Active Systemic Lupus Erythematosus
Conditions
Brief summary
The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.
Interventions
DRUGEfavaleukin Alfa
Administered as a subcutaneous (SC) injection.
DRUGPlacebo
Administered as a subcutaneous (SC) injection.
OTHERStandard of Care
Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 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 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 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 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 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. |
| 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 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 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 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 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 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 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 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. |
| 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. |
| 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 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. |
| 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. |
Countries
Austria, Bulgaria, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United States
Participant flow
Recruitment details
Participants were enrolled at 73 centers in 13 countries (Bulgaria, Chile, Colombia, Greece, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Switzerland, Taiwan, and the United States) between 06 May 2021 and 24 May 2023.
Pre-assignment details
A total of 464 participants were screened, of which 168 participants were enrolled and received efavaleukin alfa.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matching efavaleukin alfa Q2W through a SC injection for up to 52 weeks. | 41 |
| Efavaleukin Alfa Low Dose Participants received low dose efavaleukin alfa Q2W through a SC injection for up to 52 weeks. | 35 |
| Efavaleukin Alfa Medium Dose Participants received medium dose efavaleukin alfa Q2W through a SC injection for up to 52 weeks. | 34 |
| Efavaleukin Alfa High Dose Participants received high dose efavaleukin alfa Q2W through a SC injection for up to 52 weeks. | 58 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 |
| Overall Study | Decision by Sponsor | 21 | 15 | 7 | 32 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 10 | 17 | 15 |
Baseline characteristics
| Characteristic | Placebo | Total | Efavaleukin Alfa High Dose | Efavaleukin Alfa Medium Dose | Efavaleukin Alfa Low Dose |
|---|---|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 10.3 | 44.1 years STANDARD_DEVIATION 11.8 | 42.3 years STANDARD_DEVIATION 11.2 | 40.3 years STANDARD_DEVIATION 12.2 | 46.1 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 59 Participants | 22 Participants | 12 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 109 Participants | 36 Participants | 22 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 14 Participants | 5 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 19 Participants | 6 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Black (or African American) | 5 Participants | 23 Participants | 9 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 17 Participants | 9 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 25 Participants | 94 Participants | 29 Participants | 20 Participants | 20 Participants |
| Sex: Female, Male Female | 38 Participants | 158 Participants | 56 Participants | 33 Participants | 31 Participants |
| Sex: Female, Male Male | 3 Participants | 10 Participants | 2 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 41 | 0 / 35 | 0 / 33 | 0 / 59 |
| other Total, other adverse events | 18 / 41 | 27 / 35 | 33 / 33 | 48 / 59 |
| serious Total, serious adverse events | 4 / 41 | 3 / 35 | 4 / 33 | 3 / 59 |
Outcome results
Primary
Number of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at 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.
Time frame: Week 52
Population: Full Analysis Set: Included all participants randomized in the study. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 52 | 8 Participants |
| Efavaleukin Alfa Low Dose | Number of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 52 | 4 Participants |
| Efavaleukin Alfa Medium Dose | Number of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 52 | 6 Participants |
| Efavaleukin Alfa High Dose | Number of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 52 | 5 Participants |
Secondary
Annualized Flare Rate Over 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.
Time frame: Up to 52 weeks
Population: Full Analysis Set: Included all participants randomized in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Annualized Flare Rate Over 52 Weeks | 0.3 flares per participant-year |
| Efavaleukin Alfa Low Dose | Annualized Flare Rate Over 52 Weeks | 0.5 flares per participant-year |
| Efavaleukin Alfa Medium Dose | Annualized Flare Rate Over 52 Weeks | 0.7 flares per participant-year |
| Efavaleukin Alfa High Dose | Annualized Flare Rate Over 52 Weeks | 0.4 flares per participant-year |
Secondary
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
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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Week 12 | -4.12 score on a scale | Standard Deviation 7.91 |
| Placebo | 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 | Week 24 | -5.24 score on a scale | Standard Deviation 8.05 |
| Placebo | 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 | Week 36 | -3.20 score on a scale | Standard Deviation 10.7 |
| Placebo | 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 | Week 52 | -3.29 score on a scale | Standard Deviation 7.64 |
| Efavaleukin Alfa Low Dose | 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 | Week 24 | -4.95 score on a scale | Standard Deviation 8.72 |
| Efavaleukin Alfa Low Dose | 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 | Week 36 | -5.77 score on a scale | Standard Deviation 7.09 |
| Efavaleukin Alfa Low Dose | 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 | Week 52 | -8.44 score on a scale | Standard Deviation 4.21 |
| Efavaleukin Alfa Low Dose | 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 | Week 12 | -5.52 score on a scale | Standard Deviation 5.04 |
| Efavaleukin Alfa Medium Dose | 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 | Week 36 | -5.32 score on a scale | Standard Deviation 8.9 |
| Efavaleukin Alfa Medium Dose | 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 | Week 24 | -4.62 score on a scale | Standard Deviation 8.03 |
| Efavaleukin Alfa Medium Dose | 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 | Week 52 | -6.97 score on a scale | Standard Deviation 14.2 |
| Efavaleukin Alfa Medium Dose | 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 | Week 12 | -5.78 score on a scale | Standard Deviation 8.39 |
| Efavaleukin Alfa High Dose | 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 | Week 52 | -5.47 score on a scale | Standard Deviation 13.97 |
| Efavaleukin Alfa High Dose | 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 | Week 24 | -7.17 score on a scale | Standard Deviation 7.01 |
| Efavaleukin Alfa High Dose | 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 | Week 12 | -4.74 score on a scale | Standard Deviation 9.6 |
| Efavaleukin Alfa High Dose | 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 | Week 36 | -5.34 score on a scale | Standard Deviation 10.61 |
Secondary
Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 13.6 score on a scale | Standard Deviation 25.1 |
