A Phase 1 interventional study of Efavaleukin Alfa and Placebo in Systemic Lupus Erythematosus, sponsored by Amgen. Completed at 15 sites in 4 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by Amgen · Phase 1, Interventional, and Basic science
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Among 20 studies in Lupus Erythematosus, Systemic by Amgen — 1 open to participants now, 1 under way, none of them phase 3. Lupus Erythematosus, Systemic · Amgen.
Among the 20 studies in Lupus Erythematosus, Systemic by Amgen, this one is the 14th largest by enrollment, is one of 2 that started in 2018, is one of 15 in phase 1, and was the 11th registered.
1,208 studies on the registry are indexed under Lupus Erythematosus, Systemic; 404 are open to participants now.
Browse Lupus Erythematosus, Systemic studies →1 of the 20 studies in Lupus Erythematosus, Systemic by Amgen is open now, in 10 countries. Recruiting first, the newest first:
Amgen · Sites in United States, Australia, Belgium and 7 more countries
Ages 18–75
By country, each count listing its studies:
Of the 283 Lupus Erythematosus, Systemic studies recruiting now, 92 (33%) set no upper age limit and 161 (57%) stop at 75 or younger; 54 take children under 18; 33 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2018.
This study's enrollment of 35 is below the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Median enrollment 56 across the 20 interventional studies. Of the 19 that completed or were terminated, 7 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
Amgen is the lead sponsor of 1,047 studies on the registry; 51 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Lupus Erythematosus, Systemic by Amgen, from their registry updates:
Nothing recorded among them since 2026-09-25.
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To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible to be included in the study only if all of the following criteria apply:
Fulfills 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 a history of at least one of the following:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply.
Disease Related
Other Medical Conditions
Positive test for tuberculosis during screening defined as either:
a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test and negative chest X-ray.
Presence of one or more significant concurrent medical conditions per investigator judgment, including but not limited to the following:
Prior/Concomitant Therapy
Prior/Concurrent Clinical Study Experience
Participant previously enrolled in this study may not be re-enrolled unless they fulfill the following criteria:
Diagnostic Assessments
Presence of laboratory abnormalities at screening including the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 29 participants will be randomized in a 5:2 ratio (cohorts 1, 2, and 3) or in a 3:1 ratio (cohorts 4 and 5) to Efavaleukin Alfa or placebo in addition to standard of care therapy. Efavaleukin Alfa or placebo will be administered either weekly (QW) or biweekly (Q2W).
Drug: Efavaleukin Alfa
Approximately 29 participants will be randomized in a 5:2 ratio (cohorts 1, 2, and 3) or in a 3:1 ratio (cohorts 4 and 5) to Efavaleukin Alfa or placebo in addition to standard of care therapy. Efavaleukin Alfa or placebo will be administered either weekly (QW) or biweekly (Q2W).
Drug: Placebo
Efavaleukin Alfa will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm.
The placebo will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm.
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
A TEAE was defined as any adverse event (AE) starting on or after the first dose of investigational product through to the safety follow-up visit. Any clinically significant changes in physical examinations, vital signs, and clinical laboratory test results were recorded as AEs.
Time frame: Day 1 up to end of study, maximum of 18 weeks (12-week double-blind treatment, 6-week safety follow-up)
Maximum Observed Concentration (Cmax) for AMG 592
Time frame: Day 1 (pre-dose) and 6 to 72 hours post-dose, and Days 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, Day 85 (pre-dose) and 6 to 72 hours post-dose, and Days 92, 99, 113 and 127
Time of Cmax (Tmax) for AMG 592
Time frame: Day 1 (pre-dose) and 6 to 72 hours post-dose, and Days 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, Day 85 (pre-dose) and 6 to 72 hours post-dose, and Days 92, 99, 113 and 127
Area Under the Concentration-time Curve Over a Dosing Interval (AUCtau) for AMG 592
Time frame: Day 1 (pre-dose) and 6 to 72 hours post-dose, and Days 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, Day 85 (pre-dose) and 6 to 72 hours post-dose, and Days 92, 99, 113 and 127
Number of Participants With Anti-AMG 592 Binding Antibodies and Anti-Interleukin (IL-2) Binding Antibodies
Number of participants who tested positive for developing anti-AMG 592 or anti-IL-2 binding antibodies at 1 or more post-baseline time points, with a negative or no result at baseline, are reported.
