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
Parkinson's Disease
Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of RO7568282 compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.
- Trial name
- TARBELA-PD (NCT07781644)
- Testing
- RO7568282
- Where
- 2 sites in United Kingdom
- Volunteers
- 474 people
- 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
Breast Cancer, Diabetes Type II
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.
- Trial name
- NCT07748208
- Testing
- Inavolisib, Fulvestrant, Palbociclib
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 40 people
- Sponsor
- Hoffmann-La Roche
Locally Advanced or Metastatic Solid Tumors
A Study of RO7821657 in Participants With Solid Tumors
The aim of this study is to characterize the safety and tolerability of RO7821657, describe its pharmacokinetics (PK), and evaluate pharmacodynamic and biomarker effects to support selection of the recommended Phase 2 dose(s)…
- Trial name
- NCT07883577
- Testing
- RO7821657
- Volunteers
- 405 people
- 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
Lupus, Systemic Lupus Erythematosus
A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).
- Conditions
- Lupus, Systemic Lupus Erythematosus, Lupus Nephritis
- Trial name
- SOLUNA (NCT07598396)
- Testing
- Mosunetuzumab
- Where
- 24 sites in Argentina, Brazil and 4 more
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
Alzheimers Disease
Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies
This study is a pre-screening process used to assess participants' potential eligibility for Roche interventional Alzheimer's disease studies.
- Trial name
- TRAVELLER (NCT07177352)
- Testing
- No Intervention
- Where
- 234 sites in United States, Argentina and 13 more
- Volunteers
- 80,000 people
- Sponsor
- Hoffmann-La Roche
Traumatic Brain Injury
A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury
The study is intended to cover two purposes: first, to develop a blood-based biomarker test for aiding the diagnosis of traumatic brain injury (TBI) in adult participants and for prognosis of outcome of TBI (CLIN12.1); and…
- Trial name
- NCT07455136
- Testing
- Blood sample collection
- Where
- 14 sites in United States
- Volunteers
- 2,000 people
- 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
Hemophilia A
Clinical Trial of NXT007 for the Prophylactic Treatment of Hemophilia A in Infants and Children
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis in pediatric patients aged 0 to 11 years with severe or moderate congenital hemophilia A without factor…
- Trial name
- ZEBRHA 3 (NCT07838194)
- Testing
- NXT007
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Lupus Nephritis
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus…
- Trial name
- REGENCY (NCT04221477)
- Testing
- Obinutuzumab, MMF, Prednisone
- Where
- 74 sites in United States, Argentina and 13 more
- Volunteers
- 271 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)
This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF…
- Trial name
- NCT07137598
- Testing
- Afimkibart
- Where
- 65 sites in United States, Argentina and 10 more
- Volunteers
- 160 people
- 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
Moderately to Severely Active Crohns Disease
A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with…
- Trial name
- SIBERITE-1 (NCT06819878)
- Testing
- Afimkibart
- Where
- 375 sites in United States, Argentina and 36 more
- Volunteers
- 600 people
- Sponsor
- Hoffmann-La Roche
Active Ulcerative Colitis
An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis
The purpose of this study is to evaluate the disease-drug-drug interaction (DDDI) potential of afimkibart (also known as RO7790121).
- Trial name
- NCT07665723
- Testing
- Afimkibart, Caffeine, Warfarin
- Where
- 18 sites in United States, Belgium and 3 more
- Volunteers
- 25 people
- Sponsor
- Hoffmann-La Roche
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment…
- Trial name
- Meteoroid (NCT05271409)
- Testing
- Satralizumab
- Where
- 53 sites in United States, Australia and 9 more
- Volunteers
- 139 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance…
- Trial name
- INAVO122 (NCT05894239)
- Testing
- Inavolisib, Phesgo, Taxane-based Chemotherapy
- Where
- 192 sites in United States, Argentina and 27 more
- Volunteers
- 230 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis
The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis…
- Trial name
- dRAvite-LTE (NCT07620392)
- Testing
- Afimkibart
- Where
- 12 sites in United States, Brazil and 1 more
- Volunteers
- 120 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary…
- Trial name
- PORTAMENTO (NCT07074886)
- Testing
- Ocrelizumab Test Formulation, Ocrelizumab Reference Formulation
- Where
- 49 sites in United States, Argentina and 7 more
- Volunteers
- 193 people
- Sponsor
- Hoffmann-La Roche