| Placebo | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 20.4 score on a scale | Standard Deviation 26.6 |
| Placebo | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 22.0 score on a scale | Standard Deviation 26.3 |
| Placebo | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 10.4 score on a scale | Standard Deviation 7.7 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 14.3 score on a scale | Standard Deviation 21.5 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 19.5 score on a scale | Standard Deviation 20.7 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 11.1 score on a scale | Standard Deviation 17.1 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 13.7 score on a scale | Standard Deviation 23 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 24.6 score on a scale | Standard Deviation 33 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 13.8 score on a scale | Standard Deviation 23.1 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 17.9 score on a scale | Standard Deviation 29.7 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 18.8 score on a scale | Standard Deviation 22.6 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 16.7 score on a scale | Standard Deviation 37.1 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 18.4 score on a scale | Standard Deviation 26.6 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 10.2 score on a scale | Standard Deviation 23 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 15.4 score on a scale | Standard Deviation 23.3 |
Secondary
Change From Baseline in the Body Image Domain Score of the LupusQoL at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 9.6 score on a scale | Standard Deviation 26.5 |
| Placebo | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 11.6 score on a scale | Standard Deviation 30.6 |
| Placebo | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 6.1 score on a scale | Standard Deviation 25.6 |
| Placebo | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 12.5 score on a scale | Standard Deviation 33.3 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 2.3 score on a scale | Standard Deviation 25.5 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 14.7 score on a scale | Standard Deviation 21.4 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 17.0 score on a scale | Standard Deviation 22.5 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 9.0 score on a scale | Standard Deviation 18.7 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 18.8 score on a scale | Standard Deviation 41.2 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 3.0 score on a scale | Standard Deviation 28.2 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 7.7 score on a scale | Standard Deviation 37.4 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 4.1 score on a scale | Standard Deviation 34 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 5.5 score on a scale | Standard Deviation 36.6 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 5.2 score on a scale | Standard Deviation 29.6 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 4.6 score on a scale | Standard Deviation 26.6 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 6.1 score on a scale | Standard Deviation 28 |
Secondary
Change From Baseline in the Burden to Others Domain Score of the LupusQoL at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 10.784 score on a scale | Standard Deviation 28.169 |
| Placebo | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 20.115 score on a scale | Standard Deviation 31.459 |
| Placebo | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 14.773 score on a scale | Standard Deviation 30.53 |
| Placebo | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 16.667 score on a scale | Standard Deviation 22.713 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 5.682 score on a scale | Standard Deviation 24.719 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 10.088 score on a scale | Standard Deviation 22.149 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 38.333 score on a scale | Standard Deviation 19.185 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 14.333 score on a scale | Standard Deviation 17.099 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 21.795 score on a scale | Standard Deviation 22.448 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 12.083 score on a scale | Standard Deviation 23.798 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 21.212 score on a scale | Standard Deviation 23.677 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 17.803 score on a scale | Standard Deviation 30.134 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 18.333 score on a scale | Standard Deviation 28.273 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 12.778 score on a scale | Standard Deviation 29.093 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 6.944 score on a scale | Standard Deviation 29.673 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 18.519 score on a scale | Standard Deviation 26.438 |
Secondary
Change From Baseline in the Emotional Health Domain Score of the LupusQoL at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 9.681 score on a scale | Standard Deviation 21.729 |
| Placebo | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 13.218 score on a scale | Standard Deviation 26.495 |
| Placebo | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 10.038 score on a scale | Standard Deviation 25.994 |
| Placebo | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 4.167 score on a scale | Standard Deviation 20.534 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 7.765 score on a scale | Standard Deviation 19.974 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 6.798 score on a scale | Standard Deviation 18.799 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 13.333 score on a scale | Standard Deviation 21.123 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 10.667 score on a scale | Standard Deviation 19.021 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 20.192 score on a scale | Standard Deviation 24.641 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 11.458 score on a scale | Standard Deviation 20.894 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 15.530 score on a scale | Standard Deviation 27.518 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 14.962 score on a scale | Standard Deviation 28.425 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | -5.000 score on a scale | Standard Deviation 25.595 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 9.722 score on a scale | Standard Deviation 21.283 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 5.258 score on a scale | Standard Deviation 21.465 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 3.704 score on a scale | Standard Deviation 30.178 |
Secondary
Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 13.964 score on a scale | Standard Deviation 27.781 |
| Placebo | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 16.926 score on a scale | Standard Deviation 29.82 |
| Placebo | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 17.028 score on a scale | Standard Deviation 35.129 |
