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The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.
This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study in subjects with active SLE and inadequate response to SOC therapies including oral corticosteroids (OCS), immunosuppressants and immunomodulators. Previous biologic use is allowed with an adequate washout period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rozibafusp Alfa, Dose A | Experimental | Investigational product solution in vial |
|
| Rozibafusp Alfa, Dose B | Experimental | Investigational product solution in vial |
|
| Rozibafusp Alfa, Dose C | Experimental | Investigational product solution in vial |
|
| Placebo for Rozibafusp Alfa | Placebo Comparator | Placebo Investigational product solution in vial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rozibafusp Alfa | Drug | Rozibafusp Alfa will be presented in 5 mL glass vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52 | SRI-4 response at Week 52 is defined as a ≥ 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3), and no use of more than protocol allowed therapies. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a SRI-4 Response at Week 24 | SRI-4 response at Week 24 is defined as a ≥ 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies. | Week 24 |
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Inclusion Criteria Screening Visit:
Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
Age ≥ 18 years to ≤ 75 years at screening visit.
Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (Aringer et al, 2019), 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.
Additional protocol-specific rules are applied at screening and throughout the study, as follows:
Unless there is a documented intolerance, subjects must be taking:
OR
• 2 of the above-mentioned SLE treatments in which 1 must be anti-malarial (hydroxychloroquine, chloroquine, or quinacrine).
Exclusion Criteria Screening Visit
Subjects are excluded from the study if any of the following criteria apply:
Disease Related
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Imaging Endpoints |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37491104 | Derived | Garces S, Karis E, Merrill JT, Askanase AD, Kalunian K, Mo M, Milmont CE. Improving resource utilisation in SLE drug development through innovative trial design. Lupus Sci Med. 2023 Jul;10(2):e000890. doi: 10.1136/lupus-2022-000890. | |
| 33687069 | Derived | Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Response adaptive randomization was used to assign eligible participants to receive rozibafusp alfa at 70, 280, and 420 mg administered subcutaneously (SC) every 2 weeks (Q2W), or matching placebo. Randomization started with a 1:1:1:1 ratio and was subsequently adapted according to clinical efficacy.
Participants with active systemic lupus erythematosus (SLE) were recruited across 81 centers in Argentina, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Poland, Portugal, Russia, South Korea, Spain, and the United States from February 2020 to July 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo for a maximum duration of 52 weeks. |
| FG001 | Rozibafusp Alfa 70mg | Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2022 | Jul 17, 2024 |
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This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study in subjects with active SLE and inadequate response to SOC therapies including OCS, immunosuppressants, and immunomodulators. Subjects will be randomized to receive placebo or 1 of 3 doses of Rozibafusp Alfa with the last dose at week 50. Treatment will be administered every 2 weeks (Q2W). All subjects will be required to complete a 16-week follow-up period after the 52-week treatment period.
The first interim analysis (IA) will be executed after the first 40 enrolled subjects have had the opportunity to complete the week 24 assessment. Additional IAs may be executed after approximately every 32 newly enrolled subjects have had the opportunity to complete the week 24 assessment. The last IA will occur when all subjects have had the opportunity to complete the week 24 assessment.
