Joint Clinical Trials Office

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects with Moderate to Severe Atopic Dermatitis (AD) and Inadequate Response to Dupilumab (SWITCH-UP)

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD.

Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD).

Prevalence and implications of cholestatic gene mutations in suspected intrahepatic cholestasis of pregnancy among a diverse U.S. cohort: a prospective study in a diverse health setting with 8000+ annual pregnancy deliveries

This is a prospective cohort study that aims to determine the genetic risk of intrahepatic cholestasis of pregnancy (ICP) and identify if there are underlying gene mutations that lead to ICP, progressive familial intrahepatic cholestasis (PFIC), primary biliary cholangitis (PBC), and primary sclerosing cholangitis (PSC). The primary objective of the study is to determine the prevalence, predictors, and obstetric outcomes of pathogenic cholestatic genetic variants among women diagnosed with ICP. 
   

A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)

This clinical trial is for men and women with newly diagnosed multiple myeloma who are not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT).
   
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
   

Phase 1 Trial of CA-4948 in Combination with Pembrolizumab to Overcome Resistance to PD-1/PD-L1 Blockade in Metastatic Urothelial Cancer

The purpose of this study is to test the safety of a drug called CA-4948 in combination with pembrolizumab for patients with metastatic urothelial cancer. This study tests different doses of the drug to determine the highest dose with manageable side effects in people.

A Phase IV Study Evaluating the Safety and Efficacy of neffy or Intramuscular Adrenalin in Patients with Allergic Reactions after Oral Food Challenge or Allergen Immunotherapy (EPI R01)

The purpose of this research is to see if Neffy nasal spray works as well as injected epinephrine for treatment of serious allergic reaction known as anaphylaxis. 

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Expanded Access Treatment Protocol for Bulevirtide

 The primary objective of this expanded access program (EAP) is to address a significant patient unmet medical need by providing access to bulevirtide (BLV [GS-4438], Hepcludex®) 10 mg for patients in the United States of America (USA) living with chronic hepatitis delta virus (HDV) infection (CHD).

A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

The purpose of this study is to test whether it is feasible to include the study drugs, blinatumomab and venetoclax, in the chemotherapy regimen used to treat infants with KMT2A- ALL. The study will test the good and bad effects of the study drugs. Blinatumomab and venetoclax in combination with standard chemotherapy could help treat the leukemia.

A Phase III, Open-label, Randomised Study of Osimertinib With or Without Dato-DXd as First-line Treatment in Participants With Epidermal Growth Factor Receptor Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer

This clinical trial is for adults who have been diagnosed with non-small cell lung cancer (NSCLC).

A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

This clinical trial is for adults who have relapsed or refractory multiple myeloma (either their disease has come back, or it is no longer responding to their current treatment) and standard therapies available to treat their disease may have limited effectiveness.