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Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT03451422
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of AMG 592 in subjects with systemic lupus erythematosus (SLE)

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: AMG 592 Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Phase 1b The phase 1b part of the study is a double-blind, placebo-controlled, multicenter, multiple ascending dose (MAD) study to evaluate the safety, tolerability, PK, and PD of AMG 592 in subjects with SLE. Subjects will be treated for a total of 12 weeks after which they will be followed for an additional 6 weeks for safety and additional PK/PD data collection. Three dosing cohorts are planned for the phase 1b part of the study.

Phase 2a The phase 2a part of the study is a 52-week multicenter, double-blind, placebo controlled study in subjects with moderate to severe SLE or cutaneous lupus with inadequate response to standard of care therapy. The phase 2a part of the study will commence after a RP2D is identified. Subjects will be randomly assigned in a 2:1 ratio to either AMG 592 or placebo.

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The phase 1b and phase 2a parts of the study are double-blind. In the phase 1b part of the study, treatment assignment will be blinded to all subjects and site personnel as described below. In the phase 2a part of the study treatment assignment will be blinded to all subjects, site personnel, and Amgen as described below.
Primary Purpose: Treatment
Official Title: A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : August 18, 2021
Estimated Study Completion Date : February 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Active Comparator: AMG 592
For phase 1b, subjects within a dosing cohort will be randomized in a 5:2 ratio to AMG 592 or placebo in addition to standard of care therapy. AMG 592 or placebo will be administered either weekly (QW) or biweekly (Q2W) by subcutaneous (SC) injection in abdomen. The phase 2a part of the study will commence after a RP2D is identified. Approximately 111 subjects will receive AMG 592 or matching placebo by subcutaneous injection. Subjects will be randomly assigned in a 2:1 ratio to either AMG 592 or placebo.
Drug: AMG 592
For both the phase 1b and phase 2a part of the study, AMG 592 or placebo will be administered by SC injection in the abdomen, thigh or upper arm

Placebo Comparator: Placebo
For phase 1b, subjects within a dosing cohort will be randomized in a 5:2 ratio to AMG 592 or placebo in addition to standard of care therapy. AMG 592 or placebo will be administered either weekly (QW) or biweekly (Q2W) by subcutaneous (SC) injection in abdomen. The phase 2a part of the study will commence after a RP2D is identified. Approximately 111 subjects will receive AMG 592 or matching placebo by subcutaneous injection. Subjects will be randomly assigned in a 2:1 ratio to either AMG 592 or placebo.
Drug: Placebo
For both the phase 1b and phase 2a part of the study, AMG 592 or placebo will be administered by SC injection in the abdomen, thigh or upper arm




Primary Outcome Measures :
  1. Number of participants with Treatment-emergent Adverse Events. [ Time Frame: 18 weeks ]
    Phase 1: evaluate the safety and tolerability of subcutaneous (SC) dose administrations of AMG 592 in subjects with systemic lupus erythematosus (SLE).

  2. SRI-4 (Systemic Lupus Erythematosus Responder Index) response in subjects with a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) score ≥ 6 at baseline. [ Time Frame: Baseline and week 24 ]
    Phase 2: evaluate the efficacy of AMG 592 at week 24 as measured by the Systemic Lupus Erythematosus Responder Index (SRI-4).

  3. CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index score) activity score change from baseline at week 24 in subjects with a CLASI activity score ≥ 10 at baseline. [ Time Frame: 24 weeks ]
    Evaluate efficacy of AMG 592 at week 24 as measured by CLASI.

  4. Changes in blood pressure. [ Time Frame: up to 18 weeks ]
    The analysis will include summary statistics at selected time points by treatment group, and shifts between baseline and on-study values.

  5. Physical examination will be performed as per standard of care. [ Time Frame: up to 18 weeks ]
    The analysis will include summary statistics at selected time points by treatment group.

  6. Changes in heart rate. [ Time Frame: up to 18 weeks ]
    The analysis will include summary statistics at selected time points by treatment group, and shifts between baseline and on-study values.

  7. Changes in respiratory rate. [ Time Frame: up to 18 weeks ]
    The analysis will include summary statistics at selected time points by treatment group, and shifts between baseline and on-study values.

  8. Changes in temperature. [ Time Frame: up to 18 weeks ]
    The analysis will include summary statistics at selected time points by treatment group, and shifts between baseline and on-study values.

