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

Active Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04680637
• Other study ID #: 20200234
• Status: Terminated
• Phase: Phase 2
• Start date: May 6, 2021
• Est. completion date: May 22, 2023

Study information

• Verified date: October 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 168
• Est. completion date: May 22, 2023
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 requiring induction therapy currently or 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 are indicated currently or 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 with immunosuppressive/immunomodulatory activity 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.

Related Conditions & MeSH terms

• Active Systemic Lupus Erythematosus
• Lupus Erythematosus, Systemic

Intervention

Drug:
• Efavaleukin Alfa
Administered as a subcutaneous (SC) injection.
• 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.

Locations

Country	Name	City	State
Austria	Medizinische Universitaet Graz	Graz
Bulgaria	Diagnostic-Consultative Center Sveti Georgi EOOD	Plovdiv
Bulgaria	Medical Center Academy EOOD	Sofia
Bulgaria	Medical Center Excelsior OOD	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD	Sofia
Canada	Toronto Western Hospital	Toronto	Ontario
Chile	Corporacion de Beneficiencia Osorno	Osorno
Chile	Enroll SpA	Providencia	Santiago
Chile	Investigacion y Terapias Reumatologicas Innovadoras LTDA - Interin LTDA	Providencia	Santiago
Chile	Sociedad de prestaciones Medicas y Paramedicas Goecke Gatica y Compania Limitada - Prosalud	Providencia	Santiago
Chile	CECIM	Santiago
Chile	Estudios Clinicos Limitada - Centro de Estudios Reumatologicos	Santiago
Chile	Sociedad de Prestaciones Medicas Intermedica Limitada	Valdivia
Chile	Oncocentro Apys	Viña del Mar
Colombia	Centro Integral de Reumatología del Caribe Circaribe SAS	Barranquilla	Atlántico
Colombia	Centro de Investigacion en Reumatologia y Especialidades Medicas SAS	Bogota	Cundinamarca
Colombia	Solano y Terront Servicios Medicos Ltda - Uniendo	Bogota	Cundinamarca
Colombia	Mediservis del Tolima IPS SAS	Ibague	Tolima
Colombia	Hospital Pablo Tobon Uribe	Medellin	Antioquia
Colombia	Centro Medico Julian Coronel	Santiago de Cali	Valle Del Cauca
France	Centre Hospitalier Universitaire de Montpellier Hopital Lapeyronie	Montpellier cedex 05
France	Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil	Strasbourg
France	Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil	Toulouse Cedex 9
France	Centre Hospitalier Universitaire de Nancy - Hopital de Brabois	Vandoeuvre Les Nancy Cedex
Greece	Athens Naval Hospital	Athens
Greece	Attiko Hospital	Athens
Greece	Laiko General Hospital	Athens
Greece	University Hospital of Heraklion	Heraklion
Greece	Olympion Hospital-General Clinic of Patras AE	Patra
Greece	Euromedica - Kyanous Stavros	Thessaloniki
Greece	Ippokrateio Hospital of Thessaloniki	Thessaloniki
Hong Kong	Tuen Mun Hospital	New Territories
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	Università degli studi della Campania Luigi Vanvitelli	Napoli
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Azienda Ospedaliera Policlinico Umberto I	Roma
Italy	Policlinico Universitario Agostino Gemelli	Roma
Italy	Azienda Ospedaliera Ordine Mauriziano di Torino	Torino
Italy	Azienda Ospedaliero Universitaria Integrata Santa Maria della Misericordia	Udine
Italy	Centro Ricerche Cliniche	Verona
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	National Hospital Organization Chibahigashi National Hospital	Chiba-shi	Chiba
Japan	St Lukes International Hospital	Chuo-ku	Tokyo
Japan	Seirei Hamamatsu General Hospital	Hamamatsu-shi	Shizuoka
Japan	Hiroshima University Hospital	Hiroshima-shi	Hiroshima
Japan	Eiraku Clinic	Kagoshima-shi	Kagoshima
Japan	Kagoshima University Hospital	Kagoshima-shi	Kagoshima
Japan	Kanazawa University Hospital	Kanazawa-shi	Ishikawa
Japan	St Marianna University Hospital	Kawasaki-shi	Kanagawa
Japan	Hospital of the University of Occupational and Environmental Health Japan	Kitakyushu-shi	Fukuoka
Japan	National Hospital Organization Tokyo Medical Center	Meguro-ku	Tokyo
Japan	Nagasaki University Hospital	Nagasaki-shi	Nagasaki
Japan	Japan Community Healthcare Organization Chukyo Hospital	Nagoya-shi	Aichi
Japan	Nagoya City University Hospital	Nagoya-shi	Aichi
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Sapporo City General Hospital	Sapporo-shi	Hokkaido