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| Placebo for Rozibafusp Alfa | Drug | Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial |
|
| Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24 | The BICLA response is defined as:
| Week 24 |
| Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52 | LLDAS was defined as meeting all the following conditions:
| Week 52 |
| Number of Participants Who Achieved a BICLA Response at Week 52 | The BICLA response is defined as:
| Week 52 |
| Number of Participants Achieving a SRI-4 Response 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 | SRI-4 response is defined as a ≥ 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies. Participants also had to meet a reduction if OCS to ≤ 7.5 mg/day by Week 44 sustained through Week 52. | Up to Week 52 |
| Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI) | The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Moderate and severe flare: • Moderate: meeting criteria like SELENA-SLEDAI score change of 3 to 12 points, SLE symptom development, prednisone dose increase, non-steroidal anti-inflammatory drugs (NSAIDs)/hydrochloroquine addition, or PGA score increase by 1 to 2.5. • Severe: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. Annualized flare rate was calculated as the number of flares divided by flare exposure time in days, multiplied by 365.25 for each Group. | Up to Week 52 |
| Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI | The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Severe flare: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group. | Up to Week 52 |
| Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of "Worse" or "New" Resulting in a B-Score In ≥ 2 Organs or an A-Score in ≥ 1 Organ | The BILAG flare index was derived from BILAG 2004, as measured by BILAG score designation of 'worse' or 'new' resulting in a B score in >= 2 organs or an A score in >= 1 organ. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group. | Up to Week 52 |
| Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | The tender and swollen joint count is a physical assessment where for each swollen and tender joint a score of 1 is assigned. Scores are then summed up to provide a total score for both swollen and tender joints. Higher total score indicate a severe disease activity and a lower score indicates a lees severe disease activity. | Week 12, 24, 36, and 52 |
| Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | The CLASI is an assessment tool consisting of two scores: one for disease activity and one for damage. Activity Score: Ranges from 0 to 70, and is assessed based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia. Higher scores indicate more severe disease activity. Damage Score: Ranges from 0 to 56, and is evaluated through dyspigmentation and scarring, including scarring alopecia. Dyspigmentation that remains visible for more than 12 months is considered permanent, and its score is doubled. Higher scores indicate greater damage. | Week 12, 24, 36, and 52 |
| Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | The PROMIS-Fatigue SF7a is a 7-item instrument that assesses the experience of fatigue as well as its impact on physical, mental and social activities. Each item is scored on a 5-point Likert scale, ranging from "1" (Never) to "5" (Always). The scores of all 7 items are summed up with a total raw score range of 7(low level of fatigue)-35(high level of fatigue). Raw scores are converted to a T-score ranging from 29.4(low level of fatigue)-83.2(high level of fatigue). | Week 12, 24, 36, 44, and 52 |
| Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | Week 12, 24, 36, 44, and 52 |
| Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | Week 12, 24, 36, 44, and 52 |
| Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | Week 12, 24, 36, 44, and 52 |
| Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | Week 12, 24, 36, 44, and 52 |
| Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | Week 12, 24, 36, 44, and 52 |
| Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | Week 12, 24, 36, 44, and 52 |
| Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | Week 12, 24, 36, 44, and 52 |
| Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | Week 12, 24, 36, 44, and 52 |
| Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | Week 12, 24, 36, 44, and 52 |
| Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | Week 12, 24, 36, 44, and 52 |
| Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | The LupusQoL questionnaire consists of 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Each item in the questionnaire is scored on a 5 point scale and items within a given domain are summed and converted to a 0-100 scale. Each domain is scored 0-100 with higher scores representing better quality of life in the specific domain. Lower scores signify poorer quality of life within the domain. | Week 12, 24, 36, 44, and 52 |
| Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | The PtGA assesses disease activity on a 10 cm numeric rating scale (NRS; 0 to 10 cm). The scale for the assessment ranges from "very well" (0) to "very poor" (10). | Week 12, 24, 36, 44, and 52 |
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any negative medical occurrence linked to an intervention in humans, regardless of its relation to the intervention. Treatment-emergent AEs (TEAEs) were those that occurred after the first intervention dose. A serious adverse event (SAE) included outcomes such as death, life-threatening situations, hospitalization or an extended hospital stay, significant incapacity, congenital defects, or other crucial medical events. AE severity followed the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death). Clinically significant laboratory results or other assessments (e.g., ECGs, scans, vital signs) that worsened from baseline and were deemed important by the investigator, independent of disease progression, were also considered. | Up to approximately 68 weeks |
| Serum Concentration of Rozibafusp Alfa | Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36, Week 44, Week 52, Week 56, Week 60, Week 64, and Week 68 |
| Terminal Half-life of Rozibafusp Alfa | Up to Week 68 |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Medvin Clinical Research | Covina | California | 91723 | United States |
| Southern California Permanente Medical Group | Fontana | California | 92335 | United States |
| University of California San Diego | La Jolla | California | 92037 | United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| Stanford University Hospitals and Clinics | Palo Alto | California | 94304 | United States |
| TriWest Research Associates | San Diego | California | 92108 | United States |
| University of Colorado Denver | Aurora | Colorado | 80010 | United States |
| Yale University | New Haven | Connecticut | 06519 | United States |
| Centre for Rheumatology Immunology and Arthritis | Fort Lauderdale | Florida | 33309 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Lakes Research LLC | Miami Lakes | Florida | 33014 | United States |
| Heuer Medical Doctor Research LLC | Orlando | Florida | 32819 | United States |
| Southwest Florida Clinical Research Center | Tampa | Florida | 33609 | United States |
| AdventHealth Medical Group | Tampa | Florida | 33613 | United States |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30318 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc | Skokie | Illinois | 60076 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| University of Maryland School of Medicine Division of Rheumatology | Baltimore | Maryland | 21201 | United States |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| New York University Langone Orthopedic Center | New York | New York | 10016 | United States |
| Hospital For Special Surgery | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Joint and Muscle Research Institute | Charlotte | North Carolina | 28204 | United States |
| DJL Clinical Research PLLC | Charlotte | North Carolina | 28210 | United States |
| Arthritis and Rheumatology Center of Oklahoma PLLC | Oklahoma City | Oklahoma | 73102 | United States |
| The Oklahoma Center for Arthritis Therapy and Research Inc | Tulsa | Oklahoma | 74104 | United States |
| Penn State Milton South Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Articularis Healthcare Group Inc dba Low Country Rheumatology | Summerville | South Carolina | 29486 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Austin Regional Clinic Specialty Research | Austin | Texas | 78731 | United States |
| Trinity Universal Research Associates, Inc | Carrollton | Texas | 75007 | United States |
| Rheumatic Disease Clinical Research Center LLC | Houston | Texas | 77004 | United States |
| Southwest Rheumatology | Mesquite | Texas | 75150 | United States |
| Dom Centro de Reumatologia | CABA | Buenos Aires | C1111AAJ | Argentina |
| Fundacion Respirar - Centro Medico Dra De Salvo | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1426ABP | Argentina |
| Instituto de Investigaciones Clinicas Quilmes | Quilmes | Buenos Aires | B1878GEG | Argentina |
| Instituto Medico de Alta Complejidad San Isidro | San Isidro | Buenos Aires | 1642 | Argentina |
| Hospital Militar Central - Cirujano Mayor Dr Cosme Argerich | Buenos Aires | Distrito Federal | C1426BOR | Argentina |
| Centro Medico Privado de Reumatologia | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| Clinical Mayo - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L | San Miguel de Tucumán | Tucumán Province | T4000 | Argentina |
| CER San Juan - Centro Polivalente de Asistencia e Investigacion Clinica | San Juan | 5400 | Argentina |
| Holdsworth House Medical Practice | Sydney | New South Wales | 2010 | Australia |
| The Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| Multiprofile Hospital for Active Treatment Trimontium OOD | Plovdiv | 4000 | Bulgaria |
