A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

JRCT ID: jRCT2011210069

Registered date:05/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus
• Date of first enrollment: 15/02/2022
• Target sample size: 20
• Countries of recruitment: Argentina,Japan,Australia,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,France,Japan,Germany,Japan,Ireland,Japan,Mexico,Japan,Poland,Japan,Romania,Japan,Spain,Japan,Taiwan,Japan,USA,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Arm A: Afimetoran 30mg QD
Arm B: Afimetoran 10mg QD
Arm C: Afimetoran 2.5mg QD
Arm D: Placebo QD

Outcome(s)

• Primary Outcome: Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48

Secondary Outcome

1. Proportion of participants that achieve an SRI(4) response with corticosteroids (CS) reduction and maintenance to <- 7.5 mg per day at Week 48
2. Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) at Week 24 and Week 48
3. Proportion of participants who achieve an SRI(4) response without CS reduction and maintenance to <- 7.5 mg per day at Week 24
4. Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48
5. Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index; Activity (CLASI-A) score >- 10 at baseline who achieve a decrease of >- 50% from baseline CLASI-A score (CLASI-50) response at Week 24 and Week 48
6. Proportion of participants with 6 or more swollen joints and 6 or more tender joints at baseline who achieve a >- 50% reduction from baseline in both swollen and tender joints at Week 24 and Week 48
7. Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with >- 2 swollen joints at baseline
8. Mean change from baseline in tender joint count at Week 24 and Week 48 using the 28- joint count in participants with >- 2 tender joints at baseline
9. Change from baseline in PGA score of disease activity at Week 24 and Week 48 PGA = Physician Global Assessment of disease activity
10. Proportion of participants who achieve CS reduction or maintenance to <- 7.5 mg per day at Week 48
11. Change in patient reported disease activity from baseline to Week 24 and Week 48 according to the (36-item Short Form Health Questionnaire) SF-36
12. Number of participants that experience Serious Adverse Events (SAEs)
13. Proportion of participants that experience SAEs
14. Number of participants that experience Adverse Events (AEs)

Key inclusion & exclusion criteria

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

Include criteria

- Qualify as having Systemic Lupus Erythematosus (SLE), according to the SLE International Collaborating Clinics (SLICC) Classification Criteria >- 12 weeks before the screening visit
- Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody>/= 1:80, anti-double-stranded deoxyribonucleic acid
(dsDNA) antibody, or anti-Smith antibody.
- Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score >- 6 points and clinical Hybrid SLEDAI score >- 4 points with joint involvement and/or rash

Exclude criteria

- Active severe lupus nephritis (LN) as assessed by the investigator
- Neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
- Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
- Antiphospholipid Syndrome

Related Information

• Primary Sponsor: Ranganathan Usha
• Secondary ID(s): NCT04895696