Abu Dhabi

Researchers are evaluating the safety, tolerability, and effectiveness of two treatments, inebilizumab and blinatumomab, in adults with active and difficult-to-treat autoimmune diseases. This includes systemic lupus erythematosus (SLE) with nephritis, SLE with and without nephritis, and active refractory rheumatoid arthritis (RA). The study is a Phase 2, open-label, multicenter platform trial designed to assess these treatments across different subprotocols based on the specific condition and disease activity. Participants receive inebilizumab through intravenous infusion or blinatumomab via subcutaneous injection, depending on their assigned subprotocol. The study includes several parts: Subprotocol A focuses on SLE with nephritis treated with inebilizumab; Subprotocol B Part A and Part B assess blinatumomab in SLE with and without nephritis; and Subprotocol C Parts A and B evaluate blinatumomab in rheumatoid arthritis. The treatments are administered over specified periods, with some groups receiving treatment for up to 52 weeks. During the trial, participants undergo various assessments to monitor safety and disease response, including evaluation of treatment-emergent adverse events, serious adverse events, and measures of disease remission or activity. For example, kidney response and remission in SLE and disease activity scores in RA are measured at specific time points. Safety monitoring continues through the treatment period, with data collected on adverse events from Day 1 to Week 52. Participants' health status, laboratory tests, and disease activity are regularly evaluated to understand the treatments' effects and tolerability.

Researchers are evaluating the safety, side effects, and effectiveness of EP0031, a potent next-generation selective RET inhibitor, in adult patients with advanced RET-altered malignancies, including non-small cell lung cancer (NSCLC). This modular, interventional Phase I/II study aims to find the optimal dose of EP0031, especially for patients who have progressed on first-generation selective RET inhibitors (SRIs) and currently have no approved alternative therapies. The study builds on the completion of Phase I, where dose escalation and optimization led to the selection of a recommended Phase II dose (RP2D). Participants receive EP0031 treatment during the study. Phase I involved dose escalation and optimization to determine safety and tolerability. Phase II focuses on evaluating the efficacy of EP0031 at the selected dose. The treatment period includes monitoring for dose-limiting toxicities (DLTs) during the first 28 days and measuring overall response rate (ORR) over 12 months using established response criteria (RECIST v1.1). Throughout the study, participants will undergo regular assessments to monitor safety, side effects, and treatment response. These include clinical evaluations, laboratory tests, and imaging studies. Researchers will track adverse effects, pharmacokinetics, and tumor response over time. The study requires participants to be able to consent and comply with all procedures, with a minimum life expectancy of over 3 months. Continuous monitoring aims to ensure participant safety and to gather data on EP0031's potential benefits over a 12-month period.

This research aims to evaluate the safety and effectiveness of iza-bren, a bi-specific antibody-drug conjugate targeting EGFR and HER3 with a topoisomerase inhibitor, compared to the treatment of physician's choice (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, or capecitabine). The study focuses on patients with previously untreated, locally advanced, recurrent inoperable, or metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, HER2-negative breast cancer who are not eligible for anti-PD(L)1 or endocrine therapies. The trial is conducted in two phases, phase 2 and phase 3, to thoroughly assess these treatments.

This trial investigates the safety and effectiveness of risankizumab compared to vedolizumab in adults with moderate to severe ulcerative colitis (UC) who have not previously received targeted therapies. Ulcerative colitis is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. The study is a Phase 3b, randomized, open-label trial enrolling about 530 participants across 285 sites worldwide. Participants will be randomly assigned to receive either risankizumab or vedolizumab. Those in the risankizumab group will receive the drug intravenously during the initial induction phase, followed by subcutaneous injections for maintenance. Participants in the vedolizumab group will receive the drug intravenously throughout the study. The treatment period lasts 44 weeks for risankizumab and 46 weeks for vedolizumab, following a screening period of up to 35 days. During the study, participants will attend regular outpatient visits for medical assessments, side effect evaluations, and to complete questionnaires. Researchers will monitor disease activity and drug safety, focusing on the percentage of participants achieving endoscopic improvement by week 48. The total study duration is approximately 69 weeks for risankizumab and 71 weeks for vedolizumab recipients.

