Clinical trials: sponsored by Amgen
Arthritis, Psoriatic
Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 5 years of disease duration.
- Trial name
- FOREMOST (NCT03747939)
- Testing
- Apremilast (CC-10004)
- Where
- 114 sites in United States, Austria and 9 more
- Volunteers
- 310 people
- Sponsor
- Amgen
End-Stage Renal Disease (ESRD)
A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)
The primary objective of the study is to evaluate the pharmacokinetics (PK) of avacopan and metabolite (M1) after a single dose of avacopan in participants with normal renal function and participants with ESRD requiring…
- Trial name
- NCT06468826
- Testing
- Avacopan
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Amgen
Type 2 Diabetes Mellitus (T2DM)
A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)
The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.
- Trial name
- NCT06660173
- Testing
- Maridebart Cafraglutide
- Where
- 96 sites in United States, Austria and 12 more
- Volunteers
- 409 people
- Sponsor
- Amgen
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.
- Trial name
- FORTITUDE-102 (NCT05111626)
- Testing
- Bemarituzumab, Nivolumab, Chemotherapy
- Where
- 348 sites in United States, Argentina and 27 more
- Volunteers
- 515 people
- Sponsor
- Amgen
Extensive Stage Small Cell Lung Cancer
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.
- Trial name
- NCT05361395
- Testing
- Tarlatamab, Carboplatin, Etoposide
- Where
- 44 sites in United States, Australia and 13 more
- Volunteers
- 184 people
- Sponsor
- Amgen
Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).
- Trial name
- DeLLphi-312 (NCT07005128)
- Testing
- Tarlatamab, Durvalumab, Carboplatin
- Where
- 164 sites in United States, Argentina and 24 more
- Volunteers
- 350 people
- Sponsor
- Amgen
Major Cardiovascular Event, Established Atherosclerotic Cardiovascular Disease
A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease
The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI)…
- Trial name
- NCT06295679
- Where
- 90 sites in China
- Volunteers
- 7,000 people
- Sponsor
- Amgen
Prostate Cancer, High-risk Biochemical Recurrence
Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer
The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).
- Conditions
- Prostate Cancer, High-risk Biochemical Recurrence, High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer, Non-metastatic Castration-sensitive Prostate Cancer
- Trial name
- NCT06555796
- Testing
- Xaluritamig
- Where
- 11 sites in United States, Australia
- Volunteers
- 50 people
- Sponsor
- Amgen
Metastatic Colorectal Cancer
Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or…
- Trial name
- CodeBreaK 301 (NCT06252649)
- Testing
- FOLFIRI Regimen, Sotorasib, Panitumumab
- Where
- 291 sites in United States, Argentina and 33 more
- Volunteers
- 450 people
- Sponsor
- Amgen
Atopic Dermatitis
A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.
- Trial name
- ROCKET-ASTRO (NCT05704738)
- Testing
- Rocatinlimab
- Where
- 246 sites in United States, Belgium and 20 more
- Volunteers
- 532 people
- Sponsor
- Amgen
Immunoglobulin G4-related Disease
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD
The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD), as well as to assess the safety and tolerability, of inebilizumab in pediatric participants with IgG4-RD.
- Trial name
- NCT07222553
- Testing
- Inebilizumab
- Where
- 14 sites in United States, Brazil and 5 more
- Volunteers
- 15 people
- Sponsor
- Amgen
Metastatic Castration-resistant Prostate Cancer
Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)
This is a master protocol designed to evaluate the safety and efficacy of investigational therapies in participants with metastatic castration-resistant prostate cancer (mCRPC).
- Trial name
- NCT04631601
- Testing
- Acapatamab, Enzalutamide, Abiraterone
- Where
- 14 sites in United States, Australia and 4 more
- Volunteers
- 55 people
- Sponsor
- Amgen
Idiopathic Inflammatory Myositis
A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)
The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1.
- Trial name
- NCT05669014
- Testing
- Daxdilimab
- Where
- 9 sites in United States, Brazil and 4 more
- Volunteers
- 12 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to < 18 years of age, with chronic…
- Trial name
- NCT03969329
- Testing
- Etelcalcetide
- Where
- 23 sites in Belgium, Czechia and 10 more
- Volunteers
- 24 people
- Sponsor
- Amgen
Prostate Cancer
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
The overall aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of AMG 509 (monotherapy and in combination with abiraterone acetate and enzalutamide) and to evaluate preliminary efficacy.
- Trial name
- NCT04221542
- Testing
- AMG 509, Abiraterone, Enzalutamide
- Where
- 57 sites in United States, Australia and 8 more
- Volunteers
- 479 people
- Sponsor
- Amgen
Thyroid Eye Disease
TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study
This is a double-masked, randomized, parallel-assignment, multicenter trial examining the safety and tolerability of teprotumumab in the treatment of Thyroid Eye Disease (TED) in adult participants.
- Trial name
- NCT05002998
- Testing
- Teprotumumab
- Where
- 28 sites in United States, France and 4 more
- Volunteers
- 313 people
- Sponsor
- Amgen
Cardiovascular Disease
OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for…
- Trial name
- NCT07136012
- Testing
- Olpasiran
- Where
- 252 sites in United States, Australia and 1 more
- Volunteers
- 11,000 people
- Sponsor
- Amgen
Small Cell Lung Cancer
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended…
- Trial name
- DeLLphi-313 (NCT07531095)
- Testing
- ZL-1310, Tarlatamab, Durvalumab
- Where
- 27 sites in United States, Australia and 7 more
- Volunteers
- 160 people
- Sponsor
- Amgen
Non Small-cell Lung Cancer, Locally Advanced Unresectable NSCLC
Expanded Access of Sotorasib
The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer…
- Conditions
- Non Small-cell Lung Cancer, Locally Advanced Unresectable NSCLC, Locally Advanced Metastatic NSCLC
- Trial name
- NCT04667234
- Testing
- AMG 510
- Where
- 55 sites in United States, Argentina and 4 more
- Sponsor
- Amgen
Healthy Participants, Pharmacokinetics
Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.
- Trial name
- NCT07422285
- Testing
- Evolocumab Drug Substance A, Evolocumab Drug Substance B
- Where
- 4 sites in United States
- Volunteers
- 405 people, healthy volunteers welcome
- Sponsor
- Amgen