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Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus

Sponsor
Amgen (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04680637
Collaborator
(none)
320
Enrollment
137
Locations
4
Arms
37.5
Anticipated Duration (Months)
2.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.

Condition or Disease Intervention/Treatment Phase
  • Drug: Efavaleukin Alfa
  • Drug: Placebo
  • Other: Standard of Care
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy
Actual Study Start Date :
May 6, 2021
Anticipated Primary Completion Date :
May 23, 2024
Anticipated Study Completion Date :
Jun 19, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo + Standard of Care

Drug: Placebo
Administered as a subcutaneous (SC) injection.

Other: Standard of Care
Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.
Experimental: Efavaleukin Alfa Dose Level One + Standard of Care

Drug: Efavaleukin Alfa
Administered as a subcutaneous (SC) injection.
Other Names:
  • AMG 592

    • Other: Standard of Care
    Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.
    Experimental: Efavaleukin Alfa Dose Level Two + Standard of Care

    Drug: Efavaleukin Alfa
    Administered as a subcutaneous (SC) injection.
    Other Names:
  • AMG 592

    • Other: Standard of Care
    Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.
    Experimental: Efavaleukin Alfa Dose Level Three + Standard of Care

    Drug: Efavaleukin Alfa
    Administered as a subcutaneous (SC) injection.
    Other Names:
  • AMG 592

    • Other: Standard of Care
    Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.

    Outcome Measures

    Primary Outcome Measures

    1. Percent of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 52 [Week 52]

      SRI-4 response 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 domain score and no greater than 1 new BILAG 2004 B scores compared with baseline; and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) VAS (scale 0 to 3).

    Secondary Outcome Measures

    1. Percent of Participants Achieving a British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 24 and Week 52 [Week 24 and Week 52]

      BICLA response is defined as at least 1 gradation of improvement in baseline British Isles Lupus Assessment Group (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 greater than 1 new BILAG 2004 B domain scores compared with baseline; less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3); and no initiation of non-protocol treatment.

    2. Percent of Participants Achieving a Lupus Low Disease Activity State (LLDAS) Response at Week 52 [Week 52]

      LLDAS response 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.

    3. Percent of Participants with a Reduction of Oral Corticosteroid (OCS) to Less Than or Equal to 7.5 mg/day by Week 44 and Sustained Through Week 52 in Participants with a Baseline OCS Dose ≥ 10 mg/day [Week 52]

      To evaluate the efficacy of efavaleukin alfa with oral corticosteroid (OCS)-tapering in subjects with SLE with inadequate response to SOC therapy.

    4. Percent of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24 [Week 24]

      SRI-4 response is defined as a greater than or equal to 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score; no new British Isles Lupus Assessment Group (BILAG) 2004 A domain score and no greater than 1 new BILAG 2004 B scores compared with baseline; and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3).

    5. Percent of Participants Achieving a Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) Response at Week 24 and Week 52 [Week 24 and Week 52]

      hSLEDAI response is defined as a greater than or equal to 4-point decrease in score.

    6. Tender and Swollen Joint Count ≥ 50% Improvement from Baseline at Weeks 8, 12, 24, 36, and 52 in Participants with ≥ 6 Tender and Swollen Joints Involving the Hands and Wrists at Baseline [Baseline, Week 8, 12, 24, 36, and 52]

      A 28-joint count will be used to evaluate the effect of efavaleukin alfa on additional SLE efficacy endpoints. A total 28 joints will be scored for presence or absence of swelling. A separated score for joints in the hands and wrists will be calculated.

    7. Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥ 50% Improvement from Baseline at Week 8, 12, 24, 36, and 52 in Participants with a CLASI Activity Score ≥ 8 at Baseline [Baseline, Week 8, 12, 24, 36, and 52]

      To evaluate the effect of efavaleukin alfa on additional SLE efficacy endpoints.

    8. Percent of Participants who Experience a Flare [Week 52]

      A flare is defined as a British Isles Lupus Assessment Group (BILAG) score designation of 'worse' or 'new'.

    9. Change from Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS Fatigue SF 7A) Fatigue Score [Baseline, Week 12, 24, 36, and 52]

      To describe the effect of treatment with efavaleukin alfa using patient reported outcomes.

    10. Change from Baseline in Medical Outcomes Short Form-36 Questionnaire Score [Baseline, Week 12, 24, 36, and 52]

      To describe the effect of treatment with efavaleukin alfa using patient reported outcomes.