| Placebo | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 9.375 score on a scale | Standard Deviation 18.057 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | -5.208 score on a scale | Standard Deviation 23.417 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 5.952 score on a scale | Standard Deviation 24.029 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 8.334 score on a scale | Standard Deviation 14.433 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | -3.704 score on a scale | Standard Deviation 23.036 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 6.548 score on a scale | Standard Deviation 29.81 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 3.031 score on a scale | Standard Deviation 23.223 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | -2.273 score on a scale | Standard Deviation 33.144 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 4.514 score on a scale | Standard Deviation 26.236 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | -9.168 score on a scale | Standard Deviation 32.972 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 8.333 score on a scale | Standard Deviation 25.769 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 3.804 score on a scale | Standard Deviation 23.812 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | -0.440 score on a scale | Standard Deviation 33.847 |
Secondary
Change From Baseline in the Fatigue Domain Score of the LupusQoL at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 8.456 score on a scale | Standard Deviation 23.329 |
| Placebo | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 10.776 score on a scale | Standard Deviation 24.6 |
| Placebo | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 5.966 score on a scale | Standard Deviation 29.345 |
| Placebo | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 10.938 score on a scale | Standard Deviation 15.58 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 7.670 score on a scale | Standard Deviation 23.059 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 10.526 score on a scale | Standard Deviation 17.561 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 25.000 score on a scale | Standard Deviation 4.419 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 9.750 score on a scale | Standard Deviation 15.104 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 12.019 score on a scale | Standard Deviation 26.695 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 13.750 score on a scale | Standard Deviation 20.135 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 15.341 score on a scale | Standard Deviation 26.274 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 15.909 score on a scale | Standard Deviation 21.368 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 16.250 score on a scale | Standard Deviation 28.596 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 13.542 score on a scale | Standard Deviation 20.108 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 8.185 score on a scale | Standard Deviation 21.273 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 4.514 score on a scale | Standard Deviation 23.853 |
Secondary
Change From Baseline in the General Health Domain Score of the SF-36V2 at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 5.2 score on a scale | Standard Deviation 15.8 |
| Placebo | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 9.2 score on a scale | Standard Deviation 17.7 |
| Placebo | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 10.7 score on a scale | Standard Deviation 16.1 |
| Placebo | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 7.5 score on a scale | Standard Deviation 8.9 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 6.2 score on a scale | Standard Deviation 19 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 5.6 score on a scale | Standard Deviation 14.9 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 2.4 score on a scale | Standard Deviation 5.9 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 6.1 score on a scale | Standard Deviation 17.7 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 7.2 score on a scale | Standard Deviation 17.2 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 3.8 score on a scale | Standard Deviation 16.2 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 6.7 score on a scale | Standard Deviation 19 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 10.6 score on a scale | Standard Deviation 15.9 |
| Efavaleukin Alfa High Dose | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 0.5 score on a scale | Standard Deviation 29.5 |
| Efavaleukin Alfa High Dose | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 5.6 score on a scale | Standard Deviation 15.3 |
| Efavaleukin Alfa High Dose | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 2.6 score on a scale | Standard Deviation 16.2 |
| Efavaleukin Alfa High Dose | Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | -2.1 score on a scale | Standard Deviation 16.6 |
Secondary
Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 17.26 score on a scale | Standard Deviation 27.52 |
| Placebo | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 10.83 score on a scale | Standard Deviation 35 |
| Placebo | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 10.94 score on a scale | Standard Deviation 33.81 |
| Placebo | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 6.25 score on a scale | Standard Deviation 51.08 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 1.56 score on a scale | Standard Deviation 26.57 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | -1.67 score on a scale | Standard Deviation 30.2 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 0.00 score on a scale | Standard Deviation 8.84 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 3.47 score on a scale | Standard Deviation 22.61 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 11.36 score on a scale | Standard Deviation 30.34 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 19.53 score on a scale | Standard Deviation 28.86 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 9.38 score on a scale | Standard Deviation 35.83 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 14.29 score on a scale | Standard Deviation 35.65 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 8.33 score on a scale | Standard Deviation 31.29 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 13.16 score on a scale | Standard Deviation 29.01 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 11.21 score on a scale | Standard Deviation 31.04 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 12.50 score on a scale | Standard Deviation 15.99 |
Secondary
Change From Baseline in the Mental Component Score of the SF-36V2 at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 5.079 score on a scale | Standard Deviation 11.395 |
| Placebo | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 6.510 score on a scale | Standard Deviation 12.498 |
| Placebo | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 5.587 score on a scale | Standard Deviation 14.482 |
| Placebo | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 4.781 score on a scale | Standard Deviation 8.485 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 0.498 score on a scale | Standard Deviation 10.902 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | -0.118 score on a scale | Standard Deviation 10.56 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 1.106 score on a scale | Standard Deviation 9.633 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 0.080 score on a scale | Standard Deviation 10.789 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 3.129 score on a scale | Standard Deviation 12.141 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 1.585 score on a scale | Standard Deviation 9.032 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | -1.813 score on a scale | Standard Deviation 16.608 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 3.087 score on a scale | Standard Deviation 11.651 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | -2.163 score on a scale | Standard Deviation 13.023 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 3.959 score on a scale | Standard Deviation 9.22 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 1.867 score on a scale | Standard Deviation 9.092 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 0.564 score on a scale | Standard Deviation 13.586 |