| University Multiprofile Hospital for Active Treatment - Kaspela EOOD | Plovdiv | 4002 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sveti Georgi EAD | Plovdiv | 4002 | Bulgaria |
| Medical Center Excelsior OOD | Sofia | 1407 | Bulgaria |
| Medical Center Academy EOOD | Sofia | 1612 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD | Sofia | 1612 | Bulgaria |
| Medical Centre Synexus Sofia EOOD | Sofia | 1784 | Bulgaria |
| Medical Centre Synexus Sofia EOOD - Branch Stara Zagora | Stara Zagora | 6003 | Bulgaria |
| University of Calgary Cumming School of Medicine | Calgary | Alberta | T2N 4N1 | Canada |
| Shared Health Inc. operating the Health Sciences Centre Winnipeg | Winnipeg | Manitoba | R3A 1M4 | Canada |
| Groupe de recherche en maladies osseuses Incorporated | Québec | Quebec | G1V 3M7 | Canada |
| Synexus Czech sro | Prague | 120 00 | Czechia |
| Revmatologicky ustav | Prague | 128 50 | Czechia |
| Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin | Bordeaux | 33076 | France |
| CHU Hôpital Côte de Nacre | Caen | 14033 | France |
| Centre Hospitalier Universitaire Dijon Bourgogne - Hopital Francois Mitterrand | Dijon | 21079 | France |
| Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez | Lille | 59037 | France |
| Hopital Pitie-Salpetriere | Paris | 75013 | France |
| Centre Hospitalier Universitaire de Reims - Hopital Robert Debre | Reims | 51092 | France |
| Centre Hospitalier Universitaire de Strasbourg - Nouvel hopital civil | Strasbourg | 67091 | France |
| Centre Hospitalier Universitaire de Toulouse - Hopital Purpan | Toulouse | 31059 | France |
| Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil | Toulouse | 31059 | France |
| Johannes Gutenberg Universitaet Mainz | Bad Kreuznach | 55543 | Germany |
| Universitätsklinikum Leipzig AöR | Leipzig | 04103 | Germany |
| Laiko General Hospital | Athens | 11527 | Greece |
| Attiko Hospital | Athens | 12462 | Greece |
| University Hospital of Heraklion | Heraklion | 71500 | Greece |
| General University Hospital of Patras Panagia i Voithia | Pátrai | 26504 | Greece |
| Tuen Mun Hospital | New Territories | Hong Kong |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Gyula | 5700 | Hungary |
| Vita Verum Medical Bt | Székesfehérvár | 8000 | Hungary |
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| Azienda Ospedaliera Universitaria Pisana | Pisa | 56126 | Italy |
| Policlinico Universitario Agostino Gemelli | Roma | 00168 | Italy |
| IRCCS Istituto Clinico Humanitas | Rozzano MI | 20089 | Italy |
| National Hospital Organization Chibahigashi National Hospital | Chiba | Chiba | 260-8712 | Japan |
| Juntendo University Urayasu Hospital | Urayasu-shi | Chiba | 279-0021 | Japan |
| Hospital of the University of Occupational and Environmental Health Japan | Kitakyushu-shi | Fukuoka | 807-8556 | Japan |
| Gifu University Hospital | Gifu | Gifu | 501-1194 | Japan |
| Sapporo City General Hospital | Sapporo | Hokkaido | 060-8604 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Kobe University Hospital | Kobe | Hyōgo | 650-0017 | Japan |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| National University Corporation Tohoku University Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Shinshu University Hospital | Matsumoto-shi | Nagano | 390-8621 | Japan |
| Nagasaki University Hospital | Nagasaki | Nagasaki | 852-8501 | Japan |
| National Hospital Organization Nagasaki Medical Center | Omura-shi | Nagasaki | 856-8562 | Japan |
| Sasebo Chuo Hospital | Sasebo-shi | Nagasaki | 857-1195 | Japan |
| Kurashiki Medical Clinic | Kurashiki-shi | Okayama-ken | 710-8522 | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | 700-8558 | Japan |
| Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka | 430-8558 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| The University of Tokyo Hospital | Bunkyo-ku | Tokyo | 113-8655 | Japan |
| St Lukes International Hospital | Chuo-ku | Tokyo | 104-8560 | Japan |
| National Hospital Organization Tokyo Medical Center | Meguro-ku | Tokyo | 152-8902 | Japan |
| Keio University Hospital | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Centro Medico del Angel SC | Mexicali | Baja California Norte | 21100 | Mexico |
| Centro de Investigacion en Artritis y Osteoporosis SC | Mexicalli | Baja California Norte | 21200 | Mexico |
| Morales Vargas Centro de Investigacion SC | León | Guanajuato | 37000 | Mexico |
| Centro Integral en Reumatologia SA de CV | Guadalajara | Jalisco | 44160 | Mexico |
| Centro Peninsular de Investigación Clínica | Mérida | Yucatán | 97000 | Mexico |
| Centro Mexicano de Desarrollo de Estudios Clinicos | Mexico City | 06100 | Mexico |
| Synexus Polska Spzoo | Gdansk | 80-382 | Poland |
| Synexus Polska Spzoo | Gdynia | 81-537 | Poland |
| Synexus Polska Spzoo | Katowice | 40-040 | Poland |
| Silmedic Spzoo | Katowice | 40-282 | Poland |
| Tomed Tomasz Miszalski-Jamka Centrum Medyczne | Krakow | 31-209 | Poland |
