Clinical trials: sponsored by Amgen
Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia, Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia
A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia
The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.
- Trial name
- NCT07134088
- Testing
- Blinatumomab
- Where
- 5 sites in United States, Japan
- Volunteers
- 104 people
- Sponsor
- Amgen
Obesity, Overweight
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus.
- Conditions
- Obesity, Overweight, Diabetes Mellitus, Type 2
- Trial name
- NCT07684144
- Testing
- Maridebart Cafraglutide
- Where
- 45 sites in United States, Canada and 3 more
- Volunteers
- 950 people
- Sponsor
- Amgen
Healthy Participants
Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose.
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.
- Trial name
- NCT07545226
- Testing
- Evolocumab Drug Substance A (Test), Evolocumab Drug Substance B (Reference)
- Where
- 4 sites in United States
- Volunteers
- 405 people, healthy volunteers welcome
- Sponsor
- Amgen
Plaque Psoriasis
A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.
- Trial name
- NCT05565560
- Testing
- Apremilast
- Where
- 29 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Amgen
Glomerulonephritis, Membranous
A Phase 3 Study of Inebilizumab in Participants With Primary Membranous Nephropathy
The primary objective of this study to evaluate the efficacy of inebilizumab on primary membranous nephropathy (PMN) disease activity as measured by complete remission in participants with PMN.
- Trial name
- MOMENT (NCT07851220)
- Testing
- Inebilizumab, Tacrolimus
- Where
- 4 sites in United States
- Volunteers
- 159 people
- Sponsor
- Amgen
Antineutrophil Cytoplasmic Antibody-associated Vasculitis
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
- Trial name
- AVASET (NCT06072482)
- Testing
- Avacopan, Standard of Care
- Where
- 83 sites in United States, Czechia and 5 more
- Volunteers
- 300 people
- Sponsor
- Amgen
Obstructive Sleep Apnea
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are not on PAP therapy and are…
- Trial name
- MARITIME-OSA-2 (NCT07226765)
- Testing
- Maridebart cafraglutide
- Where
- 57 sites in United States, Australia and 9 more
- Volunteers
- 250 people
- Sponsor
- Amgen
Overweight or Obesity and Elevated Liver Fat
A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight
The main objective of this trial will be to determine whether maridebart cafraglutide is superior to placebo on reduction in liver fat content and body weight in participants living with obesity or overweight and elevated liver…
- Trial name
- NCT07441252
- Testing
- Maridebart cafraglutide
- Where
- 23 sites in United States
- Volunteers
- 180 people
- Sponsor
- Amgen
Extensive Stage Small Cell Lung Cancer
A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.
- Trial name
- DeLLphi-311 (NCT07037758)
- Testing
- Tarlatamab, AB248
- Where
- 19 sites in United States, South Korea and 1 more
- Volunteers
- 380 people
- Sponsor
- Amgen
Relapsing-remitting Multiple Sclerosis (RRMS)
Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)
The Main objectives of the study are to demonstrate pharmacokinetic (PK) similarity between ABP 692 and ocrelizumab (US), as well as between ABP 692 and ocrelizumab (EU).
- Trial name
- NCT06700343
- Testing
- Ocrelizumab (US), Ocrelizumab (EU), ABP 692
- Where
- 109 sites in United States, Belgium and 20 more
- Volunteers
- 152 people
- Sponsor
- Amgen
Overweight, Obesity
Comparing the Extent to Which Two Maridebart Cafraglutide Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two maridebart cafraglutide drug products in participants living with overweight or obesity.
- Trial name
- NCT07832799
- Testing
- Maridebart Cafraglutide
- Volunteers
- 340 people
- Sponsor
- Amgen
Overweight, Obesity
Effect of Maridebart Cafraglutide on the Heart's Electrical Activity
The main objective of this trial is to evaluate the effect of maridebart cafraglutide subcutaneously (SC) on the placebo-corrected, change from baseline in QT interval corrected for heart rate using Fridericia's formula in…
- Trial name
- NCT07229157
- Testing
- Maridebart Cafraglutide, Moxifloxacin
- Where
- 2 sites in United States
- Volunteers
- 81 people
- Sponsor
- Amgen
Coronary Artery Disease, Hypercholesterolemia
A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical Atheroma
The main aim of this trial is to demonstrate that Evolocumab plus routine lipid management is superior to routine lipid management alone in modifying plaque (non-calcified) volume as measured by Artificial Intelligence-enabled…
- Conditions
- Coronary Artery Disease, Hypercholesterolemia, Atheroma, Atherosclerotic Plaque
- Trial name
- NCT07803679
- Testing
- Evolocumab, Routine Lipid Management, Autoinjector
- Volunteers
- 308 people
- Sponsor
- Amgen
Obesity
Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
- Trial name
- MARITIME-1 (NCT06858839)
- Testing
- Maridebart Cafraglutide
- Where
- 243 sites in United States, Argentina and 15 more
- Volunteers
- 3,853 people
- Sponsor
- Amgen
Primary Immune Thrombocytopenia
A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)
This Phase 3 study is designed to evaluate the efficacy and safety of romiplostim in combination with predniso(lo)ne compared with predniso(lo)ne alone in adults with previously untreated Primary Immune Thrombocytopenia (ITP).
- Trial name
- ROMISTER (NCT07700238)
- Testing
- Romiplostim, Predniso(lo)ne
- Where
- 3 sites in United States
- Volunteers
- 126 people
- Sponsor
- Amgen
Gout
A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase…
- Trial name
- NCT06229145
- Testing
- Pegloticase, Methotrexate
- Where
- 74 sites in United States
- Volunteers
- 306 people
- Sponsor
- Amgen
Small Cell Lung Cancer
Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)
The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and…
- Trial name
- DeLLphi-315 (NCT07778316)
- Testing
- Tarlatamab
- Where
- 9 sites in United States, Australia and 3 more
- Volunteers
- 400 people
- Sponsor
- Amgen
Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia
A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia
The main objective of this trial is to demonstrate that subcutaneous (SC) blinatumomab in conjunction with chemotherapy (Arm B) is non-inferior to continuous intravenous infusion (cIV) blinatumomab in conjunction with…
- Trial name
- AUDAX (NCT07223190)
- Testing
- Blinatumomab, HyperCVAD
- Volunteers
- 560 people
- Sponsor
- Amgen
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer
The primary objective of this trial is to determine the safety profile of xaluritamig at the proposed regimen in adult participants with metastatic castration-resistant prostate cancer (mCRPC).
- Trial name
- NCT07493512
- Testing
- Xaluritamig
- Where
- 14 sites in United States, Australia
- Volunteers
- 40 people
- Sponsor
- Amgen
AMG 335 Expanded Access Program for IgG4-Related Disease
Expanded access requests for AMG 335 may be considered for adult patients with a confirmed diagnosis of IgG4-related disease. To request access, use Responsible Party contact information provided in this record.
- Trial name
- NCT06590051
- Testing
- UPLIZNA
- Sponsor
- Amgen