Shymkent

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

Researchers are conducting the INTERSTELLAR study to gather important real-world evidence about adding anifrolumab to the usual treatment for systemic lupus erythematosus SLE. This observational study is taking place across multiple countries, including regions like GCC, Mexico, Central America, Colombia, Argentina, Taiwan, and Egypt. It aims to provide data useful for doctors, payers, and patients by using consistent criteria and measures for SLE and skin symptoms related to lupus. Participants will be observed for one year before starting anifrolumab and followed for one year after beginning treatment. The study starts after anifrolumabs commercial launch in each country and includes patients from the time of their first anifrolumab prescription and infusion. Data collection continues even if participants stop taking anifrolumab, unless they withdraw their consent. During the study, clinical assessments and patient-reported outcomes will be collected at baseline and at months 1, 3, 6, and 12. These include disease activity scores PGA, SLEDAI-2K, skin involvement measures CLASI, fatigue assessments FACIT-Fatigue, and quality of life questionnaires LupusQoL, EQ-5D-5L. The study monitors participants until death, loss to follow-up, withdrawal, or study end, aiming to reflect real-world use and outcomes of anifrolumab in routine care.