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 - Hôpital 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
    • Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
  • 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 Clinicos
  • 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 Investigación Clínica
• 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
Percent of patients achieving Systemic Lupus Erythematosus Responder Index-4 (SRI-4) response at week 52	SRI-4 response at Week 52 is defined as a greater than or equal to 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
Percent of patients achieving a SRI-4 response at week 24	SRI-4 response at Week 24 is defined as a greater than or equal to 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 24
Percent of patients achieving Lupus Low Disease Activity State (LLDAS) at week 52	LLDAS response at week 52 is defined as a hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score ≤ 4 with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, and fever) and no haemolytic anaemia or gastrointestinal activity; no new findings of lupus disease activity compared with the previous assessment; ≤ 1-point in Physician Global Assessment (PGA) (scale 0 to 3) current prednisolone-equivalent dosage ≤ 7.5 mg/day; and standard maintenance dosages of immunosuppressive drugs and approved biologics.	Week 52
Percent of patients achieving The British Isles Lupus Assessment Group (BILAG) based Combined Lupus Assessment (BICLA) index responses	BICLA response is defined as at least 1 gradation of improvement in baseline BILAG domain scores in all body systems with moderate or severe disease activity at entry (eg, all A [severe disease] domain scores falling to B [moderate], C [mild], or D [no activity], and all B domain scores falling to C or D); no new BILAG 2004 A domain score and no > than 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 Physician Global Assessment (PGA) (scale 0 to 3); and no use of more than protocol-allowed therapies; and no initiation of non-protocol treatment for SLE.	Week 24 and Week 52
SRI-4 at week 52 with reduction of OCS to less than or equal to 7.5 mg/day by week 44 and sustained through week 52 in subjects with a baseline OCS dose ≥ 10 mg/day	To evaluate the efficacy of Rozibafusp Alfa with oral corticosteroid (OCS)-tapering in subjects with SLE with inadequate response to SOC therapy.	Week 52
Annualized moderate and severe flare rate	Measured by SELENA-SLEDAI Flare Index.	52 weeks
Annualized severe flare rate	Measured by SELENA-SLEDAI Flare Index.	52 weeks
Annualized flare rate	Measured by BILAG score designation of "worse" or "new" resulting in a B score in ≥ 2 organs or an A score in ≥ 1 organ) over 52 weeks.	52 weeks
Total tender and swollen joint count (limited to hands and wrists): ≥ 50% improvement from baseline at week 12, 24, 36, and 52 in subjects with ≥ 6 tender and swollen joints in the hands and wrists at baseline	A joint count will be used to evaluate the effect of Rozibafusp Alfa on additional SLE efficacy endpoints.	Baseline, Week 12, 24, 36, and 52
Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) activity score ≥ 50% improvement from baseline at week 12, 24, 36, and 52 in subjects with a CLASI activity score ≥ 8 at baseline	To evaluate the effect of Rozibafusp Alfa on additional SLE efficacy endpoints	Baseline, Week 12, 24, 36, and 52
Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7A) score change from baseline	To describe the effect of treatment with Rozibafusp Alfa using patient reported outcomes	Baseline, Week 12, 24, 36, 44 and 52
Medical Outcomes Short Form 36 version 2 Questionnaire (SF-36v2) physical component score change from baseline	To describe the effect of treatment with Rozibafusp Alfa using patient reported outcomes	Baseline, Week 12, 24, 36, 44 and 52
Medical Outcomes Short Form 36 version 2 Questionnaire (SF-36v2) mental component score individual domains change from baseline	To describe the effect of treatment with Rozibafusp Alfa using patient reported outcomes	Baseline, Week 12, 24, 36, 44 and 52
Lupus Quality of Life (QoL) score and change from baseline	To describe the effect of treatment with Rozibafusp Alfa using patient reported outcomes	Baseline, Week 12, 24, 36, 44 and 52
Patient Global Assessment (PtGA) score change from baseline	This is an 11-point NRS with 0 indicating lowest disease and 10 highest disease activity.	Baseline, Week 12, 24, 36, 44 and 52
Patient incidence of Treatment-Emergent Adverse Events	To characterize the safety of Rozibafusp Alfa.	52 weeks
Patient incidence of Serious adverse events	To characterize the safety of Rozibafusp Alfa.	52 weeks
Number of patients with significant changes in laboratory values	To characterize the safety of Rozibafusp Alfa.	52 weeks
Number of patients with significant changes in vital signs	To characterize the safety of Rozibafusp Alfa.	52 weeks
Serum Rozibafusp Alfa trough concentrations	To characterize the pharmacokinetics (PK) of Rozibafusp Alfa	52 Weeks
Rozibafusp Alfa terminal elimination half-life, if possible	To characterize the pharmacokinetics (PK) of Rozibafusp Alfa	52 weeks

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.
• 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.

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 (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 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