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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06015737
Other study ID # D346BC00001
Secondary ID 2021-003698-70
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date June 17, 2024
Est. completion date January 27, 2028

Study information

Verified date May 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The primary objectives of the study are to evaluate the efficacy of anifrolumab compared with placebo in reducing skin disease in participants with active chronic and/or subacute CLE who are refractory and/or intolerant to antimalarial therapy. The secondary objectives of the study are to evaluate additional efficacy parameters of anifrolumab, safety, tolerability, quality of life, pharmacokinetics, pharmacodynamics, and immunogenicity. Stage 1 and Stage 2 of the study will have broadly identical study designs with the exception of sample size. Both Stages of the study will have a randomized, double-blind, placebo-controlled design, followed by an open-label treatment period.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 460
Est. completion date January 27, 2028
Est. primary completion date January 27, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Key inclusion criteria: - 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. - CLA-IGA-R erythema score of = 3 and CLA-IGA-R-OMC score of = 1 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. - Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening. Key exclusion criteria: - 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 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design


Intervention

Combination Product:
Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Other:
Placebo
Matching placebo solution for injection in aPFS.
Combination Product:
Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Other:
Placebo
Matching placebo solution for injection in aPFS.

Locations

Country Name City State
Argentina Research Site Ciudad de Buenos Aires
Argentina Research Site Córdoba
Argentina Research Site Quilmes
Australia Research Site Box Hill
Australia Research Site Clayton
Australia Research Site Melbourne
Australia Research Site Westmead
Australia Research Site Woolloongabba
Austria Research Site Graz
Austria Research Site Innsbruck
Austria Research Site Linz
Austria Research Site Sankt Pölten
Belgium Research Site Liège
Brazil Research Site Belo Horizonte
Brazil Research Site Porto Alegre
Brazil Research Site Salvador
Bulgaria Research Site Sofia
Chile Research Site Santiago
China Research Site Baotou
China Research Site Beijing
China Research Site Beijing
China Research Site Changchun
China Research Site Chengdu
China Research Site Chongqing
China Research Site Guangzhou
China Research Site Hangzhou
China Research Site Heilongjiang
China Research Site Jinan
China Research Site Kunming
China Research Site Nanchang
China Research Site Nanjing
China Research Site Shanghai
China Research Site Shanghai
China Research Site Shenzhen
China Research Site Shijiazhuang
China Research Site Wuhan
Colombia Research Site Barranquilla
Colombia Research Site Bogota
Colombia Research Site Chia
Denmark Research Site København
France Research Site Bois Guillaume
France Research Site Chambray Les Tours
France Research Site Lille Cedex
France Research Site Lyon Cedex 03
France Research Site Nice
France Research Site Paris
France Research Site Paris
France Research Site Paris
France Research Site Paris
France Research Site Toulouse Cedex 9
Germany Research Site Berlin
Germany Research Site Bochum
Germany Research Site Dresden
Germany Research Site Hannover
Germany Research Site Kiel
Germany Research Site Leipzig
Germany Research Site Mainz
Germany Research Site Regensburg
Germany Research Site Wuppertal
Greece Research Site Athens
Greece Research Site Athens
Greece Research Site Athens
Italy Research Site Brescia
Italy Research Site Florence
Italy Research Site Napoli
Italy Research Site Rome
Italy Research Site Torrette
Japan Research Site Fukuoka-Shi
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Mexico Research Site Guadalajara
Mexico Research Site Guadalajara
Netherlands Research Site Rotterdam
Philippines Research Site Iloilo City
Philippines Research Site Lipa
Philippines Research Site Manila
Poland Research Site Katowice
Poland Research Site Olsztyn
Poland Research Site Poznan
Poland Research Site Warszawa
Poland Research Site Warszawa
Serbia Research Site Kragujevac
South Africa Research Site Cape Town
South Africa Research Site Johannesburg
Spain Research Site Barcelona
Spain Research Site Barcelona
Spain Research Site Madrid
Spain Research Site Madrid
Spain Research Site Madrid
Taiwan Research Site Kaohsiung
Taiwan Research Site Taichung
United Kingdom Research Site Cambridge
United Kingdom Research Site Leeds
United Kingdom Research Site London
United Kingdom Research Site London
United Kingdom Research Site London
United States Research Site Ann Arbor Michigan
United States Research Site Boston Massachusetts
United States Research Site Brooklyn New York
United States Research Site Charlottesville Virginia
United States Research Site Cleveland Ohio
United States Research Site Fort Lauderdale Florida
United States Research Site Glendale Arizona
United States Research Site La Jolla California
United States Research Site Miami Florida
United States Research Site Miami Florida
United States Research Site New Haven Connecticut
United States Research Site Orange California
United States Research Site Phoenix Arizona
United States Research Site Plantation Florida
United States Research Site Portland Oregon
United States Research Site Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca Parexel