Researchers are evaluating the effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.

Researchers are evaluating the effectiveness and safety of combining golcadomide with rituximab compared to the investigator's choice of treatment in adults with relapsed or refractory follicular lymphoma who have already received at least one prior systemic therapy. This Phase 3, multicenter, randomized, open-label study focuses on participants with confirmed follicular lymphoma grades 1, 2, 3a, or classic FL, who have measurable, PET-positive disease and require anti-lymphoma treatment. Participants will be assigned to receive either golcadomide plus rituximab or the investigator's choice of therapy, which may include drugs such as lenalidomide, cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone, or bendamustine. Each drug will be given at specified doses on specified days as determined by the study protocol. The study monitors treatment effects over time with a planned follow-up of up to approximately 32 months. During the study, participants will undergo various assessments including imaging scans to measure disease progression, laboratory tests, and evaluations by an independent review committee to determine progression-free survival. Safety and response to treatment will be closely monitored throughout the study. Participants must meet specific health and laboratory criteria to join and will be followed for outcomes related to disease control and treatment safety.

Researchers are evaluating the effectiveness and safety of subcutaneous amlitelimab compared with placebo in people aged 12 years and older who have moderate-to-severe atopic dermatitis (AD) and have not responded well to prior biologic or oral Janus kinase inhibitor (JAKi) therapies. This Phase 3, multinational, randomized, double-blind, placebo-controlled study includes participants who are also using background topical corticosteroids (TCS). The goal is to see how well amlitelimab works in improving AD symptoms in this group. Participants will be randomly assigned to one of three groups receiving either amlitelimab or placebo by subcutaneous injection while continuing their topical treatments, which may include corticosteroids, tacrolimus, or pimecrolimus. The total treatment period lasts up to 36 weeks during a double-blind phase. After the treatment phase, participants can choose to join a long-term safety study. The full study duration is up to 56 weeks for those not entering the safety study and up to 40 weeks for those who do, including screening, treatment, and safety follow-up periods. During the study, participants will attend up to 13 visits (or 12 for those continuing into the long-term safety study) for assessments including the Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD), Eczema Area and Severity Index (EASI), and symptom scoring. Safety monitoring and follow-up visits will track progress, side effects, and treatment response. The primary outcomes focus on improvements in skin clearing and reduction of AD severity at Week 36.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating the safety and effectiveness of a human allogeneic bone-marrow-derived mesenchymal stromal cell product called StromaForte compared with hyaluronic acid for treating knee osteoarthritis. This study focuses on adults aged 18 years and older who have knee osteoarthritis diagnosed by established criteria and confirmed with recent radiological images. The goal is to determine if a single dose of StromaForte provides better pain relief than a single dose of hyaluronic acid over a one-year follow-up period. Participants will receive either a single injection of StromaForte or a single injection of hyaluronic acid into the knee joint. The study is open-label with two treatment groups, and patients will be monitored from enrollment through one year after treatment. No additional treatments or dose escalations are described, and the comparison focuses on the pain reduction effect of these injections over six months and beyond. During the study, participants will be assessed regularly for pain using the Visual Analogue Scale and monitored for safety and any side effects. Researchers will collect data from enrollment through one year to evaluate pain changes and any complications. Participants must comply with all study procedures, including assessments and follow-ups, to contribute to measuring the treatment's effectiveness and safety over time.

Cardiovascular disease (CVD) accounts for 40% of mortality in the UAE, which is higher than the global average. Long-term trends, incidence studies, and best practice guidance on Cardiogenic Shock (CS) with ST-elevation Myocardial infarction (STEMI) in the United Arab Emirates (UAE) and the Gulf Cooperation Council (GCC) are limited. Through this retrospective study, investigators aim to identify treatment modalities and trends, hospitalization events, and patient demographics and comorbidities which lead to participant recovery or mortality in Sheikh Khalifa Medical City (SKMC) and Sheikh Shakhbout Medical City (SSMC) tertiary hospitals for patients admitted with STEMI and CS or developed CS after hospitalization with STEMI during January 2020-January 2024.\[200-400 participants\]. Data will be collected from eligible patients' electronic medical records (EMR).