Clinical trials: sponsored by Amgen
Eosinophilic Esophagitis
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult…
- Trial name
- CROSSING (NCT05583227)
- Testing
- Tezepelumab
- Where
- 124 sites in United States, Australia and 20 more
- Volunteers
- 368 people
- Sponsor
- AstraZeneca
Asthma
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
The main objective of this study is to assess the safety and tolerability of AMG 691 as single doses (healthy participants only) and multiple doses in healthy participants and participants with mild-to-moderate asthma.
- Trial name
- NCT06637371
- Testing
- AMG 691
- Where
- 21 sites in United States, Australia and 3 more
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Amgen
Atherosclerotic Cardiovascular Disease, Overweight
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.
- Conditions
- Atherosclerotic Cardiovascular Disease, Overweight, Obesity
- Trial name
- MARITIME-CV (NCT07037433)
- Testing
- Maridebart Cafraglutide
- Where
- 783 sites in United States, Argentina and 34 more
- Volunteers
- 12,800 people
- Sponsor
- Amgen
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and…
- Conditions
- Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction, Obesity
- Trial name
- MARITIME-HF (NCT07037459)
- Testing
- Maridebart cafraglutide
- Where
- 686 sites in United States, Argentina and 33 more
- Volunteers
- 5,056 people
- Sponsor
- Amgen
Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or…
- Trial name
- NCT05909761
- Testing
- UPLIZNA
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Amgen
Sjogren's Syndrome
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
Primary Objective: To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity. Secondary Objectives: 1.
- Trial name
- NCT06104124
- Testing
- Dazodalibep
- Where
- 206 sites in United States, Argentina and 24 more
- Volunteers
- 651 people
- Sponsor
- Amgen
Ewing Sarcoma
Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)
The main objectives of this trial are to determine the recommended dose for expansion of xaluritamig (dose confirmation part only) and to determine the safety and tolerability of xaluritamig in adult, adolescent and pediatric…
- Trial name
- NCT07297979
- Testing
- Xaluritamig
- Where
- 13 sites in United States, Australia
- Volunteers
- 50 people
- Sponsor
- Amgen
Migraine
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine.
- Trial name
- OASIS(CM) (NCT03832998)
- Testing
- Erenumab Dose 1, Erenumab Dose 2, Erenumab Dose 3
- Where
- 101 sites in United States, Belgium and 11 more
- Volunteers
- 284 people
- Sponsor
- Amgen
Healthy Participants
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants
- Trial name
- NCT07745907
- Testing
- AMG 691
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Amgen
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment
The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.
- Trial name
- NCT05481411
- Testing
- Olpasiran
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Amgen
Atherosclerotic Cardiovascular Disease
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in…
- Trial name
- NCT05581303
- Testing
- Olpasiran
- Where
- 492 sites in United States, Australia and 22 more
- Volunteers
- 7,297 people
- Sponsor
- Amgen
Generalized Myasthenia Gravis
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)
The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of inebilizumab administered in pediatric participants with gMG, and to assess the safety and tolerability of…
- Trial name
- THYME (NCT06987539)
- Testing
- Inebilizumab
- Where
- 14 sites in United States, Argentina and 6 more
- Volunteers
- 15 people
- Sponsor
- Amgen
Atopic Dermatitis
A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants
The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants.
- Trial name
- NCT06268860
- Testing
- Rocatinlimab vial injection, Rocatinlimab prefilled syringe
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Amgen
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants…
- Trial name
- FORTITUDE-101 (NCT05052801)
- Testing
- Bemarituzumab, mFOLFOX6
- Where
- 300 sites in United States, Argentina and 35 more
- Volunteers
- 547 people
- Sponsor
- Amgen
Non-Small Cell Lung Cancer (NSCLC)
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum…
- Trial name
- NCT05920356
- Testing
- Sotorasib, Pembrolizumab
- Where
- 424 sites in United States, Argentina and 36 more
- Volunteers
- 750 people
- Sponsor
- Amgen
Plaque Psoriasis
A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
The primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate plaque psoriasis.
- Trial name
- NCT06088199
- Testing
- Apremilast
- Where
- 30 sites in United States
- Volunteers
- 51 people
- Sponsor
- Amgen
Basic Science
A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants
The primary objective of the study is: To assess the effects of a single therapeutic and supratherapeutic dose of olpasiran on the placebo-corrected change from baseline in QT corrected for heart rate (ΔΔQT)/QTc interval in…
- Trial name
- NCT06411860
- Testing
- Olpasiran, Moxifloxacin
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen
Obesity or Overweight
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.
- Trial name
- NCT07575399
- Testing
- Maridebart Cafraglutide
- Where
- 54 sites in United States, Puerto Rico
- Volunteers
- 300 people
- Sponsor
- Amgen
Advanced Solid Tumors
Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
- Trial name
- NCT04362748
- Testing
- AMG 256
- Where
- 11 sites in United States, Australia and 2 more
- Volunteers
- 34 people
- Sponsor
- Amgen
Chemotherapy-induced Thrombocytopenia
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer
- Trial name
- RECITE (NCT03362177)
- Testing
- Romiplostim
- Where
- 117 sites in United States, Argentina and 18 more
- Volunteers
- 165 people
- Sponsor
- Amgen
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