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

Primary Purpose

Systemic Lupus Erythematosus (SLE)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rozibafusp Alfa
Placebo for Rozibafusp Alfa
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus (SLE) focused on measuring Standard of Care therapies, Oral Corticosteroids, Inmunosuppressants, Immunomodulators, Systemic Lupus Erythematosus, B cell Activating Factor (BAFF), Inducible T cell costimulator ligand (ICOSL)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Imaging Endpoints
  • Medvin Clinical Research
  • Southern California Permanente Medical Group
  • University of California San Diego
  • University of California Los Angeles
  • Stanford University Hospitals and Clinics
  • TriWest Research Associates
  • University of Colorado Denver
  • Yale University
  • Centre for Rheumatology Immunology and Arthritis
  • University of Florida
  • Lakes Research LLC
  • Heuer Medical Doctor Research LLC
  • Southwest Florida Clinical Research Center
  • AdventHealth Medical Group
  • Piedmont Atlanta Hospital
  • The Emory Clinic
  • Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc
  • Ochsner Clinic Foundation
  • University of Maryland School of Medicine Division of Rheumatology
  • Feinstein Institute for Medical Research
  • New York University Langone Orthopedic Center
  • Hospital For Special Surgery
  • Columbia University Medical Center
  • SUNY Upstate Medical University
  • Joint and Muscle Research Institute
  • DJL Clinical Research PLLC
  • Arthritis and Rheumatology Center of Oklahoma PLLC
  • The Oklahoma Center for Arthritis Therapy and Research Inc
  • Penn State Milton South Hershey Medical Center
  • University of Pennsylvania
  • Medical University of South Carolina
  • Articularis Healthcare Group Inc dba Low Country Rheumatology
  • Vanderbilt University Medical Center
  • Austin Regional Clinic Specialty Research
  • Trinity Universal Research Associates, Inc
  • Rheumatic Disease Clinical Research Center LLC
  • Southwest Rheumatology
  • Dom Centro de Reumatologia
  • Fundacion Respirar - Centro Medico Dra De Salvo
  • Instituto de Investigaciones Clinicas Quilmes
  • Instituto Medico de Alta Complejidad San Isidro
  • Hospital Militar Central - Cirujano Mayor Dr Cosme Argerich
  • Centro Medico Privado de Reumatologia
  • Clinical Mayo - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L
  • CER San Juan - Centro Polivalente de Asistencia e Investigacion Clinica
  • Holdsworth House Medical Practice
  • The Queen Elizabeth Hospital
  • Multiprofile Hospital for Active Treatment Trimontium OOD
  • University Multiprofile Hospital for Active Treatment - Kaspela EOOD
  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
  • Medical Center Excelsior OOD
  • Medical Center Academy EOOD
  • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
  • Medical Centre Synexus Sofia EOOD
  • Medical Centre Synexus Sofia EOOD - Branch Stara Zagora
  • University of Calgary Cumming School of Medicine
  • Shared Health Inc. operating the Health Sciences Centre Winnipeg
  • Groupe de recherche en maladies osseuses Incorporated
  • Synexus Czech sro
  • Revmatologicky ustav
  • Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
  • CHU Hôpital Côte de Nacre
  • Centre Hospitalier Universitaire Dijon Bourgogne - Hopital Francois Mitterrand
  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
  • Hopital Pitie-Salpetriere
  • Centre Hospitalier Universitaire de Reims - Hopital Robert Debre
  • Centre Hospitalier Universitaire de Strasbourg - Nouvel hopital civil
  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
  • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
  • Johannes Gutenberg Universitaet Mainz
  • Universitätsklinikum Leipzig AöR
  • Laiko General Hospital
  • Attiko Hospital
  • University Hospital of Heraklion
  • General University Hospital of Patras Panagia i Voithia
  • Tuen Mun Hospital
  • Debreceni Egyetem Klinikai Kozpont
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
  • Vita Verum Medical Bt
  • IRCCS Ospedale San Raffaele
  • Azienda Ospedaliera Universitaria Pisana
  • Policlinico Universitario Agostino Gemelli
  • IRCCS Istituto Clinico Humanitas
  • National Hospital Organization Chibahigashi National Hospital
  • Juntendo University Urayasu Hospital
  • Hospital of the University of Occupational and Environmental Health Japan
  • Gifu University Hospital
  • Sapporo City General Hospital
  • Hokkaido University Hospital
  • Kobe University Hospital
  • Kanazawa University Hospital
  • National University Corporation Tohoku University Tohoku University Hospital
  • Shinshu University Hospital
  • Nagasaki University Hospital
  • National Hospital Organization Nagasaki Medical Center
  • Sasebo Chuo Hospital
  • Kurashiki Medical Clinic
  • Okayama University Hospital
  • Seirei Hamamatsu General Hospital
  • Juntendo University Hospital
  • The University of Tokyo Hospital
  • St Lukes International Hospital
  • National Hospital Organization Tokyo Medical Center
  • Keio University Hospital
  • Keimyung University Dongsan Hospital
  • Seoul National University Hospital
  • Ewha Womans University Mokdong Hospital
  • Ajou University Hospital
  • Centro Medico del Angel SC
  • Centro de Investigacion en Artritis y Osteoporosis SC
  • Morales Vargas Centro de Investigacion SC
  • Centro Integral en Reumatologia SA de CV
  • Centro Peninsular de Investigación Clínica
  • Centro Mexicano de Desarrollo de Estudios Clinicos
  • Synexus Polska Spzoo
  • Synexus Polska Spzoo
  • Synexus Polska Spzoo
  • Silmedic Spzoo
  • Tomed Tomasz Miszalski-Jamka Centrum Medyczne
  • Synexus Polska Spzoo
  • Somed cr
  • 1 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  • Clinical Best Solutions Spolka z ograniczona odpowiedzialnoscia Spolka komandytowa
  • Synexus Polska Spzoo
  • Sanus Szpital Specjalistyczny Spzoo
  • SOMED CR
  • Synexus Polska Spolka z ograniczona odpowiedzialnoscia
  • Futuremeds spolka z ograniczona odpowiedzialnoscia
  • Synexus Polska Spzoo
  • Hospital Garcia de Orta, EPE
  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz
  • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
  • Centro Hospitalar do Porto EPE - Hospital de Santo Antonio
  • Centro Hospitalar Universtario de Sao Joao, EPE
  • State Budget Medical Institution Sverdlovsk Regional Clinical Hospital N1
  • Limited liability company Scientific Research Medical Complex Your Health
  • LLC Medical Center Maksimum Zdorovia
  • LLC Medical center Revma Med
  • FSBSI SRI of Rheumatology na V A Nasonova
  • LLC Center of medicine Healthy family
  • LLC Center of general medicine
  • LLC Medical Sanitary Unit №157
  • Hospital Infanta Luisa
  • Hospital Universitari Vall d Hebron
  • Complexo Hospitalario Universitario A Coruña

