Clinical trials: sponsored by 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
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
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
Follicular Lymphoma
Frontline Treatment of Follicular Lymphoma With AtezolizUmab and Obinutuzumab With and Without RadiOtherapy
This single-arm phase II interventional study aims to assess disease response to, and toxicity of, a combination of obinutuzumab and atezolizumab, with or without radiotherapy, in treatment naive Follicular Lymphoma.
- Trial name
- FLUORO (NCT04962126)
- Testing
- Obinutuzumab 25 MG/1 ML Intravenous Solution, Atezolizumab 1200 MG/40mL Intravenous Solution, 4 Gy in 2 fractions
- Where
- 3 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Olivia Newton-John Cancer Research Institute
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
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
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
Diffuse Large B-Cell Lymphoma
Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL
This study aims to assess the efficacy and safety of the chemotherapy-light combination of glofitamab, polatuzumab vedotin and zanubrutinib (GPZ) in elderly patients with previously untreated diffuse large B-cell lymphoma.
- Trial name
- NCT07012980
- Testing
- Glofitamab, Polatuzumab Vedotin, Zanubrutinib
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Shanghai Zhongshan Hospital
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
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
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
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
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
Parkinson Disease, Prodromal Stage
Slow-SPEED: Slowing Parkinson's Early Through Exercise Dosage
The goal of this clinical trial is two-fold. First to investigate the feasibility of whether a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in individuals with a…
- Conditions
- Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases, Basal Ganglia Diseases
- Trial name
- Slow-SPEED (NCT06993142)
- Testing
- Increase of physical activity volume and intensity with the use of a motivational smartphone application
- Where
- 2 sites in United States, Netherlands
- Volunteers
- 600 people
- Sponsor
- Radboud University Medical Center
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
High Risk Cardiovascular Disease, Hypertension
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events.
- Conditions
- High Risk Cardiovascular Disease, Hypertension, High Cardiovascular Risk
- Trial name
- ZENITH (NCT07181109)
- Testing
- Zilebesiran
- Where
- 1,190 sites in United States, Argentina and 33 more
- Volunteers
- 11,000 people
- Sponsor
- Alnylam Pharmaceuticals
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, 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