Clinical trials: sponsored by 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
Hemophilia A
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
WP44714 is a Phase I/II, open-label, non-randomized, global, multicenter trial consisting of two parts: Part 1 is a multiple-ascending dose (MAD) study in adult and adolescent male participants with severe or moderate hemophilia…
- Trial name
- NCT05987449
- Testing
- NXT007
- Where
- 14 sites in United States, Canada and 4 more
- Volunteers
- 60 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
- 19 sites in United States, Australia and 6 more
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers, Overweight or Obesity
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
This is an investigator- and participant-blind, randomized, placebo-controlled, parallel-group, Phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of orally administered…
- Trial name
- NCT07499050
- Testing
- RO7795081
- Where
- 2 sites in China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Obesity or Overweight, Type 2 Diabetes
A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes
This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or…
- Trial name
- ZUPREME-4 (NCT07843485)
- Testing
- Petrelintide
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- Hoffmann-La Roche
Mature B-Cell Non-Hodgkin Lymphoma
A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric…
- Trial name
- iMATRIX GLO (NCT05533775)
- Testing
- Obinutuzumab, Glofitamab, Rituximab
- Where
- 30 sites in United States, Australia and 11 more
- Volunteers
- 65 people
- Sponsor
- Hoffmann-La Roche
Relapsing Multiple Sclerosis
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and, pharmacodynamics (PD) of subcutaneously administered RO7845860 in participants with relapsing multiple sclerosis (RMS).
- Trial name
- NOVA-BEAM (NCT07749157)
- Testing
- RO7845860
- Volunteers
- 85 people
- Sponsor
- Hoffmann-La Roche
Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer
A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS…
- Trial name
- Krascendo 2 (NCT06793215)
- Testing
- Divarasib, Pembrolizumab, Pemetrexed
- Where
- 299 sites in United States, Argentina and 26 more
- Volunteers
- 600 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
- 219 sites in United States, Argentina and 24 more
- Volunteers
- 650 people
- Sponsor
- Hoffmann-La Roche
Non-Small Cell Lung Cancer
A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic…
- Trial name
- KRAScendo 170 (NCT05789082)
- Testing
- Divarasib, Pembrolizumab, Carboplatin
- Where
- 71 sites in United States, Argentina and 16 more
- Volunteers
- 320 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
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
Multiple Myeloma
A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma
CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM).
- Trial name
- PLYCOM (NCT05583617)
- Testing
- Cevostamab, Lenalidomide, Tocilizumab
- Where
- 16 sites in Australia, France and 4 more
- Volunteers
- 200 people
- Sponsor
- 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
- 29 sites in United States, Australia and 7 more
- Volunteers
- 100 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
- 5 sites in Germany
- Volunteers
- 45 people
- Sponsor
- Hoffmann-La Roche
Obesity or Overweight
A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity
This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or…
- Trial name
- ZUPREME-3 (NCT07843498)
- Testing
- Petrelintide
- Where
- 8 sites in United States
- Volunteers
- 3,900 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
Spinal Muscular Atrophy (SMA)
A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy
Risdiplam works by helping the body produce more survival motor neuron (SMN) protein throughout the body. This means fewer motor neurons - nerve cells that pass impulses from nerves to muscles to cause movement - are lost, which…
- Trial name
- MANATEE (NCT05115110)
- Testing
- RO7204239, Risdiplam
- Where
- 29 sites in United States, Australia and 10 more
- Volunteers
- 97 people
- Sponsor
- Hoffmann-La Roche
Atopic Dermatitis
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).
- Trial name
- NCT06863961
- Testing
- Afimkibart
- Where
- 52 sites in United States, Brazil and 6 more
- Volunteers
- 162 people
- Sponsor
- Hoffmann-La Roche
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