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Chile,  China,  Colombia,  Denmark,  France,  Germany,  Greece,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Philippines,  Poland,  Serbia,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Stage 1 and Stage 2 (US, EU and ROW): Number of participants with adverse events To evaluate the safety and tolerability of anifrolumab compared with placebo in participants with CLE. Screening (up to and including 42 days before Day 1) until Safety Follow-up Period (13 weeks from Week 52/ EDV)
Primary 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 The CLA-IGA-R is an assessment tool that scores the three key disease components (erythema; other morphological characteristics [OMC] and follicular activity) of CLE independently. The CLA-IGA-R erythema is scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4 (0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE). On all IGA scales, a decrease in score relates to an improvement in signs and symptoms. CLA-IGA-R erythema responder is defined as a participant who achieves a CLA-IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline. Otherwise, the participant is considered a non-responder. At Week 24
Primary 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 CLASI is a validated index used for assessing the cutaneous lesions of SLE. 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 Stage 1 and Stage 2 (US): Number of participants who achieve a CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline The CLA-IGA-R is an assessment tool that scores the three key disease components (erythema; OMC and follicular activity) of CLE independently. The CLA-IGA-R OMC is scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE. Assessment of CLA-IGA-R OMC score captures other morphological changes in CLE patients. A decrease in score relates to an improvement in signs and symptoms. A responder (yes/no) is defined as a participant who achieves a CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline. Otherwise, the participant is considered a non-responder. At Week 24
Secondary Stage 1 and Stage 2 (US): Number of participants who achieve a CLA-IGA-R OMC score of 0. The CLA-IGA-R is an assessment tool that scores the three key disease components (erythema; OMC and follicular activity) of CLE independently. The CLA-IGA-R OMC is scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE. CLA-IGA-R OMC complete response is defined as a participant who scores 0. Otherwise, the participant is a non-responder. Only participants with CLA-IGA-OMC = 3 at baseline will be included in the analysis. At Week 24
Secondary Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R follicular activity score of 0 The CLA-IGA-R is a tool that scores the three key disease components (erythema; OMC and follicular activity) of CLE independently.
CLA-IGA-R follicular activity provides a global clinical assessment on a 2-point binary scale ranging from 0 to 1, where 0 indicates absent and 1 indicates present. On all IGA scales, a decrease in score relates to an improvement in signs and symptoms. A responder (yes/no) is defined as a participant who achieves a CLA-IGA-R follicular activity score of 0. Otherwise, the participant is a non-responder. Only participants with follicular activity score of 1 at baseline will be included in the analysis.
At Week 24
Secondary Stage 1 and Stage 2 (EU/ROW): Percent change from baseline in total CLASI-A erythema score The Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) is a validated index used for assessing the cutaneous lesions of SLE. The CLASI-A erythema score is interpreted as follows: 0-absent; 1-pink; faint erythema; 2-red; 3-dark red; purple/violaceous/crusted/ hemorrhagic At Week 24
Secondary Stage 1 and Stage 2 (EU/ROW): Percent change from baseline in total CLASI-A scale/hypertrophy score The CLASI-A is a validated index used for assessing the cutaneous lesions of SLE. CLASI-A Scale/Hypertrophy can be measured as 0, 1, and 2 where 0 is absent, 1 is scale, and 2 is verrucuos and hypertrohic. At Week 24
Secondary Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline, or a CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline The CLA-IGA-R is a tool that scores the three key disease components (erythema; OMC and follicular activity) of CLE independently. The CLA-IGA-R erythema and OMC are scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE. A responder (yes/no) is defined as a participant who achieves either a CLA-IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline, or a CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline. Otherwise, the participant is a non-responder. On all IGA scales, a decrease in score relates to an improvement in signs and symptoms. At Week 24
Secondary Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline The CLA-IGA-R is a tool that scores the three key disease components (erythema; OMC and follicular activity) of CLE independently. The CLA-IGA-R erythema is scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4 (0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE). A responder is defined as a participant who achieves a CLA-IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline. Otherwise, the participant is a non-responder. On all IGA scales, a decrease in score relates to an improvement in signs and symptoms. At Week 12
Secondary Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline The CLA-IGA-R is a tool that scores the three key disease components (erythema; OMC, and follicular activity) of CLE independently. The CLA-IGA-R OMC is scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4 (0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE). A responder (yes/no) is defined as a participant who achieves a CLA- IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline. Otherwise, the participant is a non-responder. On all IGA scales, a decrease in score relates to an improvement in signs and symptoms. At Week 12
Secondary Stage 1 and Stage 2 (EU/ROW): 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. At Week 12
Secondary Stage 1 and Stage 2 (US/EU/ROW): Change from baseline in Skindex-29+3 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. The symptom domain in the Skindex-29+3 evaluates the symptom burden of the disease and includes symptom concepts such as pain, itching, burning, stinging, and sensitivity. At Week 24
Secondary Stage 1 and Stage 2 (US/EU/ROW): Serum trough (pre-dose) concentrations of anifrolumab The Ctrough of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated. 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)
Secondary Stage 1 and Stage 2 (US/EU/ROW): Number of participants with positive antidrug antibody The immunogenicity of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated. 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)
Secondary Stage 1 and Stage 2 (US/EU/ROW): 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. 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)
Secondary Stage 2 (US/EU/ROW): 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. 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. A 7-point reduction CLASI-A is established as clinically meaningful improvement in disease for CLE and as being impactful for patients. Achieving a CLASI-A total score of 9 or below is an accepted threshold for mild disease. At Week 24
Secondary Stage 2 (US): Number of participants who are CLA-IGA-R erythema responders from Week 24 up to and including Week 52 The CLA-IGA-R is an assessment tool that scores the three key disease components (erythema; OMC and follicular activity) of CLE independently. The CLA-IGA-R erythema is scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE. On all IGA scales, a decrease in score relates to an improvement in signs and symptoms. Assessment of CLA-IGA-R erythema score captures changes in erythema, a clinically important feature in CLE patients. A responder is defined as a participant who achieves a CLA- IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline. Otherwise, the participant is a non-responder. Amongst participants randomized to anifrolumab during the double-blind treatment period, the number of participants who maintained a CLA-IGA-R erythema response from Week 24 up to Week 52 will be evaluated. Up to Week 52
Secondary Stage 2 (EU): Number of participants who are CLASI-70 responders up to and including Week 52 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 during the double-blind treatment period, the number of participants who maintained a CLASI-70 response from Week 24 up to Week 52 will be evaluated. Up to Week 52
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