 CK
Research Site
Rotterdam, 3015 GD
South Africa2 sites
Research Site
Cape Town, 7500
Research Site
Johannesburg, 2193
About this study
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.
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).
Read the detailed description
This is 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 CLE who are refractory and/or intolerant to antimalarial therapy. The study has a randomized, 24-week double-blind, placebo-controlled study period (Week 0 to Week 23), to evaluate the efficacy and safety of anifrolumab. The double-blind study period will be followed by an open-label, uncontrolled treatment period in which all participants will receive treatment with anifrolumab from Week 24 to Week 51. After the open-label treatment period, participants will enter a 12-week Safety Follow-up Period.
- Conditions
- Cutaneous Lupus Erythematosus
- Being tested
- Anifrolumab, Placebo
- Keywords
- Lupus erythematosus, Cutaneous lupus erythematosus, Anifrolumab, Cutaneous Lupus Erythematosus Disease Area Severity Index, Subacute lupus, Discoid lupus
- Medical subject headings
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnifrolumabCombination product
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
PlaceboOther
Matching placebo solution for injection in aPFS.
| Study group | Role | What they receive |
|---|---|---|
| Anifrolumab | Experimental | Participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to Week 51. Receives: Combination Product: Anifrolumab |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 24
Secondary outcomes (15)
Change from baseline in total CLASI-A score
The CLASI-A is a validated index used for assessing the cutaneous lesions of SLE.
Measured: At Week 24
Number of participants with CLASI-70 response
The CLASI is a validated index used for assessing the cutaneous lesions of SLE. CLASI-70 responder 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.
Measured: At Week 12
Number of participants with ≥ 7-point reduction from baseline in CLASI-A total score
The CLASI is a validated index used for assessing the cutaneous lesions of SLE. A 7-point reduction CLASI-A is established as clinically meaningful improvement in disease for CLE and as being impactful for patients.
Measured: At Week 12
Number of participants with CLASI-50 response
The CLASI is a validated index used for assessing the cutaneous lesions of SLE. CLASI-50 responder is defined as a responder (yes/no) is defined as a participant who achieves at least a 50% reduction relative to baseline in CLASI-A score. Otherwise, the participant is a non-responder.
Measured: At Week 12 and Week 24
Number of participants who are sustained CLASI-70 responders
The CLASI is a validated index used for assessing the cutaneous lesions of SLE. CLASI-70 responder 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. Amongst participants randomized to anifrolumab, the number of participants who maintained a CLASI-70 response from Week 24 up to Week 52 will be evaluated.
Measured: Up to Week 52
Serum trough (pre-dose) concentrations of anifrolumab
The Ctrough of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated.
Measured: Double-blind: Pre-dose on Day 1 (Week 0), Weeks 1, 4, 12, 24; Open-label: Weeks 40, and 52 or early discontinuation visit [EDV] and follow-up visit (13 Weeks after last dose)
Number of participants with positive antidrug antibody
The immunogenicity of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated.
Measured: Double-blind: Pre-dose on Day 1 (Week 0), Weeks 4, 12, and 24; Open-label: Pre-dose on Weeks 40, and 52 or EDV and follow-up visit (13 weeks after last dose)
Percent change from baseline in suppression of the Interferon 21-gene
The pharmacodynamics of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated.
Measured: Double-blind: Day 1 (Week 0), Week 1, 4, 12, and 24; Open-label; Week 40 and 52 or EDV and follow-up visit (13 weeks after last dose)
Change from baseline in Skindex-29+3 Symptom domain scores
The Skindex-29+3 is based on a previous instrument, the Skindex-29 and has been modified to include items related to CLE. The instrument consists of 33 items, which are used to calculate 4 domains: Symptoms (7 items), Emotions (10 items), Functioning (12 items), and Lupus-specific (3 items). The remaining item asks the participants to rate how often they worry about side effects from treatment; however, this item is not used to calculate the domain scores. The response options are on a 5-point verbal rating scale, ranging from 1 (Never) to 5 (All the time). The instrument has a recall period of the previous 4 weeks. Each domain score ranges from 0 to 100 points, with higher scores indicating worse health-related quality of life.
Measured: At Week 24
Change from baseline in Skindex-29+3 Emotion domain scores
The Skindex-29+3 is based on a previous instrument, the Skindex-29 and has been modified to include items related to CLE.
Measured: At Week 24
Change from baseline in Skindex-29+3 Function domain scores
The Skindex-29+3 is based on a previous instrument, the Skindex-29 and has been modified to include items related to CLE.
