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A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (MDI) Relative to Budesonide and Formoterol Fumarate MDI and Symbicort® Pressurized MDI in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS)

To evaluate the effect of triple-therapy wih Budesonide, Glycopyrronium and Formoterol Fumarate (PT010) versus dual therapy with Budesonide and Formoterol Fumarate on asthma exacerbations in adult and adolescent subjects with inadequately controlled…

A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT)

Primary Objective:To demonstrate the efficacy of repeated daily doses of 120 µg/kg/day odevixibat in relieving pruritus in patients with ALGS.Secondary Objectives:To assess the impact of odevixibat on serum bile acid levels in patients with ALGS.To…

A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

Primary Objective:To evaluate the duration of clinical response of ruxolitinib cream in participants with vitiligo.

A PHASE 3, RANDOMIZED, DOUBLE-BLINDED,
PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND
SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F
SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING
PREGNANCY
Short title: A Phase 3 Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

to assess the efficacy, safety, and immunogenicity of bivalent RSVpreF or placebo (1:1 randomization) in infants born to healthy women vaccinated during pregnancy, as well as the safety and immunogenicity in the pregnant women.

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734*) in Participants with Moderate COVID-19 Compared to Standard of Care Treatment

The purpose of this study is to provide remdesivir (RDV) to participants with moderate COVID-19. The primary objective of this study is as follows: To evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with…

An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals with Angelman Syndrome (ELARA)

The primary objective of this study is to evaluate the long-term safety and tolerability of OV101 in individuals with AS assessed by the incidence and severity of AEs and SAEs in subjects who are at least 2 years old.The secondary objectives of this…

A phase 3, randomised, double-blind, multi-centre trial to evaluate the efficacy,
safety, and tolerability of brodalumab treatment compared to placebo (blinded) and
ustekinumab (open-label) in adolescent subjects (12-17 years of age) with
moderate-to-severe plaque psoriasis

To determine the efficacy of subcutaneous administration of brodalumab compared with placebo in treating adolescents with moderate-to-severe plaque psoriasis.

High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

This study has been transitioned to CTIS with ID 2024-514917-36-00 check the CTIS register for the current data. PRIMARY OBJECTIVES*Rx-induction: Comparison of the 3 year EFS rate of 2 induction regimens, GPOH and RAPID COJEC, in patients with high-…

A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism

To evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF subjects with impaired glucose tolerance (IGT) or CF related diabetes (CFRD)

A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITH COMPLEMENT INHIBITORS

This study has been transitioned to CTIS with ID 2023-506498-36-00 check the CTIS register for the current data. To evaluate the efficacy of crovalimab compared to eculizumab

A multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema

The primary objective of this study is to evaluate the efficacy of SC administration of CSL312 as prophylaxis to prevent HAE attacks in subjects with HAE.The secondary objectives of the study are:1. To characterize the clinical efficacy of SC CSL312…

A Randomized, Double-Blind, Dose Finding and Comparison Study of the Safety and Efficacy of High Doses of Eteplirsen, Preceded by an Open-Label Dose Escalation, in Patients with Duchenne Muscular Dystrophy With Deletion Mutations Amenable to Exon 51 Skipping

This study has been transitioned to CTIS with ID 2024-511492-15-00 check the CTIS register for the current data. Part 1:to evaluate the safety and tolerability of 2 doses (100 milligrams/kilogram [mg/kg] and 200 mg/kg) of eteplirsen in approximately…

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis

Primary objective: The primary objective is to assess the efficacy and safety of nemolizumab (CD14152) after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with…

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of Linaclotide Administered Orally to Children, Ages 6 to 17 Years, With Functional Constipation (FC)

To evaluate the safety and efficacy of 12 weeks of linaclotide therapy in comparison with placebo in pediatric participants aged 6 to 17 years who fulfill modified Rome III Criteria for Child/Adolescent FC

Effectiveness of blood flow restriction training after bone-patellar tendon-bone anterior cruciate ligament reconstruction: a randomized placebo-controlled trial

The purpose of this study is to evaluate the effect of low-load BFR therapy on quadriceps and hamstring strength 8-, 14-, 26-, 39- and 52-weeks after BPTB ACL reconstruction compared to placebo BFR therapy and conventional HLR training.

Do effects of methylphenidate decline after long-term use? A double-blind, placebo-controlled cross-over study of effects of methylphenidate on cognitive functioning and real world behavior in treatment naïve children compared to effects after 9 months of treatment in clinical practice

The main objective of this study is to compare the acute effects of methylphenidate on behavioral and cognitive functioning in 6 to 12 year old treatment naïve children compared to the effects after nine months of treatment with methylphenidate in…

A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing selpercatinib (LOXO-292) to Physicians Choice of Cabozantinib or Vandetanib in Patients with Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)

Primary* To compare TFFS of patients with progressive, advanced, kinase inhibitor naïve, RET-mutant MTC treated with LOXO-292 versus cabozantinib or vandetanib.Secondary* To compare other efficacy outcomes, based on RECIST 1.1 criteria, observed in…

A Phase 3, Double blind, Randomized, Multicenter, Parallel Group, Placebo controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects from 5 to < 18 Years of Age with Overactive Bladder

ObjectivesPrimary* To evaluate the efficacy of mirabegron in children (5 to < 18 years of age) with OABSecondary* To evaluate the efficacy of mirabegron in children (5 to < 18 years of age) with OAB* To evaluate the safety and…

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734*) in Participants with Severe COVID-19

The primary objective of this study is as follows: -To evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14The secondary objective of this study is as follows: - To…

A Phase 3, 12-Month, Open-Label Study of Lasmiditan in
Pediatric Patients with Migraine - PIONEER-PEDS2

This study has been transitioned to CTIS with ID 2023-506724-85-00 check the CTIS register for the current data. Primary- To evaluate the safety and tolerability of long-term intermittent use of lasmiditan for the acute treatment of migraine in…