Japan	National University Corporation Tohoku University Tohoku University Hospital	Sendai-shi	Miyagi
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjuku-ku	Tokyo
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Korea, Republic of	Daegu Catholic Universtiy Medcial Center	Daegu
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon-si, Gyeonggi-do
Mexico	Centro de Investigacion Integral Medivest SC	Chihuahua
Mexico	Phylasis Clínicas Research S. De R. L. De C. V.	Cuautitlan Izcalli
Mexico	Centro de Estudios de Investigacion Basica y Clinica, Sc	Guadalajara	Jalisco
Mexico	Centro Integral en Reumatologia SA de CV	Guadalajara	Jalisco
Mexico	CITER SA de CV (Centro de Investigación y Tratamiento de las Enfermedades Reumáticas SA de CV)	Mexico City	Distrito Federal
Mexico	Eukarya Pharmasite sc	Monterrey	Nuevo León
Poland	Centrum medyczne intercore sp zoo	Bydgoszcz
Poland	Centrum Medyczne Pratia Czestochowa	Czestochowa
Poland	Centrum Badan Klinicznych Wojciech Brzezicki	Malbork
Poland	NZOZ Lecznica MAK-MED sc	Nadarzyn
Poland	Gabinety Lekarskie RIVERMED	Poznan
Poland	Reumatop Grzegorz Rozumek, Karin Pistorius	Wroclaw
Russian Federation	Limited liability company Scientific Research Medical Complex Your Health	Kazan
Russian Federation	FSBSI SRI of Rheumatology na V A Nasonova	Moscow
Russian Federation	I M Sechenov First Medical University of the MoH of RF	Moscow
Russian Federation	LLC Medical Sanitary Unit ?157	Saint Petersburg
Russian Federation	Saint-Petersburg State Budget Healthcare Institution Clinical Rheumatology Hospital 25	Saint-Petersburg
Russian Federation	Center for medical consultations and research - practice	Yaroslavl
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluña
Spain	Hospital Universitario Reina Sofia	Cordoba	Andalucía
Spain	Corporacio Sanitaria Parc Tauli	Sabadell	Cataluña
Spain	Hospital Universitario Hospiten Rambla	Santa Cruz de Tenerife	Canarias
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela	Galicia
Spain	Hospital Infanta Luisa	Sevilla	Andalucía
Spain	Hospital Universitari i Politecnic La Fe	Valencia	Comunidad Valenciana
Spain	Hospital Universitario Araba	Vitoria	País Vasco
Switzerland	Universitaetsspital Basel	Basel
Switzerland	Kantonsspital St Gallen	Sankt Gallen
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Turkey	Cukurova Universitesi Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi	Adana
Turkey	Hacettepe Universitesi Tip Fakultesi	Ankara
Turkey	Akdeniz Universitesi Tip Fakultesi	Antalya
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi	Istanbul
United States	Arthritis and Rheumatology Institute	Allen	Texas
United States	Arthritis and Rheumatic Disease Specialties	Aventura	Florida
United States	Life Clinical Trials	Aventura	Florida
United States	University of Alabama at Birmingham,Arthritis Clinical Intervention Program	Birmingham	Alabama
United States	Institute for Clinical and Translation Research at Einstein and Montefiore Clinical Research Center	Bronx	New York
United States	New York University Langone Ambulatory Care Brooklyn Heights	Brooklyn	New York
United States	University of North Carolina at Chapel Hill Thurston Arthritis Research Center	Chapel Hill	North Carolina
United States	Atrium Health Rheumatology	Charlotte	North Carolina
United States	DJL Clinical Research PLLC	Charlotte	North Carolina
United States	Javara	Charlotte	North Carolina
United States	Joint and Muscle Research Institute	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Precision Comprehensive Clinical Research Solutions	Colleyville	Texas
United States	Columbia Arthritis Center, PA	Columbia	South Carolina
United States	Texas Arthritis Center PA	El Paso	Texas
United States	Centre for Rheumatology Immunology and Arthritis	Fort Lauderdale	Florida
United States	Arizona Arthritis and Rheumatology Associates PC	Gilbert	Arizona
United States	Arizona Arthritis And Rheumatology Associates PC	Glendale	Arizona
United States	Michigan Rheumatology Group, PC - Grand Blanc Office	Grand Blanc	Michigan
United States	Piedmont Arthritis Clinic	Greenville	South Carolina
United States	GNP Research	Hollywood	Florida
United States	Western Kentucky Rheumatology PLLC	Hopkinsville	Kentucky
United States	Accurate Clinical Management	Houston	Texas
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Laila A Hassan, MD, PA	Houston	Texas
United States	West Tennessee Research Institute, LLC	Jackson	Tennessee
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Accurate Clinical Research	Lake Charles	Louisiana
