10 results
The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…
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.
Primary objective:• Assess the safety of ARC Therapy at supporting the management of hemodynamic instability in participants with sub-acute or chronic Spinal Cord Injury suffering from orthostatic hypotensionSecondary objectives with clinical…
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-…
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.
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.
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…
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.…
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…