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

JRCT ID: jRCT2051240101

Registered date:30/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic and/or subacute cutaneous lupus erythematosus
• Date of first enrollment: 29/10/2024
• Target sample size: 28
• Countries of recruitment: South Korea,Japan,China,Japan,Taiwan,Japan,Philippines,Japan,United States,Japan,Austria,Japan,Bulgaria,Japan,Germany,Japan,Denmark,Japan,Spain,Japan,France,Japan,United Kingdom,Japan,Greece,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Argentina,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Australia,Japan,South Africa,Japan,Belgium,Japan,Serbia,Japan
• Study type: Interventional

Intervention(s)

Stage 1:
Eligible participants will be randomized on Week 0 / Day 1 to receive either anifrolumab or placebo as a SC injection once weekly (QW) to Week 23. From Week 24, all participants will receive anifrolumab as a SC injection QW up to and including Week 51.
Stage 2:
Eligible participants will be randomized on Week 0 / Day 1 to receive either anifrolumab or placebo as a SC injection once weekly (QW) to Week 23. From Week 24, all participants will receive anifrolumab as a SC injection QW up to and including Week 51.

Outcome(s)

Primary Outcome

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 [ Time Frame: At Week 24 ]
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.

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 [ Time Frame: At Week 24 ]
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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

1. 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.

2. 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.

3. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

4. Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.

Exclude criteria

1. History or evidence of suicidal ideation.

2. Severe or life-threatening Systemic lupus erythematosus (SLE).

3. Active SLE or Sjogren's Syndrome.

4. Any active skin conditions other than CLE that may interfere with the study.

5.History of recurrent infection requiring hospitalization and IV antibiotics.

6. COVID-19 infection

7. Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.

8. 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.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT06015737