14 results
The main objective of this study is to assess incidence of, clinical determinants for, dose reduction in and reversibility of tenofovir associated renal insufficiency and KPTD.Secondary objectives are to assess kidney tubular function in patients…
Primary objectives:• To evaluate the safety and tolerability of BMS-914143 as measured by the frequency of SAEs and discontinuations due to AEs;• To assess the HBeAg seroconversion rate at 24 weeks off treatment (Week 72).Secondary objective• To…
To investigate the use of a temporary peginterferon alpha-2a add-on strategy during entecavir therapy in patients with HBeAg-positive chronic hepatitis B by comparing the efficacy of this regimen versus entecavir monotherapy.To evaluate the long-…
To evaluate the safety and efficacy of multiple doses of ABT-494 (Upadacitinib) monotherapy versus placebo in the treatment of adults with moderate to severe atopic dermatitis.
The primary objective of the study is to determine the safety and tolerability of 4 week oral administration of EYP001a in subjects with Chronic Hepatitis B Virus Infection (CHBV) when given as monotherapy or in combination with Pegylated interferon…
The objective of Study M14-675 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg once daily (QD) compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely…
The primary objective of this study is to observe the long-term efficacy, safety, and tolerability of repeated administration of Upadacitinib (ABT-494) in subjects with Crohn's disease (CD) who completed Study M13-740.
1. Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the efficacy and safety of dose escalation to upadacitinib 30 mg QD insubjects who do not achieve Eczema Area and Severity Index (EASI) 90 on upadacitinib 15 mg QD after 12…
Main objective:1. To compare the safety and efficacy of upadacitinib 15 mg once daily (QD) versus abatacept intravenous (IV) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-inadequate response (bDMARD-IR) or bDMARD-…
This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.
The objectives of this study, in patients with moderately to severely active UC who are administered JAKi SOC therapy are to evaluate the following (ranked according to priority), both for JAKi as a class of drugs and for each individual JAKi:1.…
The aim of this study is to measure microcirculation density and flow parameters and oxygenation parameters in oral mucosa before and after 30 min of oral cooling with two different cooling methods, in an effort to identify whether oral cooling has…
Primary :• To evaluate the safety and tolerability of blinatumomab incombination with AMG 404 in adults with R/R B-ALL• To estimate the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of AMG 404 when combined with cIV…
To assess long-term safety, tolerability and efficacy of upadacitinib in adult subjects with moderate to severe atopic dermatitis who successfully completed treatment in the M16-046 study. Efficacy will be evaluated through Week 52, and safety and…