  9. Changes in laboratory test results. [ Time Frame: up to 18 weeks ]
    The analysis will include summary statistics at selected time points by treatment group, and shifts between baseline and on-study values.

  10. Area under the concentration-time curve over a dosing interval (AUCtau) of AMG 592. [ Time Frame: 52 weeks ]
    Phase 2: Characterize the PK of AMG 592 in subjects with SLE.


Secondary Outcome Measures :
  1. Maximum observed concentration (Cmax) for AMG 592. [ Time Frame: 12 weeks ]
    Phase 1: characterize the pharmacokinetic (PK) profile following treatment with AMG 592.

  2. Time of maximum observed concentration (Tmax) for AMG 592. [ Time Frame: 12 weeks ]
    Phase 1: characterize the pharmacokinetic (PK) profile following treatment with AMG 592.

  3. Area under the concentration-time curve over a dosing interval (AUCtau). [ Time Frame: 12 weeks ]
    Phase 1: characterize the pharmacokinetic (PK) profile following treatment with AMG 592.

  4. Incidence of anti‑AMG 592 antibodies, week 18. [ Time Frame: 18 weeks ]
    Phase 1: To evaluate anti‑AMG 592 antibody formation.

  5. SRI-4 response in subjects with a SLEDAI 2K score ≥ 6 at baseline. [ Time Frame: baseline and week 52 ]
    Phase 2: evaluate the effect of treatment with AMG 592 on other measures of disease activity at various time points.

  6. SRI-4 response at week 52 in subjects with baseline SLEDAI 2K score ≥ 6 who achieve a prednisone dose reduction to ≤ 10 mg/day and ≤ their baseline prednisone dose at week 44 and maintained through week 52. [ Time Frame: up to 52 weeks ]
    Phase 2: evaluate the effect of treatment with AMG 592 on other measures of disease activity at various time points.

  7. Change from baseline in SLEDAI 2K at week 24 and week 52 in subjects with a SLEDAI 2K score ≥ 6 at baseline. [ Time Frame: baseline, weeks 24 and 52 ]
    Phase 2: evaluate the effect of treatment with AMG 592 on other measures of disease activity at various time points.

  8. CLASI activity score 50% improvement from baseline at weeks 12, 24, 36, and 52 in subjects with a CLASI activity score ≥ 10 at baseline. [ Time Frame: baseline, weeks 12, 24, 36 and 52 ]
    Phase 2: evaluate the effect of treatment with AMG 592 on other measures of disease activity at various time points.

  9. CLASI activity score change from baseline at weeks 12, 36 and 52, in subjects with a CLASI activity score ≥ 10 at baseline. [ Time Frame: baseline, weeks 12, 24, 36 and 52 ]
    Phase 2: evaluate the effect of treatment with AMG 592 on other measures of disease activity at various time points.

  10. SRI-4 response at week 24 in subjects with baseline SLEDAI 2K score ≥ 6 who achieve a prednisone dose reduction to ≤ 10 mg/day and ≤their baseline prednisone dose at week 16 and maintained through week 24. [ Time Frame: up to 24 Weeks ]
    Phase 2: evaluate the effect of treatment with AMG 592 on other measures of disease activity at various time points.

  11. Proportion of subjects at week 16 and maintained through week 24 with a prednisone dose reduction to ≤ 7.5 mg/day and ≤ their baseline prednisone dose. [ Time Frame: up to 24 Weeks ]
    Phase 2: evaluate the effect of AMG 592 on tapering of corticosteroids.

  12. Proportion of subjects at week 44 and maintained through week 52 with a prednisone dose reduction to ≤ 7.5mg/day and ≤ their baseline prednisone dose. [ Time Frame: up to 52 Weeks ]
    Phase 2: evaluate the effect of AMG 592 on tapering of corticosteroids.

  13. Treatment-emergent adverse events. [ Time Frame: 52 Weeks ]
    Phase 2: evaluate the safety of AMG 592.

  14. Incidence of anti‑AMG 592 antibodies. [ Time Frame: 52 Weeks ]
    Evaluate anti‑AMG 592 antibody formation.

  15. Cross‑reactivity of anti‑AMG 592 antibodies with IL‑2. [ Time Frame: 52 Weeks ]
    Phase 2: evaluate anti‑AMG 592 antibody formation.

