Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus

Phase 2

Terminated

Conditions: Active Systemic Lupus Erythematosus

Interventions: Drug: Placebo
Drug: Efavaleukin Alfa
Other: Standard of Care

Registration Number: NCT04680637

Lead Sponsor: Amgen

Brief Summary: The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 168

Inclusion Criteria

Participant has provided informed consent prior to initiation of any study specific activities/procedures.
Participant is aged between 18 and 75.
Fulfills classification criteria for systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE with antinuclear antibody ≥ 1:80 by immunofluorescence on Hep-2 cells being present at screening.
Hybrid SLEDAI score ≥ 6 points with a "Clinical" hSLEDAI score ≥ 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters.
British-Isles Lupus Assessment Group (BILAG) index score (BILAG 2004) of ≥ 1 A item or ≥ 2 B items.
Must be taking ≥ 1 of the following SLE treatments (or regional equivalent): hydroxychloroquine, chloroquine, quinacrine, mycophenolate mofetil, azathioprine, methotrexate, dapsone, or oral calcineurin inhibitors, or OCS. A participant may enter the study on OCS alone (prednisone ≥ 10 mg/day or equivalent) only if the participant has previously documented trial of anti-malarial or immunosuppressant treatment for SLE. Participants must be on a stable dose for ≥ 8 weeks prior to screening for all antimalarials and immunosuppressants, with the exception of OCS doses which must be stable for ≥ 2 weeks prior to screening.
For participants taking OCS, dose must be ≤ 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit and for ≥ 2 weeks prior to screening visit.
Stability of SLE treatments: OCS and other immunosuppressants/immunomodulator agents and doses must be stable since screening visit.
Disease activity: active disease as indicated by clinical hSLEDAI score ≥ 4 must be observed (clinical hSLEDAI score is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results including urine and immunologic parameters).

Exclusion Criteria

Lupus nephritis if any of the following are present: urine protein creatinine ratio ≥ 2000 mg/g (or equivalent) at screening, OR requiring induction therapy currently or within 1 year prior to screening, OR histological evidence (if available) of diffuse proliferative glomerulonephritis within 12 weeks prior to screening.
Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.
Currently present or within 1 year prior to screening a diagnosis of any chronic inflammatory disease other than SLE (eg, rheumatoid arthritis) which would interfere with SLE disease assessment.
History of any disease other than SLE that has required treatment with oral or parenteral corticosteroids for > 2 weeks within 4 months prior to screening.
Active infection (including chronic or localized infections) for which anti-infectives are indicated currently or within 4 weeks prior to screening visit OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening visit.
Active tuberculosis or latent tuberculosis with no documented past history of adequate treatment per local standard of care.
Positive test for tuberculosis during creening defined as: either a positive or indeterminate QuantiFERON®-TB or T-spot test OR positive purified protein derivative (PPD) (≥5 mm of induration at 48 to 72 hours after test is placed).
Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb). A history of hepatitis B vaccination without history of hepatitis B infection (ie, positive hepatitis B surface antibody (HBsAb), negative HBsAg and negative HBcAb) is allowed.
Positive for hepatitis C antibody.
Known history of HIV or positive HIV test at screening.
Presence of 1 or more significant concurrent medical conditions, including but not limited to the following:
- poorly controlled diabetes (hemoglobin A1C > 7) or hypertension
- symptomatic heart failure (New York Heart Association class III or IV)
- myocardial infarction or unstable angina pectoris within the past 12 months prior to screening
- severe chronic pulmonary disease requiring oxygen therapy
- multiple sclerosis or any other demyelinating disease
Any history of malignancy with the following exceptions:
resolved non-melanoma skin cancers > 5 years prior to screening
resolved cervical carcinoma > 5 years prior to screening
resolved breast ductal carcinoma in situ > 5 years of screening
Currently receiving or had treatment with: cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent within 6 months prior to screening or sirolimus within 4 weeks prior screening.
Currently receiving or had treatment with a Janus kinase (JAK) inhibitor within 3 months or less than 5 drug half-lives (whichever is longer) prior to screening.
Currently receiving or had treatment with an immune checkpoint inhibitor (eg, programmed death 1 [PD-1] inhibitor, programmed death ligand 1 [PD-L1] inhibitor, cytotoxic T-lymphocyte associated protein 4 [CTLA-4] inhibitor).

