Clinical trials: open to volunteers, sponsored by Hoffmann-La Roche
Moderately to Severely Active Ulcerative Colitis
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis…
- Trial name
- AMETRINE-PEDS (NCT07158242)
- Testing
- Afimkibart
- Where
- 26 sites in United States, Australia and 7 more
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Parkinson's Disease
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with…
- Trial name
- PARAISO (NCT07174310)
- Testing
- Prasinezumab
- Where
- 192 sites in United States, Australia and 15 more
- Volunteers
- 900 people
- Sponsor
- Hoffmann-La Roche
Diffuse Large B-Cell Lymphoma
An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma
This study will investigate how well glofitamab-based therapy works and how safe it is in Chinese adult participants with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
- Trial name
- GlofitReal (NCT07200375)
- Testing
- Glofitamab
- Where
- 22 sites in China, Hong Kong
- Volunteers
- 300 people
- Sponsor
- Hoffmann-La Roche
Atopic Dermatitis
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.
- Trial name
- Velarite-LTE (NCT07223697)
- Testing
- Afimkibart
- Where
- 31 sites in United States, Brazil and 5 more
- Volunteers
- 120 people
- Sponsor
- Hoffmann-La Roche
Moderately to Severely Active Crohns Disease
A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease
This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
- Trial name
- SIBERITE-PEDS (NCT07298421)
- Testing
- Afimkibart
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Locally Advanced Breast Cancer, Metastatic Breast Cancer
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated…
- Trial name
- reaINAVO (NCT07347600)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 32 sites in China
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive…
- Trial name
- optINAVO (NCT07368998)
- Testing
- Inavolisib, Fulvestrant
- Where
- 34 sites in United States, Argentina and 6 more
- Volunteers
- 80 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with…
- Trial name
- NCT07405801
- Testing
- Inavolisib, Ribociclib, Fulvestrant
- Where
- 58 sites in United States, Argentina and 10 more
- Volunteers
- 80 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to tucatinib in combination with trastuzumab and capecitabine.
- Trial name
- BREnnA (NCT07413939)
- Testing
- RO7771950, Tucatinib, Trastuzumab
- Where
- 206 sites in United States, Argentina and 23 more
- Volunteers
- 650 people
- Sponsor
- Hoffmann-La Roche
Metastatic Colorectal Cancer
A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
This study will evaluate the dosimetry, safety, efficacy, pharmacokinetics (PK), pharmacodynamics and immunogenicity of CEA-PRIT 2.0 in participants with metastatic microsatellite-stable (MSS) mCRC who are intolerant to or have…
- Trial name
- NCT07416552
- Testing
- SPLIT Abs, 203Pb-DOTAM, 212Pb-DOTAM
- Where
- 5 sites in United States
- Volunteers
- 180 people
- Sponsor
- Hoffmann-La Roche
Hemophilia A
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NXT007 prophylaxis compared with emicizumab prophylaxis in people age 12 years and older with severe or moderate congenital…
- Trial name
- ZEBRHA 2 (NCT07416604)
- Testing
- NXT007, Emicizumab
- Where
- 59 sites in United States, Argentina and 20 more
- Volunteers
- 360 people
- Sponsor
- Hoffmann-La Roche
Healthy Participants
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Enicepatide in Generally Healthy Adult Chinese Participants
This is a Phase I, randomized, double-blinded, placebo-controlled, study to assess the safety, tolerability, and pharmacokinetics (PK) of enicepatide in generally healthy adult Chinese participants with body mass index (BMI)…
- Trial name
- NCT07626515
- Testing
- Enicepatide
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Muscular Atrophy, Spinal
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered as an early intervention in pediatric participants with spinal muscular atrophy (SMA) and 2 SMN2…
- Trial name
- HINALEA 1 (NCT05861986)
- Testing
- Risdiplam
- Where
- 16 sites in United States, Germany and 2 more
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
Cancer
A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants…
- Trial name
- UmbrellaMAX (NCT05862285)
- Testing
- Ipatasertib, Tiragolumab, Atezolizumab
- Where
- 77 sites in Belgium, Canada and 13 more
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Spinal Muscle Atrophy
A Study of Risdiplam in Participants With Type I and Type II Spinal Muscle Atrophy (SMA)
This multicenter, non-interventional, prospective study with a retrospective component aims to evaluate the real-world clinical outcomes, safety profile, and motor function improvements of Risdiplam treatment in participants with…
- Trial name
- NCT07531719
- Where
- 2 sites in Egypt
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
Neuromyelitis Optica Spectrum Disorder, NMOSD
A Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)
This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD).
- Trial name
- SAkuraSun (NCT05199688)
- Testing
- Satralizumab
- Where
- 14 sites in United States, Argentina and 7 more
- Volunteers
- 8 people
- Sponsor
- Hoffmann-La Roche
Moderately to Severely Active Ulcerative Colitis
A Study to Assess the Efficacy and Safety of Afimkibart for Induction Therapy 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
- Volunteers
- 350 people
- Sponsor
- Hoffmann-La Roche
Neovascular Age-Related Macular Degeneration
Extension Study for the Port Delivery System With Ranibizumab (Portal)
This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed…
- Trial name
- Portal (NCT03683251)
- Testing
- PDS Implant with Ranibizumab 100 mg/mL
- Where
- 165 sites in United States, Argentina and 13 more
- Volunteers
- 1,000 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor…
- Trial name
- INAVO121 (NCT05646862)
- Testing
- Inavolisib, Fulvestrant, Alpelisib
- Where
- 210 sites in United States, Argentina and 18 more
- Volunteers
- 420 people
- Sponsor
- Hoffmann-La Roche
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
This is an open label, two-arm, randomized multi-center clinical device study in adult subjects with Type 1 diabetes (T1D) or insulin-dependent Type 2 diabetes (T2D) on a multiple daily injection (MDI) regime.
- Trial name
- NCT06704672
- Testing
- Accu-Chek SmartGuide CGM Solution, Accu-Chek SmartGuide Sensor and Blinded Apps, SMBG Device
- Where
- 19 sites in Poland, Turkey (Türkiye)
- Volunteers
- 270 people
- Sponsor
- Hoffmann-La Roche