A Phase 1/2 interventional study of Efavaleukin alfa and Placebo in Rheumatoid Arthritis RA, sponsored by Amgen. Terminated at 15 sites in 5 countries. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-22.
Sponsored by Amgen · Phase 1/2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 57 studies in Arthritis, Rheumatoid by Amgen — 1 open to participants now, 1 under way, none of them phase 3. Arthritis, Rheumatoid · Amgen.
Among the 57 studies in Arthritis, Rheumatoid by Amgen, this one is the 40th largest by enrollment of the 47 interventional ones that give a count, is the only one that started in 2018, is one of 3 in phase 1/2, and was the 55th registered.
3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.
Browse Arthritis, Rheumatoid studies →1 of the 57 studies in Arthritis, Rheumatoid 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 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
57 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 17 · Phase 3 17 · Phase 4 12
First in 1997; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 95 across 2,221 interventional studies indexed under Arthritis, Rheumatoid.
Median enrollment 211 across the 47 interventional studies, 2,522 across the 4 observational. Of the 56 that completed or were terminated, 30 (54%) 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 57 studies in Arthritis, Rheumatoid by Amgen, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin alfa in subjects with active rheumatoid arthritis (RA).
Phase 2a. To evaluate the efficacy of Efavaleukin alfa at week 12 as measured by the American College of Rheumatology 20 percent improvement criteria (ACR 20) in adult subjects with moderate to severe RA.
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.
Exclusion Criteria:
Prior treatment with more than a total of 3 therapies that include biologic disease modifying anti-rheumatic drug (DMARDs) or oral synthetic DMARDs (such as tofacinitib, baricitinib). Prior treatment consists of at least 4 doses of a given therapy where the doses were given solely for treatment of RA disease. Prior therapies must not have been used within the following time periods:
Currently receiving or had treatment with any of the following ≤ 12 weeks prior to day 1:
Phase 2a only: Currently receiving or had treatment with any of the following ≤ 4 weeks prior to day 1:
acetaminophen, NSAIDs, tramadol, and/or any narcotic analgesics such as but not limited to hydrocodone, codeine, tramadol, propoxyphene and/or oxycodone (unless in the form of oxycontin). Subject has taken oxycontin within 24 hours prior to screening or day 1.
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.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
Drug: Placebo
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
Drug: Efavaleukin alfa
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
Drug: Efavaleukin alfa
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
Drug: Efavaleukin alfa
A medium/high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
Drug: Efavaleukin alfa
Matching placebo administered via subcutaneous injection, depending on the recommended phase 2 dose (RP2D) and dosing schedule as determined in phase 1b, for a total of up to 12 weeks.
Drug: Placebo
Efavaleukin alfa administered via subcutaneous injection depending on the RP2D and dosing schedule determined in phase 1b, for up to a total of up to 12 weeks.
Drug: Efavaleukin alfa
Efavaleukin alfa administered as a subcutaneous injection.
Also known as: AMG 592
Placebo administered as a subcutaneous injection.
Phase 1b: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
TEAEs were events with an onset after the administration of the first dose of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE). Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria: * Results in death (fatal) * Immediately life-threatening * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other medically important serious event
Time frame: Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
Phase 1b: Number of Participants Who Experienced a Clinically Significant Change in Vital Signs
Any changes in systolic/diastolic blood pressure, heart rate, respiratory rate, and temperature that were deemed as clinically significant by the Investigator were reported.
Time frame: Baseline up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
Phase 1b: Number of Participants Who Experienced a Clinically Significant Change in Laboratory Safety Tests
Laboratory safety tests included chemistry and hematology parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated.
Time frame: Baseline up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
Phase 1b: Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs)
Any changes in ECG parameters that were deemed clinically significant by the investigator were reported.
Time frame: Baseline up to end of treatment maximum of 12 weeks
Phase 2a: Number of Participants Who Achieved an American College of Rheumatology 20 Percent Improvement Criteria (ACR 20) at Week 12
ACR 20 response defined as at least 20 percent improvement from baseline in both tender and swollen joint counts, and a 20 percent improvement or more in at least 3 of the following 5 criteria: * physician global assessment of disease activity (PGA) * subject global assessment of disease activity (SGA) * patient global assessment of joint pain * subject self-assessment of disability (HAQ-DI) * C-Reactive Protein (CRP)
Time frame: Baseline and Week 12
Phase 1b: Efavaleukin Alfa Serum Concentrations
A summary of mean serum concentrations of Efavaleukin alfa over time is presented. Any results below the lower limit of quantification were set to 0.00.