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Rozibafusp Alfa, Dose A

Rozibafusp Alfa, Dose B

Rozibafusp Alfa, Dose C

Placebo for Rozibafusp Alfa

Arm Description

Investigational product solution in vial

Investigational product solution in vial

Investigational product solution in vial

Placebo Investigational product solution in vial

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Annualized moderate and severe flare rate
Measured by SELENA-SLEDAI Flare Index.
Annualized severe flare rate
Measured by SELENA-SLEDAI Flare Index.
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.
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.
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
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
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
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
Lupus Quality of Life (QoL) score and change from baseline
To describe the effect of treatment with Rozibafusp Alfa using patient reported outcomes
Patient Global Assessment (PtGA) score change from baseline
This is an 11-point NRS with 0 indicating lowest disease and 10 highest disease activity.
Patient incidence of Treatment-Emergent Adverse Events
To characterize the safety of Rozibafusp Alfa.
Patient incidence of Serious adverse events
To characterize the safety of Rozibafusp Alfa.
Number of patients with significant changes in laboratory values
To characterize the safety of Rozibafusp Alfa.
Number of patients with significant changes in vital signs
To characterize the safety of Rozibafusp Alfa.
Serum Rozibafusp Alfa trough concentrations
To characterize the pharmacokinetics (PK) of Rozibafusp Alfa
Rozibafusp Alfa terminal elimination half-life, if possible
To characterize the pharmacokinetics (PK) of Rozibafusp Alfa

