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

NCT ID: NCT04058028

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-19
• Study Completion Date: 2023-07-25

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.

Conditions

Systemic Lupus Erythematosus (SLE)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rozibafusp Alfa, Dose A

Investigational product solution in vial

Group Type: EXPERIMENTAL

Rozibafusp Alfa

Intervention Type: DRUG

Rozibafusp Alfa will be presented in 5 mL glass vial

Rozibafusp Alfa, Dose B

Investigational product solution in vial

Group Type: EXPERIMENTAL

Rozibafusp Alfa

Intervention Type: DRUG

Rozibafusp Alfa will be presented in 5 mL glass vial

Rozibafusp Alfa, Dose C

Investigational product solution in vial

Group Type: EXPERIMENTAL

Rozibafusp Alfa

Intervention Type: DRUG

Rozibafusp Alfa will be presented in 5 mL glass vial

Placebo for Rozibafusp Alfa

Placebo Investigational product solution in vial

Group Type: PLACEBO_COMPARATOR

Placebo for Rozibafusp Alfa

Intervention Type: DRUG

Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial

Interventions

Rozibafusp Alfa

Rozibafusp Alfa will be presented in 5 mL glass vial

Intervention Type: DRUG

Placebo for Rozibafusp Alfa

Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Imaging Endpoints

Scottsdale, Arizona, United States

Medvin Clinical Research

Covina, California, United States

Southern California Permanente Medical Group

Fontana, California, United States

University of California San Diego

La Jolla, California, United States

University of California Los Angeles

Los Angeles, California, United States

Stanford University Hospitals and Clinics

Palo Alto, California, United States

TriWest Research Associates

San Diego, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Centre for Rheumatology Immunology and Arthritis

Fort Lauderdale, Florida, United States

University of Florida

Gainesville, Florida, United States

Lakes Research LLC

Miami Lakes, Florida, United States

Heuer Medical Doctor Research LLC

Orlando, Florida, United States

Southwest Florida Clinical Research Center

Tampa, Florida, United States

AdventHealth Medical Group

Tampa, Florida, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

The Emory Clinic

Atlanta, Georgia, United States

Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc

Skokie, Illinois, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

University of Maryland School of Medicine Division of Rheumatology

Baltimore, Maryland, United States

Feinstein Institute for Medical Research

Manhasset, New York, United States

New York University Langone Orthopedic Center

New York, New York, United States

Hospital For Special Surgery

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Joint and Muscle Research Institute

Charlotte, North Carolina, United States

DJL Clinical Research PLLC

Charlotte, North Carolina, United States

Arthritis and Rheumatology Center of Oklahoma PLLC

Oklahoma City, Oklahoma, United States

The Oklahoma Center for Arthritis Therapy and Research Inc

Tulsa, Oklahoma, United States

Penn State Milton South Hershey Medical Center

Hershey, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Articularis Healthcare Group Inc dba Low Country Rheumatology

Summerville, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Austin Regional Clinic Specialty Research

Austin, Texas, United States

Trinity Universal Research Associates, Inc

Carrollton, Texas, United States

Rheumatic Disease Clinical Research Center LLC

Houston, Texas, United States

Southwest Rheumatology

Mesquite, Texas, United States

Dom Centro de Reumatologia

CABA, Buenos Aires, Argentina

Fundacion Respirar - Centro Medico Dra De Salvo

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Buenos Aires, Argentina

Instituto Medico de Alta Complejidad San Isidro

San Isidro, Buenos Aires, Argentina

Hospital Militar Central - Cirujano Mayor Dr Cosme Argerich

Buenos Aires, Distrito Federal, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, Argentina

Clinical Mayo - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

CER San Juan - Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, , Argentina

Holdsworth House Medical Practice

Sydney, New South Wales, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Multiprofile Hospital for Active Treatment Trimontium OOD