Secondary
Change From Baseline in the Mental Health Domain Score of the SF-36V2 at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 8.2 score on a scale | Standard Deviation 19.3 |
| Placebo | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 12.0 score on a scale | Standard Deviation 21.2 |
| Placebo | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 9.6 score on a scale | Standard Deviation 23.2 |
| Placebo | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 7.5 score on a scale | Standard Deviation 16.7 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | -2.1 score on a scale | Standard Deviation 22.7 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | -1.9 score on a scale | Standard Deviation 18.4 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 3.8 score on a scale | Standard Deviation 22.4 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 1.3 score on a scale | Standard Deviation 18.7 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 6.4 score on a scale | Standard Deviation 22.6 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 0.5 score on a scale | Standard Deviation 33 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 7.5 score on a scale | Standard Deviation 19.6 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 9.4 score on a scale | Standard Deviation 22.5 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 1.5 score on a scale | Standard Deviation 28.5 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 5.2 score on a scale | Standard Deviation 17.4 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 9.4 score on a scale | Standard Deviation 17.8 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 6.6 score on a scale | Standard Deviation 24.3 |
Secondary
Change From Baseline in the Pain Domain Score of the LupusQoL at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 17.892 score on a scale | Standard Deviation 22.392 |
| Placebo | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 21.264 score on a scale | Standard Deviation 28.311 |
| Placebo | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 12.879 score on a scale | Standard Deviation 25.423 |
| Placebo | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 14.583 score on a scale | Standard Deviation 18.767 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 14.773 score on a scale | Standard Deviation 25.708 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 17.105 score on a scale | Standard Deviation 21.956 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 16.667 score on a scale | Standard Deviation 8.333 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 16.333 score on a scale | Standard Deviation 23.873 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 16.667 score on a scale | Standard Deviation 30.238 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 11.667 score on a scale | Standard Deviation 23.939 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 8.333 score on a scale | Standard Deviation 27.639 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 17.424 score on a scale | Standard Deviation 23.975 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 11.667 score on a scale | Standard Deviation 27.833 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 11.944 score on a scale | Standard Deviation 28.339 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 13.294 score on a scale | Standard Deviation 24.072 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 5.556 score on a scale | Standard Deviation 28.296 |
Secondary
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
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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Week 12 | 4.349 score on a scale | Standard Deviation 7.526 |
| Placebo | 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 | Week 24 | 6.709 score on a scale | Standard Deviation 7.52 |
| Placebo | 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 | Week 36 | 5.391 score on a scale | Standard Deviation 9.04 |
| Placebo | 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 | Week 52 | 3.678 score on a scale | Standard Deviation 2.958 |
| Efavaleukin Alfa Low Dose | 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 | Week 24 | 5.544 score on a scale | Standard Deviation 7.624 |
| Efavaleukin Alfa Low Dose | 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 | Week 36 | 6.576 score on a scale | Standard Deviation 6.331 |
| Efavaleukin Alfa Low Dose | 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 | Week 52 | 6.206 score on a scale | Standard Deviation 4.144 |
| Efavaleukin Alfa Low Dose | 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 | Week 12 | 6.016 score on a scale | Standard Deviation 7.854 |
| Efavaleukin Alfa Medium Dose | 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 | Week 36 | 7.524 score on a scale | Standard Deviation 8.988 |
| Efavaleukin Alfa Medium Dose | 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 | Week 24 | 4.726 score on a scale | Standard Deviation 7.058 |
| Efavaleukin Alfa Medium Dose | 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 | Week 52 | 8.724 score on a scale | Standard Deviation 9.159 |
| Efavaleukin Alfa Medium Dose | 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 | Week 12 | 6.450 score on a scale | Standard Deviation 6.701 |
| Efavaleukin Alfa High Dose | 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 | Week 52 | 6.252 score on a scale | Standard Deviation 12.226 |
| Efavaleukin Alfa High Dose | 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 | Week 24 | 5.136 score on a scale | Standard Deviation 8.351 |
| Efavaleukin Alfa High Dose | 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 | Week 12 | 2.615 score on a scale | Standard Deviation 7.622 |
| Efavaleukin Alfa High Dose | 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 | Week 36 | 3.648 score on a scale | Standard Deviation 8.269 |
Secondary
Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 14.460 score on a scale | Standard Deviation 21.532 |
| Placebo | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 13.477 score on a scale | Standard Deviation 26.261 |
| Placebo | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 20.469 score on a scale | Standard Deviation 23.048 |
| Placebo | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 8.750 score on a scale | Standard Deviation 14.083 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 10.713 score on a scale | Standard Deviation 20.078 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 15.714 score on a scale | Standard Deviation 13.973 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 6.876 score on a scale | Standard Deviation 20.998 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 7.963 score on a scale | Standard Deviation 15.888 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 14.545 score on a scale | Standard Deviation 21.816 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 16.786 score on a scale | Standard Deviation 29.91 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 14.165 score on a scale | Standard Deviation 22.489 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 18.183 score on a scale | Standard Deviation 28.919 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 15.001 score on a scale | Standard Deviation 31.622 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 5.761 score on a scale | Standard Deviation 22.034 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 9.736 score on a scale | Standard Deviation 29.603 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 10.607 score on a scale | Standard Deviation 24.036 |
