Clinical trials: sponsored by Sanofi
Chronic Obstructive Pulmonary Disease
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive)…
- Trial name
- THESEUS (NCT07190222)
- Testing
- Lunsekimig
- Where
- 314 sites in United States, Argentina and 24 more
- Volunteers
- 942 people
- Sponsor
- Sanofi
Renal Impairment, Healthy Volunteers
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
The purpose of this Phase 1, open-label, 2-arm study is to assess the effect of severe RI on PK, safety, and tolerability of rilzabrutinib compared with normal renal function, in male and female participants aged from 18 to 75…
- Trial name
- NCT07853131
- Testing
- rilzabrutinib
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
Immunization, Healthy Volunteers
Study of a Combination SARS-CoV-2 Recombinant Spike and High-Dose Inactivated Influenza Vaccine With Matrix-M Adjuvant in Adult Participants 60 Years of Age and Older
The purpose of this study is to assess the safety and immunogenicity of IIV-HD + NVXC19 vaccine compared to seasonal influenza vaccine (IIV-HD) and COVID-19 vaccine, adjuvanted (NVXC19) coadministered in adult participants 60…
- Conditions
- Immunization, Healthy Volunteers, COVID-19 Immunization, Influenza Immunization
- Trial name
- NCT07890454
- Testing
- IIV-HD (standalone), NVXC19 (EU licensed, standalone), IIV-HD + NVXC19 combination
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Sanofi
Colitis Ulcerative, Crohn's Disease
A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS)
LTS19689 is a multinational, multicenter extension study to evaluate the long-term safety, tolerability and efficacy of balinatunfib in participants with Crohn's disease (CD) or ulcerative colitis (UC) who completed the 52-week…
- Trial name
- NCT07222189
- Testing
- balinatunfib
- Where
- 10 sites in United States, Argentina and 5 more
- Volunteers
- 7 people
- Sponsor
- Sanofi
Healthy Volunteer
An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Inhibition
The study is a single-center, Phase-1, open-label, one-sequence, two-treatment period, cross-over, DDI study designed to investigate the effects of rilzabrutinib on the PK of digoxin (as P-gp substrate) and of rosuvastatin (as…
- Trial name
- NCT07855250
- Testing
- Rilzabrutinib, Rosuvastatin, Digoxin
- Where
- Canada
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Sanofi
Chronic Obstructive Pulmonary Disease
A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)
This is an open-label, Phase 3, long-term safety extension study including participants of previous lunsekimig clinical trials with inadequately controlled chronic obstructive pulmonary disease (COPD ) characterized by an…
- Trial name
- COLOSSUS (NCT07793409)
- Testing
- Lunsekimig
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 1,508 people
- Sponsor
- Sanofi
Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA)
A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases
This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid…
- Trial name
- NCT06647069
- Testing
- SAR448501
- Where
- 8 sites in Australia, Bosnia and Herzegovina and 3 more
- Volunteers
- 62 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis With Nasal Polyps
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
EFC18419 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups.
- Trial name
- CEREN-2 (NCT06834360)
- Testing
- Itepekimab (SAR440340), Mometasone furoate nasal spray (MFNS)
- Where
- 111 sites in United States, Argentina and 21 more
- Volunteers
- 216 people
- Sponsor
- Sanofi
Polymyalgia Rheumatica
Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 3, 3-arm study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week…
- Trial name
- ZIRCON (NCT07286214)
- Testing
- Sarilumab
- Where
- 85 sites in United States, Austria and 8 more
- Volunteers
- 300 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis With Nasal Polyps
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
EFC18418 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups.
- Trial name
- CEREN-1 (NCT06834347)
- Testing
- Itepekimab (SAR440340), Mometasone furoate nasal spray (MFNS)
- Where
- 121 sites in United States, Argentina and 19 more
- Volunteers
- 231 people
- Sponsor
- Sanofi
Crohn's Disease
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD).
- Trial name
- STARSCAPE-2 (NCT07184944)
- Testing
- Duvakitug
- Where
- 109 sites in United States, Australia and 25 more
- Volunteers
- 751 people
- Sponsor
- Sanofi
Crohn's Disease
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely…
- Trial name
- STARSCAPE-1 (NCT07184931)
- Testing
- Duvakitug
- Where
- 461 sites in United States, Argentina and 34 more
- Volunteers
- 980 people
- Sponsor
- Sanofi
Colitis Ulcerative
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC.
- Trial name
- SPECIFI-UC (NCT06867094)
- Testing
- SAR441566
- Where
- 117 sites in United States, Argentina and 22 more
- Volunteers
- 170 people
- Sponsor
- Sanofi
Chronic Obstructive Pulmonary Disease
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups.
- Trial name
- AEOLUS (NCT07053423)
- Testing
- Dupilumab
- Where
- 85 sites in United States, Argentina and 20 more
- Volunteers
- 218 people
- Sponsor
- Sanofi
Influenza Immunization, Healthy Volunteers
Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe
To objective of this study is to investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda® in adults aged 65 years or older under routine clinical practice…
- Trial name
- NCT07282795
- Testing
- Efluelda® Pre-filled syringe
- Where
- 15 sites in South Korea
- Volunteers
- 670 people, healthy volunteers welcome
- Sponsor
- Sanofi
Geographic Atrophy
A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular…
- Trial name
- NCT07215234
- Testing
- SAR446597
- Where
- 35 sites in United States, Australia and 1 more
- Volunteers
- 104 people
- Sponsor
- Sanofi
Autoimmune Haemolytic Anaemia
A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia
This is a parallel-group, Phase 3, double-blind, 2-arm study to investigate the efficacy, safety, PK and PD of oral rilzabrutinib in achieving durable Hb response (DHR) compared with placebo in approximately 90 male and female…
- Trial name
- LUMINA 3 (NCT07086976)
- Testing
- rilzabrutinib
- Where
- 105 sites in United States, Argentina and 16 more
- Volunteers
- 90 people
- Sponsor
- Sanofi
Immunoglobulin G4 Related Disease
A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
This is a Phase 3, parallel group, 2-arm, randomized, double blind, placebo-controlled, 52-week treatment study to assess the efficacy and safety of rilzabrutinib as a treatment for adult patients with active IgG4-RD.
- Trial name
- RILIEF (NCT07190196)
- Testing
- Rilzabrutinib, Glucocorticoid
- Where
- 95 sites in United States, Argentina and 17 more
- Volunteers
- 124 people
- Sponsor
- Sanofi
Chronic Obstructive Pulmonary Disease
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive)…
- Trial name
- PERSEPHONE (NCT07190209)
- Testing
- Lunsekimig
- Where
- 314 sites in United States, Argentina and 23 more
- Volunteers
- 942 people
- Sponsor
- Sanofi
Meningococcal Infection, Healthy Volunteers
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
The purpose of this study is to describe the safety and immunogenicity of MenACYW conjugate vaccine compared with locally-licensed meningococcal vaccines in healthy infants and toddlers in China.
- Trial name
- NCT07710872
- Testing
- MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA), Menhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China)
- Where
- 8 sites in China
- Volunteers
- 4,568 people, healthy volunteers welcome
- Sponsor
- Sanofi