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

PHASE3RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-06-29

Primary completion: 2027-12-29

Study completion finish: 2027-12-29

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06015737

Intervention or treatment

COMBINATION_PRODUCT: Anifrolumab

OTHER: Placebo

COMBINATION_PRODUCT: Anifrolumab

OTHER: Placebo

Conditions

• Cutaneous Lupus Erythematosus

Image related to Cutaneous Lupus Erythematosus

Condition: Cutaneous Lupus Erythematosus
COMBINATION_PRODUCT: Anifrolumab and other drugs
Clayton, Not Specified, Australia and more
Sponsor: AstraZeneca

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Closest Location:

Research Site

Research sites nearby

Select from list below to view details:

Research Site
Clayton, Not Specified, Australia
Research Site
Melbourne, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Stage 1: Anifrolumab The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.	COMBINATION_PRODUCT: Anifrolumab Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
PLACEBO_COMPARATOR: Stage 1: 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 anifrolumab up to and including Week 51.	OTHER: Placebo Matching placebo solution for injection in aPFS.
EXPERIMENTAL: Stage 2: Anifrolumab The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.	COMBINATION_PRODUCT: Anifrolumab Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
PLACEBO_COMPARATOR: Stage 2: 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 anifrolumab up to and including Week 51.	OTHER: Placebo Matching placebo solution for injection in aPFS.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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
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
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
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
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
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
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
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
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
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
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)
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)
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)
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
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
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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References

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