Secondary
Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 12 | 13.7868 score on a scale | Standard Deviation 20.5586 |
| Placebo | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 24 | 15.5172 score on a scale | Standard Deviation 23.777 |
| Placebo | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 36 | 11.3636 score on a scale | Standard Deviation 20.6738 |
| Placebo | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 52 | 9.3750 score on a scale | Standard Deviation 11.8114 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 24 | 9.5109 score on a scale | Standard Deviation 25.1501 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 36 | 13.4375 score on a scale | Standard Deviation 20.2549 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 52 | 20.8333 score on a scale | Standard Deviation 21.164 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 12 | 12.6202 score on a scale | Standard Deviation 18.9259 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 36 | 18.7500 score on a scale | Standard Deviation 24.4404 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 24 | 15.4688 score on a scale | Standard Deviation 17.7205 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 52 | 15.6250 score on a scale | Standard Deviation 27.0994 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 12 | 13.7784 score on a scale | Standard Deviation 18.3909 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 52 | 10.6250 score on a scale | Standard Deviation 29.5437 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 24 | 13.8542 score on a scale | Standard Deviation 25.3834 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 12 | 11.5327 score on a scale | Standard Deviation 22.3595 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52 | Week 36 | 5.7292 score on a scale | Standard Deviation 24.3304 |
Secondary
Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 12.838 score on a scale | Standard Deviation 24.516 |
| Placebo | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 18.359 score on a scale | Standard Deviation 22.221 |
| Placebo | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 11.685 score on a scale | Standard Deviation 26.935 |
| Placebo | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 11.719 score on a scale | Standard Deviation 15.468 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 14.323 score on a scale | Standard Deviation 26.29 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 14.881 score on a scale | Standard Deviation 26.917 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 18.750 score on a scale | Standard Deviation 14.878 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 15.509 score on a scale | Standard Deviation 26.081 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 15.179 score on a scale | Standard Deviation 24.966 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 9.091 score on a scale | Standard Deviation 20.479 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 19.318 score on a scale | Standard Deviation 25.381 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 13.802 score on a scale | Standard Deviation 22.571 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 6.875 score on a scale | Standard Deviation 35.041 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 15.909 score on a scale | Standard Deviation 23.804 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 6.929 score on a scale | Standard Deviation 21.899 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 7.895 score on a scale | Standard Deviation 29.377 |
Secondary
Change From Baseline in the Planning Domain Score of the LupusQoL at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 9.804 score on a scale | Standard Deviation 23.071 |
| Placebo | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 11.494 score on a scale | Standard Deviation 29.915 |
| Placebo | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 12.500 score on a scale | Standard Deviation 30.834 |
| Placebo | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 15.625 score on a scale | Standard Deviation 29.693 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 14.015 score on a scale | Standard Deviation 28.334 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 9.211 score on a scale | Standard Deviation 23.553 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 15.000 score on a scale | Standard Deviation 18.066 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 17.000 score on a scale | Standard Deviation 23.259 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 13.462 score on a scale | Standard Deviation 23.457 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 15.833 score on a scale | Standard Deviation 22.926 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 10.606 score on a scale | Standard Deviation 25.025 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 13.636 score on a scale | Standard Deviation 23.925 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 52 | 12.500 score on a scale | Standard Deviation 27.287 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 24 | 14.722 score on a scale | Standard Deviation 22.391 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 12 | 7.143 score on a scale | Standard Deviation 23.825 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52 | Week 36 | 5.093 score on a scale | Standard Deviation 29.861 |
Secondary
Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 15.54 score on a scale | Standard Deviation 29.82 |
| Placebo | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 21.88 score on a scale | Standard Deviation 33.15 |
| Placebo | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 13.04 score on a scale | Standard Deviation 38.71 |
| Placebo | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 10.94 score on a scale | Standard Deviation 28.69 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 13.02 score on a scale | Standard Deviation 23.16 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 8.93 score on a scale | Standard Deviation 26.26 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 21.43 score on a scale | Standard Deviation 20.04 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 9.72 score on a scale | Standard Deviation 22.29 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 16.96 score on a scale | Standard Deviation 32.75 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 3.98 score on a scale | Standard Deviation 24.52 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 5.68 score on a scale | Standard Deviation 35.95 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 7.81 score on a scale | Standard Deviation 26.79 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | -1.25 score on a scale | Standard Deviation 36.54 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 9.47 score on a scale | Standard Deviation 25.39 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 2.17 score on a scale | Standard Deviation 21.46 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 1.32 score on a scale | Standard Deviation 29.14 |
Secondary
Change From Baseline in the Vitality Domain Score of the SF-36V2 at 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.