Note: Abatacept is not considered a CTLA-4 inhibitor and is referred to below.

Currently receiving or had treatment within 12 months prior to screening with T-cell depleting agents (eg, antithymocyte globulin, Campath).
Currently receiving of had treatment with an interleukin 2 (IL-2) based therapy (eg, Proleukin).
Current or previous treatment with a biologic agent with immunosuppressive/immunomodulatory activity as follows: rituximab within 6 months prior to screening; abatacept and belimumab within the past 3 months prior to screening; other biologics within < 5 drug half lives prior to screening.
Participants who have received intraarticular, intralesional, or intramuscular corticosteroids within 2 weeks prior to screening or intravenous corticosteroids within 6 weeks prior to screening.
Participants who have received live vaccines within 5 weeks prior to screening, or plan to receive live vaccines during the treatment period and up to 6 weeks after the end of treatment period in the study.
Currently receiving treatment in another investigational device or drug study.
Ending a treatment with an investigational drug or investigational device less than 3 months or 5 half-lives from the last dose of the investigational drug (whichever is longer) at screening.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Standard of Care	Standard of Care	-
Efavaleukin Alfa Dose Level One + Standard of Care	Standard of Care	-
Efavaleukin Alfa Dose Level Three + Standard of Care	Standard of Care	-
Placebo + Standard of Care	Placebo	-
Efavaleukin Alfa Dose Level Two + Standard of Care	Standard of Care	-
Efavaleukin Alfa Dose Level Two + Standard of Care	Efavaleukin Alfa	-
Efavaleukin Alfa Dose Level One + Standard of Care	Efavaleukin Alfa	-
Efavaleukin Alfa Dose Level Three + Standard of Care	Efavaleukin Alfa	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 52	Week 52	A participant achieved an SRI-4 response if all the following criteria were met: * ≥ 4-point reduction from baseline in Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score (scale 0-105, with higher scores indicating more disease activity). * No new British-Isles Lupus Assessment Group (BILAG) A score and no \> 1 new BILAG B organ domain scores compared with baseline. The BILAG index evaluates disease activity in 9 separate organ systems. Each of the organ systems are allocated an alphabetical score of A (most active), B (moderate activity), C (minor activity), D (stable) or E (never present). * \< 0.3-points deterioration from baseline in Physician Global Assessment (PGA) visual analogue (VAS) score (scale 0 to 3, with higher scores indicating more severe disease). Participants were considered non-responders for using more than protocol-permitted therapies.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52	Week 52	A participant achieved an LLDAS response if all the following criteria were met: * hSLEDAI ≤ 4 (scale 0-105, higher scores indicating more disease activity) with no activity in major organ systems (renal \[proteinuria, hematuria, pyuria, urinary casts\], central nervous system \[seizure, psychosis, organic brain syndrome, cranial nerve disorder, cerebrovascular accident\], cardiopulmonary \[pericarditis, pleurisy\], vasculitis and fever) \& no hemolytic anemia or gastrointestinal activity in BILAG. The BILAG index evaluates disease activity in 9 separate organ systems. Each of the organ systems are allocated an alphabetical score of A (most active) to E (never present). * No new lupus disease activity compared with previous assessment defined as no new descriptor scores in hSLEDAI. * A score of \< 1 in PGA VAS score (scale 0 to 3, with higher scores indicating more severe disease). * Current prednisolone dose ≤ 7.5 mg daily. * No increase or initiation of immunosuppressive drugs.
Number of Participants Who Achieved a BILAG-based Composite Lupus Assessment (BICLA) Response at Week 52	Week 52	A participant achieved a BICLA response if all the following criteria were met: * At least 1 gradation of improvement in baseline BILAG domain scores in all body systems with moderate or severe disease activity at entry and no \> 1 BILAG B domain scores compared with baseline. The BILAG index evaluates disease activity in 9 separate organ systems. Each of the organ systems are allocated an alphabetical score of A (most active), B (moderate activity), C (minor activity), D (stable) or E (never present). * No worsening of the hSLEDAI score from baseline (scale 0-105, with higher scores indicating more disease activity). * \< 0.3-points deterioration from baseline in PGA VAS (scale 0 to 3, with higher scores indicating more severe disease). * No initiation of non-protocol treatment.
Number of Participants With a Reduction of Oral Corticosteroids (OCS) to ≤ 7.5 mg/Day by Week 44 and Sustained Through Week 52 in Participants With a Baseline OCS Dose ≥ 10 mg/Day	Baseline to Week 52	Participants taking OCS could begin tapering OCS after the Week 12 assessment up to the Week 44 assessment with initiation of tapering based upon clinical judgement of the treating physician. The tapering schedule was at the discretion of the investigator but should not have been tapered more than 20% of the prior dose per week. Tapering OCS before Week 12 was not encouraged but may have been allowed based upon investigator's judgement. Between weeks 44 and 52, the OCS dosing must again have remained stable.
