Phase 1 and 2 Randomized Clinical Studies Determine Lack of Efficacy for Anti-IL-17C Antibody MOR106 in Moderate-Severe Atopic Dermatitis.

Interleukin 17C (IL-17C) modulates epithelial inflammation and has a possible role in atopic dermatitis (AD) pathology. Four randomized clinical studies (Phase 1 and 2) investigated the safety, tolerability, efficacy, and pharmacokinetic profile of the anti-IL-17C monoclonal antibody MOR106 for up to 12 weeks (NCT03568071: = 207 adults with moderate-severe AD; NCT03689829 Part 1: = 32 healthy males; NCT03689829 Part 2: = 44 adults with moderate-severe AD; and NCT03864627: = 76 adults with moderate-severe AD). In these studies, MOR106 was either administered intravenously (i.

The Self-Regulation Assessment (SeRA) questionnaire: development and exploratory analyses of a new patient-reported outcome measure for rehabilitation.

Purpose: To develop and explore underlying dimensions of the Self-Regulation Assessment (SeRA) and psychometric features of potential components. Further, to identify associations between the SeRA and disability-management self-efficacy, type of diagnosis, and type of rehabilitation.

Materials And Methods: Based on a previously developed model of self-regulation, expert and patient opinions, and cognitive interviews, a list of 22 items on self-regulation (the SeRA) was constructed.

How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example.

During development of a drug, the requirement of evaluating the proarrhythmic risk and delayed repolarization needs to be fulfilled. Would it be possible to create an alternative to a thorough QT (TQT) study or is there a need to perform a dedicated TQT study? How is an alternative approach generated, what information is available, and which instructions are considered missing today to generate such an approach? This tutorial describes the considerations and path followed to create an early and feasible alternative to a TQT study using experience-based insights from a successful application to the US Food and Drug Administration for GLPG1972, an ADAMTS-5 inhibitor, and discusses the approach used in light of the current guidelines and literature.

Safety, Pharmacokinetics, and Pharmacodynamics of the ADAMTS-5 Inhibitor GLPG1972/S201086 in Healthy Volunteers and Participants With Osteoarthritis of the Knee or Hip.

GLPG1972/S201086 is a disintegrin and metalloproteinase with thrombospondin motif-5 (ADAMTS-5) inhibitor in development as an osteoarthritis disease-modifying therapy. We report the safety, tolerability, pharmacokinetics, and pharmacodynamics (turnover of plasma/serum ARGS-aggrecan neoepitope fragments [ARGS]) of GLPG1972 in 3 randomized, double-blind, placebo-controlled phase 1 trials. Study A, a first-in-human trial of single (≤2100 mg [fasted] and 300 mg [fed]) and multiple (≤1050 mg once daily [fed]; 14 days) ascending oral (solution) doses, investigated GLPG1972 in healthy men (N = 41; NCT02612246).

Comparison between EQ-5D-5L and PROMIS-10 to evaluate health-related quality of life 3 months after stroke: a cross-sectional multicenter study.

Background: Although the use of patient-reported outcome measures to assess Health-Related Quality of Life (HRQoL) has been advocated, it is still open to debate which patient-reported outcome measure should be preferred to evaluate HRQoL after stroke.

Aim: To compare the measurement properties (including concurrent validity and discriminant ability) between the 5-dimensional 5-level EuroQol (EQ-5D-5L) and the Patient-Reported Outcomes Measurement Information System 10-Question Global Health Short Form (PROMIS-10) to evaluate HRQoL 3 months after stroke.

Design: Cross-sectional study.