Time frame: Day 1 (pre-dose), 6 and 12 hours post-dose, and days 2, 3, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and Day 85 (pre-dose), 6 and 12 hours post-dose and days 86, 87, 88, 92, 99, 113 and 127
Phase 1b: Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa
Time frame: Day 1 (pre-dose) and 6 to 48 hours post-dose, and days 4, 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
Phase 1b: Time to Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa
Time frame: Day 1 (pre-dose) and 6 to 48 hours post-dose, and days 4, 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
Phase 1b: Area Under the Concentration-time Curve From Time 0 to 14 Days (AUC0-14) Post Dose
AUC0-14 was only assessed for the participants who received Efavaleukin alfa using dosing schedule A.
Time frame: Day 1 (pre-dose) and 6 to 48 hours post-dose, and days 4, 8, 11 and 15, Day 85 (pre-dose) and 6 to 72 hours post-dose, and days 92 and 99
Phase 1b: Area Under the Concentration-time Curve From Time 0 to 7 Days (AUC0-7) Post Dose
AUC0-7 was only assessed for the participants who received Efavaleukin alfa using dosing schedule B.
Time frame: Day 1 (pre-dose) and 6 to 48 hours post-dose, and days 4 and 8, Day 85 (pre-dose) and 6 to 72 hours post-dose, and Day 92
Phase 1b: Number of Participants With Anti-Efavaleukin Alfa Binding Antibodies and Anti-Interleukin (IL-2) Binding Antibodies
Number of participants who tested positive for anti-Efavaleukin alfa binding antibodies and number of those participants who cross-reacted with native human IL-2 (i.e. with anti-IL-2 binding antibodies) are reported.
Time frame: Baseline up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
Phase 1b: Number of Participants With Anti-Efavaleukin Alfa Neutralizing Antibodies and Anti-IL-2 Neutralizing Antibodies
The number of participants who tested positive for anti-Efavaleukin alfa neutralizing antibodies and number of participants with anti-IL2 neutralizing antibodies who tested negative or no result at baseline are reported.
Time frame: Baseline up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
Phase 2a: Number of Participants Who Achieved an American College of Rheumatology 50 Percent Improvement Criteria (ACR 50) or 70 Percent Improvement Criteria (ACR 70) at Week 12
ACR 50 and ACR 70 response defined as at least 50 percent or 70 percent improvement from baseline in both tender and swollen joint counts, and a 50 percent or 70 percent improvement or more in at least 3 of the following 5 criteria: * physician global assessment of disease activity (PGA) * subject global assessment of disease activity (SGA) * patient global assessment of joint pain * subject self-assessment of disability (HAQ-DI) * C-Reactive Protein (CRP)
Time frame: Baseline and Week 12
Phase 2a: Change From Baseline in Disease Activity Score (28 Joint) Calculated Using The Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at Week 12
Change from baseline in DAS28-ER at Week 12. DAS28-ESR was to assess disease activity in patients with rheumatoid arthritis. DAS28-ESR is a composite score that includes 4 variables: tender joint count (TJC) (based on 28 joints); swollen joint count (SJC) (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable); marker of inflammation assessed by ESR in mm/h. DAS28-ESR total score range from 0-10, higher score indicates more disease activity.
Time frame: Baseline and Week 12
Phase 2a: Change From Baseline in Disease Activity Score (28 Joint) Calculated Using the C-reactive Protein Formula (DAS-28-CRP) at Week 12
Change from baseline in DAS28-CRP at Week 12. 2. DAS28-CRP was to assess disease activity in patients with rheumatoid arthritis. DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable); marker of inflammation assessed by CRP in mg/L. DAS28-CRP total score range from 0-10, higher score indicates more disease activity.
Time frame: Baseline and Week 12
Phase 2a: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
TEAEs were events with an onset after the administration of the first dose of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: Baseline up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
Phase 2a: Number of Participants Who Experienced a Clinically Significant Change in Vital Signs
Any changes in systolic/diastolic blood pressure, heart rate, respiratory rate, and temperature that were deemed as clinically significant by the Investigator were reported.
Time frame: Baseline up to Week 12
Phase 2a: Number of Participants Who Experienced a Clinically Significant Change in Laboratory Safety Tests
Laboratory safety tests included chemistry and hematology parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated.
Time frame: Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
Phase 2a: Efavaleukin Alfa Serum Concentration
A summary of mean serum concentrations of Efavaleukin alfa over time.