Number of Participants With an Improvement From Baseline in Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥ 50% at Week 8, 12, 24, 36, and 52 in Participants With a CLASI Activity Score ≥ 8 at Baseline	Weeks 8, 12, 24, 36 and 52	The CLASI consists of 2 scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The total score ranges from 0-70, with higher scores indicating more severe disease.
Change From Baseline in Fatigue Standardized Score Using the Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a Instrument at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The PROMIS Fatigue SF 7a assesses the experience of fatigue as well as its impact on physical, mental and social activities. The score ranges from 7 to 35, with higher scores indicating more fatigue. A negative change from baseline indicates a reduction in fatigue. Efficacy data collected after the study termination decision date were censored and excluded from analyses for that particular visit.
Number of Participants With a hSLEDAI Response at Week 24 and Week 52	Week 24 and Week 52	The hSLEDAI is a global index that evaluates disease activity and includes both laboratory and clinical parameters. The score ranges from 0 to 105, with higher scores indicating more disease activity. A participant achieved a hSLEDAI response if there was a ≥ 4-point reduction in hSLEDAI from baseline.
Annualized Flare Rate Over 52 Weeks	Up to 52 weeks	A flare was defined as a BILAG score designation of "worse" or "new" resulting in a B score in ≥ 2 organs or an A score in ≥ 1 organ. The BILAG index evaluates disease activity in 9 separate organ systems. Each of the organ systems are allocated an alphabetical score of A (most active), B (moderate activity), C (minor activity), D (stable) or E (never present). The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied by 365.25.
Number of Participants Who Achieved a SRI-4 Response at Week 24	Week 24	A participant achieved an SRI-4 response if all the following criteria were met: * ≥ 4-point reduction from baseline in hSLEDAI score (scale 0-105, with higher scores indicating more disease activity). * No new BILAG A score and no \> 1 new BILAG B organ domain scores compared with baseline. The BILAG index evaluates disease activity in 9 separate organ systems. Each of the organ systems are allocated an alphabetical score of A (most active), B (moderate activity), C (minor activity), D (stable) or E (never present). * \< 0.3-points deterioration from baseline in PGA VAS score (scale 0 to 3, with higher scores indicating more severe disease). Participants were considered non-responders for using more than protocol-permitted therapies.
Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The SF-36v2 contains 36 items and yields assessments of 8 domains of health-related quality of life: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems. 3. Limitations in usual role activities because of physical health problems. 4. Bodily pain. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perceptions. The scores from the 8 domains will be evaluated independently and aggregated into 2 norm-based summary component measures of physical and mental health. The recall period is the past 7 days. The score ranges from 0-100 for the summary components and for each domain, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The SF-36v2 contains 36 items and yields assessments of 8 domains of health-related quality of life: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems. 3. Limitations in usual role activities because of physical health problems. 4. Bodily pain. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perceptions. The scores from the 8 domains will be evaluated independently and aggregated into 2 norm-based summary component measures of physical and mental health. The recall period is the past 7 days. The score ranges from 0-100 for the summary components and for each domain, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The LupusQoL is a SLE-specific health-related QoL instrument and consists of 8 domains: 1. Physical health. 2. Pain. 3. Planning. 4. Intimate relationships. 5. Burden to others. 6. Emotional health. 7. Body image. 8. Fatigue. The score for each domain ranges from 0-100, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The LupusQoL is a SLE-specific health-related QoL instrument and consists of 8 domains: 1. Physical health. 2. Pain. 3. Planning. 4. Intimate relationships. 5. Burden to others. 6. Emotional health. 7. Body image. 8. Fatigue. The score for each domain ranges from 0-100, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Number of Participants Who Achieved a BICLA Response at Week 24	Week 24	A participant achieved a BICLA response if all the following criteria were met: * At least 1 gradation of improvement in baseline BILAG domain scores in all body systems with moderate or severe disease activity at entry and no \> 1 BILAG B domain scores compared with baseline. The BILAG index evaluates disease activity in 9 separate organ systems. Each of the organ systems are allocated an alphabetical score of A (most active), B (moderate activity), C (minor activity), D (stable) or E (never present). * No worsening of the hSLEDAI score from baseline (scale 0-105, with higher scores indicating more disease activity). * \< 0.3-points deterioration from baseline in PGA VAS (scale 0 to 3, with higher scores indicating more severe disease). * No initiation of non-protocol treatment.