  16. Incidence of anti‑AMG 592 and anti‑IL 2 neutralizing antibodies. [ Time Frame: 52 weeks ]
    Phase 2: evaluate anti‑AMG 592 antibody formation.

  17. Maximum observed concentration (Cmax) of AMG 592. [ Time Frame: 52 weeks ]
    Phase 2: Characterize the PK of AMG 592 in subjects with SLE.

  18. Change from baseline in Physician Global Assessment (PGA) at week 24 and week 52 in subjects with a SLEDAI 2K score ≥ 6 at baseline. [ Time Frame: baseline, weeks 24 and 52 ]
    Phase 2: evaluate the effect of treatment with AMG 592 on other measures of disease activity at various time points.

  19. Time of maximum observed concentration (Tmax) of AMG 592. [ Time Frame: 52 weeks ]
    Phase 2: Characterize the PK of AMG 592 in subjects with SLE.


Other Outcome Measures:
  1. Exploratory - Change from baseline in anti-double stranded DNA (anti-dsDNA). [ Time Frame: Up to 12 Weeks ]
    Phase 1: explore the effect of treatment with AMG 592 on measures of inflammation at various time points.

  2. Exploratory - SLEDAI 2K score at all time points collected. [ Time Frame: Up to 12 Weeks ]
    Phase 1: To explore the effect of treatment with AMG 592 on measures of disease activity at various time points.

  3. Exploratory - fold changes from baseline of Treg after AMG 592 administration. [ Time Frame: Up to 12 Weeks ]
    Phase 1: evaluate the immunological effects of AMG 592.

  4. Exploratory - Changes in Treg/Tcon ratio after AMG 592 administration. [ Time Frame: 12 Weeks ]
    Phase 1: evaluate the immunological effects of AMG 592.

  5. Exploratory - SRI-4 response at weeks 12 and 36 in subjects with a SLEDAI 2K score ≥ 6 at baseline. [ Time Frame: up to 36 Weeks ]
    Phase 2: explore the effect of AMG 592 on other measures of disease activity at various time points.

  6. Exploratory: Tender and swollen joint count 50% improvement from baseline at week 24 and week 52 in subjects with a tender joint count ≥ 6 and swollen joint count ≥ 6 at baseline. [ Time Frame: baseline, weeks 24 and 52 ]
    Phase 2: explore the effect of AMG 592 on other measures of disease activity at various time points.

  7. Exploratory: Change from baseline in anti-dsDNA. [ Time Frame: 52 Weeks ]
    Phase 2: explore the effect of AMG 592 on other measures of inflammatory activity at various time points.

  8. Exploratory - Medical Outcomes Short Form 36 version 2 Questionnaire (SF36v2) score change from baseline at various timepoints [ Time Frame: up to 52 weeks ]

    SF36 is standard, well-recognized, validated, quality of life questionnaire for subjects in trials, with a standard, well-recognized, validated method of analysis.

    Phase 2: To describe the effect of treatment with AMG 592 on clinical outcomes.


  9. Exploratory - functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score change from baseline at various time points. [ Time Frame: up to 52 weeks ]

    FACIT-Fatigue is standard, well-recognized, validated, quality of life questionnaire for subjects in trials, with a standard, well-recognized, validated method of analysis.

    Phase 2: To describe the effect of treatment with AMG 592 on clinical outcomes.


  10. Exploratory - Modified LupusQoL score change from baseline at various timepoints. [ Time Frame: up to 52 weeks ]

    Modified LupusQoL is standard, well-recognized, validated, quality of life questionnaire for subjects in SLE trials, with a standard, well-recognized, validated method of analysis.

    Phase 2: To describe the effect of treatment with AMG 592 on clinical outcomes.


  11. Exploratory - Change from baseline in C3 complements. [ Time Frame: Up to 12 Weeks ]
    Phase 1: explore the effect of treatment with AMG 592 on measures of inflammation at various time points.

  12. Exploratory - Change from baseline in C4 complements. [ Time Frame: Up to 12 Weeks ]
    Phase 1: explore the effect of treatment with AMG 592 on measures of inflammation at various time points.

  13. Exploratory - SLEDAI 2K change from baseline at all time points collected. [ Time Frame: Up to 12 Weeks ]
    Phase 1: To explore the effect of treatment with AMG 592 on measures of disease activity at various time points.

