Clinical trials: sponsored by Hoffmann-La Roche
Facioscapulohumeral Muscular Dystrophy (FSHD)
A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy
The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and efficacy of RO7204239, a humanized monoclonal antibody that binds to human latent myostatin, in ambulant adult…
- Trial name
- MANOEUVRE (NCT05548556)
- Testing
- RO7204239
- Where
- 9 sites in United States, Denmark and 2 more
- Volunteers
- 51 people
- Sponsor
- Hoffmann-La Roche
Neovascular Age-related Macular Degeneration
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.
- Trial name
- Sightspire (NCT06847542)
- Testing
- Susvimo PDS Implant, Ranibizumab
- Where
- 61 sites in Austria, Czechia and 11 more
- Volunteers
- 250 people
- Sponsor
- Hoffmann-La Roche
Multiple Myeloma
Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple Myeloma
The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) in patients with multiple myeloma (MM) who have received one to four prior lines of therapy…
- Trial name
- NCT07825064
- Testing
- Cevostamab, Pomalidomide, Dexamethasone
- Where
- 2 sites in Germany
- Volunteers
- 45 people
- Sponsor
- Hoffmann-La Roche
Early Breast Cancer
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk…
- Trial name
- NCT04961996
- Testing
- Giredestrant, Physician's Choice of Endocrine Therapy, LHRH Agonist
- Where
- 621 sites in United States, Argentina and 52 more
- Volunteers
- 4,170 people
- Sponsor
- Hoffmann-La Roche
Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer
A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast…
- Conditions
- Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Trial name
- kalitERA (NCT07827573)
- Testing
- Giredestrant
- Volunteers
- 1,500 people
- Sponsor
- Hoffmann-La Roche
Childhood Idiopathic Nephrotic Syndrome
A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
This open-label, randomized multicenter study is to assess the efficacy, safety, and pharmacokinetics (PK)/pharmacodynamics (PD) of obinutuzumab compared with mycophenolate mofetil (MMF) in children and young adults (aged >= 2-25…
- Trial name
- INShore (NCT05627557)
- Testing
- Obinutuzumab, MMF, Prednisone
- Where
- 35 sites in United States, Belgium and 7 more
- Volunteers
- 85 people
- Sponsor
- Hoffmann-La Roche
Relapsing-remitting Multiple Sclerosis
A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
The main purpose of this study is to evaluate the pharmacokinetics (PK) of ocrelizumab administered subcutaneously (SC) in children and adolescents aged 10 to <18 years with RRMS.
- Trial name
- Operetta III (NCT07503340)
- Testing
- Ocrelizumab co-formulated with rHuPH20
- Volunteers
- 25 people
- Sponsor
- Hoffmann-La Roche
Carcinoma, Non-Small-Cell Lung
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting.
- Trial name
- NCT03456076
- Testing
- Alectnib, Cisplatin, Vinorelbine
- Where
- 114 sites in United States, Australia and 25 more
- Volunteers
- 257 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
A Study to Investigate Effects of Ocrelizumab Treatment on Neurofilament Light Chain (NfL) Levels and Participant Satisfaction in Participants With Multiple Sclerosis (MS)
The main purpose of the study is to evaluate participant satisfaction after administration of ocrelizumab subcutaneously (SC) after 12 months using the therapy administration satisfaction questionnaire subcutaneous (TASQ-SC).
- Trial name
- SurfSubQ (NCT06780150)
- Testing
- Ocrelizumab
- Where
- 93 sites in Germany, Switzerland
- Volunteers
- 842 people
- Sponsor
- Hoffmann-La Roche
Multiple Myeloma
Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma
The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received…
- Trial name
- CEVOLUTION (NCT07555938)
- Testing
- Cevostamab, Pomalidomide, Dexamethasone
- Where
- 93 sites in United States, Australia and 16 more
- Volunteers
- 380 people
- Sponsor
- Hoffmann-La Roche
Obesity or Overweight
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with…
- Trial name
- Enith1 (NCT07351045)
- Testing
- Enicepatide
- Where
- 209 sites in United States, Argentina and 19 more
- Volunteers
- 2,000 people
- Sponsor
- Hoffmann-La Roche
Relapsing Multiple Sclerosis
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
This open label, single arm study will evaluate the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and < 18 years.
- Trial name
- FENerations1 (NCT07161258)
- Testing
- Fenebrutinib
- Where
- 17 sites in Argentina, Brazil and 5 more
- Volunteers
- 12 people
- Sponsor
- Hoffmann-La Roche
Hemophilia A
A Gene Therapy Study of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A
This study will assess the safety and tolerability of SPK-8011QQ in adult males with moderately severe to severe hemophilia A.
- Trial name
- NCT07226206
- Testing
- SPK-8011QQ
- Where
- 6 sites in United States
- Volunteers
- 5 people
- Sponsor
- Hoffmann-La Roche
Non-small Cell Lung Cancer
A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)
The main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral…
- Trial name
- KRASCENDO 3 (NCT07541170)
- Testing
- Divarasib, Pembrolizumab, Nivolumab
- Where
- 46 sites in United States, Argentina and 12 more
- Volunteers
- 400 people
- Sponsor
- Hoffmann-La Roche
Diabetic Retinopathy
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).
- Trial name
- CENOTE (NCT07588100)
- Testing
- RO7663498
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
Alzheimer's Disease
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild…
- Trial name
- PrevenTRON (NCT07717411)
- Testing
- Trontinemab
- Where
- 34 sites in United States, Argentina and 5 more
- Volunteers
- 1,600 people
- Sponsor
- Hoffmann-La Roche
Obesity or Overweight, Type 2 Diabetes Mellitus
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with…
- Trial name
- Enith2 (NCT07351058)
- Testing
- Enicepatide
- Where
- 210 sites in United States, Argentina and 19 more
- Volunteers
- 1,600 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages.
- Trial name
- Morpheus-panBC (NCT03424005)
- Testing
- Capecitabine, Atezolizumab, Ipatasertib
- Where
- 55 sites in United States, Australia and 7 more
- Volunteers
- 1,132 people
- Sponsor
- Hoffmann-La Roche
Von Willebrand Disease, Type 3
A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease
This is a Phase III, multicenter, open-label clinical study designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab prophylaxis in participants aged 1 month and above, who have been…
- Trial name
- WILL-EMI (NCT06998524)
- Testing
- Emicizumab, von Willebrand Factor (VWF) Concentrates, Factor VIII (FVIII) Concentrates
- Where
- 29 sites in United States, Belgium and 12 more
- Volunteers
- 75 people
- Sponsor
- Hoffmann-La Roche
Lung Cancer, Hepatocellular Carcinoma
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
This is a non-interventional, multi-country, multi-centre, multicohort, primary data collection study, designed to assess patients' reported satisfaction with Atezolizumab Subcutenous (SC) treatment and Health-related Quality of…
- Trial name
- NCT07284121
- Testing
- Atezolizumab
- Where
- 92 sites in Austria, Belgium and 6 more
- Volunteers
- 700 people
- Sponsor
- Hoffmann-La Roche