Tuzla Grad

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 evaluating the safety, tolerability, early clinical effects, and how the body processes azenosertib ZN-c3 when combined with other drugs in patients with advanced ovarian, peritoneal, or fallopian tube cancer. This Phase 1b open-label study includes patients with platinum-resistant or maintenance therapy contexts, aiming to understand dosing and treatment combinations better. The study has two parts Part 1 assessed azenosertib with chemotherapy drugs including carboplatin, pegylated liposomal doxorubicin PLD, paclitaxel, and gemcitabine in platinum-resistant cases. Part 2 explores azenosertib with bevacizumab as first- or second-line maintenance therapy after platinum chemotherapy. Dose escalation and expansion phases determine recommended doses and evaluate safety. Participants will receive study treatments in combination regimens and undergo regular assessments over about one year. Researchers monitor safety, side effects, and drug levels, aiming to find the maximum tolerated dose and recommended dosing. The study includes clinical evaluations, laboratory tests, and ongoing monitoring of patient response and tolerability throughout the study period.

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

Researchers are evaluating the pharmacokinetics PK and safety of subcutaneous SC ublituximab in people with relapsing multiple sclerosis RMS. The study aims to compare how ublituximab is absorbed and tolerated when injected at different sites on the body and when administered using either a prefilled pen device or a syringe. This Phase 2 trial involves adult participants with RMS who meet specific neurological stability and disability criteria. Participants will receive ublituximab SC either by syringe at one of three injection sites or by randomized assignment to receive the drug with either a prefilled pen or a syringe. The study evaluates the relative bioavailability of ublituximab delivered by these two methods over a planned treatment period extending up to 120 weeks, with key assessments occurring up to 12 weeks and beyond. During the study, participants will undergo plasma concentration measurements of ublituximab at various time points to determine drug levels and steady state exposure. Safety will be monitored through tracking treatment-emergent adverse events throughout the study. Participant satisfaction with the SC administration method will also be assessed. This long-term study may involve multiple visits for drug administration, monitoring, and questionnaires, continuing for up to five years.

This research aims to compare two asthma inhalers that use different propellants in people with mild to moderate asthma. The study evaluates whether an investigational inhaler with a new climate-friendly propellant, HFA-152a, works as safely and effectively as inhalers using the existing HFA-134a propellant. This global Phase II study plans to enroll 468 patients in Europe, Latin America, Ukraine, South Africa, and the United Kingdom. Participants will use one of three inhaler treatments in a randomized, double-blind crossover design the investigational CHF5993 pMDI with HFA-152a, CHF5993 pMDI with HFA-134a, or CHF718 pMDI with HFA-134a. Each inhaler is taken as two puffs twice daily. The study compares lung function effects of these inhalers during treatment periods. During the trial, participants will be assessed for lung function through measurements like forced expiratory volume in 1 second FEV1 at baseline and after treatment. Researchers will monitor safety, treatment adherence, and asthma control over the study period. Participants undergo scheduled visits for these evaluations, with the study expected to complete in June 2027.