Time frame: Day 1 (pre-dose) and weeks 2, 4, 6, 8, 10 and 12
Phase 2a: Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa
Time frame: Day 1 (pre-dose) and weeks 2, 4, 6, 8, 10 and 12
Phase 2a: Time to Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa
Time frame: Day 1 (pre-dose) and weeks 2, 4, 6, 8, 10 and 12
Phase 2a: Area Under the Concentration-time Curve (AUC) of Efavaleukin Alfa
Time frame: Day 1 (pre-dose) and weeks 2, 4, 6, 8, 10 and 12
Participants in phase 1b were to be enrolled into 1 of 4 planned dosing cohorts and randomized in a 3:1 ratio to receive Efavaleukin alfa or placebo according to 1 of 2 dosing schedules; A (less frequent) and B (more frequent).
| Milestone | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 | Phase 1b: Efavaleukin Alfa Cohort 4 | Phase 2a: Placebo | Phase 2a: Efavaleukin Alfa |
|---|---|---|---|---|---|---|---|
| Started | 8 | 6 | 11 | 11 | 0 | 0 | 0 |
| Received treatment | 8 | 6 | 11 | 11 | 0 | 0 | 0 |
| Completed | 8 | 4 | 3 | 6 | 0 | 0 | 0 |
| Not completed | 0 | 2 | 8 | 5 | 0 | 0 | 0 |
| Withdrew: Decision by sponsor | 0 | 0 | 3 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 | 5 | 5 | 0 | 0 | 0 |
TEAEs were events with an onset after the administration of the first dose of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE). Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria: * Results in death (fatal) * Immediately life-threatening * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other medically important serious event
| Participants | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 |
|---|---|---|---|---|
| TEAEs | 3 | 5 | 11 | 11 |
| Grade ≥ 2 TEAEs | 2 | 3 | 8 | 8 |
| Grade ≥ 3 TEAEs | 0 | 0 | 1 | 0 |
| Grade ≥ 4 TEAEs | 0 | 0 | 0 | 0 |
| SAEs | 0 | 0 | 1 | 0 |
| TEAEs leading to discontinuation of study treatment | 0 | 1 | 7 | 3 |
| Life-threatening TEAEs | 0 | 0 | 0 | 0 |
| Fatal TEAEs | 0 | 0 | 0 | 0 |
Any changes in systolic/diastolic blood pressure, heart rate, respiratory rate, and temperature that were deemed as clinically significant by the Investigator were reported.
| Participants | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 |
|---|---|---|---|---|
| Phase 1b: Number of Participants Who Experienced a Clinically Significant Change in Vital Signs | 0 | 0 | 0 | 0 |
Laboratory safety tests included chemistry and hematology parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated.
| Participants | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 |
|---|---|---|---|---|
| Phase 1b: Number of Participants Who Experienced a Clinically Significant Change in Laboratory Safety Tests | 0 | 0 | 1 | 0 |
Any changes in ECG parameters that were deemed clinically significant by the investigator were reported.
| Participants | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 |
|---|---|---|---|---|
| Phase 1b: Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs) | 0 | 0 | 0 | 0 |
ACR 20 response defined as at least 20 percent improvement from baseline in both tender and swollen joint counts, and a 20 percent improvement or more in at least 3 of the following 5 criteria: * physician global assessment of disease activity (PGA) * subject global assessment of disease activity (SGA) * patient global assessment of joint pain * subject self-assessment of disability (HAQ-DI) * C-Reactive Protein (CRP)
No measurements were reported for this outcome.
A summary of mean serum concentrations of Efavaleukin alfa over time is presented. Any results below the lower limit of quantification were set to 0.00.
