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ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Primary:To provide access to abrocitinib to adolescent and adult patients with or without background topical therapy who have inadequate treatment options due to inadequate response or intolerance to available approved medicated topical and systemic…

Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis

This study has been transitioned to CTIS with ID 2024-515964-30-00 check the CTIS register for the current data. • Allow patients to continue or start AP01 therapy for the treatment of ILD and IPF prior to regulatory approval or until the study is…

A Phase 3b, Randomized, Double-blind, Placebo-controlled, 24-week Study to Assess the Efficacy and Safety of Fezolinetant in Menopausal Women Suffering from Moderate to Severe Vasomotor Symptoms (Hot Flashes) and Considered Unsuitable for Hormone Replacement Therapy.

PrimaryTo evaluate the efficacy of fezolinetant 45 mg versus placebo on the frequency of moderate to severe VMSKey secondaryTo evaluate the efficacy of fezolinetant 45 mg versus placebo on the severity of moderate to severe VMSSecondary• To evaluate…

An open-label, single-dose study to assess the absolute oral bioavailability and pharmacokinetics of JNJ-42847922 (seltorexant) administered as oral tablet and an intravenous microdose of 14C-seltorexant in healthy participants

In this study we will investigate how safe the new compound seltorexant is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent seltorexant is absorbed, transported, and eliminated…

A randomized, controlled, partial-blind, parallel-group study evaluating the effect of oral administration of BAY 1834845 and BAY 1830839 twice daily for 7 consecutive days on local and systemic IRAK4 pathway-related challenges in healthy male participants

Primair1. Assessment of the pharmacological activity of BAY·1834845 and BAY 1830839 on IMQ induced skin inflammation compared to placebo (prednisolone serves as active control), as quantified by laser speckle contrast imaging (LSCI, perfusion/basal…

A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

Primary end point• Progression-free survival (PFS) per ICR central assessmentSecondary end point• Objective response rate (ORR)• Disease control rate (DCR)• Overall survival (OS)• PFS according to Investigator assessment of radiologic images•…

A randomized, double-blinded, placebo-Controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BMS-986224 in healthy subjects and chronic heart failure patients with reduced ejection fraction

The purpose of this study is to investigate how safe the new compound BMS-986224 is when it is administered as a single dose to healthy subjects and patients with chronic hart failure. It will also be investigated how quickly and to what extent BMS-…

Phase I, Open-Label, 2-Period, Single-Sequence Study to Evaluate the Mass Balance and Absorption, Disposition, Metabolism and Excretion of [14C] enpatoran, and the Absolute Bioavailability of Enpatoran in Healthy Male Participants

The study includes 2 periods, Period 1 and Period 2. Subjects will participate in both periods. Period 1:The purpose of Period 1 is to investigate how quickly and to what extent enpatoran is absorbed, transported and eliminated from the body (this…

A double-blind, placebo-controlled, randomized, single and multiple ascending dose study of the safety and tolerability, and pharmacokinetics (including food effect, pH effect and Japanese bridging study) of BMS-986337 following oral administration in healthy participants

The purpose of this study is to investigate how safe the new compound BMS-986337 is and how well it is tolerated when it is administered as single or multiple doses to healthy volunteers. BMS-986337 has not been administered to humans before. It has…

A single-center, open-label study to investigate the absorption, distribution, metabolism and excretion (ADME) of HDM201 (Siremadlin) after a single oral dose of 25 mg [14C]HDM201 in healthy subjects

The purpose of this study is to investigate how quickly and to what extent HDM201 is absorbed, broken down and eliminated from the body (this is called pharmacokinetics). HDM201 will be labeled with 14-carbon (14C) and is thus radioactive. In this…

A Phase 1/2 Study of FPA008, an anti-CSF1 Receptor Antibody, in Patients with Pigmented Villonodular Synovitis (PVNS)/ Diffuse Type Tenosynovial Giant Cell Tumor (dt-TGCT)

Primary- Phase 1: To determine the recommended dose (RD) of cabiralizumab in patients with pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT)- Phase 2: To estimate the objective response rate (ORR = CR+PR)…

An open-label, single-sequence study to investigate the effects of gastric acid suppression by Rabeprazole on the pharmacokinetics of BMS-986165 in healthy participants

The purpose of this study is to investigate how quickly and to what extent the new compound BMS-986165 is absorbed and eliminated from the body (this is called pharmacokinetics) when it is administered to healthy volunteers without and with…

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

OBJECTIVES of the Study:Primary ObjectiveTo evaluate if the addition of ibrutinib to R-CHOP prolongs event-free survival (EFS) compared withR-CHOP alone in subjects with newly diagnosed non-GCB DLBCL.Secondary ObjectivesTo compare ibrutinib in…

A single dose, randomised, double-blind parallel group study to compare the pharmacokinetics and pharmacodynamics of PB006 with Tysabri® in healthy subjects

The sponsor is developing a compound (PB006) similar to Tysabri® (natalizumab, hereafter referred to as Tysabri). As part of medical-scientific studies to confirm the similarity of the two compounds, the Sponsor wants to compare PB006 with EU-…

An open-label, fixed sequence, crossover, 1-way drug­-drug-­interaction study between IMB-1018972 and each of repaglinide, midazolam, paroxetine, and fluvoxamine in healthy subjects

The purpose of Part 1 is to investigate the effect of multiple doses of IMB-1018972 on the absorption, distribution and elimination of single doses of repaglinide and metformin and thereby understand to what extent IMB-1018972 may possibly change…

A Phase 2, Randomized Study of MLN0128 (a Dual TORC1/2 Inhibitor), MLN0128+MLN1117 (a PI3Kα Inhibitor), Weekly Paclitaxel, or the Combination of Weekly Paclitaxel and MLN0128 in Women With Advanced, Recurrent, or Persistent Endometrial Cancer

The primary objective of this phase 2 study in patients with advanced endometrial cancer is to compare the clinical efficacy of MLN0128 + weekly paclitaxel to weekly paclitaxel alone in second- or third-line treatment of advanced, recurrent, or…

A Phase 1/2 Study Targeting Acquired Resistance Mechanisms in Patients with EGFR Mutant Non-Small Cell Lung Cancer

Phase 1• To determine the maximum tolerated dose (MTD) and RP2D of BLU 945 as monotherapy and in combination with osimertinib• To determine the safety and tolerability of BLU 945 as monotherapy and in combination with osimertinibPhase 2• To assess…

A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

This study has been transitioned to CTIS with ID 2024-512622-29-00 check the CTIS register for the current data. To determine the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) of RLY-4008 and to determine RLY-4008's safety…

An open label Phase I PET imaging study to investigate the bio-distribution and tumor uptake of [89Zr]Zr-BI 765063 and [89Zr]Zr-BI 770371 in patients with head and neck squamous cell carcinoma, non-small cell lung cancer or melanoma who are treated with ezabenlimab

This study has been transitioned to CTIS with ID 2024-514034-20-00 check the CTIS register for the current data. The primary objective is to estimate the average relative change from baseline in tumoruptake of [89Zr]Zr-BI 765063 (arm A) or [89Zr]Zr-…

A Phase 1/2 study of the dose-response in pharmacodynamics and safety of prothrombin complex concentrate Cofact in healthy subjects under vitamin K antagonist anticoagulation

In this study we will investigate the pharmacodynamics of the compound Cofact, whereby the Cofact that will be used in this study is a modified version of the existing compound Cofact. The effect on the physiologic functions will be evaluated by…