Clinical trials: sponsored by Hoffmann-La Roche
Influenza, Human, Respiratory Tract Infections
A Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants
The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in…
- Conditions
- Influenza, Human, Respiratory Tract Infections, Post-exposure Prophylaxis
- Trial name
- Pearlstone (NCT07827599)
- Testing
- Baloxavir marboxil
- Where
- 8 sites in China
- Volunteers
- 325 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Chronic Obstructive Pulmonary Disease (COPD), Healthy Participants
A Study of RO7830698 in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
This study will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of single and multiple doses of RO7830698 in healthy participants and participants with chronic obstructive…
- Trial name
- NCT07822334
- Testing
- RO7830698
- Where
- United Kingdom
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants
The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.
- Trial name
- NCT07271693
- Testing
- RO7806881
- Where
- New Zealand
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A Study to Assess the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single subcutaneous (SC) dose of pegozafermin administered in the abdomen, thigh, or upper arm in healthy participants.
- Trial name
- NCT07835243
- Testing
- Pegozafermin
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Bacterial Vaginosis, Candida Vaginitis
Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500…
- Trial name
- NCT06975436
- Testing
- cobas® BV/CV test, BD Max™ Vaginal Panel, Cepheid Xpert Xpress MVP
- Where
- 10 sites in United States, Bulgaria and 1 more
- Volunteers
- 738 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Renal Impairment
A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) and safety of RO7795081, following a single oral dose in participants with renal impairment compared with participants with normal…
- Trial name
- NCT07741604
- Testing
- RO7795081
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Squamous Cell Carcinoma of the Anal Canal
Tiraglolumab Atezolizumab and Chemoradiotherapy in Localized Anal Carcinoma (TIRANUS)
The peculiarity of anal cancers, with well-established radical chemoradiotherapy that allows tumor-neoantigen formation with platinum-based chemotherapy and radiotherapy with radio-sensitizing chemotherapy could create the…
- Trial name
- TIRANUS (NCT05661188)
- Testing
- Atezolizumab plus Tiraglolumab
- Where
- 13 sites in Spain
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Grupo Espanol Multidisciplinario del Cancer Digestivo
Healthy Participants
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Enicepatide in Generally Healthy Adult Chinese Participants
This is a Phase I, randomized, double-blinded, placebo-controlled, study to assess the safety, tolerability, and pharmacokinetics (PK) of enicepatide in generally healthy adult Chinese participants with body mass index (BMI)…
- Trial name
- NCT07626515
- Testing
- Enicepatide
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Participants
A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081
This is a single-center, non-randomized, open-label, cross-over study in healthy male and female participants. Part 1 of the study has a 2-period (a single fixed sequence) design and will investigate the impact of itraconazole on…
- Trial name
- NCT06809608
- Testing
- RO7795081, Itraconazole, Gemfibrozil
- Where
- Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Overweight, Obesity
A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants
This is a randomized, investigator-and-participant-blind, placebo-controlled, fixed sequence, cross-over, Phase 1 study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of orally administered…
- Trial name
- NCT06982131
- Testing
- RO7795081, Rosuvastatin, Pitavastatin
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Stable Coronary Artery Disease, Healthy Volunteers
A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease
This study will evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) (Part 1a), multiple ascending doses (MAD) (Part 1b), and the food effect (Part 1c) of RO7763505 in…
- Trial name
- NCT07495813
- Testing
- RO7763505
- Where
- Netherlands
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Paroxysmal Hemoglobinuria, Nocturnal
Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria
This is a Phase I/II, first-in-human study consisting of four sequential parts and an open-label extension (OLE). The safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single doses of crovalimab will be…
- Trial name
- COMPOSER (NCT03157635)
- Testing
- Crovalimab
- Where
- 15 sites in France, Germany and 5 more
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers, Overweight or Obesity
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
This is an investigator- and participant-blind, randomized, placebo-controlled, parallel-group, Phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of orally administered…
- Trial name
- NCT07499050
- Testing
- RO7795081
- Where
- 2 sites in China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Alzheimers Disease, Dementia
Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001
The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with…
- Conditions
- Alzheimers Disease, Dementia, Alzheimers Disease, Familial
- Trial name
- DIAN-TU (NCT01760005)
- Testing
- Gantenerumab, Solanezumab, E2814
- Where
- 38 sites in United States, Argentina and 13 more
- Volunteers
- 490 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Dry Eye Disease
A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment
This study aims to evaluate the performance of biomarkers and their responsiveness to standard-of-care treatments (Vevye® or Xiidra®), in participants with dry eye disease (DED) compared to healthy volunteers (control…
- Trial name
- NCT07025811
- Testing
- Vevye®, Xiidra®
- Where
- 8 sites in United States
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Alzheimer Disease
R21 Roche: 3-Way Tau Tracers in AD
This is an open label study to compare three new generation TAU radioligands, 18F-RO948 (formerly known as 18F-6958948), 18F-MK6240, and [18F]GTP1for imaging of taupathy and demonstrate their absence of off-target binding in…
- Trial name
- NCT05464368
- Testing
- [18F]RO-948, 18F-MK6240, 18F-GTP1
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Multiple Sclerosis
DreaMS - Validation Study 1
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) causing focal lesions of demyelination and diffuse neurodegeneration in the grey and white matter of the brain and spinal cord, leading…
- Trial name
- NCT05009160
- Testing
- dreaMS App R2.1
- Where
- 6 sites in Switzerland
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Research Center for Clinical Neuroimmunology and Neuroscience Basel
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
A Study Conducted to Evaluate the Conjunctiva and Tenon's Capsule Status of Healthy Subjects and in Participants With Neovascular Age-related Macular Degeneration (nAMD)/Diabetic Macular Edema (DME)
The purpose of this study is to obtain conjunctiva and tenon's capsule thickness measurements in vivo using spectral domain-optical coherence tomography (SD-OCT) in participants with nAMD/DME and age-matched healthy subjects.
- Trial name
- NCT06723288
- Where
- 20 sites in Spain
- Volunteers
- 736 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics…
- Trial name
- NCT05763576
- Testing
- RO7565020, Nucleos(t)ide analogue (NUC) treatment
- Where
- 9 sites in United States, Hong Kong and 5 more
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis, NMO Spectrum Disorder
Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.
The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease…
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Radiologically Isolated Syndrome
- Trial name
- RECLAIM (NCT06280755)
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- icometrix