    11. Change from Baseline in Lupus Quality of Life (QoL) Questionnaire Score [Baseline, Week 12, 24, 36, and 52]

      To describe the effect of treatment with efavaleukin alfa using patient reported outcomes.

    12. Number of Participants who Experience a Treatment-Emergent Adverse Event (AE) and Serious Adverse Event (SAE) [Up to Week 56]

      To characterize the safety of efavaleukin alfa.

    13. Number of Participants who Experience a Clinically Significant Change in Laboratory Values and Vital Sign Measurements [Up to Week 56]

      To characterize the safety of efavaleukin alfa.

    14. Trough Serum and Sparse Postdose Serum Concentration of Efavaleukin Alfa [Up to Week 52]

      To characterize the pharmacokinetics (PK) of efavaleukin alfa.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participant has provided informed consent prior to initiation of any study specific activities/procedures.

    • Participant is aged between 18 and 75.

    • Fulfills classification criteria for systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE with antinuclear antibody ≥ 1:80 by immunofluorescence on Hep-2 cells being present at screening.

    • Hybrid SLEDAI score ≥ 6 points with a "Clinical" hSLEDAI score ≥ 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters.

    • British-Isles Lupus Assessment Group (BILAG) index score (BILAG 2004) of ≥ 1 A item or ≥ 2 B items.

    • Must be taking ≥ 1 of the following SLE treatments (or regional equivalent): hydroxychloroquine, chloroquine, quinacrine, mycophenolate mofetil, azathioprine, methotrexate, dapsone, or oral calcineurin inhibitors, or OCS. A participant may enter the study on OCS alone (prednisone ≥ 10 mg/day or equivalent) only if the participant has previously documented trial of anti-malarial or immunosuppressant treatment for SLE. Participants must be on a stable dose for ≥ 8 weeks prior to screening for all antimalarials and immunosuppressants, with the exception of OCS doses which must be stable for ≥ 2 weeks prior to screening.

    • For participants taking OCS, dose must be ≤ 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit and for ≥ 2 weeks prior to screening visit.

    • Stability of SLE treatments: OCS and other immunosuppressants/immunomodulator agents and doses must be stable since screening visit.

    • Disease activity: active disease as indicated by clinical hSLEDAI score ≥ 4 must be observed (clinical hSLEDAI score is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results including urine and immunologic parameters).

    Exclusion Criteria:

    • Lupus nephritis if any of the following are present: urine protein creatinine ratio ≥ 2000 mg/g (or equivalent) at screening, OR having required induction therapy within 1 year prior to screening, OR histological evidence (if available) of diffuse proliferative glomerulonephritis within 12 weeks prior to screening.

    • Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.

    • Currently present or within 1 year prior to screening a diagnosis of any chronic inflammatory disease other than SLE (eg, rheumatoid arthritis) which would interfere with SLE disease assessment.

    • History of any disease other than SLE that has required treatment with oral or parenteral corticosteroids for > 2 weeks within 4 months prior to screening.

    • Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to screening visit OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening visit.

    • Active tuberculosis or latent tuberculosis with no documented past history of adequate treatment per local standard of care.

    • Positive test for tuberculosis during creening defined as: either a positive or indeterminate QuantiFERON®-TB or T-spot test OR positive purified protein derivative (PPD) (≥5 mm of induration at 48 to 72 hours after test is placed).

    • Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb). A history of hepatitis B vaccination without history of hepatitis B infection (ie, positive hepatitis B surface antibody (HBsAb), negative HBsAg and negative HBcAb) is allowed.

    • Positive for hepatitis C antibody.

    • Known history of HIV or positive HIV test at screening.

    • Presence of 1 or more significant concurrent medical conditions, including but not limited to the following:

    • poorly controlled diabetes (hemoglobin A1C > 7) or hypertension

    • symptomatic heart failure (New York Heart Association class III or IV)

    • myocardial infarction or unstable angina pectoris within the past 12 months prior to screening

    • severe chronic pulmonary disease requiring oxygen therapy

    • multiple sclerosis or any other demyelinating disease

    • Any history of malignancy with the following exceptions:

    • resolved non-melanoma skin cancers > 5 years prior to screening

    • resolved cervical carcinoma > 5 years prior to screening

    • resolved breast ductal carcinoma in situ > 5 years of screening

    • Currently receiving or had treatment with: cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent within 6 months prior to screening or sirolimus within 4 weeks prior screening.

    • Currently receiving or had treatment with a Janus kinase (JAK) inhibitor within 3 months or less than 5 drug half-lives (whichever is longer) prior to screening.

