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Researchers are evaluating the safety and effectiveness of rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.

Researchers are evaluating the safety, tolerability, and effectiveness of DermaBind TL, a placental membrane allograft, in adult patients with chronic non-healing wounds such as diabetic foot ulcers and venous leg ulcers. This Phase 4, open-label, single-arm clinical trial aims to collect patient outcome data over a 12-week treatment period, comparing results to each participant's historical treatment data. The study focuses on wound area preservation, infection rates, wound recurrence, graft usage, and treatment-emergent adverse events. During the 12-week treatment phase, participants will receive DermaBind TL applied to their affected chronic wounds. The trial involves two phases: screening and treatment. Clinicians will assess wounds regularly, and the intervention will be monitored for its ability to protect wounds, reduce infections, and promote healing. The study includes careful evaluation of wound characteristics and patient response to the graft treatment. Participants will be closely monitored throughout the trial, including wound assessments by clinicians and data collection on infection rates, wound size, and safety events. The primary outcome is to measure how well the wound covering protects the wound over the 13-week treatment period. The study also tracks adverse events and other clinical outcomes through the end of the study. Overall participation includes screening and a 12-week treatment period, with detailed follow-up to evaluate the intervention's effects.

Researchers are assessing the effectiveness and safety of current standard treatments in people with active systemic lupus erythematosus (SLE), including lupus nephritis, who have not adequately responded to glucocorticoids and at least two immunosuppressant therapies. The study focuses on participants with active disease despite treatment, aiming to better understand outcomes in this group. Participants receive standard care treatments based on product labels, which include glucocorticoids and immunosuppressants, with at least one biologic therapy used for a minimum of three months. The study includes those with lupus nephritis confirmed by recent kidney biopsy showing specific active disease features. Treatment follows usual clinical practice without experimental therapies. During the study, participants will be monitored for disease remission using established lupus criteria at six months. Researchers will collect routine clinical data and track safety and response to treatments. The study requires participants to be at least 16 years old and to provide informed consent. Pregnant women and those involved in other experimental drug trials are excluded. The study involves ongoing clinical follow-up to evaluate outcomes over time.

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

Researchers are evaluating the effectiveness of adding tirzepatide to ixekizumab therapy in adults with active psoriatic arthritis (PsA) who are overweight or obese and have at least one weight-related health issue. This Phase 4 study aims to understand how well this combination works in standard clinical practice over a period of up to 12 months. The focus is on improving physical function and achieving weight loss in this patient group. Participants will receive tirzepatide administered by subcutaneous injection after having been treated with ixekizumab for about three months. The study is open-label and single-arm, meaning all participants will get tirzepatide alongside their ongoing ixekizumab therapy. Treatment will begin within 30 days after deciding to add tirzepatide. No placebo or comparison group is mentioned. During the study, researchers will monitor participants for up to 12 months, measuring their physical functioning using the Health Assessment Questionnaire Disability Index and tracking weight loss. Safety and treatment effects will be assessed through regular evaluations. The study seeks to see how many participants achieve improved function and at least 10% weight loss by the end of the 12-month therapy period.

Researchers are evaluating the safety and effectiveness of subcutaneous anifrolumab compared with placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies (IIM), specifically polymyositis (PM) or dermatomyositis (DM). This multicenter, randomized, double-blind, placebo-controlled Phase III study adds anifrolumab or placebo to participants' standard of care treatment to assess overall disease activity. Participants will receive weekly subcutaneous injections of either anifrolumab or placebo for 52 weeks. After this period, all participants will receive open-label anifrolumab injections once weekly for an additional 52 weeks. This design allows researchers to evaluate initial treatment effects and longer-term outcomes with anifrolumab. During the study, participants will be monitored regularly for disease activity and safety. The main outcome measured is the Total Improvement Score (TIS) with a response defined as a score of 40 or higher at 52 weeks. The total study participation lasts up to 104 weeks, including the double-blind and open-label extension periods, ensuring comprehensive assessment of the treatment's impact and participant safety.

This research aims to understand how avacincaptad pegol, a treatment approved in the US, is used for people with geographic atrophy caused by age-related macular degeneration (AMD). Geographic atrophy is an advanced stage of AMD where cells in the retina waste away, leading to worsening central vision and possible permanent vision loss. The study focuses on observing treatment patterns and safety in routine clinical practice rather than testing new effects. Participants in this study will receive avacincaptad pegol through intravitreal injections, which are injections into the eye. The study collects information from patients who have already been prescribed this treatment by their doctors. There is no experimental intervention from the study team, and treatment decisions are made by the patients' doctors. The study follows patients for up to 3 to 5 years, depending on when they join. While in the study, participants will have regular eye exams as part of their usual care. They will also complete surveys about their eye health at the start of treatment, every 6 months for the first 2 years, then annually afterward. Researchers will track treatment details like the number and dose of injections, treatment duration, reasons for stopping treatment, and patient characteristics. Safety and treatment patterns are monitored through medical records during and after treatment.

Researchers are conducting the Descemet Endothelial Thickness Comparison Trial (DETECT) II, a phase 3, multi-center clinical trial focusing on patients with Fuchs endothelial dystrophy. The study aims to compare outcomes between two treatments: Descemet Membrane Endothelial Keratoplasty (DMEK) and Descemet Stripping Only (DSO) with adjunctive use of Ripasudil. This trial is placebo-controlled and outcome assessor-masked, involving 60 patients diagnosed with this corneal condition. Participants will be randomly assigned to receive either DMEK surgery or DSO combined with topical Ripasudil 0.4% or a placebo. The interventions are delivered topically to the eye. The study evaluates the effectiveness and safety of these approaches in treating corneal endothelial dysfunction associated with Fuchs dystrophy. Throughout the 12-month study period, participants will be closely monitored for changes in their best spectacle-corrected visual acuity (BSCVA), which is the primary measure of treatment success. Researchers will assess visual clarity and corneal health, tracking patient outcomes and any side effects. The study involves regular follow-ups to ensure proper adherence to post-operative instructions and to capture comprehensive data on the treatments' impacts.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.