| Synexus Polska Spzoo | Lodz | 90-127 | Poland |
| Somed cr | Lodz | 90-368 | Poland |
| 1 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Lublin | 20-049 | Poland |
| Clinical Best Solutions Spolka z ograniczona odpowiedzialnoscia Spolka komandytowa | Lublin | 20-078 | Poland |
| Synexus Polska Spzoo | Poznan | 60-702 | Poland |
| Sanus Szpital Specjalistyczny Spzoo | Stalowa Wola | 37-450 | Poland |
| SOMED CR | Warsaw | 01-737 | Poland |
| Synexus Polska Spolka z ograniczona odpowiedzialnoscia | Warsaw | 02-672 | Poland |
| Futuremeds spolka z ograniczona odpowiedzialnoscia | Wroclaw | 50-088 | Poland |
| Synexus Polska Spzoo | Wroclaw | 50-381 | Poland |
| Hospital Garcia de Orta, EPE | Almada | 2801-951 | Portugal |
| Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz | Lisbon | 1349-019 | Portugal |
| Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar do Porto EPE - Hospital de Santo Antonio | Porto | 4099-001 | Portugal |
| Centro Hospitalar Universtario de Sao Joao, EPE | Porto | 4200-319 | Portugal |
| Limited liability company Scientific Research Medical Complex Your Health | Kazan' | 420097 | Russia |
| LLC Medical Center Maksimum Zdorovia | Kemerovo | 650066 | Russia |
| LLC Medical center Revma Med | Kemerovo | 650070 | Russia |
| FSBSI SRI of Rheumatology na V A Nasonova | Moscow | 115522 | Russia |
| LLC Center of medicine Healthy family | Novosibirsk | 630061 | Russia |
| LLC Center of general medicine | Novosibirsk | 630091 | Russia |
| LLC Medical Sanitary Unit №157 | Saint Petersburg | 196066 | Russia |
| State Budget Medical Institution Sverdlovsk Regional Clinical Hospital N1 | Yekaterinburg | 620102 | Russia |
| Keimyung University Dongsan Hospital | Daegu | 42601 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Ajou University Hospital | Suwon-si, Gyeonggi-do | 443-380 | South Korea |
| Hospital Infanta Luisa | Seville | Andalusia | 41010 | Spain |
| Hospital Universitari Vall d Hebron | Barcelona | Catalonia | 08035 | Spain |
| Complexo Hospitalario Universitario A Coruña | A Coruña | Galicia | 15006 | Spain |
| FG002 | Rozibafusp Alfa 280mg | Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks. |
| FG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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The Full Analysis Set (FAS) included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo for a maximum duration of 52 weeks. |
| BG001 | Rozibafusp Alfa 70mg | Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks. |
| BG002 | Rozibafusp Alfa 280mg | Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks. |
| BG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52 | SRI-4 response at Week 52 is defined as a ≥ 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3), and no use of more than protocol allowed therapies. | The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis. | Posted | Count of Participants | Participants | Week 52 |
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| Secondary | Number of Participants With a SRI-4 Response at Week 24 | SRI-4 response at Week 24 is defined as a ≥ 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies. | The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis. | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24 | The BICLA response is defined as:
| The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis. | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52 | LLDAS was defined as meeting all the following conditions:
| The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis. | Posted | Count of Participants | Participants | Week 52 |
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| Secondary | Number of Participants Who Achieved a BICLA Response at Week 52 | The BICLA response is defined as:
| The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis. | Posted | Count of Participants | Participants | Week 52 |
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| Secondary | Number of Participants Achieving a SRI-4 Response 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 | SRI-4 response is defined as a ≥ 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies. Participants also had to meet a reduction if OCS to ≤ 7.5 mg/day by Week 44 sustained through Week 52. | The FAS included all randomized participants. Only participants who had a baseline OCS dose ≥ 10 mg/day and had the opportunity to complete Week 52 visit by the date of the study termination were included in the analysis. | Posted | Count of Participants | Participants | Up to Week 52 |
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| Secondary | Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI) | The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Moderate and severe flare: • Moderate: meeting criteria like SELENA-SLEDAI score change of 3 to 12 points, SLE symptom development, prednisone dose increase, non-steroidal anti-inflammatory drugs (NSAIDs)/hydrochloroquine addition, or PGA score increase by 1 to 2.5. • Severe: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. Annualized flare rate was calculated as the number of flares divided by flare exposure time in days, multiplied by 365.25 for each Group. | The FAS included all randomized participants. | Posted | Number | Flares/year | Up to Week 52 |
