Clinical trials: sponsored by Amgen
Vasculitis
Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV.
The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.
- Trial name
- NCT06321601
- Testing
- Avacopan
- Where
- 34 sites in United States, Belgium and 8 more
- Volunteers
- 19 people
- Sponsor
- Amgen
Overweight, Obesity
Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity
The primary objective of the trial is to evaluate the effect of maridebart cafraglutide on the pharmacokinetics (PK) of a combined oral contraceptive (COC) in postmenopausal female participants living with overweight or obesity.
- Trial name
- NCT07523711
- Testing
- COC, Maridebart Cafraglutide
- Where
- 2 sites in United States
- Volunteers
- 49 people
- Sponsor
- Amgen
Atopic Dermatitis
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.
- Trial name
- ROCKET-ASCEND (NCT05882877)
- Testing
- Rocatinlimab
- Where
- 547 sites in United States, Argentina and 40 more
- Volunteers
- 2,621 people
- Sponsor
- Amgen
Non-small Cell Lung Cancer
A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment
The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily…
- Trial name
- CodeBreaK201 (NCT04933695)
- Testing
- Sotorasib
- Where
- 67 sites in United States, Belgium and 8 more
- Volunteers
- 42 people
- Sponsor
- Amgen
Thyroid Eye Disease
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.
- Trial name
- NCT06248619
- Testing
- Teprotumumab
- Where
- 38 sites in United States, Argentina and 9 more
- Volunteers
- 89 people
- Sponsor
- Amgen
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
- Trial name
- NCT07140900
- Testing
- Xaluritamig, Darolutamide, Abiraterone
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 60 people
- Sponsor
- Amgen
KRAS p.G12C Mutant Advanced Solid Tumors
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS…
- Trial name
- NCT03600883
- Testing
- sotorasib, Anti PD-1/L1, Midazolam
- Where
- 133 sites in United States, Australia and 14 more
- Volunteers
- 713 people
- Sponsor
- Amgen
Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy.
- Trial name
- NCT04994717
- Testing
- Blinatumomab, Low-intensity chemotherapy regimen, SOC chemotherapy regimen
- Where
- 192 sites in United States, Australia and 30 more
- Volunteers
- 303 people
- Sponsor
- Amgen
Extensive Stage Small Cell Lung Cancer
Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
- Trial name
- DeLLphi-308 (NCT06598306)
- Testing
- Tarlatamab
- Where
- 31 sites in United States, Australia and 8 more
- Volunteers
- 220 people
- Sponsor
- Amgen
Atopic Dermatitis
A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
The co-primary objectives of the study are to: Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
- Trial name
- ROCKET-Horizon (NCT05651711)
- Testing
- Rocatinlimab
- Where
- 197 sites in United States, Australia and 19 more
- Volunteers
- 726 people
- Sponsor
- Amgen
Leukemia, Acute Lymphoblastic
Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)
B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse.
- Trial name
- NCT02393859
- Testing
- Blinatumomab, Dexamethasone, Vincrisitne
- Where
- 103 sites in Argentina, Australia and 22 more
- Volunteers
- 111 people
- Sponsor
- Amgen
Adalimumab
A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants
To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the…
- Trial name
- NCT05909852
- Testing
- ABP 501-HCF, ABP 501-LCF
- Where
- 3 sites in United States
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- Amgen
Coronary Heart Disease (CHD)
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a…
- Trial name
- VESALIUS-CV (NCT03872401)
- Testing
- Evolocumab
- Where
- 852 sites in United States, Argentina and 31 more
- Volunteers
- 12,301 people
- Sponsor
- Amgen
Osteogenesis Imperfecta
Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta
The primary objective of this trial is to evaluate the safety of romosozumab in participants with osteogenesis imperfecta (OI) that have completed Study 20200105, regardless of whether they received investigational product…
- Trial name
- NCT07366086
- Testing
- Vitamin D, Calcium
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 71 people
- Sponsor
- Amgen
Solid Tumors
A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.
- Trial name
- FORTITUDE-301 (NCT05325866)
- Testing
- Bemarituzumab
- Where
- 115 sites in United States, Argentina and 24 more
- Volunteers
- 260 people
- Sponsor
- Amgen
Overweight, Obesity
Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) Presentations
The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity.
- Trial name
- NCT07226778
- Testing
- Maridebart Cafraglutide
- Where
- 4 sites in United States
- Volunteers
- 348 people
- Sponsor
- Amgen
Type 2 Diabetes Mellitus
A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus
The primary objective of this study is to determine the effect of maridebart cafraglutide relative to placebo on insulin sensitivity in participants with Type 2 Diabetes Mellitus (T2DM) treated with stable dose of metformin.
- Trial name
- NCT07160257
- Testing
- Maridebart cafraglutide
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Amgen
Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers
A Study Evaluating Anvumetostat in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103)
The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat administered in combination with other therapies in adult participants with metastatic…
- Trial name
- MTAPESTRY 103 (NCT06360354)
- Testing
- Anvumetostat, Gemcitabine, Nab-paclitaxel
- Where
- 77 sites in United States, Australia and 14 more
- Volunteers
- 120 people
- Sponsor
- Amgen
Thoracic Tumors, Non-small Cell Lung Cancer
Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).
The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat administered in combination with other therapies in adult participants with metastatic…
- Trial name
- NCT06333951
- Testing
- Anvumetostat, Carboplatin, Paclitaxel
- Where
- 83 sites in United States, Argentina and 18 more
- Volunteers
- 49 people
- Sponsor
- Amgen
MTAP-deleted NSCLC
A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)
The main objective of the study is to characterize safety and efficacy of 2 dose levels of anvumetostat by investigator, and to evaluate anvumetostat monotherapy efficacy by Blinded Independent Central Review (BICR).
- Trial name
- NCT06593522
- Testing
- anvumetostat
- Where
- 91 sites in United States, Australia and 14 more
- Volunteers
- 61 people
- Sponsor
- Amgen