    • Currently receiving or had treatment with an immune checkpoint inhibitor (eg, programmed death 1 [PD-1] inhibitor, programmed death ligand 1 [PD-L1] inhibitor, cytotoxic T-lymphocyte associated protein 4 [CTLA-4] inhibitor).

    Note: Abatacept is not considered a CTLA-4 inhibitor and is referred to below.

    • Currently receiving or had treatment within 12 months prior to screening with T-cell depleting agents (eg, antithymocyte globulin, Campath).

    • Currently receiving of had treatment with an interleukin 2 (IL-2) based therapy (eg, Proleukin).

    • Current or previous treatment with a biologic agent as follows: rituximab within 6 months prior to screening; abatacept and belimumab within the past 3 months prior to screening; other biologics within < 5 drug half lives prior to screening.

    • Participants who have received intraarticular, intralesional, or intramuscular corticosteroids within 2 weeks prior to screening or intravenous corticosteroids within 6 weeks prior to screening.

    • Participants who have received live vaccines within 5 weeks prior to screening, or plan to receive live vaccines during the treatment period and up to 6 weeks after the end of treatment period in the study.

    • Currently receiving treatment in another investigational device or drug study.

    • Ending a treatment with an investigational drug or investigational device less than 3 months or 5 half-lives from the last dose of the investigational drug (whichever is longer) at screening.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham,Arthritis Clinical Intervention Program Birmingham Alabama United States 35294
    2 Arizona Arthritis and Rheumatology Associates PC Gilbert Arizona United States 85297
    3 Arizona Arthritis And Rheumatology Associates PC Glendale Arizona United States 85306
    4 Arizona Arthritis and Rheumatology Associates PC Tucson Arizona United States 85704
    5 Loma Linda University Health Care Loma Linda California United States 92354
    6 University of California at Los Angeles Medical Center Los Angeles California United States 90024
    7 Robin K Dore MD Inc Tustin California United States 92780
    8 Arthritis and Rheumatic Disease Specialties Aventura Florida United States 33180
    9 Life Clinical Trials Aventura Florida United States 33180
    10 Centre for Rheumatology Immunology and Arthritis Fort Lauderdale Florida United States 33309
    11 Millennium Research Ormond Beach Florida United States 32174
    12 Integral Rheumatology and Immunology Specialists Plantation Florida United States 33324
    13 Suncoast Medical Clinic Saint Petersburg Florida United States 33710
    14 Baycare Medical Group Inc Tampa Florida United States 33614
    15 Greater Chicago Specialty Physicians Schaumburg Illinois United States 60195
    16 Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc Skokie Illinois United States 60076
    17 Western Kentucky Rheumatology PLLC Hopkinsville Kentucky United States 42240
    18 Accurate Clinical Research Lake Charles Louisiana United States 70605
    19 Michigan Rheumatology Group, PC - Grand Blanc Office Grand Blanc Michigan United States 48439
    20 Arthritis and Rheumatology of Michigan Lansing Michigan United States 48910
    21 Institute for Clinical and Translation Research at Einstein and Montefiore Clinical Research Center Bronx New York United States 10461
    22 Feinstein Institute for Medical Research Manhasset New York United States 11030
    23 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    24 SUNY Upstate Medical University Syracuse New York United States 13210
    25 University of North Carolina at Chapel Hill Thurston Arthritis Research Center Chapel Hill North Carolina United States 27599
    26 Joint and Muscle Research Institute Charlotte North Carolina United States 28204
    27 DJL Clinical Research PLLC Charlotte North Carolina United States 28210
    28 Javara Charlotte North Carolina United States 28210
    29 Atrium Health Rheumatology Charlotte North Carolina United States 28211
    30 Arthritis and Rheumatology Center of Oklahoma PLLC Oklahoma City Oklahoma United States 73102
    31 Oklahoma Medical Research Foundation Oklahoma City Oklahoma United States 73104