Measured: At Week 24
Change from baseline in Skindex-29+3 Lupus-Specific domain scores
The Skindex-29+3 is based on a previous instrument, the Skindex-29 and has been modified to include items related to CLE.
Measured: At Week 24
Change from baseline in Skindex-29+3 Total score
The Skindex-29+3 is based on a previous instrument, the Skindex-29 and has been modified to include items related to CLE.
Measured: At Week 24
Time from IP start date to CLASI-70 response.
To assess the efficacy of anifrolumab compared with placebo on the onset of reduction in skin manifestations in participants with chronic and/or subacute CLE.
Measured: From Week 0/Day 1 up to Week 24
Time from IP start date to CLASI-50 response.
To assess the efficacy of anifrolumab compared with placebo on the onset of reduction in skin manifestations in participants with chronic and/or subacute CLE.
Measured: From Week 0/Day 1 up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start29 Jun 2024
- Primary completion2 Nov 2026 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel group treatment study with two arms.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015737
- Sponsor's protocol ID
- D346BC00001
- Other IDs
- 2021-003698-70
- Acronym
- LAVENDER
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06015737
- Acronym / sponsor ID
- LAVENDER / D346BC00001
- Conditions
- Cutaneous Lupus Erythematosus
- Keywords
- Lupus erythematosus, Cutaneous lupus erythematosus, Anifrolumab, Cutaneous Lupus Erythematosus Disease Area Severity Index, Subacute lupus, Discoid lupus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 339 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 29 Jun 2024 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is 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 CLE who are refractory and/or intolerant to antimalarial therapy. The study has a randomized, 24-week double-blind, placebo-controlled study period (Week 0 to Week 23), to evaluate the efficacy and safety of anifrolumab. The double-blind study period will be followed by an open-label, uncontrolled treatment period in which all participants will receive treatment with anifrolumab from Week 24 to Week 51. After the open-label treatment period, participants will enter a 12-week Safety Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a parallel group treatment study with two arms.
| Arm | Type | Receives |
|---|---|---|
| Anifrolumab | Experimental | Combination Product: AnifrolumabParticipants will receive anifrolumab as a SC injection from Week 0/Day 1 up to Week 51. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnifrolumabAnifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS). | Combination product | Anifrolumab |
| PlaceboMatching placebo solution for injection in aPFS. | Other | Placebo |
Primary outcome
Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score
Time frame: At Week 24
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.
15 secondary outcomes
Change from baseline in total CLASI-A score
Time frame: At Week 24
Number of participants with CLASI-70 response
Time frame: At Week 12
Number of participants with ≥ 7-point reduction from baseline in CLASI-A total score
Time frame: At Week 12
Number of participants with CLASI-50 response
Time frame: At Week 12 and Week 24
Number of participants who are sustained CLASI-70 responders
Time frame: Up to Week 52
Serum trough (pre-dose) concentrations of anifrolumab
Time frame: Double-blind: Pre-dose on Day 1 (Week 0), Weeks 1, 4, 12, 24; Open-label: Weeks 40, and 52 or early discontinuation visit [EDV] and follow-up visit (13 Weeks after last dose)
Number of participants with positive antidrug antibody
Time frame: Double-blind: Pre-dose on Day 1 (Week 0), Weeks 4, 12, and 24; Open-label: Pre-dose on Weeks 40, and 52 or EDV and follow-up visit (13 weeks after last dose)
Percent change from baseline in suppression of the Interferon 21-gene
Time frame: Double-blind: Day 1 (Week 0), Week 1, 4, 12, and 24; Open-label; Week 40 and 52 or EDV and follow-up visit (13 weeks after last dose)
Change from baseline in Skindex-29+3 Symptom domain scores
Time frame: At Week 24
Change from baseline in Skindex-29+3 Emotion domain scores
Time frame: At Week 24
Change from baseline in Skindex-29+3 Function domain scores
Time frame: At Week 24
Change from baseline in Skindex-29+3 Lupus-Specific domain scores
Time frame: At Week 24
Change from baseline in Skindex-29+3 Total score
Time frame: At Week 24
Time from IP start date to CLASI-70 response.
Time frame: From Week 0/Day 1 up to Week 24
Time from IP start date to CLASI-50 response.
Time frame: From Week 0/Day 1 up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
188 sites in 32 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anifrolumab in people with Cutaneous Lupus Erythematosus, run by AstraZeneca at 188 sites in 32 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 188 sites in United States, Spain, China, Germany, France and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score (time frame: At Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.