Plovdiv, , Bulgaria

University Multiprofile Hospital for Active Treatment - Kaspela EOOD

Plovdiv, , Bulgaria

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

Plovdiv, , Bulgaria

Medical Center Excelsior OOD

Sofia, , Bulgaria

Medical Center Academy EOOD

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

Sofia, , Bulgaria

Medical Centre Synexus Sofia EOOD

Sofia, , Bulgaria

Medical Centre Synexus Sofia EOOD - Branch Stara Zagora

Stara Zagora, , Bulgaria

University of Calgary Cumming School of Medicine

Calgary, Alberta, Canada

Shared Health Inc. operating the Health Sciences Centre Winnipeg

Winnipeg, Manitoba, Canada

Groupe de recherche en maladies osseuses Incorporated

Québec, Quebec, Canada

Synexus Czech sro

Prague, , Czechia

Revmatologicky ustav

Prague, , Czechia

Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

Bordeaux, , France

CHU Hôpital Côte de Nacre

Caen, , France

Centre Hospitalier Universitaire Dijon Bourgogne - Hopital Francois Mitterrand

Dijon, , France

Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

Lille, , France

Hopital Pitie-Salpetriere

Paris, , France

Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

Reims, , France

Centre Hospitalier Universitaire de Strasbourg - Nouvel hopital civil

Strasbourg, , France

Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

Toulouse, , France

Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

Toulouse, , France

Johannes Gutenberg Universitaet Mainz

Bad Kreuznach, , Germany

Universitätsklinikum Leipzig AöR

Leipzig, , Germany

Laiko General Hospital

Athens, , Greece

Attiko Hospital

Athens, , Greece

University Hospital of Heraklion

Heraklion, , Greece

General University Hospital of Patras Panagia i Voithia

Pátrai, , Greece

Tuen Mun Hospital

New Territories, , Hong Kong

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, , Hungary

Vita Verum Medical Bt

Székesfehérvár, , Hungary

IRCCS Ospedale San Raffaele

Milan, , Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, , Italy

Policlinico Universitario Agostino Gemelli

Roma, , Italy

IRCCS Istituto Clinico Humanitas

Rozzano MI, , Italy

National Hospital Organization Chibahigashi National Hospital

Chiba, Chiba, Japan

Juntendo University Urayasu Hospital

Urayasu-shi, Chiba, Japan

Hospital of the University of Occupational and Environmental Health Japan

Kitakyushu-shi, Fukuoka, Japan

Gifu University Hospital

Gifu, Gifu, Japan

Sapporo City General Hospital

Sapporo, Hokkaido, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

National University Corporation Tohoku University Tohoku University Hospital

Sendai, Miyagi, Japan

Shinshu University Hospital

Matsumoto-shi, Nagano, Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

National Hospital Organization Nagasaki Medical Center

Omura-shi, Nagasaki, Japan

Sasebo Chuo Hospital

Sasebo-shi, Nagasaki, Japan

Kurashiki Medical Clinic

Kurashiki-shi, Okayama-ken, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

St Lukes International Hospital

Chuo-ku, Tokyo, Japan

National Hospital Organization Tokyo Medical Center

Meguro-ku, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Centro Medico del Angel SC

Mexicali, Baja California Norte, Mexico

Centro de Investigacion en Artritis y Osteoporosis SC

Mexicalli, Baja California Norte, Mexico

Morales Vargas Centro de Investigacion SC

León, Guanajuato, Mexico

Centro Integral en Reumatologia SA de CV

Guadalajara, Jalisco, Mexico

Centro Peninsular de Investigación Clínica

Mérida, Yucatán, Mexico

Centro Mexicano de Desarrollo de Estudios Clinicos

Mexico City, , Mexico

Synexus Polska Spzoo

Gdansk, , Poland

Synexus Polska Spzoo

Gdynia, , Poland

Synexus Polska Spzoo

Katowice, , Poland

Silmedic Spzoo

Katowice, , Poland

Tomed Tomasz Miszalski-Jamka Centrum Medyczne

Krakow, , Poland

Synexus Polska Spzoo

Lodz, , Poland

Somed cr

Lodz, , Poland

1 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Lublin, , Poland

Clinical Best Solutions Spolka z ograniczona odpowiedzialnoscia Spolka komandytowa

Lublin, , Poland

Synexus Polska Spzoo

Poznan, , Poland

Sanus Szpital Specjalistyczny Spzoo

Stalowa Wola, , Poland

SOMED CR

Warsaw, , Poland

Synexus Polska Spolka z ograniczona odpowiedzialnoscia

Warsaw, , Poland

Futuremeds spolka z ograniczona odpowiedzialnoscia

Wroclaw, , Poland

Synexus Polska Spzoo

Wroclaw, , Poland

Hospital Garcia de Orta, EPE

Almada, , Portugal

Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, , Portugal

Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria

Lisbon, , Portugal

Centro Hospitalar do Porto EPE - Hospital de Santo Antonio

Porto, , Portugal

Centro Hospitalar Universtario de Sao Joao, EPE

Porto, , Portugal

Limited liability company Scientific Research Medical Complex Your Health

Kazan', , Russia

LLC Medical Center Maksimum Zdorovia

Kemerovo, , Russia

LLC Medical center Revma Med

Kemerovo, , Russia

FSBSI SRI of Rheumatology na V A Nasonova

Moscow, , Russia

LLC Center of medicine Healthy family

Novosibirsk, , Russia

LLC Center of general medicine

Novosibirsk, , Russia

LLC Medical Sanitary Unit №157

Saint Petersburg, , Russia

State Budget Medical Institution Sverdlovsk Regional Clinical Hospital N1

Yekaterinburg, , Russia

Keimyung University Dongsan Hospital

Daegu, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Ajou University Hospital

Suwon-si, Gyeonggi-do, , South Korea

Hospital Infanta Luisa

Seville, Andalusia, Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Complexo Hospitalario Universitario A Coruña

A Coruña, Galicia, Spain

Countries

United States; Argentina; Australia; Bulgaria; Canada; Czechia; France; Germany; Greece; Hong Kong; Hungary; Italy; Japan; Mexico; Poland; Portugal; Russia; South Korea; Spain

References

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.

Reference Type: DERIVED

PMID: 37491104 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33687069 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20170588

Identifier Type: -

Identifier Source: org_study_id