    32 University of Pittsburgh Medical Center Lupus Center of Excellence Pittsburgh Pennsylvania United States 15213
    33 Columbia Arthritis Center, PA Columbia South Carolina United States 29204
    34 Piedmont Arthritis Clinic Greenville South Carolina United States 29601
    35 West Tennessee Research Institute, LLC Jackson Tennessee United States 38305
    36 University of Tennessee Medical Center Knoxville Tennessee United States 37920
    37 Ramesh C Gupta MD Memphis Tennessee United States 38119
    38 Arthritis and Rheumatology Institute Allen Texas United States 75013
    39 Precision Comprehensive Clinical Research Solutions Colleyville Texas United States 76034
    40 Texas Arthritis Center PA El Paso Texas United States 79902
    41 Biopharma Informatic, LLC Houston Texas United States 77043
    42 Accurate Clinical Management Houston Texas United States 77084
    43 Laila A Hassan, MD, PA Houston Texas United States 77089
    44 Trinity Universal Research Associates, LLC Plano Texas United States 75024
    45 Clinical Trials of Texas San Antonio Texas United States 78229
    46 University of Texas Health Science Center at San Antonio Medical Arts Research Clinic Marc San Antonio Texas United States 78229
    47 Arthritis and Osteoporosis Clinic Waco Texas United States 76710
    48 Medizinische Universitaet Graz Graz Austria 8036
    49 Diagnostic-Consultative Center Sveti Georgi EOOD Plovdiv Bulgaria 4002
    50 Medical Center Excelsior OOD Sofia Bulgaria 1407
    51 Medical Center Academy EOOD Sofia Bulgaria 1612
    52 University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD Sofia Bulgaria 1612
    53 Toronto Western Hospital Toronto Ontario Canada M5T 2S8
    54 Investigacion y Terapias Reumatologicas Innovadoras LTDA - Interin LTDA Providencia Santiago Chile 7500010
    55 Enroll SpA Providencia Santiago Chile 7500587
    56 Estudios Clinicos Limitada - Centro de Estudios Reumatologicos Providencia Santiago Chile 7501126
    57 Sociedad de prestaciones Medicas y Paramedicas Goecke Gatica y Compania Limitada - Prosalud Providencia Santiago Chile 7510047
    58 Corporacion de Beneficiencia Osorno Osorno Chile 5311092
    59 Biocinetic SpA Santiago Chile 8320000
    60 Sociedad de Prestaciones Medicas Intermedica Limitada Valdivia Chile 5111847
    61 Hospital Pablo Tobon Uribe Medellin Antioquia Colombia 050034
    62 Centro Integral de Reumatología del Caribe Circaribe SAS Barranquilla Atlántico Colombia 080002
    63 Centro de Investigacion en Reumatologia y Especialidades Medicas SAS Bogota Cundinamarca Colombia 110221
    64 Solano y Terront Servicios Medicos Ltda - Uniendo Bogota Cundinamarca Colombia 110221
    65 Mediservis del Tolima IPS SAS Ibague Tolima Colombia 730006
    66 Centro Medico Julian Coronel Santiago de Cali Valle Del Cauca Colombia 760035
    67 Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil Strasbourg France 67091
    68 Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil Toulouse Cedex 9 France 31059
    69 Athens Naval Hospital Athens Greece 11521
    70 Laiko General Hospital Athens Greece 11527
    71 Attiko Hospital Athens Greece 12462
    72 University Hospital of Heraklion Heraklion Greece 71110
    73 Olympion Hospital-General Clinic of Patras AE Patra Greece 26443
    74 Ippokrateio Hospital of Thessaloniki Thessaloniki Greece 54642
    75 Tuen Mun Hospital New Territories Hong Kong
    76 Azienda Ospedaliera Universitaria Careggi Firenze Italy 50134
    77 Università degli studi della Campania Luigi Vanvitelli Napoli Italy 80131
    78 Azienda Ospedaliera di Padova Padova Italy 35128
    79 Azienda Ospedaliera Policlinico Umberto I Roma Italy 00161
    80 Policlinico Universitario Agostino Gemelli Roma Italy 00168
    81 Azienda Ospedaliera Ordine Mauriziano di Torino Torino Italy 10128
    82 Presidio Ospedaliero Universitario Santa Maria della Misericordia di Udine Udine Italy 33100
    83 Centro Ricerche Cliniche di Verona Verona Italy 37134
    84 National Hospital Organization Chibahigashi National Hospital Chiba-shi Chiba Japan 260-8712
    85 Hospital of the University of Occupational and Environmental Health Kitakyushu-shi Fukuoka Japan 807-8556
    86 Hiroshima University Hospital Hiroshima-shi Hiroshima Japan 734-8551
    87 Sapporo City General Hospital Sapporo-shi Hokkaido Japan 060-8604