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| Secondary | Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI | The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Severe flare: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group. | The FAS included all randomized participants. | Posted | Number | Flares/year | Up to Week 52 |
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| Secondary | Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of "Worse" or "New" Resulting in a B-Score In ≥ 2 Organs or an A-Score in ≥ 1 Organ | The BILAG flare index was derived from BILAG 2004, as measured by BILAG score designation of 'worse' or 'new' resulting in a B score in >= 2 organs or an A score in >= 1 organ. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group. | The FAS included all randomized participants. | Posted | Number | Flares/year | Up to Week 52 |
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| Secondary | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | The tender and swollen joint count is a physical assessment where for each swollen and tender joint a score of 1 is assigned. Scores are then summed up to provide a total score for both swollen and tender joints. Higher total score indicate a severe disease activity and a lower score indicates a lees severe disease activity. | The FAS included all randomized participants. Only participants who had ≥ 6 tender and swollen joints involving hands and wrists at baseline and had opportunity to complete the visit by the date of the study termination were included in the analysis. | Posted | Count of Participants | Participants | Week 12, 24, 36, and 52 |
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| Secondary | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | The CLASI is an assessment tool consisting of two scores: one for disease activity and one for damage. Activity Score: Ranges from 0 to 70, and is assessed based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia. Higher scores indicate more severe disease activity. Damage Score: Ranges from 0 to 56, and is evaluated through dyspigmentation and scarring, including scarring alopecia. Dyspigmentation that remains visible for more than 12 months is considered permanent, and its score is doubled. Higher scores indicate greater damage. | The FAS included all randomized participants. Only participants who had CLASI activity score ≥ 8 at baseline and had the opportunity to complete the visit by the date of the study termination were included in the analysis. | Posted | Count of Participants | Participants | Week 12, 24, 36, and 52 |
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| Secondary | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | The PROMIS-Fatigue SF7a is a 7-item instrument that assesses the experience of fatigue as well as its impact on physical, mental and social activities. Each item is scored on a 5-point Likert scale, ranging from "1" (Never) to "5" (Always). The scores of all 7 items are summed up with a total raw score range of 7(low level of fatigue)-35(high level of fatigue). Raw scores are converted to a T-score ranging from 29.4(low level of fatigue)-83.2(high level of fatigue). | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | T-score | Week 12, 24, 36, 44, and 52 |
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| Secondary | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 12, 24, 36, 44, and 52 |
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| Secondary | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 12, 24, 36, 44, and 52 |
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| Secondary | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 12, 24, 36, 44, and 52 |
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| Secondary | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 12, 24, 36, 44, and 52 |
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| Secondary | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 12, 24, 36, 44, and 52 |
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| Secondary | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 12, 24, 36, 44, and 52 |
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| Secondary | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 12, 24, 36, 44, and 52 |
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| Secondary | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 12, 24, 36, 44, and 52 |
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| Secondary | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 12, 24, 36, 44, and 52 |