Number of Participants With an Improvement From Baseline in Tender and Swollen Joint Count ≥ 50% at Weeks 8, 12, 24, 36, and 52 in Participants With ≥ 6 Tender and Swollen Joints in Hands and Wrists	Weeks 8, 12, 24, 36 and 52	The swollen and tender join count assessments were performed at the site by an experienced independent and blinded joint evaluator. Joints in hands and wrists were scored for the simultaneous presence (1) or absence (0) of swelling and tenderness. Scores ranged from 0-28. A higher score indicates more severe disease.
Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The SF-36v2 contains 36 items and yields assessments of 8 domains of health-related quality of life: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems. 3. Limitations in usual role activities because of physical health problems. 4. Bodily pain. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perceptions. The scores from the 8 domains will be evaluated independently and aggregated into 2 norm-based summary component measures of physical and mental health. The recall period is the past 7 days. The score ranges from 0-100 for the summary components and for each domain, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)	Day 1 to Week 56	A TEAE was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment and had emerged or worsened during treatment. A serious TEAE was defined as any untoward medical occurrence that, met at least 1 of the following criteria: * Resulted in death (fatal). * Was immediately life-threatening. * Required in-patient hospitalization or prolongation of existing hospitalization. * Resulted in persistent or significant disability/incapacity. * Was a congenital anomaly/birth defect. * Was any other medically important serious event. Clinically significant changes from baseline in laboratory values and vital signs were also recorded as TEAEs.
Change From Baseline in the Physical Component Score of the Medical Outcomes Short Form-36 Questionnaire Version 2 (SF-36V2) at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The SF-36v2 contains 36 items and yields assessments of 8 domains of health-related quality of life: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems. 3. Limitations in usual role activities because of physical health problems. 4. Bodily pain. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perceptions. The scores from the 8 domains will be evaluated independently and aggregated into 2 norm-based summary component measures of physical and mental health. The recall period is the past 7 days. The score ranges from 0-100 for the summary components and for each domain, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The SF-36v2 contains 36 items and yields assessments of 8 domains of health-related quality of life: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems. 3. Limitations in usual role activities because of physical health problems. 4. Bodily pain. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perceptions. The scores from the 8 domains will be evaluated independently and aggregated into 2 norm-based summary component measures of physical and mental health. The recall period is the past 7 days. The score ranges from 0-100 for the summary components and for each domain, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The SF-36v2 contains 36 items and yields assessments of 8 domains of health-related quality of life: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems. 3. Limitations in usual role activities because of physical health problems. 4. Bodily pain. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perceptions. The scores from the 8 domains will be evaluated independently and aggregated into 2 norm-based summary component measures of physical and mental health. The recall period is the past 7 days. The score ranges from 0-100 for the summary components and for each domain, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The SF-36v2 contains 36 items and yields assessments of 8 domains of health-related quality of life: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems. 3. Limitations in usual role activities because of physical health problems. 4. Bodily pain. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perceptions. The scores from the 8 domains will be evaluated independently and aggregated into 2 norm-based summary component measures of physical and mental health. The recall period is the past 7 days. The score ranges from 0-100 for the summary components and for each domain, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The SF-36v2 contains 36 items and yields assessments of 8 domains of health-related quality of life: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems. 3. Limitations in usual role activities because of physical health problems. 