    88 Hokkaido University Hospital Sapporo Hokkaido Japan 060-8648
    89 Kanazawa University Hospital Kanazawa-shi Ishikawa Japan 920-8641
    90 Eiraku Clinic Kagoshima-shi Kagoshima Japan 890-0063
    91 Kagoshima University Hospital Kagoshima-shi Kagoshima Japan 890-8520
    92 St Marianna University Hospital Kawasaki-shi Kanagawa Japan 216-8511
    93 National University Corporation Tohoku University Tohoku University Hospital Sendai-shi Miyagi Japan 980-8574
    94 Nagasaki University Hospital Nagasaki-shi Nagasaki Japan 852-8501
    95 Seirei Hamamatsu General Hospital Hamamatsu-shi Shizuoka Japan 430-8558
    96 Juntendo University Hospital Bunkyo-ku Tokyo Japan 113-8431
    97 St Lukes International Hospital Chuo-ku Tokyo Japan 104-8560
    98 National Hospital Organization Tokyo Medical Center Meguro-ku Tokyo Japan 152-8902
    99 Keio University Hospital Shinjuku-ku Tokyo Japan 160-8582
    100 Center Hospital of the National Center for Global Health and Medicine Shinjuku-ku Tokyo Japan 162-8655
    101 Daegu Catholic Universtiy Medcial Center Daegu Korea, Republic of 42472
    102 Seoul National University Hospital Seoul Korea, Republic of 03080
    103 Ajou University Hospital Suwon-si, Gyeonggi-do Korea, Republic of 16499
    104 CITER SA de CV (Centro de Investigación y Tratamiento de las Enfermedades Reumáticas SA de CV) Mexico City Distrito Federal Mexico 06700
    105 Centro Integral en Reumatologia SA de CV Guadalajara Jalisco Mexico 44160
    106 Centro de Estudios de Investigacion Basica y Clinica, Sc Guadalajara Jalisco Mexico 44690
    107 Eukarya Pharmasite sc Monterrey Nuevo León Mexico 64718
    108 Centro de Investigacion Integral Medivest SC Chihuahua Mexico 31203
    109 Phylasis Clínicas Research S. De R. L. De C. V. Cuautitlan Izcalli Mexico 54769
    110 CENTRUM MEDYCZNE INTERCOR Spzoo Bydgoszcz Poland 85-605
    111 Centrum Medyczne Pratia Czestochowa Czestochowa Poland 42-200
    112 Centrum Badan Klinicznych Wojciech Brzezicki Malbork Poland 82-200
    113 NZOZ Lecznica MAK-MED sc Nadarzyn Poland 05-830
    114 Gabinety Lekarskie RIVERMED Poznan Poland 61-441
    115 Reumatop Grzegorz Rozumek, Karin Pistorius Wroclaw Poland 52-210
    116 Limited liability company Scientific Research Medical Complex Your Health Kazan Russian Federation 420097
    117 FSBSI SRI of Rheumatology na V A Nasonova Moscow Russian Federation 115522
    118 I M Sechenov First Medical University of the MoH of RF Moscow Russian Federation 119435
    119 LLC Medical Sanitary Unit №157 Saint Petersburg Russian Federation 196066
    120 Saint-Petersburg State Budget Healthcare Institution Clinical Rheumatology Hospital 25 Saint-Petersburg Russian Federation 190068
    121 Center for medical consultations and research - practice Yaroslavl Russian Federation 150003
    122 Hospital Universitario Reina Sofia Cordoba Andalucía Spain 14004
    123 Hospital de la Santa Creu i Sant Pau Barcelona Cataluña Spain 08041
    124 Corporacio Sanitaria Parc Tauli Sabadell Cataluña Spain 08208
    125 Hospital Universitari i Politecnic La Fe Valencia Comunidad Valenciana Spain 46026
    126 Hospital Clinico Universitario de Santiago Santiago de Compostela Galicia Spain 15706
    127 Hospital Universitario Araba Vitoria País Vasco Spain 01009
    128 Universitaetsspital Basel Basel Switzerland 4031
    129 Kantonsspital St Gallen Sankt Gallen Switzerland 9007
    130 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan 83301
    131 Chung Shan Medical University Hospital Taichung Taiwan 40201
    132 Taichung Veterans General Hospital Taichung Taiwan 40705
    133 National Taiwan University Hospital Taipei Taiwan 10002
    134 Cukurova Universitesi Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi Adana Turkey 01790
    135 Hacettepe Universitesi Tip Fakultesi Ankara Turkey 06100
    136 Akdeniz Universitesi Tip Fakultesi Antalya Turkey 07070
    137 Istanbul Universitesi Istanbul Tip Fakultesi Istanbul Turkey 34093

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT04680637
    Other Study ID Numbers:
    • 20200234
    First Posted:
    Dec 23, 2020
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lupus Erythematosus, Systemic

    Study Results

    No Results Posted as of Jul 28, 2022