Time frame: Day 1 up to end of study, maximum of 18 weeks (12-week double-blind treatment, 6-week safety follow-up)
Number of Participants With Anti-AMG 592 Neutralizing Antibodies and Anti-IL-2 Neutralizing Antibodies
Number of participants who tested positive for developing anti-AMG 592 or anti-IL-2 neutralizing antibodies at 1 or more post-baseline time points, with a negative or no result at baseline, are reported.
Time frame: Day 1 up to end of study, maximum of 18 weeks (12-week double-blind treatment, 6-week safety follow-up)
Participants were enrolled at 10 centers in the United States, France, and Poland from 10 April 2018 to 12 October 2021.
| Milestone | Placebo | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 |
|---|---|---|---|---|---|---|
| Started | 10 | 5 | 5 | 7 | 4 | 4 |
| Completed | 9 | 5 | 2 | 4 | 2 | 2 |
| Not completed | 1 | 0 | 3 | 3 | 2 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Decision by sponsor | 1 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 | 3 | 2 | 1 |
A TEAE was defined as any adverse event (AE) starting on or after the first dose of investigational product through to the safety follow-up visit. Any clinically significant changes in physical examinations, vital signs, and clinical laboratory test results were recorded as AEs.
| Participants | Placebo | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 |
|---|---|---|---|---|---|---|
| Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | 7 | 5 | 5 | 7 | 3 | 4 |
| ng/mL | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 |
|---|---|---|---|---|---|
| First dose (Day 1) | 7.92 (5.52 to 13.8) | 13.0 (5.01 to 15.8) | 25.7 (9.74 to 43.7) | 30.7 (16.2 to 37.7) | 44.3 (29.6 to 67.9) |
| Last dose (Day 85) | 9.24 (7.05 to 13.7) | 18.9 (14.0 to 23.7) | 10.0 (8.77 to 11.3) | 56.5 (47.1 to 65.8) | 51.6 (25.7 to 77.5) |
| hours | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 |
|---|---|---|---|---|---|
| First dose (Day 1) | 24.0 (12.0 to 74.2) | 47.6 (20.3 to 48.0) | 24.1 (11.9 to 48.0) | 24.6 (24.0 to 27.1) | 17.8 (11.9 to 24.0) |
| Last dose (Day 85) | 25.2 (18.8 to 47.5) | 26.2 (23.4 to 28.9) | 18.0 (12.0 to 24.1) | 24.1 (23.5 to 24.7) | 16.7 (12.0 to 21.4) |
| hour*ng/mL | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 |
|---|---|---|---|---|---|
| First dose (Day 1) | 538 (261 to 986) | 915 (317 to 1360) | 1560 (971 to 2730) | 1960 (1960 to 1960) | 3770 (2020 to 5680) |
| Last dose (Day 85) | 773 (444 to 1160) | 1120 (779 to 1460) | 542 (347 to 736) | 3260 (2110 to 4420) | 3010 (1090 to 4930) |
Number of participants who tested positive for developing anti-AMG 592 or anti-IL-2 binding antibodies at 1 or more post-baseline time points, with a negative or no result at baseline, are reported.
| Participants | Placebo | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 |
|---|---|---|---|---|---|---|
| Binding anti-AMG 592 antibody | 0 | 3 | 3 | 6 | 2 | 4 |
| Binding anti-IL-2 antibody | — | 1 | 2 | 0 | 1 | 0 |
Number of participants who tested positive for developing anti-AMG 592 or anti-IL-2 neutralizing antibodies at 1 or more post-baseline time points, with a negative or no result at baseline, are reported.