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| Secondary | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 12, 24, 36, 44, and 52 |
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| Secondary | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | The LupusQoL questionnaire consists of 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Each item in the questionnaire is scored on a 5 point scale and items within a given domain are summed and converted to a 0-100 scale. Each domain is scored 0-100 with higher scores representing better quality of life in the specific domain. Lower scores signify poorer quality of life within the domain. | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 12, 24, 36, 44, and 52 |
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| Secondary | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | The PtGA assesses disease activity on a 10 cm numeric rating scale (NRS; 0 to 10 cm). The scale for the assessment ranges from "very well" (0) to "very poor" (10). | The FAS included all randomized participants. Only participants with observed data were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 12, 24, 36, 44, and 52 |
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| Secondary | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any negative medical occurrence linked to an intervention in humans, regardless of its relation to the intervention. Treatment-emergent AEs (TEAEs) were those that occurred after the first intervention dose. A serious adverse event (SAE) included outcomes such as death, life-threatening situations, hospitalization or an extended hospital stay, significant incapacity, congenital defects, or other crucial medical events. AE severity followed the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death). Clinically significant laboratory results or other assessments (e.g., ECGs, scans, vital signs) that worsened from baseline and were deemed important by the investigator, independent of disease progression, were also considered. | The Safety Analysis Set (SAS) included all randomized participants who received at least 1 dose of investigational product (IP). | Posted | Count of Participants | Participants | Up to approximately 68 weeks |
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| Secondary | Serum Concentration of Rozibafusp Alfa | The pharmacokinetic (PK) concentration analysis set contained all participants who received at least one dose of IP and had at least one quantifiable PK sample collected. PK concentration data was analyzed according to the actual treatment received. | Posted | Mean | Standard Deviation | μg/mL | Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36, Week 44, Week 52, Week 56, Week 60, Week 64, and Week 68 |
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| Secondary | Terminal Half-life of Rozibafusp Alfa | Per the SAP, data for this outcome measure was not to be analyzed unless it could be adequately estimated. | Posted | Up to Week 68 |
|
|
Up to approximately 68 weeks
The SAS included all randomized participants who received at least 1 dose of IP. All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received matching placebo for a maximum duration of 52 weeks. | 0 | 62 | 6 | 62 | 29 | 62 |
| EG001 | Rozibafusp Alfa 70 mg | Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks. | 1 | 58 | 7 | 58 | 34 | 58 |
| EG002 | Rozibafusp Alfa 280 mg | Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks. | 0 | 36 | 5 | 36 | 20 | 36 |
| EG003 | Rozibafusp Alfa 420 mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. | 0 | 88 | 3 | 87 | 51 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Serositis | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SLE arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Benign pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vocal cord thickening | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 3, 2023 | Jul 17, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729492 | rozibafusp alfa |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black (or African American) |
|
| Multiple |
|
| Native Hawaiian or Other Pacific Islander |
|
| Unknown |
|
| White |
|
| Other |
|
Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks.
| OG002 | Rozibafusp Alfa 280mg | Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks. |
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks.
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| Rozibafusp Alfa 280mg |
Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks. |
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
| OG003 |
| Rozibafusp Alfa 420mg |
Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
|
|
| OG002 | Rozibafusp Alfa 280mg | Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks. |
| OG003 | Rozibafusp Alfa 420mg | Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. |
|
|
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|---|---|
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