14 results
Primary: To evaluate the effects of multiple subcutaneous (SC) doses of elamipretide on left ventricular end systolic volume (LV ESV) assessed by cardiac Magnetic Resonance Imaging (MRI)Secondary:* To evaluate the safety and tolerability of multiple…
The primary objectives are:- To evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn*s disease who have failed or are intolerant to one or more tumor…
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…
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 objectives are:- To evaluate clinical remission for the 2 subcutaneous (SC) maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn*s disease induced into clinical response with ustekinumab in the…
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…
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 primary objective is to evaluate the achievement of clinical response at Week 16 following a single IV re-induction dose of *6 mg/kg ustekinumab, compared with continuing regular SC q8w 90 mg ustekinumab administration, in participants with…
The primary objective of this study is to evaluate the effect of single daily SC administration of elamipretide for 48 weeks on the distance walked (in meters) on the 6-minute walk test.The secondary objectives of this study are:- To evaluate the…
MAIN Trial:Primary:To evaluate whether the efficacy of mirikizumab is superior to placebo in participants with Crohn's disease as assessed by- clinical response by patient reported outcome (PRO) at Week 12 andendoscopic response at Week 52-…
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.
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 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…