| Participants | Placebo | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 |
|---|---|---|---|---|---|---|
| Neutralizing anti-AMG 592 antibody | 0 | 0 | 2 | 1 | 0 | 2 |
| Neutralizing anti-IL-2 antibody | — | 0 | 0 | 0 | 0 | 0 |
Collected over Day 1 up to end of study, maximum of 18 weeks (12-week double-blind treatment, 6-week safety follow-up). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/10 (0%) | 0/10 (0%) | 7/10 (70%) |
| AMG 592 Cohort 1 | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| AMG 592 Cohort 2 | 0/5 (0%) | 1/5 (20%) | 5/5 (100%) |
| AMG 592 Cohort 3 | 0/7 (0%) | 0/7 (0%) | 7/7 (100%) |
| AMG 592 Cohort 4 | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| AMG 592 Cohort 5 | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| Event | Placebo | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 |
|---|---|---|---|---|---|---|
| EosinophiliaBlood and lymphatic system disorders | 0/10 | 0/5 | 0/5 | 0/7 | 0/4 | 1/4 |
| SyncopeNervous system disorders | 0/10 | 0/5 | 1/5 | 0/7 | 0/4 | 0/4 |
| Event | Placebo | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 |
|---|---|---|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/10 | 0/5 | 4/5 | 0/7 | 1/4 | 0/4 |
| Injection site reactionGeneral disorders | 0/10 | 2/5 | 3/5 | 2/7 | 2/4 | 3/4 |
| Injection site erythemaGeneral disorders | 0/10 | 3/5 | 3/5 | 5/7 | 2/4 | 2/4 |
| Injection site indurationGeneral disorders | 0/10 | 0/5 | 1/5 | 1/7 | 2/4 | 2/4 |
| Injection site pruritusGeneral disorders | 0/10 | 1/5 | 1/5 | 2/7 | 2/4 | 2/4 |
| Dry mouthGastrointestinal disorders | 0/10 | 2/5 | 0/5 | 0/7 | 0/4 | 0/4 |
| AstheniaGeneral disorders | 0/10 | 2/5 | 0/5 | 0/7 | 0/4 | 1/4 |
| FatigueGeneral disorders | 0/10 | 2/5 | 1/5 | 0/7 | 0/4 | 0/4 |
| Non-cardiac chest painGeneral disorders | 0/10 | 2/5 | 1/5 | 0/7 | 0/4 | 0/4 |
| Upper respiratory tract infectionInfections and infestations | 1/10 | 1/5 | 2/5 | 0/7 | 0/4 | 0/4 |
The Safety Analysis Set: All participants who received at least 1 dose of investigational product. Participants re-enrolled to new cohorts were counted as different participants, as pre-specified.
| Age, Continuous(years) | Placebo | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 47.2 ± 17.4 | 44.4 ± 13.4 | 44.4 ± 9.2 | 13.9 ± 63.0 | 16.6 ± 57.0 | 6.6 ± 60.0 | 14.4 ± 54.0 |
| Sex: Female, Male(Participants) | Placebo | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 | Total |
|---|---|---|---|---|---|---|---|
| Female | 8 | 3 | 5 | 6 | 4 | 4 | 30 |
| Male | 2 | 2 | 0 | 1 | 0 | 0 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 10 | 5 | 5 | 7 | 4 | 4 | 35 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Placebo | AMG 592 Cohort 1 | AMG 592 Cohort 2 | AMG 592 Cohort 3 | AMG 592 Cohort 4 | AMG 592 Cohort 5 | Total |
|---|---|---|---|---|---|---|---|
| Black or African American | 4 | 0 | 0 | 3 | 3 | 2 | 12 |
| Black or African American and American Indian or Alaska Native | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| White | 4 | 5 | 5 | 4 | 1 | 2 | 21 |
| African and White | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Data sharing details ↗ · www.amgen.com
Ran from Apr 2018 to primary completion in Oct 2021, 42 months.
Results were first posted in Jul 2023, 1 year 9 months after primary completion.
Of 108 industry-sponsored phase 1 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 35. This study's 42 months is above that.
Counting every sponsor, half of 147 studies reached it within 28 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Efavaleukin alfa
Lupus Erythematosus, Systemic →