Time frame: Baseline to Week 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study and had observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 10.642 score on a scale | Standard Deviation 20.405 |
| Placebo | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 13.477 score on a scale | Standard Deviation 23.283 |
| Placebo | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 11.685 score on a scale | Standard Deviation 26.935 |
| Placebo | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 15.625 score on a scale | Standard Deviation 19.48 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 8.333 score on a scale | Standard Deviation 23.936 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 6.548 score on a scale | Standard Deviation 19.811 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 4.464 score on a scale | Standard Deviation 22.16 |
| Efavaleukin Alfa Low Dose | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 12.037 score on a scale | Standard Deviation 21.225 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 14.732 score on a scale | Standard Deviation 23.718 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 8.523 score on a scale | Standard Deviation 20.912 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 9.659 score on a scale | Standard Deviation 28.141 |
| Efavaleukin Alfa Medium Dose | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 15.365 score on a scale | Standard Deviation 23.384 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 52 | 13.750 score on a scale | Standard Deviation 26.484 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 24 | 12.879 score on a scale | Standard Deviation 19.884 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 12 | 7.609 score on a scale | Standard Deviation 20.536 |
| Efavaleukin Alfa High Dose | Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52 | Week 36 | 5.592 score on a scale | Standard Deviation 22.812 |
Secondary
Number of Participants Who Achieved a BICLA Response at 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.
Time frame: Week 24
Population: Full Analysis Set: Included all participants randomized in the study. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Achieved a BICLA Response at Week 24 | 17 Participants |
| Efavaleukin Alfa Low Dose | Number of Participants Who Achieved a BICLA Response at Week 24 | 12 Participants |
| Efavaleukin Alfa Medium Dose | Number of Participants Who Achieved a BICLA Response at Week 24 | 5 Participants |
| Efavaleukin Alfa High Dose | Number of Participants Who Achieved a BICLA Response at Week 24 | 17 Participants |
Secondary
Number of Participants Who Achieved a BILAG-based Composite Lupus Assessment (BICLA) Response at 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.
Time frame: Week 52
Population: Full Analysis Set: Included all participants randomized in the study. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included. Participants were considered non-responders for using more than protocol-permitted therapies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Achieved a BILAG-based Composite Lupus Assessment (BICLA) Response at Week 52 | 6 Participants |
| Efavaleukin Alfa Low Dose | Number of Participants Who Achieved a BILAG-based Composite Lupus Assessment (BICLA) Response at Week 52 | 2 Participants |
| Efavaleukin Alfa Medium Dose | Number of Participants Who Achieved a BILAG-based Composite Lupus Assessment (BICLA) Response at Week 52 | 4 Participants |
| Efavaleukin Alfa High Dose | Number of Participants Who Achieved a BILAG-based Composite Lupus Assessment (BICLA) Response at Week 52 | 4 Participants |
Secondary
Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at 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.
Time frame: Week 52
Population: Full Analysis Set: Included all participants randomized in the study. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included. Participants were considered non-responders for using more than protocol-permitted therapies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52 | 2 Participants |
| Efavaleukin Alfa Low Dose | Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52 | 3 Participants |
| Efavaleukin Alfa Medium Dose | Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52 | 3 Participants |
| Efavaleukin Alfa High Dose | Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52 | 1 Participants |
Secondary
Number of Participants Who Achieved a SRI-4 Response at 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.
Time frame: Week 24
Population: Full Analysis Set: Included all participants randomized in the study. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Achieved a SRI-4 Response at Week 24 | 20 Participants |
| Efavaleukin Alfa Low Dose | Number of Participants Who Achieved a SRI-4 Response at Week 24 | 13 Participants |
| Efavaleukin Alfa Medium Dose | Number of Participants Who Achieved a SRI-4 Response at Week 24 | 13 Participants |
| Efavaleukin Alfa High Dose | Number of Participants Who Achieved a SRI-4 Response at Week 24 | 21 Participants |
Secondary
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
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.