| ng/mL | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 |
|---|---|---|---|
| Day 1 (pre-dose) | 0.00 ± 0.00 | 0.0 ± 0.00 | 0.00 ± 0.00 |
| Day 1 (6 hours post-dose) | 1.35 ± 0.795 | 7.67 ± 8.01 | 2.13 ± 2.98 |
| Day 1 (12 hours post-dose) | 2.43 ± 0.867 | 14.6 ± 12.1 | 4.09 ± 4.70 |
| Day 2 | 2.59 ± 0.875 | 22.0 ± 11.5 | 5.44 ± 5.09 |
| Day 3 | 1.70 ± 0.850 | 18.6 ± 9.16 | 3.65 ± 3.13 |
| Day 4 | 0.727 ± 0.277 | 7.65 ± 5.85 | 2.36 ± 2.84 |
| Day 8 | 0.0555 ± 0.0924 | 0.108 ± 0.146 | 0.0284 ± 0.0624 |
| Day 11 | 0.0230 ± 0.0514 | 0.0115 ± 0.0364 | 0.930 ± 0.780 |
| Day 15 | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.107 ± 0.150 |
| Day 22 | 0.0830 ± 0.144 | 0.0703 ± 0.112 | 0.235 ± 0.373 |
| Day 29 | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.217 ± 0.344 |
| Day 36 | 0.0644 ± 0.144 | 0.102 ± 0.203 | 0.239 ± 0.425 |
| Day 43 | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.104 ± 0.275 |
| Day 50 | 0.205 ± 0.304 | 0.105 ± 0.210 | 0.122 ± 0.322 |
| Day 57 | 0.0368 ± 0.0735 | 0.00 ± 0.00 | 0.0886 ± 0.234 |
| Day 64 | 0.336 ± NA | 0.212 ± 0.424 | 0.0294 ± 0.0657 |
| Day 71 | 0.0635 ± NA | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Day 78 | 0.154 ± 0.267 | 0.355 ± 0.614 | 0.0508 ± 0.0819 |
| Day 85 (pre-dose) | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.0578 ± 0.0958 |
| Day 85 (6 hours post-dose) | 2.41 ± 1.56 | 5.91 ± NA | 1.92 ± 2.64 |
| Day 85 (12 hours post-dose) | 4.00 ± 2.05 | 12.9 ± NA | 2.92 ± 4.03 |
| Day 86 | 3.60 ± 2.07 | 12.3 ± NA | 2.97 ± 4.48 |
| Day 87 | 2.10 ± 1.15 | 4.39 ± NA | 1.87 ± 2.43 |
| Day 88 | 1.48 ± 0.623 | 1.01 ± NA | 0.903 ± 1.17 |
| Day 92 | 0.113 ± NA | 0.00 ± NA | 0.0953 ± 0.115 |
| Day 99 | 0.00 ± 0.00 | 0.00 ± NA | 0.110 ± 0.268 |
| Day 113 | 0.00 ± 0.00 | 0.00 ± NA | 0.00 ± 0.00 |
| Day 127 | 0.00 ± 0.00 | 0.00 ± NA | 0.00 ± 0.00 |
| ng/mL | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 |
|---|---|---|---|
| First dose (Day 1) | 2.66 ± 0.852 | 23.0 ± 11.2 | 5.71 ± 5.10 |
| Last dose (Day 85) | 4.00 ± 2.05 | NA ± NA | 3.22 ± 4.35 |
| hours | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 |
|---|---|---|---|
| First dose (Day 1) | 18 (12 to 24) | 24 (24 to 48) | 24 (12 to 72) |
| Last dose (Day 85) | 12 (12 to 12) | 30 (12 to 48) | 12 (6.0 to 24) |
AUC0-14 was only assessed for the participants who received Efavaleukin alfa using dosing schedule A.
| hr*ng/mL | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 |
|---|---|---|
| First dose (Day 1) | 167 ± 60.9 | 1570 ± 859 |
| Last dose (Day 85) | 282 ± 207 | NA ± NA |
AUC0-7 was only assessed for the participants who received Efavaleukin alfa using dosing schedule B.
| hr*ng/mL | Phase 1b: Efavaleukin Alfa Cohort 3 |
|---|---|
| First dose (Day 1) | 315 ± 239 |
| Last dose (Day 85) | 195 ± 264 |
Number of participants who tested positive for anti-Efavaleukin alfa binding antibodies and number of those participants who cross-reacted with native human IL-2 (i.e. with anti-IL-2 binding antibodies) are reported.
| Participants | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 |
|---|---|---|---|---|
| Binding anti-AMG 592 antibody positive post-baseline with a negative or no result at baseline | 2 | 3 | 6 | 5 |
| Binding anti-IL2 antibody positive post-baseline with a negative or no result at baseline | 0 | 0 | 1 | 1 |
The number of participants who tested positive for anti-Efavaleukin alfa neutralizing antibodies and number of participants with anti-IL2 neutralizing antibodies who tested negative or no result at baseline are reported.
| Participants | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 |
|---|---|---|---|---|
| Neutralizing anti-AMG 592 antibodies positive post-baseline with a negative or no result at baseline | 2 | 1 | 7 | 5 |
| Neutralizing anti-IL2 antibody positive post-baseline with a negative or no result at baseline | 0 | 0 | 1 | 1 |
ACR 50 and ACR 70 response defined as at least 50 percent or 70 percent improvement from baseline in both tender and swollen joint counts, and a 50 percent or 70 percent improvement or more in at least 3 of the following 5 criteria: * physician global assessment of disease activity (PGA) * subject global assessment of disease activity (SGA) * patient global assessment of joint pain * subject self-assessment of disability (HAQ-DI) * C-Reactive Protein (CRP)
No measurements were reported for this outcome.