United States	Arthritis and Rheumatology of Michigan	Lansing	Michigan
United States	Loma Linda University Health Care	Loma Linda	California
United States	University of California Los Angeles	Los Angeles	California
United States	Feinstein Institute for Medical Research	Manhasset	New York
United States	Ramesh C Gupta MD	Memphis	Tennessee
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Arthritis and Rheumatology Center of Oklahoma PLLC	Oklahoma City	Oklahoma
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	University of California Irvine	Orange	California
United States	Millennium Research	Ormond Beach	Florida
United States	University of Pittsburgh Medical Center Lupus Center of Excellence	Pittsburgh	Pennsylvania
United States	Trinity Universal Research Associates, LLC	Plano	Texas
United States	Integral Rheumatology and Immunology Specialists	Plantation	Florida
United States	Suncoast Medical Clinic	Saint Petersburg	Florida
United States	Clinical Trials of Texas	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio Medical Arts Research Clinic Marc	San Antonio	Texas
United States	Greater Chicago Specialty Physicians	Schaumburg	Illinois
United States	Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc	Skokie	Illinois
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	Baycare Medical Group Inc	Tampa	Florida
United States	Arizona Arthritis and Rheumatology Associates PC	Tucson	Arizona
United States	Robin K Dore MD Inc	Tustin	California
United States	Arthritis and Osteoporosis Clinic	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Canada,  Chile,  Colombia,  France,  Greece,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  Spain,  Switzerland,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at 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).	Week 52
Secondary	Percent of Participants Achieving a British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at 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.	Week 24 and Week 52
Secondary	Percent of Participants Achieving a Lupus Low Disease Activity State (LLDAS) Response at 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.	Week 52
Secondary	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	To evaluate the efficacy of efavaleukin alfa with oral corticosteroid (OCS)-tapering in subjects with SLE with inadequate response to SOC therapy.	Week 52
Secondary	Percent of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at 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).	Week 24
Secondary	Percent of Participants Achieving a Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) Response at Week 24 and Week 52	hSLEDAI response is defined as a greater than or equal to 4-point decrease in score.	Week 24 and Week 52
Secondary	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	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.	Baseline, Week 8, 12, 24, 36, and 52
Secondary	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	To evaluate the effect of efavaleukin alfa on additional SLE efficacy endpoints.	Baseline, Week 8, 12, 24, 36, and 52
Secondary	Percent of Participants who Experience a Flare	A flare is defined as a British Isles Lupus Assessment Group (BILAG) score designation of 'worse' or 'new'.	Week 52
Secondary	Change from Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS Fatigue SF 7A) Fatigue Score	To describe the effect of treatment with efavaleukin alfa using patient reported outcomes.	Baseline, Week 12, 24, 36, and 52
Secondary	Change from Baseline in Medical Outcomes Short Form-36 Questionnaire Score	To describe the effect of treatment with efavaleukin alfa using patient reported outcomes.	Baseline, Week 12, 24, 36, and 52
Secondary	Change from Baseline in Lupus Quality of Life (QoL) Questionnaire Score	To describe the effect of treatment with efavaleukin alfa using patient reported outcomes.	Baseline, Week 12, 24, 36, and 52
Secondary	Number of Participants who Experience a Treatment-Emergent Adverse Event (AE) and Serious Adverse Event (SAE)	To characterize the safety of efavaleukin alfa.	Up to Week 56
Secondary	Number of Participants who Experience a Clinically Significant Change in Laboratory Values and Vital Sign Measurements	To characterize the safety of efavaleukin alfa.	Up to Week 56
Secondary	Trough Serum and Sparse Postdose Serum Concentration of Efavaleukin Alfa	To characterize the pharmacokinetics (PK) of efavaleukin alfa.	Up to Week 52

External Links

•   AmgenTrials clinical trials website