Clinical trials

The main aim of the study to describe the characteristics of participants with asthma across the spectrum of disease severity, including sociodemographic and clinical characteristics, treatment and disease burden, biomarkers, and both disease-specific and generic health-related quality of life. The study consists of two parts: a cross-sectional study, and a prospective follow-up evaluate changes in disease trajectories in participants with asthma.

This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™). The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations. There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days

The purpose of this study is to evaluate the safety and immunogenicity of a single dose of Sanofi's Omicron subvariant-based Nuvaxovid in participants ≥ 65 years of age and participants 12 through 64 years of age who have at least one underlying condition that puts them at increased risk for severe outcomes of COVID-19 and who have been previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination. Study details include: * The study duration will be approximately 3 months per participant. * Study intervention will be administered via a single intramuscular (IM) injection into the deltoid muscle on Day 1. * The visit frequency will be Day 1, Day 9 telephone call, Day 29, and Day 91 telephone call (3-month safety follow-up).

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) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.

This is a parallel group, Phase 2, 2-arm study to measure the treatment effect and safety of rilzabrutinib dose 1 or rilzabrutinib dose 2 in participants with Graves' disease, with and without Graves' orbitopathy, aged 18 years or older. Study details include: * Screening period (up to 4 weeks). * Treatment period (up to 16 weeks). * Follow-up period (4 weeks). The number of visits will be up to 13.

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 substrate of BCRP, OATP1B1, and OATP1B3) in healthy male and female participants. For this study a cocktail of digoxin and rosuvastatin will be used.

The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions. The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.

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 years. The total duration of the study per participant will be approximately 30 days, including: * A screening period of up to 27 days. * A 3-day, open-label treatment period, with a single dose on Day 1. * A 1-day follow-up period (Day 3) with an allowable 2-day window (ie, Day 3 to Day 5).

This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate. The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups). The duration of the study will be approximately 12 months for each participant.

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 Degeneration (AMD). The core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase. The treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).

This study is a pharmacoepidemiologic method study based on the secondary use of pre-existing data that examines whether TriNetX, a global health research network encompassing a worldwide electronic health record (EHR), database in the US is an appropriate real-world data (RWD) source for conducting chlamydia-related research to support the chlamydia trachomatis (CT) messenger Ribonucleic acid (mRNA) vaccine program. There are two primary objectives for this study: 1. To determine the validity of ICD, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic codes to identify patients with chlamydial infections using TriNetX EHR data in the US 2. To describe screening or diagnostic testing and treatment patterns in patients with chlamydia using TriNetX EHR data in the US There are also two secondary objectives for this study: 1. To explore the feasibility of developing a modified algorithm for identifying patients with chlamydia applicable for Merative MarketScan Commercial Claims and Encounters (CCAE) database based on the findings from the primary objectives 2. To compare patient characteristics, use of screening or diagnostic testing, and treatment patterns among patients with chlamydia between TriNetX EHR data and the MarketScan CCAE data in the US

The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.

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. Study details include: * Study duration (including 6-month safety follow-up after the last dose): * Cohort I (Groups 1 and 2): approximately 211 or 271 days (approximately 7 or 9 months) * Cohort II (Groups 3 and 4): up to 18 months * Cohort III (Groups 5 and 6): up to 21 months * Cohort III (Group 7): approximately 16 months * Vaccination Visits Period: * Cohort I (Groups 1 and 2): a 2-dose vaccination at V01 (D01) and V02 (D31) or V03 (D91). Two blood samples are collected pre-vaccination (D01) and 30 days post the 2nd dose of vaccination (D61 or D121). Telephone calls (TCs) are planned on the 4th, the 9th, and the 21st day after each vaccination, and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit for safety follow-up. For participants receiving the second vaccination with a 3-month interval: an on-site visit is planned 30 days post the 1st dose of vaccination (V02, D31) for participant diary collection. \- Cohort II (Groups 3 and 4): a 2-dose vaccination at V01 (D01) and V02 (D31) or V03 (D91). A 1-dose booster is planned for Group 3 only at 18 MoA (within the 18th month from the participant's birth date). Up to 4 blood samples will be collected. In the primary vaccination period, blood samples are collected before the first primary vaccination (D01) and 30 days post the 2nd dose of primary vaccination (D61 or D121). A blood sample will be collected from all participants at 18 MoA. A post-booster blood sample will be collected from participants in Group 3, 30 days post their booster vaccination. Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods, respectively, for safety follow-up. For participants receiving the second vaccination with a 3-month interval: an on-site visit is planned 30 days post the 1st dose of vaccination (V02, D31) for participant diary collection. \- Cohort III - Groups 5 and 6: a 3-dose primary vaccination at V01 (D01), V02 (D31) and V03 (D61), a 1-dose booster at 12 MoA (within the 12th months from the participant's birth date) on V05 or at 18 MoA (within the 18th months from the participant's birth date) on V06. In total 4 blood samples are to be collected. In the primary vaccination period, blood samples are to be collected before the first primary vaccination (D01) and 30 days post the 3rd dose of primary vaccination (D91); in the booster vaccination period, blood samples are to be collected before booster vaccination at V05 (for participants receiving the booster at 12 MoA) or V06 (for participants receiving the booster at 18 MoA), and 30 days post booster vaccination (V05 + 30 days or V06 + 30 days). Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods respectively for safety follow-up. \- Cohort III - Group 7: a 3-dose primary vaccination at V01 (D01), V02 (D61) and V03 (D121), a 1-dose booster at V05 at 12 MoA (within the 12th months from the participant's birth date). In total 4 blood samples are to be collected. In the primary vaccination period, blood samples are to be collected before the first primary vaccination (D01) and 30 days post the 3rd dose of primary vaccination (D151); in the booster vaccination period, blood samples are to be collected before booster vaccination at V05 and 30 days post booster vaccination (V06). Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods (ie, V04 and V06), respectively, for safety follow-up. A safety visit is planned on the 9th day after the first vaccination for the ESDR participants (the first 30 participants in this group).

