Clinical trials: sponsored by Hoffmann-La Roche
Age-Related Macular Degeneration
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
The main objective of the study is evaluation of the safety and tolerability of OpRegen - Human embryonic stem cell-derived retinal pigment epithelial (RPE) cells.
- Trial name
- NCT02286089
- Testing
- OpRegen
- Where
- 7 sites in United States, Israel
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Severe Hemophilia A, Moderate Hemophilia A
A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis
Study MO42623 is a Phase IV, multicenter, open-label, three cohort study designed to evaluate the impact of emicizumab prophylaxis on overall health, physical activity, and joint outcomes in participants aged ≥13 and <70 years…
- Trial name
- Beyond ABR (NCT05181618)
- Testing
- Emicizumab
- Where
- 26 sites in United States, Brazil and 10 more
- Volunteers
- 136 people
- Sponsor
- Hoffmann-La Roche
Influenza
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
This study consists of two parts: Part A Surveillance and Part B Transmission. The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' <12…
- Trial name
- Pebblestone (NCT06094010)
- Testing
- Baloxavir Marboxil
- Where
- 51 sites in United States, Bulgaria and 2 more
- Volunteers
- 1,100 people
- Sponsor
- Hoffmann-La Roche
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
- Trial name
- NCT06318169
- Testing
- Pegozafermin
- Where
- 370 sites in United States, Argentina and 25 more
- Volunteers
- 1,350 people
- Sponsor
- Hoffmann-La Roche
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .
- Trial name
- NCT06419374
- Testing
- Pegozafermin
- Where
- 330 sites in United States, Argentina and 23 more
- Volunteers
- 1,800 people
- Sponsor
- Hoffmann-La Roche
Cancer
A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during…
- Trial name
- IMbrella B (NCT03768063)
- Testing
- Atezolizumab, Bevacizumab, Alectinib
- Where
- 80 sites in United States, Australia and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Hoffmann-La Roche
Muscular Atrophy, Spinal
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered in Pediatric Patients With Spinal Muscular Atrophy Who Experienced a Plateau or Decline in Function After Gene Therapy
This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered in pediatric participants with SMA and 2 SMN2 copies who previously received onasemnogene…
- Trial name
- HINALEA 2 (NCT05861999)
- Testing
- Risdiplam
- Where
- 17 sites in United States, Germany and 4 more
- Volunteers
- 19 people
- Sponsor
- 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
Type 2 Diabetes Mellitus
A Clinical Study to Evaluate the Effects of Enicepatide Versus Tirzepatide in Participants With Type 2 Diabetes and Inadequate Blood Sugar Control on Oral Glucose-Lowering Medications
The study will evaluate the efficacy and safety of enicepatide, a glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide receptor (GLP-1/GIP) receptor agonist (RA), compared with tirzepatide among participants with…
- Trial name
- ENI-SPIRE-2 (NCT07889648)
- Testing
- Enicepatide, Tirzepatide
- Volunteers
- 948 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Estrogen Receptor Positive Tumor
To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in…
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
- Trial name
- TOUCH (NCT03644186)
- Testing
- Paclitaxel, Trastuzumab, Pertuzumab
- Where
- 54 sites in Belgium, France and 2 more
- Volunteers
- 147 people
- Sponsor
- ETOP IBCSG Partners Foundation
Multiple Myeloma
A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma
This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab…
- Trial name
- CAMMA 1 (NCT04910568)
- Testing
- Cevostamab, Tocilizumab, Pomalidomide
- Where
- 34 sites in United States, Australia and 11 more
- Volunteers
- 186 people
- Sponsor
- Genentech, Inc.
Locally Advanced Hepatocellular Carcinoma
Multinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab, vs SIRT (SIRT-Y90) Followed by Placebo in Locally Advanced HCC Patients
This is a multi-national, phase II, parallel-arm, double-blind, placebo-controlled, two-arm study designed to assess the efficacy and safety of SIRT-Y90 followed by atezolizumab plus bevacizumab [study arm], versus SIRT-Y90…
- Trial name
- STRATUM (NCT05377034)
- Testing
- SIRT-Y90 with Atezolizumab + Bevacizumab
- Where
- 14 sites in China, Singapore and 2 more
- Volunteers
- 119 people
- Sponsor
- National Cancer Centre, Singapore
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
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
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
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
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
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
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