Time frame: Day 1 to Week 56
Population: Safety Analysis Set: All randomized participants who received at least 1 dose of investigational product. After randomization, 1 participant received more than their planned medium dose of efavaleukin alfa in error, therefore the participant is also counted in the efavaleukin alfa high dose arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | TEAE | 29 Participants |
| Placebo | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Serious TEAE | 4 Participants |
| Efavaleukin Alfa Low Dose | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Serious TEAE | 3 Participants |
| Efavaleukin Alfa Low Dose | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | TEAE | 29 Participants |
| Efavaleukin Alfa Medium Dose | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | TEAE | 33 Participants |
| Efavaleukin Alfa Medium Dose | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Serious TEAE | 4 Participants |
| Efavaleukin Alfa High Dose | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | TEAE | 55 Participants |
| Efavaleukin Alfa High Dose | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Serious TEAE | 3 Participants |
Secondary
Number of Participants With a hSLEDAI Response at 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.
Time frame: Week 24 and Week 52
Population: Full Analysis Set: Included all participants randomized in the study. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With a hSLEDAI Response at Week 24 and Week 52 | Week 24 | 23 Participants |
| Placebo | Number of Participants With a hSLEDAI Response at Week 24 and Week 52 | Week 52 | 8 Participants |
| Efavaleukin Alfa Low Dose | Number of Participants With a hSLEDAI Response at Week 24 and Week 52 | Week 52 | 4 Participants |
| Efavaleukin Alfa Low Dose | Number of Participants With a hSLEDAI Response at Week 24 and Week 52 | Week 24 | 14 Participants |
| Efavaleukin Alfa Medium Dose | Number of Participants With a hSLEDAI Response at Week 24 and Week 52 | Week 24 | 13 Participants |
| Efavaleukin Alfa Medium Dose | Number of Participants With a hSLEDAI Response at Week 24 and Week 52 | Week 52 | 7 Participants |
| Efavaleukin Alfa High Dose | Number of Participants With a hSLEDAI Response at Week 24 and Week 52 | Week 24 | 23 Participants |
| Efavaleukin Alfa High Dose | Number of Participants With a hSLEDAI Response at Week 24 and Week 52 | Week 52 | 6 Participants |
Secondary
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
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.
Time frame: Weeks 8, 12, 24, 36 and 52
Population: Full Analysis Set: Included all participants randomized in the study. Only participants who had a CLASI activity score ≥ 8 at baseline and the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 | Week 36 | 5 Participants |
| Placebo | 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 | Week 12 | 6 Participants |
| Placebo | 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 | Week 52 | 3 Participants |
| Placebo | 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 | Week 24 | 4 Participants |
| Placebo | 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 | Week 8 | 2 Participants |
| Efavaleukin Alfa Low Dose | 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 | Week 24 | 4 Participants |
| Efavaleukin Alfa Low Dose | 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 | Week 36 | 5 Participants |
| Efavaleukin Alfa Low Dose | 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 | Week 52 | 0 Participants |
| Efavaleukin Alfa Low Dose | 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 | Week 12 | 2 Participants |
| Efavaleukin Alfa Low Dose | 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 | Week 8 | 1 Participants |
| Efavaleukin Alfa Medium Dose | 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 | Week 24 | 5 Participants |
| Efavaleukin Alfa Medium Dose | 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 | Week 8 | 5 Participants |
| Efavaleukin Alfa Medium Dose | 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 | Week 12 | 5 Participants |
| Efavaleukin Alfa Medium Dose | 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 | Week 36 | 4 Participants |
| Efavaleukin Alfa Medium Dose | 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 | Week 52 | 3 Participants |
| Efavaleukin Alfa High Dose | 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 | Week 36 | 5 Participants |
| Efavaleukin Alfa High Dose | 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 | Week 12 | 7 Participants |
| Efavaleukin Alfa High Dose | 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 | Week 8 | 9 Participants |
| Efavaleukin Alfa High Dose | 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 | Week 24 | 6 Participants |
| Efavaleukin Alfa High Dose | 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 | Week 52 | 3 Participants |
Secondary
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
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.
Time frame: Weeks 8, 12, 24, 36 and 52
Population: Full Analysis Set: Full Analysis Set: Included all participants randomized in the study. Only participants who had ≥ 6 tender and swollen joints involving hands and wrists at baseline and the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 | Week 36 | 11 Participants |
| Placebo | 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 | Week 12 | 16 Participants |
| Placebo | 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 | Week 52 | 2 Participants |
| Placebo | 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 | Week 24 | 13 Participants |
| Placebo | 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 | Week 8 | 16 Participants |
| Efavaleukin Alfa Low Dose | 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 | Week 24 | 9 Participants |
| Efavaleukin Alfa Low Dose | 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 | Week 36 | 8 Participants |
| Efavaleukin Alfa Low Dose | 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 | Week 52 | 1 Participants |
| Efavaleukin Alfa Low Dose | 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 | Week 12 | 7 Participants |
| Efavaleukin Alfa Low Dose | 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 | Week 8 | 8 Participants |
| Efavaleukin Alfa Medium Dose | 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 | Week 24 | 9 Participants |
| Efavaleukin Alfa Medium Dose | 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 | Week 8 | 8 Participants |
| Efavaleukin Alfa Medium Dose | 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 | Week 12 | 7 Participants |
| Efavaleukin Alfa Medium Dose | 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 | Week 36 | 8 Participants |
| Efavaleukin Alfa Medium Dose | 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 | Week 52 | 7 Participants |
| Efavaleukin Alfa High Dose | 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 | Week 36 | 3 Participants |
| Efavaleukin Alfa High Dose | 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 | Week 12 | 13 Participants |
| Efavaleukin Alfa High Dose | 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 | Week 8 | 13 Participants |
| Efavaleukin Alfa High Dose | 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 | Week 24 | 11 Participants |
| Efavaleukin Alfa High Dose | 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 | Week 52 | 3 Participants |
Secondary
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
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.