  14. Exploratory - fold changes from baseline of Tcon after AMG 592 administration. [ Time Frame: Up to 12 Weeks ]
    Phase 1: evaluate the immunological effects of AMG 592.

  15. Exploratory - fold changes from baseline of NK absolute cell counts (cells/μL) after AMG 592 administration. [ Time Frame: Up to 12 Weeks ]
    Phase 1: evaluate the immunological effects of AMG 592.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects are eligible to be included in the study only if all of the following criteria apply:

  • 101 Subject has provided informed consent prior to initiation of any study specific activities/procedures.
  • 102 Age ≥ 18 years to ≤ 60 years at screening.
  • 103 Fulfils diagnostic criteria for SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) criteria or by at least 4 of the 11 criteria of the 1997 American College of Rheumatology (ACR) classification criteria for SLE, with at least one of the following being present at screening:
  • Antinuclear antibody ≥ 1:80; or
  • Elevated anti-dsDNA antibodies
  • 104 Phase 2a Subjects Only: At least one of the following at screening:
  • SLEDAI 2K ≥ 6 without including anti-dsDNA or C3 and C4 complement toward the total score. If a subject qualifies for the study by scoring for arthritis on the SLEDAI 2K form, they must have ≥ 3 swollen and/or tender joints; or
  • CLASI score ≥10
  • 105 Phase 2a Subjects Only: Meets SLE diagnostic and severity requirements per Central Review team at screening
  • 106 Phase 2a Subjects Only: Taking at least 1 but not more than 3 of the following SLE treatments: mycophenolate mofetil, azathioprine, methotrexate, hydroxychloroquine, chloroquine, dapsone (confirmed by blood specific drug levels) or quinacrine. Subjects must be on SLE treatment for ≥ 12 weeks and have a stable dose for ≥ 4 weeks prior to day 1.
  • 107 Phase 1b Subjects only: May be taking ≤ 3 systemic SLE treatments and the dose must be stable for ≥ 4 weeks prior to day 1.
  • 108 Prednisone dose ≤ 20 mg daily (or other equivalent oral corticosteroid) with stable dose ≥ 2 weeks prior to day 1
  • 109 Phase 1b Subjects Only: Normal or clinically acceptable ECG values (12-lead reporting ventricular rate and PR, QRS, QT and QTc interval) at screening and baseline based on opinion of the investigator.
  • 110 Immunizations (tetanus, diphtheria, pertussis [Td/Tdap]), seasonal influenza (during flu season), and pneumococcal (polysaccharide) vaccinations] up to date per local standards as determined by the investigator.

Exclusion Criteria:

  • Subjects are excluded from the study if any of the following criteria apply. Disease Related
  • 201 History of lupus nephritis requiring induction therapy and/or lupus cerebritis ≤ 1 year prior to screening
  • 202 Phase 2a only: Spot urine protein to creatinine ratio > 2 mg/g at screening Other Medical Conditions
  • 203 Diagnosis of inflammatory joint or skin disease other than SLE which would interfere with SLE disease assessment based on investigator judgement.
  • 204 Diagnosis of fibromyalgia which would interfere with SLE assessment according to the investigator
  • 205 Prosthetic joint infection within 3 years of screening or native joint infection within 1 year prior to screening.
  • 206 Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to day 1.
  • 207 Known history of active tuberculosis
  • 208 Positive test for tuberculosis during screening defined as either:
  • positive purified protein derivative (PPD) (≥ 5 mm of induration at 48 to 72 hours after test is placed) OR positive Quantiferon test
  • a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test and negative chest X-ray
  • a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or a positive or indeterminate Quantiferon test are allowed if they have ALL of the following at screening:
  • no symptoms per tuberculosis worksheet provided by Amgen
  • documented history of a completed course of adequate prophylaxis (completed treatment for latent tuberculosis per local standard of care prior to the start of investigational product)
  • no known exposure to a case of active tuberculosis after most recent prophylaxis
  • negative chest X-ray
  • 209 Positive for hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B DNA polymerase chain reaction [PCR] test) or detectable hepatitis C virus RNA by PCR (screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive). A history of hepatitis B vaccination without history of hepatitis B is allowed.
  • 210 Phase 1b Subjects Only: Positive for Human Immunodeficiency Virus (HIV) at screening, or known to be HIV positive Phase 2a Subjects Only: Known history of HIV
  • 211 Presence of one or more significant concurrent medical conditions per investigator judgment, including but not limited to the following:
  • poorly controlled diabetes or hypertension
  • chronic kidney disease stage IIIb, IV, or V
  • symptomatic heart failure (New York Heart Association class II, III, or IV)
  • myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
  • severe chronic pulmonary disease (eg, requiring oxygen therapy)
  • multiple sclerosis or any other demyelinating disease
  • major chronic inflammatory disease or connective tissue disease other than SLE (eg, RA)
  • 212 Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within 5 years of screening
  • 213 Positive drug or alcohol urine test at screening
  • 214 History of alcohol or substance abuse within 6 months of screening 215 Phase 1b Subjects Only: Current smoker, and/or use of any nicotine or tobacco containing products within the last 6 months prior to day 1. These types of products include but are not limited to: snuff, chewing tobacco, cigars, cigarettes, electronic cigarettes, pipes, or nicotine patches.
  • 216 Phase 1b Subjects Only: Subject unwilling to limit alcohol consumption to ≤ 1 drink of alcohol per day and ≤3 drinks per week for the duration of the study, where a drink is equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine, or 1.5 ounces of 80 proof distilled spirits.

