Clinical trials: sponsored by Amgen
Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc
A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.
- Trial name
- NCT02780674
- Testing
- MEDI7734
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)…
- Conditions
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis
- Trial name
- NCT03817424
- Testing
- VIB7734
- Where
- 30 sites in United States, Poland and 1 more
- Volunteers
- 31 people
- Sponsor
- Amgen
Dendritic Cell -Mediated Rheumatic Diseases
A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases
A first-in-human study to evaluate the safety and tolerability of escalating, single and multiple ascending doses of VIB1116 in adult participants with rheumatic diseases.
- Trial name
- NCT04948099
- Testing
- VIB1116
- Where
- 11 sites in United States, Poland
- Volunteers
- 73 people
- Sponsor
- Amgen
Cystic Fibrosis
Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- TIS (NCT01270347)
- Testing
- MP-376 (Levofloxacin Solution for Inhalation), TIS (Tobramycin Inhalation Solution)
- Where
- 130 sites in United States, France and 4 more
- Volunteers
- 282 people
- Sponsor
- Amgen
Safety Issues
A Phase1 Study of VIB9600
Overall design: Single-center, randomized, blinded, placebo-controlled single- and multiple-ascending dose study in healthy adult subjects.
- Trial name
- NCT03621605
- Testing
- VIB9600
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
Plaque Psoriasis
A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
The purpose of the study is to evaluate the efficacy, safety, and immunogenicity of ABP 654 compared with ustekinumab in participants with moderate to severe plaque psoriasis.
- Trial name
- NCT04607980
- Testing
- ABP 654, Ustekinumab
- Where
- 84 sites in United States, Canada and 6 more
- Volunteers
- 563 people
- Sponsor
- Amgen
Healthy Participants
A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
The primary objective of this study is to evaluate the PK of AMG 510 alone and in combination with either famotidine or omeprazole in healthy participants under fed conditions.
- Trial name
- NCT05599828
- Testing
- AMG 510, Omeprazole, Famotidine
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Amgen
Friedreich's Ataxia
Long-Term Safety Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia
The purpose of this long term extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia (FA).
- Trial name
- STEADFAST (NCT02797080)
- Testing
- interferon γ-1b
- Where
- 4 sites in United States
- Volunteers
- 38 people
- Sponsor
- Amgen
Cystic Fibrosis
Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- NCT00503490
- Testing
- MP-376 (Levofloxacin solution for Inhalation)
- Where
- 14 sites in United States
- Volunteers
- 40 people
- Sponsor
- Amgen
Chronic Obstructive Pulmonary Disease
A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an…
- Trial name
- NCT00752414
- Testing
- MP-376 (Levofloxacin solution for Inhalation)
- Where
- 5 sites in United States
- Volunteers
- 21 people
- Sponsor
- Amgen
Cystic Fibrosis
"Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients"
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- NCT00840333
- Testing
- MP-376 (Levofloxacin solution for Inhalation)
- Where
- 6 sites in United States
- Volunteers
- 27 people
- Sponsor
- Amgen
Hypercholesterolemia, Familial Hypercholesterolemia
Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan
The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.
- Trial name
- NCT02808403
- Testing
- No intervention
- Where
- 138 sites in Japan
- Volunteers
- 6,000 people
- Sponsor
- Amgen
Healthy Volunteers
A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Participants
The primary objective of this trial are to assess the pharmacokinetics (PK) of a single subcutaneous (SC) administration of teprotumumab high-concentration formula (HCF) in healthy adult non-Japanese and Japanese participants and…
- Trial name
- NCT06674941
- Testing
- Teprotumumab
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Amgen
Osteoporosis
Denosumab Safety Assessment in Multiple Observational Databases
This is a prospective open-cohort study with annual assessment and reporting of descriptive findings from 5 secondary data sources, US Medicare, Optum Research Database (formerly United HealthCare), Scandinavian national health…
- Trial name
- NCT02520362
- Testing
- denosumab, bisphosphonate
- Volunteers
- 517,991 people
- Sponsor
- Amgen
Glioblastoma or Malignant Glioma
Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma
This is a Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 monotherapy or in combination with AMG 404 in Subjects with Glioblastoma or Malignant Glioma Expressing Mutant…
- Trial name
- NCT03296696
- Testing
- AMG 596, AMG 404
- Where
- 10 sites in United States, Australia and 4 more
- Volunteers
- 30 people
- Sponsor
- Amgen
Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
The primary objective of the study is to determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adults with relapsed or refractory (r/r) DLBCL.
- Trial name
- HARBOUR (NCT03340766)
- Testing
- Blinatumomab, Pembrolizumab
- Where
- 22 sites in United States, Australia and 4 more
- Volunteers
- 31 people
- Sponsor
- Amgen
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Evaluate the safety and tolerability of AMG 427 in adult subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). Estimate the maximum tolerated dose (MTD) and / or a biologically optimal dose (eg, recommended phase…
- Trial name
- 20170528 (NCT03541369)
- Testing
- AMG 427
- Where
- 16 sites in United States, Australia and 4 more
- Volunteers
- 64 people
- Sponsor
- Amgen
Relapsed or Refractory Multiple Myeloma
Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in participants with relapsed refractory multiple myeloma.
- Trial name
- INTREPID-1 (NCT02939183)
- Testing
- Immediate Release (IR) Formulation, Gastro-Retentive (GR) Formulation, Dexamethasone
- Where
- 20 sites in United States, Australia and 2 more
- Volunteers
- 61 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus (SLE)
Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care…
- Trial name
- NCT04058028
- Testing
- Rozibafusp Alfa
- Where
- 147 sites in United States, Argentina and 17 more
- Volunteers
- 244 people
- Sponsor
- Amgen
AMG 701 Expanded Access Program
Expanded access requests for AMG 701 may be considered for adult patients with relapsed and/or refractory multiple myeloma whose disease is in partial response or better after AMG 420 therapy.
- Trial name
- NCT05256446
- Testing
- AMG 701
- Sponsor
- Amgen
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