Allen

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis. This Phase 2 study compares ianalumab with a placebo in participants diagnosed according to established classification criteria, focusing on those with active disease and specific autoantibodies. The goal is to better understand ianalumab's impact on this condition over a long treatment period. The study includes several phases: up to 6 weeks for screening, followed by a 52-week initial treatment period where participants receive either ianalumab or placebo by subcutaneous injection. After this, there is a second 52-week open-label treatment period where all participants receive ianalumab. Finally, a post-treatment follow-up period lasts at least 20 weeks and can extend up to 2 years after the last dose. Participants will undergo various assessments throughout the study, including evaluations of their skin condition using the rCRISS25 response at week 52. Safety and tolerability will also be closely monitored. The study involves regular visits for clinical evaluations, laboratory tests, and monitoring of disease activity and antibody status, with the total participation potentially lasting over two years including follow-up.

Researchers are evaluating VENT-03 to see if it can treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study also aims to learn about the safety of VENT-03 and how the body processes it. Participants will be compared to those receiving a placebo to determine if VENT-03 affects disease activity and severity, as well as to monitor any side effects. Participants will take either VENT-03 tablets or placebo tablets for 4 weeks in a double-blind phase. After this, all participants will switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study involves monthly clinic visits for checkups and tests throughout the treatment periods. During the study, researchers will assess the effect of VENT-03 on the interferon gene signature in the skin from baseline to the end of the double-blind treatment (up to Day 28). Participants will have regular evaluations including clinical assessments and safety monitoring to track how the treatment affects their condition and to watch for any side effects or adverse events over the total duration of the study.

Researchers are evaluating budoprutug, a humanized IgG1 monoclonal antibody that targets CD19 cells, in adults with active, seropositive Systemic Lupus Erythematosus (SLE) who have not responded adequately to standard treatments. This Phase 1b open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early signs of effectiveness of budoprutug in this population. Participants will receive a single intravenous infusion of budoprutug on the first day of the study in ascending dose groups. The study focuses on how the drug affects B cells and antibody levels in the blood over time after the infusion. During the study, researchers will monitor participants for treatment-emergent adverse events and laboratory abnormalities up to 24 weeks. Vital signs including blood pressure, heart rate, respiratory rate, body temperature, and ECG parameters will be measured to assess safety. The study will track changes from baseline in these measures and collect data on pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy over the 24-week period.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the safety and effects of a medicine called disitamab vedotin for adults with advanced breast cancer that is hard to treat and has spread in the body. This study focuses on participants whose tumors express HER2 and who have received previous treatments for their advanced breast cancer. The goal is to understand how well this medicine works and its safety in these patients through a Phase 1b/2 open-label study. All participants will receive disitamab vedotin intravenously (IV) once every two weeks at the study clinic. They will continue the treatment until they or their doctor decide to stop, which could be due to cancer progression, side effects, or personal choice. During treatment, study visits occur every two weeks. After stopping treatment, participants will have follow-up visits about every six weeks, and later follow-up phone calls approximately every twelve weeks. Participants will undergo evaluations including assessments of their cancer response by the study doctors, following recognized criteria. The study team will monitor the participants for up to about two years or until their disease progresses or they pass away. This includes safety monitoring and collecting information about the medicine’s effects to determine its safety and effectiveness.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the safety and effectiveness of enpatoran in adults with active skin symptoms of lupus erythematosus, with or without systemic lupus disease. This global Phase 3 study focuses on patients diagnosed with cutaneous lupus manifestations such as Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Acute Cutaneous Lupus Erythematosus. Participants may also have systemic lupus erythematosus (SLE) meeting specific classification criteria. The study aims to assess skin disease improvement over a 24-week treatment period. Participants will be randomly assigned to receive either enpatoran or a placebo, both given as film-coated tablets taken orally twice daily for 24 weeks. All participants will continue to receive standard care treatments recommended by their investigators alongside the study drugs. The study involves regular visits every four weeks with one televisit at week 2, allowing close monitoring of treatment progress and safety. During the study, participants will undergo assessments including evaluation of skin disease activity using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI). The primary measure is the percentage of participants achieving at least a 70% improvement in their CLASI activity score by week 24. Safety and tolerability of the treatments will also be monitored throughout the study, which lasts up to 35 weeks including screening and follow-up.

Researchers are evaluating how well nipocalimab works compared to a placebo in adults with moderate to severe systemic lupus erythematosus (SLE), a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study focused on adults aged 18 to 75 who have active SLE symptoms and have been diagnosed for at least 24 weeks. Participants will receive either nipocalimab or a placebo alongside standard of care treatments, which include protocol-defined topical and systemic therapies. Nipocalimab and placebo are administered as drugs while maintaining background treatments. The study monitors participants over time, including a primary outcome measurement at Week 52 to assess the percentage of participants achieving a systemic lupus erythematosus responder index (SRI)-4 composite response. During the study, participants will be regularly assessed for disease activity, vital signs, and safety. Screening includes physical examinations, medical history review, vital signs, and electrocardiograms. Researchers will monitor disease activity scores and evaluate response to the treatment at Week 52. Safety is closely observed throughout the study, with particular attention to any adverse reactions or changes in health status. The total participation and follow-up extend at least through Week 52.

Researchers are investigating targeted therapies to treat adults with moderately to severely active Rheumatoid Arthritis (RA), a chronic inflammatory disease that causes pain, stiffness, swelling, and loss of joint function. This Phase 2 study includes three substudies that evaluate different treatments for participants who have not responded well to one or two prior biologic or targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies. The study aims to assess both the effectiveness and safety of these therapies. The study tests three treatment approaches: lutikizumab alone, ravagalimab alone, and a combination of lutikizumab and ravagalimab, each compared against placebo. All treatments are given by subcutaneous injection. About 180 participants will be enrolled across approximately 65 sites worldwide. Participants must be on a stable dose of methotrexate to join the study. The study requires regular visits to hospitals or clinics for treatment and monitoring. During the study, participants will undergo medical assessments, blood tests, and questionnaires to monitor treatment effects and side effects. The main outcomes measured include the percentage of participants achieving a 50% improvement in Rheumatoid Arthritis symptoms by week 12 and the number of participants experiencing adverse events up to about week 22. Participants may have a higher treatment burden than usual care due to the study procedures and visits.

Researchers are evaluating the ability of dapirolizumab pegol (DZP) added to standard care medications to improve moderate to severe systemic lupus erythematosus (SLE) symptoms over the long term. This Phase 3 trial focuses on participants aged 16 and older who have active SLE with specific disease activity and serological markers. The goal is to assess clinical improvement using the British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) at Week 48. Participants will be randomly assigned to receive either dapirolizumab pegol (DZP) or placebo at scheduled times alongside their stable standard of care treatments. Standard medications include antimalarials combined with glucocorticoids and/or immunosuppressants or glucocorticoids and/or immunosuppressants alone if antimalarials are not suitable. The study is double-blind and placebo-controlled, ensuring unbiased comparison between the two groups. Throughout the study, participants will undergo regular assessments to monitor disease activity and treatment safety up to Week 48. Researchers will track responses based on disease activity indices and monitor for any adverse effects. The study includes careful screening and follow-up evaluations to understand the long-term effects of adding DZP to usual care in people with moderately to severely active SLE.