Prior/Concomitant Therapy

  • 217 Currently receiving or had treatment with: cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent ≤ 6 months prior to day 1 OR oral calcineurin inhibitors (eg, cyclosporine, tacrolimus, sirolimus) ≤ 4 weeks prior to day 1.
  • 218 Current or previous treatment for SLE with a biologic agent as follows: rituximab < 6 months prior to day 1, belimumab < 3 months prior to day 1, abatacept < 8 weeks prior to day 1.
  • 219 Currently receiving or had treatment with T cell depleting agents (eg, antithymocyte globulin, Campath) or recombinant IL-2 (eg, Proleukin).
  • 220 Subjects who have received intra-articular or systemic corticosteroid injections within 4 weeks prior to day 1 or topical steroids within 2 weeks prior to day 1.
  • 221 Phase 1b Subjects only: Administration of herbal supplements, vitamins, or nutritional supplements within 30 days prior to the first dose of investigational product, and continuing use, if applicable, will be reviewed by the Investigator and the Amgen Medical Monitor to determine acceptability. Written documentation of this review and Amgen acknowledgment is required for subject participation.

Prior/Concurrent Clinical Study Experience

  • 222 Currently receiving treatment in another investigational device or drug study, or less than 30 days at day 1 since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
  • 223 Subject previously enrolled in this study Diagnostic Assessments
  • 224 Presence of laboratory abnormalities at screening including the following:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5x upper limit of normal (ULN)
  • Serum total bilirubin (TBL) ≥ 1.5 mg/dL (≥ 26 μmol/L)
  • Hemoglobin < 9.0 g/dL(< 90 g/L)
  • Platelet count < 100,000/mm3 (100 x 109/L)
  • White blood cell count < 3,000 cells/mm3 (3.0 x 109/L)
  • Absolute neutrophil count (ANC) < 1,500/mm3 (1.5 x 109/L)
  • Calculated glomerular filtration rate of ≤ 50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
  • 225 Any other laboratory abnormality, which, in the opinion of the investigator, poses a safety risk, will prevent the subject from completing the study, will interfere with the interpretation of the study results, or might cause the study to be detrimental to the subject.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451422


Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
United States, New York
Research Site Recruiting
Great Neck, New York, United States, 11021
United States, Pennsylvania
Research Site Recruiting
Duncansville, Pennsylvania, United States, 16635
France
Research Site Recruiting
Lille cedex 01, France, 59037
Research Site Recruiting
Paris Cedex 13, France, 75651
Research Site Recruiting
Strasbourg, France, 67091
Germany
Research Site Recruiting
Berlin, Germany, 10117
Poland
Research Site Recruiting
Poznan, Poland, 60-848
Research Site Recruiting
Swidnik, Poland, 21-040
Research Site Recruiting
Warszawa, Poland, 00-874
Research Site Recruiting
Wroclaw, Poland, 51-124
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03451422     History of Changes
Other Study ID Numbers: 20170103
2017-002564-40 ( EudraCT Number )
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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 (or other new use) 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.
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.
URL: https://www.amgen.com/datasharing

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:
AMG 592
Systemic lupus erythematosus
Phase 1b/2a

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases