Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus (SLE)
• Intervention / Treatment: Drug: Rozibafusp Alfa; Drug: Placebo for Rozibafusp Alfa

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • San Juan, Argentina, 5400
    • CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1111AAJ
      • DOM Centro de Reumatología
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
      • Fundacion Respirar - Centro Medico Dra De Salvo
    • Quilmes, Buenos Aires, Argentina, B1878GEG
      • Instituto De Investigaciones Clinicas Quilmes
    • San Isidro, Buenos Aires, Argentina, 1642
      • Instituto Medico de Alta Complejidad San Isidro
  • Distrito Federal
    • Buenos Aires, Distrito Federal, Argentina, C1426BOR
      • Hospital Militar Central - Cirujano Mayor Dr Cosme Argerich
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
      • Centro Medico Privado de Reumatologia
    • San Miguel de Tucuman, Tucuman, Argentina, T4000
      • Clinical Mayo - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L
• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
  • Plovdiv, Bulgaria, 4000
    • Multiprofile Hospital for Active Treatment Trimontium OOD
  • Plovdiv, Bulgaria, 4002
    • University Multiprofile Hospital for Active Treatment - Kaspela EOOD
  • Sofia, Bulgaria, 1784
    • Medical Centre Synexus Sofia EOOD
  • Sofia, Bulgaria, 1407
    • Medical Center Excelsior OOD
  • Sofia, Bulgaria, 1612
    • Medical Center Academy EOOD
  • Sofia, Bulgaria, 1612
    • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
  • Stara Zagora, Bulgaria, 6003
    • Medical Centre Synexus Sofia EOOD - Branch Stara Zagora
• Canada
  • Quebec, Canada, G1V 3M7
    • Groupe de recherche en maladies osseuses Incorporated
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • University of Calgary Cumming School of Medicine
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M4
      • Shared Health Inc. operating the Health Sciences Centre Winnipeg
• Czechia
  • Praha 2, Czechia, 128 50
    • Revmatologicky Ustav
  • Praha 2, Czechia, 120 00
    • Synexus Czech sro
• France
  • Bordeaux, France, 33076
    • Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
  • Caen Cedex 9, France, 14033
    • CHU Hôpital Côte de Nacre
  • Dijon Cedex, France, 21079
    • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand
  • Lille cedex 01, France, 59037
    • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
  • Paris, France, 75013
    • Hôpital Pitié-Salpêtrière
  • Reims Cedex, France, 51092
    • Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré
  • Strasbourg, France, 67091
    • Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
  • Toulouse Cedex 9, France, 31059
    • Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil
• Germany
  • Bad Kreuznach, Germany, 55543
    • Johannes Gutenberg Universitaet Mainz
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig AöR
• Greece
  • Athens, Greece, 11527
    • Laiko General Hospital
  • Athens, Greece, 12462
    • Attiko Hospital
  • Heraklion, Greece, 71500
    • University Hospital of Heraklion
  • Patra, Greece, 26504
    • General University Hospital of Patras Panagia i Voithia
• Hong Kong
  • New Territories, Hong Kong
    • Tuen Mun Hospital
• Hungary
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Gyula, Hungary, 5700
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
  • Szekesfehervar, Hungary, 8000
    • Vita Verum Medical Bt
• Italy
  • Milano, Italy, 20132
    • Irccs Ospedale San Raffaele
  • Pisa, Italy, 56126
    • Azienda Ospedaliera Universitaria Pisana
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Rozzano MI, Italy, 20089
    • IRCCS Istituto Clinico Humanitas
• Japan
  • Chiba
    • Chiba-shi, Chiba, Japan, 260-8712
      • National Hospital Organization Chibahigashi National Hospital
    • Urayasu-shi, Chiba, Japan, 279-0021
      • Juntendo University Urayasu Hospital
  • Fukuoka
    • Kitakyushu-shi, Fukuoka, Japan, 807-8556
      • Hospital of the University of Occupational and Environmental Health Japan
  • Gifu
    • Gifu-shi, Gifu, Japan, 501-1194
      • Gifu University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
    • Sapporo-shi, Hokkaido, Japan, 060-8604
      • Sapporo City General Hospital
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0017
      • Kobe University Hospital
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 980-8574
      • National University Corporation Tohoku University Tohoku University Hospital
  • Nagano
    • Matsumoto-shi, Nagano, Japan, 390-8621
      • Shinshu University Hospital
  • Nagasaki
    • Nagasaki-shi, Nagasaki, Japan, 852-8501
      • Nagasaki University Hospital
    • Omura-shi, Nagasaki, Japan, 856-8562
      • National Hospital Organization Nagasaki Medical Center
    • Sasebo-shi, Nagasaki, Japan, 857-1195
      • Sasebo Chuo Hospital
  • Okayama
    • Kurashiki-shi, Okayama, Japan, 710-8522
      • Kurashiki Medical Clinic
    • Okayama-shi, Okayama, Japan, 700-8558
      • Okayama University Hospital
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 430-8558
      • Seirei Hamamatsu General Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Bunkyo-ku, Tokyo, Japan, 113-8655
      • The University of Tokyo Hospital
    • Chuo-ku, Tokyo, Japan, 104-8560
      • St Lukes International Hospital
    • Meguro-ku, Tokyo, Japan, 152-8902
      • National Hospital Organization Tokyo Medical Center
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
    • Keimyung University Dongsan Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 07985
    • Ewha Womans University MokDong Hospital
  • Suwon-si, Gyeonggi-do, Korea, Republic of, 443-380
    • Ajou University Hospital
• Mexico
  • Ciudad de Mexico, Mexico, 06100
    • Centro Mexicano de Desarrollo de Estudios Clínicos
  • Baja California Norte
    • Mexicali, Baja California Norte, Mexico, 21100
      • Centro Medico del Angel SC
    • Mexicalli, Baja California Norte, Mexico, 21200
      • Centro de Investigacion en Artritis y Osteoporosis SC
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37000
      • Morales Vargas Centro de Investigacion SC
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Centro Integral en Reumatologia SA de CV
  • Yucatán
    • Merida, Yucatán, Mexico, 97000
      • Centro Peninsular De Investigacion Clinica
• Poland
  • Gdansk, Poland, 80-382
    • Synexus Polska Spzoo
  • Gdynia, Poland, 81-537
    • Synexus Polska Spzoo
  • Katowice, Poland, 40-040
    • Synexus Polska Spzoo
  • Katowice, Poland, 40-282
    • Silmedic Spzoo
  • Krakow, Poland, 31-209
    • Tomed Tomasz Miszalski-Jamka Centrum Medyczne
  • Lodz, Poland, 90-127
    • Synexus Polska Spzoo
  • Lodz, Poland, 90-368
    • SOMED CR
  • Lublin, Poland, 20-049
    • 1 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  • Lublin, Poland, 20-078
    • Clinical Best Solutions Spolka z ograniczona odpowiedzialnoscia Spolka komandytowa
  • Poznan, Poland, 60-702
    • Synexus Polska Spzoo
  • Stalowa Wola, Poland, 37-450
    • Sanus Szpital Specjalistyczny Spzoo
  • Warszawa, Poland, 01-737
    • SOMED CR
  • Warszawa, Poland, 02-672
    • Synexus Polska Spolka z ograniczona odpowiedzialnoscia
  • Wroclaw, Poland, 50-088
    • Futuremeds spolka z ograniczona odpowiedzialnoscia
  • Wroclaw, Poland, 50-381
    • Synexus Polska Spzoo
• Portugal
  • Almada, Portugal, 2801-951
    • Hospital Garcia de Orta, EPE
  • Lisboa, Portugal, 1349-019
    • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto EPE - Hospital de Santo Antonio
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universtario de Sao Joao, EPE
• Russian Federation
  • Ekaterinburg, Russian Federation, 620102
    • State Budget Medical Institution Sverdlovsk Regional Clinical Hospital N1
  • Kazan, Russian Federation, 420097
    • Limited liability company Scientific Research Medical Complex Your Health
  • Kemerovo, Russian Federation, 650066
    • LLC Medical Center Maksimum Zdorovia
  • Kemerovo, Russian Federation, 650070
    • LLC Medical center Revma Med
  • Moscow, Russian Federation, 115522
    • FSBSI SRI of Rheumatology na V A Nasonova
  • Novosibirsk, Russian Federation, 630061
    • LLC Center of medicine Healthy family
  • Novosibirsk, Russian Federation, 630091
    • LLC Center of general medicine
  • Saint Petersburg, Russian Federation, 196066
    • LLC Medical Sanitary Unit №157
• Spain
  • Andalucía
    • Sevilla, Andalucía, Spain, 41010
      • Hospital Infanta Luisa
  • Cataluña
    • Barcelona, Cataluña, Spain, 08035
      • Hospital Universitari Vall D Hebron
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Complexo Hospitalario Universitario A Coruña
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Imaging Endpoints
  • California
    • Covina, California, United States, 91723
      • Medvin Clinical Research
    • Fontana, California, United States, 92335
      • Southern California Permanente Medical Group
    • La Jolla, California, United States, 92037
      • University of California San Diego
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Palo Alto, California, United States, 94304
      • Stanford University Hospitals and Clinics
    • San Diego, California, United States, 92108
      • TriWest Research Associates
  • Colorado
    • Aurora, Colorado, United States, 80010
      • University of Colorado Denver
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University
  • Florida
    • Fort Lauderdale, Florida, United States, 33309
      • Centre for Rheumatology Immunology and Arthritis
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Miami Lakes, Florida, United States, 33014
      • Lakes Research LLC
    • Orlando, Florida, United States, 32819
      • Heuer Medical Doctor Research LLC
    • Tampa, Florida, United States, 33609
      • Southwest Florida Clinical Research Center
    • Tampa, Florida, United States, 33613
      • AdventHealth Medical Group
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic
    • Atlanta, Georgia, United States, 30318
      • Piedmont Atlanta Hospital
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine Division of Rheumatology
  • New York
    • Manhasset, New York, United States, 11030
      • Feinstein Institute for Medical Research
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • New York, New York, United States, 10016
      • New York University Langone Orthopedic Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Joint and Muscle Research Institute
    • Charlotte, North Carolina, United States, 28210
      • DJL Clinical Research PLLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Arthritis and Rheumatology Center of Oklahoma PLLC
    • Tulsa, Oklahoma, United States, 74104
      • The Oklahoma Center for Arthritis Therapy and Research Inc
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton South Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Summerville, South Carolina, United States, 29486
      • Articularis Healthcare Group Inc dba Low Country Rheumatology
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78731
      • Austin Regional Clinic Specialty Research
    • Carrollton, Texas, United States, 75007
      • Trinity Universal Research Associates, Inc
    • Houston, Texas, United States, 77004
      • Rheumatic Disease Clinical Research Center LLC
    • Mesquite, Texas, United States, 75150
      • Southwest Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

  • Arthritis: Arthritis (at least 3 tender and swollen joints) must involve joints in the hands or wrists for the hSLEDAI scoring.
  • Alopecia: Subjects should have hair loss without scarring; should neither have alopecia areata nor androgenic alopecia; and should have a CLASI activity score for alopecia ≥ 2.
  • Oral ulcers: Ulcers location and appearance must be documented by the investigator.
  • Scleritis and Episcleritis: the presence of stable SLE-related scleritis and episcleritis must be documented by an ophthalmologist and other causes excluded.
  • Renal: subjects with urine protein/creatinine ratio < 3000 mg/g (or equivalent method) in a clear catch spot urine sample can enroll and be scored in the hSLEDAI, provided the subject has a clinical hSLEDAI ≥ 4 and did not receive induction treatment for nephritis within the last year.
  • Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must be accompanied by objective findings to be scored in the hSLEDAI.

• Unless there is a documented intolerance, subjects must be taking:

  • Only 1 of the following SLE treatments: anti-malarial (hydroxychloroquine, chloroquine, or quinacrine), azathioprine, methotrexate, leflunomide, mycophenolate mofetil/acid mycophenolic, or dapsone.

OR

• 2 of the above-mentioned SLE treatments in which 1 must be anti-malarial (hydroxychloroquine, chloroquine, or quinacrine).

• Treatment should be taken for ≥ 12 weeks prior to screening and must be a stable dose for ≥ 8 weeks prior to screening.
• For subjects taking OCS, dose must be ≤ 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit for ≥ 2 weeks prior to screening visit.

Exclusion Criteria Screening Visit

Subjects are excluded from the study if any of the following criteria apply:

Disease Related

• Urine protein creatinine ratio ≥ 3000 mg/g (or equivalent) at screening or induction therapy for lupus nephritis within 1 year prior to screening visit.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rozibafusp Alfa, Dose A; Investigational product solution in vial	Drug: Rozibafusp Alfa; Rozibafusp Alfa will be presented in 5 mL glass vial
Experimental: Rozibafusp Alfa, Dose B; Investigational product solution in vial	Drug: Rozibafusp Alfa; Rozibafusp Alfa will be presented in 5 mL glass vial
Experimental: Rozibafusp Alfa, Dose C; Investigational product solution in vial	Drug: Rozibafusp Alfa; Rozibafusp Alfa will be presented in 5 mL glass vial
Placebo Comparator: Placebo for Rozibafusp Alfa; Placebo Investigational product solution in vial	Drug: Placebo for Rozibafusp Alfa; Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24	The BICLA response is defined as: An improvement in baseline BILAG domain scores across all body systems with moderate (domain B) or severe disease activity (domain A); No new BILAG 2004 A domain score and no > 1 new BILAG 2004 B domain scores compared with baseline; No worsening of the hSLEDAI score from baseline; No ≥ 0.3-point deterioration from baseline in PGA; No use of more than protocol-allowed therapies; No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants.	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: hSLEDAI ≤ 4, with no activity in major organ system (renal, central nervous system [CNS], cardiopulmonary, vasculitis, fever) and hemolytic anemia or gastrointestinal activity; No new lupus disease activity as compared with the previous assessment; PGA ≤ 1 (on a scale of 0 to 3); Current prednisone or equivalent dose of ≤ 7.5 mg/day; Well-tolerated standard maintenance doses of immunosuppressive drugs and approved treatments, as allowed and specified in the protocol.	Week 52
Number of Participants Who Achieved a BICLA Response at Week 52	The BICLA response is defined as: An improvement in baseline BILAG domain scores across all body systems with moderate (domain B) or severe disease activity (domain A); No new BILAG 2004 A domain score and no > 1 new BILAG 2004 B domain scores compared with baseline; No worsening of the hSLEDAI score from baseline; No ≥ 0.3-point deterioration from baseline in PGA; No use of more than protocol-allowed therapies; No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants.	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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• 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.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2020
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Systemic Lupus Erythematosus; Immunomodulators; Oral Corticosteroids; Standard of Care therapies; Inmunosuppressants; B cell Activating Factor (BAFF); Inducible T cell costimulator ligand (ICOSL)
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 20170588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No