This is an open-label, single group, Phase 1/2, 1-arm study for treatment of children aged 1 to \<18 years with active moderate-to-severe cGVHD that is refractory to or recurred after at least 2 prior lines of systemic therapy for cGVHD. The purpose of Phase 1 is to determine the PK profiles and to establish the Recommended Pediatric Equivalent Dose (RPED) of belumosudil in participants aged 1 to \<12 years with active moderate to severe cGVHD. Upon completion and evaluation of Phase 1, Phase 2 will commence with the purpose of determining safety and efficacy (ORR by 24 weeks) of belumosudil in participants aged 1 to \<18 years. Study details include: The end of study is defined as 3 years after the last participant is recruited or all participants have discontinued treatment, or have died, whichever comes first. Minimum of 6 participants ages 1 to 6 years will be enrolled for each phase of study Individual participant duration on study will consist of: Up to 4 weeks for screening. Treatment until clinically significant progression of cGVHD, relapse/recurrence of the underlying disease, start of a new systemic treatment for cGVHD, experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first. 30 days of post treatment safety follow-up. Long-term follow-up until death or end of study, whichever occurs first.

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 participants ≥ 18 years of age with a confirmed diagnosis of primary wAIHA. Following a 4-week screening period, eligible participants will be randomized in a 2:1 ratio to receive rilzabrutinib or placebo in primary analysis period (PAP) for a duration of up to 24 weeks. All participants who completed PAP will then continue in open-label period (OLP) to receive rilzabrutinib for a duration of 28 weeks. Upon the completion of OLP, only participants who demonstrate Hb increase during the last 8 weeks of OLP per specified criteria in the protocol will be eligible to continue in long-term extension (LTE) of the study. The duration of the LTE period will be from the first-participant-in (FPI)-LTE until the last participant completes 52 weeks in LTE. The safety follow-up period of this study following treatment completion or discontinuation will be 2 weeks.

This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.

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) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.

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. The purpose of this study is to measure time to adjudicated IgG4-RD clinical disease flare, and other relevant efficacy endpoints including flare-free rate, control of IgG4-RD disease activity, use of GC rescue and safety parameters such as treatment-emergent adverse events, clinical laboratory values and electrocardiograms (ECG) in participants aged 18 years and above, diagnosed with IgG4-RD and treated with rilzabrutinib tablets over a 52-week placebo-controlled period. Study details include: The study duration will be up to 60 weeks, including a Screening period of 4 to 6 weeks, a 52-week double blind treatment period, and 2 weeks of follow up (plus an optional OLE of 108 weeks). The number of visits will be 16 (plus an optional 9 visits during the OLE).

This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, brivekimig or rilzabrutinib compared with placebo in participants with primary FSGS or MCD aged 16 to 75 years. Study details for each participant include: The study duration will be up to 52 weeks. The treatment duration will be 24 weeks. There will be up to 16 visits.

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 eosinophilic phenotype. The purpose of the LTS 18211 study is to characterize the long-term safety and efficacy of lunsekimig in adults with COPD who completed studies EFC18243 or EFC18244 in the main study, and to assess the impact of inhaled corticosteroids (ICS ) withdrawal in the ICS withdrawal sub-study. The study duration will be up to 100 weeks, including the following components: * Baseline Visit (Visit 1 / Week 0) will coincide with the End-of-Intervention visit from the parent study (EFC18243 or EFC18244) if possible * Treatment duration of up to 96 weeks * Safety follow-up period of approximately 4 weeks * The number of visits will be 26

The OBS19236 is a retrospective and prospective, non-interventional observational study in COPD patients treated with dupilumab as part of routine clinical care. It will follow-up about 350 to 500 participants over 36 months in up to 50 sites in France.

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). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-Up visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study

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 active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week Screening Period. * 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction). * 12-week Sub-Study 3 (Extended Induction for non-responders). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

This is a parallel, placebo-controlled, multicenter, randomized, double-blind, Phase 2, proof of concept study. The study aims to evaluate the efficacy and safety of SAR444336 in adult participants with microscopic colitis. Participants are required to have a histologically confirmed diagnosis of microscopic colitis, be in clinical remission and be receiving budesonide therapy. The overall study duration is approximately 32 weeks.

This is a Phase 1/Phase 2 open-label single arm, multicenter, and multinational study with SAR446268 for treatment of male and female participants 10 to 55 years old with non-congenital myotonic dystrophy (DM) type 1 (DM1). The purpose of this study is to evaluate the safety and efficacy of SAR446268 in knocking down dystrophia myotonica protein kinase (DMPK) messenger ribonucleic acid (mRNA) levels and improving neuromuscular function in DM1 participants receiving a single intravenous (IV) administration of SAR446268. The study consists of a dose escalation part (Part A) during which single ascending doses of SAR446268 will be evaluated in 3 distinct cohorts and an optional fourth dose cohort. Once a safe and effective dose is identified, additional participants will be treated in Part B, the dose expansion phase of the study. The study duration will be 112 weeks (approximately 2 years) for each participant in Parts A and B respectively and includes an optional pre-screening period, approximately 8-week screening phase and a 104-week follow-up period post-SAR446268 administration.