Change from baseline in DAS28-ER at Week 12. DAS28-ESR was to assess disease activity in patients with rheumatoid arthritis. DAS28-ESR is a composite score that includes 4 variables: tender joint count (TJC) (based on 28 joints); swollen joint count (SJC) (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable); marker of inflammation assessed by ESR in mm/h. DAS28-ESR total score range from 0-10, higher score indicates more disease activity.
No measurements were reported for this outcome.
Change from baseline in DAS28-CRP at Week 12. 2. DAS28-CRP was to assess disease activity in patients with rheumatoid arthritis. DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable); marker of inflammation assessed by CRP in mg/L. DAS28-CRP total score range from 0-10, higher score indicates more disease activity.
No measurements were reported for this outcome.
TEAEs were events with an onset after the administration of the first dose of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE).
No measurements were reported for this outcome.
Any changes in systolic/diastolic blood pressure, heart rate, respiratory rate, and temperature that were deemed as clinically significant by the Investigator were reported.
No measurements were reported for this outcome.
Laboratory safety tests included chemistry and hematology parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated.
No measurements were reported for this outcome.
A summary of mean serum concentrations of Efavaleukin alfa over time.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1b: Placebo | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Phase 1b: Efavaleukin Alfa Cohort 1 | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Phase 1b: Efavaleukin Alfa Cohort 2 | 0/11 (0%) | 1/11 (9.1%) | 11/11 (100%) |
| Phase 1b: Efavaleukin Alfa Cohort 3 | 0/11 (0%) | 0/11 (0%) | 11/11 (100%) |
| Event | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 |
|---|---|---|---|---|
| HypersensitivityImmune system disorders | 0/8 | 0/6 | 1/11 | 0/11 |
| Event | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 |
|---|---|---|---|---|
| Injection site reactionGeneral disorders | 0/8 | 0/6 | 6/11 | 8/11 |
| Injection site erythemaGeneral disorders | 0/8 | 4/6 | 2/11 | 3/11 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 1/8 | 0/6 | 4/11 | 2/11 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/8 | 2/6 | 0/11 | 0/11 |
| EosinophiliaBlood and lymphatic system disorders | 0/8 | 0/6 | 3/11 | 1/11 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/8 | 1/6 | 3/11 | 0/11 |
| Abdominal painGastrointestinal disorders | 0/8 | 0/6 | 2/11 | 0/11 |
| Peripheral swellingGeneral disorders | 0/8 | 0/6 | 2/11 | 1/11 |
| Back painMusculoskeletal and connective tissue disorders | 0/8 | 0/6 | 0/11 | 2/11 |
| HeadacheNervous system disorders | 1/8 | 0/6 | 1/11 | 2/11 |
The safety analysis set: All participants who received at least 1 dose of investigational product. Only cohorts with enrolled participants are included in the baseline population.
| Age, Continuous(years) | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 | Total |
|---|---|---|---|---|---|
| Mean | 46.4 ± 12.1 | 57.8 ± 8.4 | 53.1 ± 10.7 | 51.4 ± 15.3 | 51.9 ± 12.4 |
| Sex: Female, Male(Participants) | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 | Total |
|---|---|---|---|---|---|
| Female | 4 | 6 | 9 | 8 | 27 |
| Male | 4 | 0 | 2 | 3 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 2 | 1 | 4 |
| Not Hispanic or Latino | 7 | 6 | 9 | 10 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Phase 1b: Placebo | Phase 1b: Efavaleukin Alfa Cohort 1 | Phase 1b: Efavaleukin Alfa Cohort 2 | Phase 1b: Efavaleukin Alfa Cohort 3 | Total |
|---|---|---|---|---|---|
| Black or African American | 2 | 1 | 0 | 0 | 3 |
| White | 6 | 5 | 11 | 11 | 33 |
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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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 May 2018 to primary completion in Dec 2019, 18 months.
Results were first posted in Jun 2021, 1 year 5 months after primary completion. A results delay was requested in Oct 2020.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2021. 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.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Efavaleukin alfa