4. Bodily pain. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perceptions. The scores from the 8 domains will be evaluated independently and aggregated into 2 norm-based summary component measures of physical and mental health. The recall period is the past 7 days. The score ranges from 0-100 for the summary components and for each domain, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The LupusQoL is a systemic lupus erythematosus (SLE)-specific health-related QoL instrument and consists of 8 domains: 1. Physical health. 2. Pain. 3. Planning. 4. Intimate relationships. 5. Burden to others. 6. Emotional health. 7. Body image. 8. Fatigue. The score for each domain ranges from 0-100, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The SF-36v2 contains 36 items and yields assessments of 8 domains of health-related quality of life: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems. 3. Limitations in usual role activities because of physical health problems. 4. Bodily pain. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perceptions. The scores from the 8 domains will be evaluated independently and aggregated into 2 norm-based summary component measures of physical and mental health. The recall period is the past 7 days. The score ranges from 0-100 for the summary components and for each domain, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The LupusQoL is a SLE-specific health-related QoL instrument and consists of 8 domains: 1. Physical health. 2. Pain. 3. Planning. 4. Intimate relationships. 5. Burden to others. 6. Emotional health. 7. Body image. 8. Fatigue. The score for each domain ranges from 0-100, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The LupusQoL is a SLE-specific health-related QoL instrument and consists of 8 domains: 1. Physical health. 2. Pain. 3. Planning. 4. Intimate relationships. 5. Burden to others. 6. Emotional health. 7. Body image. 8. Fatigue. The score for each domain ranges from 0-100, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Serum Efavaleukin Alfa Concentrations by Timepoint	Day 1: 6-24 and 48-96 hrs, Day 29, Day 43: 6-24 and 48-96 hrs, Day 85, Day 169, Day 253, Day 309, and Day 365	Serum efavaleukin alfa concentrations by timepoint after multiple dose subcutaneous administration of efavaleukin alfa to participants with active systemic lupus erythematosus. Lower limit of quantification= 0.100 ng/mL.
Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The SF-36v2 contains 36 items and yields assessments of 8 domains of health-related quality of life: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems. 3. Limitations in usual role activities because of physical health problems. 4. Bodily pain. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perceptions. The scores from the 8 domains will be evaluated independently and aggregated into 2 norm-based summary component measures of physical and mental health. The recall period is the past 7 days. The score ranges from 0-100 for the summary components and for each domain, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The LupusQoL is a SLE-specific health-related QoL instrument and consists of 8 domains: 1. Physical health. 2. Pain. 3. Planning. 4. Intimate relationships. 5. Burden to others. 6. Emotional health. 7. Body image. 8. Fatigue. The score for each domain ranges from 0-100, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The LupusQoL is a SLE-specific health-related QoL instrument and consists of 8 domains: 1. Physical health. 2. Pain. 3. Planning. 4. Intimate relationships. 5. Burden to others. 6. Emotional health. 7. Body image. 8. Fatigue. The score for each domain ranges from 0-100, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.
Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52	Baseline to Week 12, 24, 36 and 52	The LupusQoL is a SLE-specific health-related QoL instrument and consists of 8 domains: 1. Physical health. 2. Pain. 3. Planning. 4. Intimate relationships. 5. Burden to others. 6. Emotional health. 7. Body image. 8. Fatigue. The score for each domain ranges from 0-100, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement in outcomes.

Trial Locations

Locations (149): University of Alabama at Birmingham,Arthritis Clinical Intervention Program
🇺🇸
Birmingham, Alabama, United States
Arizona Arthritis and Rheumatology Associates PC
🇺🇸
Tucson, Arizona, United States
Arizona Arthritis And Rheumatology Associates PC
🇺🇸
Glendale, Arizona, United States
Loma Linda University Health Care
🇺🇸
Loma Linda, California, United States
University of California Los Angeles
🇺🇸
Los Angeles, California, United States
University of California Irvine
🇺🇸
Orange, California, United States
Robin K Dore MD Inc
🇺🇸
Tustin, California, United States
Arthritis and Rheumatic Disease Specialties
🇺🇸
Aventura, Florida, United States
Life Clinical Trials
🇺🇸
Aventura, Florida, United States
Centre for Rheumatology Immunology and Arthritis
🇺🇸
Fort Lauderdale, Florida, United States
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University of Alabama at Birmingham,Arthritis Clinical Intervention Program
🇺🇸Birmingham, Alabama, United States