Full Information

First Posted
July 30, 2019
Last Updated
October 2, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04058028
Brief Title
Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus (SLE)
Keywords
Standard of Care therapies, Oral Corticosteroids, Inmunosuppressants, Immunomodulators, Systemic Lupus Erythematosus, B cell Activating Factor (BAFF), Inducible T cell costimulator ligand (ICOSL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model 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 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rozibafusp Alfa, Dose A
Arm Type
Experimental
Arm Description
Investigational product solution in vial
Arm Title
Rozibafusp Alfa, Dose B
Arm Type
Experimental
Arm Description
Investigational product solution in vial
Arm Title
Rozibafusp Alfa, Dose C
Arm Type
Experimental
Arm Description
Investigational product solution in vial
Arm Title
Placebo for Rozibafusp Alfa
Arm Type
Placebo Comparator
Arm Description
Placebo Investigational product solution in vial
Intervention Type
Drug
Intervention Name(s)
Rozibafusp Alfa
Intervention Description
Rozibafusp Alfa will be presented in 5 mL glass vial
Intervention Type
Drug
Intervention Name(s)
Placebo for Rozibafusp Alfa
Intervention Description
Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial
Primary Outcome Measure Information:
Title
Percent of patients achieving Systemic Lupus Erythematosus Responder Index-4 (SRI-4) response at week 52
Description
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.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percent of patients achieving a SRI-4 response at week 24
Description
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.
Time Frame
Week 24
Title
Percent of patients achieving Lupus Low Disease Activity State (LLDAS) at week 52
Description
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.
Time Frame
Week 52
Title
Percent of patients achieving The British Isles Lupus Assessment Group (BILAG) based Combined Lupus Assessment (BICLA) index responses
Description
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.
Time Frame
Week 24 and Week 52
Title
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
Description
To evaluate the efficacy of Rozibafusp Alfa with oral corticosteroid (OCS)-tapering in subjects with SLE with inadequate response to SOC therapy.
Time Frame
Week 52
Title
Annualized moderate and severe flare rate
Description
Measured by SELENA-SLEDAI Flare Index.
Time Frame
52 weeks
Title
Annualized severe flare rate
Description
Measured by SELENA-SLEDAI Flare Index.
Time Frame
52 weeks
Title
Annualized flare rate
Description
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.
Time Frame
52 weeks
Title
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
Description
A joint count will be used to evaluate the effect of Rozibafusp Alfa on additional SLE efficacy endpoints.
Time Frame
Baseline, Week 12, 24, 36, and 52
Title
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
Description
To evaluate the effect of Rozibafusp Alfa on additional SLE efficacy endpoints
Time Frame
Baseline, Week 12, 24, 36, and 52
Title
Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7A) score change from baseline
Description
To describe the effect of treatment with Rozibafusp Alfa using patient reported outcomes
Time Frame
Baseline, Week 12, 24, 36, 44 and 52
Title
Medical Outcomes Short Form 36 version 2 Questionnaire (SF-36v2) physical component score change from baseline
Description
To describe the effect of treatment with Rozibafusp Alfa using patient reported outcomes
Time Frame
Baseline, Week 12, 24, 36, 44 and 52
Title
Medical Outcomes Short Form 36 version 2 Questionnaire (SF-36v2) mental component score individual domains change from baseline
Description
To describe the effect of treatment with Rozibafusp Alfa using patient reported outcomes
Time Frame
Baseline, Week 12, 24, 36, 44 and 52
Title
Lupus Quality of Life (QoL) score and change from baseline
Description
To describe the effect of treatment with Rozibafusp Alfa using patient reported outcomes
Time Frame
Baseline, Week 12, 24, 36, 44 and 52
Title
Patient Global Assessment (PtGA) score change from baseline
Description
This is an 11-point NRS with 0 indicating lowest disease and 10 highest disease activity.
Time Frame
Baseline, Week 12, 24, 36, 44 and 52
Title
Patient incidence of Treatment-Emergent Adverse Events
Description
To characterize the safety of Rozibafusp Alfa.
Time Frame
52 weeks
Title
Patient incidence of Serious adverse events
Description
To characterize the safety of Rozibafusp Alfa.
Time Frame
52 weeks
Title
Number of patients with significant changes in laboratory values
Description
To characterize the safety of Rozibafusp Alfa.
Time Frame
52 weeks
Title
Number of patients with significant changes in vital signs
Description
To characterize the safety of Rozibafusp Alfa.
Time Frame
52 weeks
Title
Serum Rozibafusp Alfa trough concentrations
Description
To characterize the pharmacokinetics (PK) of Rozibafusp Alfa
Time Frame
52 Weeks
Title
Rozibafusp Alfa terminal elimination half-life, if possible
Description
To characterize the pharmacokinetics (PK) of Rozibafusp Alfa
Time Frame
52 weeks

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.amgen.com/datasharing
Citations:
PubMed Identifier
33687069
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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