Time frame: Baseline to Week 52
Population: Full Analysis Set: Included all participants randomized in the study. Only participants with a baseline OCS dose ≥ 10 mg/day and had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | 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 | 0 Participants |
| Efavaleukin Alfa Low Dose | 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 | 1 Participants |
| Efavaleukin Alfa Medium Dose | 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 | 2 Participants |
| Efavaleukin Alfa High Dose | 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 | 0 Participants |
Secondary
Serum Efavaleukin Alfa Concentrations by Timepoint
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.
Time frame: 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
Population: The PK Concentration Analysis Set is defined as the subset of participants in the Safety Analysis Set who had at least 1 evaluable serum concentration (including results below the level of detection) of investigational product. PK concentration data will be analyzed according to the actual treatment received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 169 | 0.349 ng/mL | Standard Deviation 1.1 |
| Placebo | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 43: 6-24 hrs | 4.34 ng/mL | Standard Deviation 5.55 |
| Placebo | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 309 | 0.252 ng/mL | Standard Deviation 0.502 |
| Placebo | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 85 | 0.0577 ng/mL | Standard Deviation 0.223 |
| Placebo | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 43: 48-96 hrs | 2.80 ng/mL | Standard Deviation 4.39 |
| Placebo | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 1: 48-96 hrs | 2.34 ng/mL | Standard Deviation 2.52 |
| Placebo | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 1: 6-24 hrs | 5.46 ng/mL | Standard Deviation 5.18 |
| Placebo | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 253 | 0.530 ng/mL | Standard Deviation 1.48 |
| Placebo | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 29 | 0.0201 ng/mL | Standard Deviation 0.0649 |
| Placebo | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 365 | 0.00 ng/mL | Standard Deviation 0 |
| Efavaleukin Alfa Low Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 85 | 0.00712 ng/mL | Standard Deviation 0.0293 |
| Efavaleukin Alfa Low Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 1: 6-24 hrs | 12.8 ng/mL | Standard Deviation 12.3 |
| Efavaleukin Alfa Low Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 1: 48-96 hrs | 5.93 ng/mL | Standard Deviation 6.45 |
| Efavaleukin Alfa Low Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 29 | 0.0179 ng/mL | Standard Deviation 0.0496 |
| Efavaleukin Alfa Low Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 43: 6-24 hrs | 13.9 ng/mL | Standard Deviation 11.7 |
| Efavaleukin Alfa Low Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 43: 48-96 hrs | 12.7 ng/mL | Standard Deviation 17.2 |
| Efavaleukin Alfa Low Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 169 | 0.0588 ng/mL | Standard Deviation 0.133 |
| Efavaleukin Alfa Low Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 253 | 0.155 ng/mL | Standard Deviation 0.221 |
| Efavaleukin Alfa Low Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 309 | 0.0558 ng/mL | Standard Deviation 0.167 |
| Efavaleukin Alfa Low Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 365 | 0.00 ng/mL | Standard Deviation 0 |
| Efavaleukin Alfa Medium Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 365 | 0.136 ng/mL | Standard Deviation 0.236 |
| Efavaleukin Alfa Medium Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 169 | 0.140 ng/mL | Standard Deviation 0.178 |
| Efavaleukin Alfa Medium Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 1: 48-96 hrs | 21.8 ng/mL | Standard Deviation 30.5 |
| Efavaleukin Alfa Medium Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 309 | 0.308 ng/mL | Standard Deviation 0.533 |
| Efavaleukin Alfa Medium Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 253 | 0.458 ng/mL | Standard Deviation 0.71 |
| Efavaleukin Alfa Medium Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 1: 6-24 hrs | 27.4 ng/mL | Standard Deviation 25.7 |
| Efavaleukin Alfa Medium Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 43: 48-96 hrs | 18.1 ng/mL | Standard Deviation 19 |
| Efavaleukin Alfa Medium Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 43: 6-24 hrs | 25.0 ng/mL | Standard Deviation 22.6 |
| Efavaleukin Alfa Medium Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 85 | 0.191 ng/mL | Standard Deviation 0.316 |
| Efavaleukin Alfa Medium Dose | Serum Efavaleukin Alfa Concentrations by Timepoint | Day 29 | 0.0699 ng/mL | Standard Deviation 0.173 |