Efavaleukin Alfa for Systemic Lupus Erythematosus (SLE)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Systemic Lupus Erythematosus (SLE)Efavaleukin Alfa - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it is effective and safe for people with Lupus.

Eligible Conditions
  • Systemic Lupus Erythematosus (SLE)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: Baseline, Week 8, 12, 24, 36, and 52

Week 12
Change from Baseline in Lupus Quality of Life (QoL) Questionnaire Score
Change from Baseline in Medical Outcomes Short Form-36 Questionnaire Score
Change from Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS Fatigue SF 7A) Fatigue Score
Week 8
Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥ 50% Improvement from Baseline at Week 8, 12, 24, 36, and 52 in Participants with a CLASI Activity Score ≥ 8 at Baseline
Tender and Swollen Joint Count ≥ 50% Improvement from Baseline at Weeks 8, 12, 24, 36, and 52 in Participants with ≥ 6 Tender and Swollen Joints Involving the Hands and Wrists at Baseline
Up to Week 52
Trough Serum and Sparse Postdose Serum Concentration of Efavaleukin Alfa
Up to Week 56
Number of Participants who Experience a Clinically Significant Change in Laboratory Values and Vital Sign Measurements
Number of Participants who Experience a Treatment-Emergent Adverse Event (AE) and Serious Adverse Event (SAE)
Week 24
Percent of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24
Week 52
Percent of Participants Achieving a British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 24 and Week 52
Percent of Participants Achieving a Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) Response at Week 24 and Week 52
Week 52
Percent of Participants Achieving a Lupus Low Disease Activity State (LLDAS) Response at Week 52
Percent of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 52
Percent of Participants who Experience a Flare
Percent of Participants with a Reduction of Oral Corticosteroid (OCS) to Less Than or Equal to 7.5 mg/day by Week 44 and Sustained Through Week 52 in Participants with a Baseline OCS Dose ≥ 10 mg/day

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Efavaleukin Alfa Dose Level Two + Standard of Care
1 of 4
Efavaleukin Alfa Dose Level Three + Standard of Care
1 of 4
Efavaleukin Alfa Dose Level One + Standard of Care
1 of 4
Placebo + Standard of Care
1 of 4

Experimental Treatment

Non-Treatment Group

320 Total Participants · 4 Treatment Groups

Primary Treatment: Efavaleukin Alfa · Has Placebo Group · Phase 2

Efavaleukin Alfa Dose Level Two + Standard of CareExperimental Group · 2 Interventions: Efavaleukin Alfa, Standard of Care · Intervention Types: Drug, Other
Efavaleukin Alfa Dose Level Three + Standard of CareExperimental Group · 2 Interventions: Efavaleukin Alfa, Standard of Care · Intervention Types: Drug, Other
Efavaleukin Alfa Dose Level One + Standard of CareExperimental Group · 2 Interventions: Efavaleukin Alfa, Standard of Care · Intervention Types: Drug, Other
Placebo + Standard of CarePlaceboComparator Group · 2 Interventions: Placebo, Standard of Care · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efavaleukin alfa
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 8, 12, 24, 36, and 52

Who is running the clinical trial?

AmgenLead Sponsor
1,296 Previous Clinical Trials
1,328,498 Total Patients Enrolled
10 Trials studying Systemic Lupus Erythematosus (SLE)
744 Patients Enrolled for Systemic Lupus Erythematosus (SLE)
MDStudy DirectorAmgen
838 Previous Clinical Trials
897,599 Total Patients Enrolled
10 Trials studying Systemic Lupus Erythematosus (SLE)
744 Patients Enrolled for Systemic Lupus Erythematosus (SLE)

Eligibility Criteria

Age 18 - 75 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have provided informed consent prior to study participation.
You have at least 1 A item or 2 B items.
You are taking hydroxychloroquine, chloroquine, quinacrine, mycophenolate mofetil, azathioprine, methotrexate, dapsone, or oral calcineurin inhibitors, or OCS
You have active disease as indicated by clinical hSLEDAI score ≥ 4 must be observed.