11 results
This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).
This is an exploratory study to assess changes in colonic inflammation after 8 weeks of treatment with tofacitinib (XELJANZ) 2 x 5 mg BID in patients with moderate to severely active UC.
The primary objective of this endpoint study is to evaluate the safety of tofacitinib at two doses versus TNFi; the co-primary endpoints are adjudicated major adverse cardiovascular events (MACE) and adjudicated malignancies excluding non-melanoma…
The primary objective of the study is to assess the safety and tolerability of long-term open-label CP-690,550 therapy in subjects with CD.Secondary objectives are to evaluate the effect of CP-690,550 maintenance therapy on clinical remission and on…
1. To compare the efficacy of tofacitinib, in doses of 2 mg, 5 mg, and 10 mg BID versus placebo on the ASAS20 response rate at Week 12 in subjects with active AS that have had an inadequate response to previous treatment.2. To estimate the placebo-…
Primary Objective* To demonstrate the efficacy of tofacitinib in inducing remission in subjects with moderately to severely active UC.Secondary Objectives* To evaluate the safety and tolerability of tofacitinib in subjects with moderately to…
In the current phase 2 study we will investigate the efficacy of the combination of fulvestrant and alpelisib directly after progression on 1st or 2nd line therapy with fulvestrant with or without a CDK 4/6 inhibitor in patients with HR+HER2-…
Primary objective:* To demonstrate the efficacy of alpelisib as measured by the proportion of participants randomized to alpelisib with a response at Week 24 in at least one of the following groups:* Group 1 (>= 18 yr-old)* Group 2 (6 - 17 yr…
The purpose of the study is to determine whether treatment with alpelisib in combination with olaparib can delay the time to cancer progression compared to standard-of-care chemotherapy in participants with your type of ovarian cancer known as…
Primary ObjectivesSafety run-in Part 1:To confirm the recommended dose of alpelisib in combination with trastuzumab and pertuzumab for Part 2.Double-blind, randomized, placebo-controlled Part 2:To determine whether treatment with alpelisib in…
To evaluate the efficacy of tofacitinib treatment in patients with RCDII with persistent or recurrent villous atrophy (Marsh III ABC) and aberrant IEL T-cells (> 20% as assessed by flow cytometry).