The primary objective was to identify well-tolerated doses of cimlanod in patients with acute heart failure (AHF). Secondary objectives were signals efficacy, including biomarkers, symptoms, and clinical events. Nitroxyl (HNO) donors have vasodilator, inotropic lusitropic effects. Bristol-Myers Squibb-986231 (cimlanod) is an HNO donor being developed for This a phase IIb, double-blind, randomiz...

Abstract BACKGROUND Newly diagnosed glioblastoma (nGBM) has a dismal prognosis with survival of 15-18 months. Tumor associated “survivin” protein is expressed in >95% nGBM and targetable the use SurVaxM, shown to be effective at generating cytotoxic T lymphocytes. METHODS patients are being enrolled this randomized placebo-controlled trial phase II study. Eligibility Criteria includes ag...

BackgroundAtopic dermatitis (AD) is associated with a substantial burden on quality of life (QoL).ObjectiveTo evaluate the effects tralokinumab health-related QoL in patients moderate-to-severe AD using patient-reported outcomes.MethodsThis was phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study adults AD. The received subcutaneous or placebo (1:1:1:1) every 2 weeks for 1...

Mood congruent alterations in information processing such as an impaired memory bias for emotional information and impaired inhibitory functions are prominent features of a major depressive disorder (MDD). Furthermore, in MDD patients hypothalamic-pituitary-adrenal axis dysfunctions are frequently found. Impairing effects of stress or cortisol administration on memory retrieval as well as impai...

In Effisayil 1 (NCT03782792), the safety and efficacy of spesolimab was assessed in patients with a GPP flare. Patients (N=53) were randomised (2:1) to intravenous 900 mg or placebo on Day followed for 12 weeks. The primary key secondary endpoints Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore 0 GPPGA total score at Week 1, respectively. We explore basel...

Abstract Introduction Patients with insomnia disorder have difficulty initiating or maintaining sleep and impaired daytime functioning. Daridorexant is a dual orexin receptor antagonist approved for the treatment of insomnia. This analysis reports number needed to treat (NNT), harm (NNH), likelihood be helped harmed (LHH) daridorexant 25 mg 50 versus placebo over 3 months. Methods Phase data fr...

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved by the US FDA for treatment of adults with moderate-to-severe plaque psoriasis who are candidates systemic therapy or phototherapy. Deucravacitinib was significantly more efficacious than placebo apremilast and well tolerated in previous reports from phase 3 POETYK PSO-1 trial. Here, we examin...

DUPISTAD (NCT04033367) evaluated the impact of dupilumab on sleep. Adults with moderate-to-severe AD (EASI ≥12, Pruritus numerical rating scale (NRS) ≥ 3 and sleep NRS ≥5) were randomized 2:1 to 300mg every 2 weeks (q2w) or placebo for 12 (W12); both groups permitted concomitant topical corticosteroids. The primary efficacy endpoint was quality percentage change from baseline W12, assessed by 1...

Immune dysregulation may be involved in the pathophysiology of schizophrenia. Given need for new treatment options schizophrenia, anti-inflammatory medication could a potential this illness. In double-blind, placebo-controlled clinical trial, patients with schizoaffective disorder or psychosis NOS were randomized 1:1 to either prednisolone placebo, addition their regular antipsychotic medicatio...