Clinical trials: sponsored by 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
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
Postmenopausal Osteoporosis
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
The primary objective of this study is to characterize safety and tolerability of romosozumab in postmenopausal women with osteoporosis and a high risk of fracture in India.
- Trial name
- NCT06079476
- Testing
- Romosozumab
- Where
- 10 sites in India
- Volunteers
- 100 people
- Sponsor
- Amgen
Extensive Stage Small Cell Lung Cancer
Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
The primary aim of this study is to evaluate the efficacy of tarlatamab as assessed by objective response rate (ORR) based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1…
- Trial name
- DeLLphi-307 (NCT06502977)
- Testing
- Tarlatamab
- Where
- 12 sites in China
- Volunteers
- 32 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
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
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
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
Atopic Dermatitis
A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
The coprimary objectives of the study are to: evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at…
- Trial name
- ROCKET-SHUTTLE (NCT05724199)
- Testing
- Rocatinlimab
- Where
- 234 sites in United States, Argentina and 24 more
- Volunteers
- 746 people
- Sponsor
- Amgen
Atopic Dermatitis
A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
- Trial name
- ROCKET-Orbit (NCT05633355)
- Testing
- Rocatinlimab
- Where
- 77 sites in United States, Argentina and 7 more
- Volunteers
- 187 people
- Sponsor
- Amgen
Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis
A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
The primary objectives of this study are to: estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24 estimate vaccine response in rocatinlimab group vs placebo…
- Trial name
- ROCKET-VOYAGER (NCT05899816)
- Testing
- Rocatinlimab
- Where
- 85 sites in United States, Canada
- Volunteers
- 221 people
- Sponsor
- Amgen
Atopic Dermatitis
A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.
- Trial name
- ROCKET-Ignite (NCT05398445)
- Testing
- Rocatinlimab
- Where
- 202 sites in United States, Argentina and 19 more
- Volunteers
- 769 people
- Sponsor
- Amgen
KRAS p, G12c Mutated /Advanced Metastatic NSCLC
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
- Trial name
- NCT04303780
- Testing
- AMG 510, Docetaxel
- Where
- 274 sites in United States, Australia and 21 more
- Volunteers
- 345 people
- Sponsor
- Amgen
Colorectal Cancer (CRC)
Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation
The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and…
- Trial name
- CodeBreak300 (NCT05198934)
- Testing
- Sotorasib, Panitumumab, Trifluridine and Tipiracil
- Where
- 105 sites in United States, Australia and 10 more
- Volunteers
- 160 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
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
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