Clinical trials: sponsored by Hoffmann-La Roche
Paroxysmal Nocturnal Hemoglobinuria
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
A study designed to evaluate the safety of crovalimab with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 190 participants.
- Trial name
- COMMODORE 1 (NCT04432584)
- Testing
- Crovalimab, Eculizumab
- Where
- 80 sites in United States, Belgium and 22 more
- Volunteers
- 190 people
- Sponsor
- Hoffmann-La Roche
Paroxysmal Nocturnal Hemoglobinuria
A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors
A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy.
- Trial name
- COMMODORE 2 (NCT04434092)
- Testing
- Crovalimab, Eculizumab
- Where
- 63 sites in Argentina, Brazil and 21 more
- Volunteers
- 210 people
- Sponsor
- Hoffmann-La Roche
Moderately to Severely Active Crohns Disease
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's…
- Trial name
- SIBERITE-2 (NCT06819891)
- Testing
- Afimkibart
- Where
- 208 sites in United States, Argentina and 25 more
- Volunteers
- 425 people
- Sponsor
- Hoffmann-La Roche
Moderately to Severely Active Ulcerative Colitis
A Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- AMETRINE-SC (NCT07846683)
- Testing
- Afimkibart
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Hoffmann-La Roche
Hemophilia A
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis compared with Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital…
- Trial name
- ZEBRHA 1 (NCT07416526)
- Testing
- NXT007, Human Coagulation Factor VIII
- Where
- 36 sites in United States, Argentina and 16 more
- Volunteers
- 138 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
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
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
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
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
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
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
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
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
Neoplasms
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who…
- Trial name
- NCT03194893
- Testing
- Alectinib, Crizotinib
- Where
- 29 sites in United States, France and 7 more
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Cancer
A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)
This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or…
- Trial name
- NCT03148418
- Testing
- Atezolizumab, Bevacizumab
- Where
- 170 sites in United States, Argentina and 30 more
- Volunteers
- 382 people
- Sponsor
- Hoffmann-La Roche
Muscular Atrophy, Spinal
A Study of Risdiplam in Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy
A global study of oral risdiplam in pre-symptomatic participants with spinal muscular atrophy (SMA).
- Trial name
- Rainbowfish (NCT03779334)
- Testing
- Risdiplam
- Where
- 7 sites in United States, Australia and 5 more
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche