Upland

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.

This research investigates how using cannabis (also known as marijuana, weed, or THC) affects the quality of life for patients with multiple myeloma who are undergoing chemotherapy. It aims to compare the experiences of cannabis users and non-users, focusing on potential benefits and harms related to cannabis use. The study uses specific tools like the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) and symptom assessments to better understand these effects over time. Participants are divided into two groups. One group completes surveys and provides blood samples regularly throughout the study, while healthcare providers complete separate surveys about their care practices. This observational study does not involve giving any new treatments but monitors patients receiving their usual cancer-directed therapies, including any cannabis use. During the study, patients complete questionnaires about their quality of life and symptoms, and medical professionals assess any side effects. The study measures outcomes over up to one year, tracking changes in quality of life and any therapeutic benefits or adverse effects linked to cannabis. Researchers monitor these factors through patient reports and medical evaluations to better understand the impact of cannabis in this patient group.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are evaluating the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adults diagnosed with moderate-to-severe Major Depressive Disorder (MDD). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants aged 18 to 74 who have experienced their first major depressive episode before age 50. The study aims to compare azetukalner with placebo in treating MDD over a 6-week period. Participants will receive either azetukalner 20 mg or placebo orally once a day with food, preferably with the evening meal, for 6 weeks. The treatment is administered as a daily oral dose, and participants are randomly assigned to one of the two groups. The study is designed to maintain blinding of treatments to both participants and researchers. During the study, participants' depression symptoms will be assessed using the Hamilton Depression Rating Scale (HAMD-17) to measure changes from baseline to Week 6. Researchers will also monitor safety and tolerability throughout the treatment period. Participants will undergo regular evaluations, and the study includes careful screening to ensure eligibility and monitor any adverse effects during the 6 weeks of treatment.

Researchers are studying the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered through a multidose dry powder inhaler with an electronic module (Fp/ABS eMDPI). This Phase 3 trial focuses on people aged 12 years and older who have asthma. The study also looks at the safety and tolerability of this inhaler when used four times daily over four weeks, as well as the pharmacokinetics of the combination and its individual components after a single dose. Participants will be randomly assigned to receive either the Fp/ABS combination inhaler, fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. All treatments are given as inhalation powders. The main treatment period lasts four weeks, during which the inhalers are taken four times a day. The total study duration for each participant is about 10 weeks, not counting an optional prescreening visit. Throughout the study, researchers will measure lung function changes, specifically forced expiratory volume in one second (FEV1), from baseline to week 4. Participants will undergo assessments including lung function tests and safety evaluations. The study monitors how the inhaler affects breathing over time and checks for any side effects or tolerability issues during the treatment period.

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Researchers are evaluating the efficacy and safety of enpatoran in adults with active skin symptoms of lupus erythematosus, including those with or without systemic lupus. This global, multicenter Phase 3 study focuses on participants with cutaneous lupus manifestations such as Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, and Acute Cutaneous Lupus Erythematosus. Participants with systemic lupus must meet specific classification criteria and have active cutaneous disease. Participants will be randomly assigned to receive either enpatoran or a placebo, both given orally twice daily for 24 weeks (from Day 1 to Day 168). Alongside these treatments, participants will continue to receive standard of care as recommended by their investigator. The enpatoran and placebo are administered as film-coated tablets. Visits occur every four weeks during the treatment period, with one televisit at Week 2. During the study, participants will be monitored regularly with assessments every four weeks over the 24-week treatment phase, followed by additional observation to reach a total study duration of up to 35 weeks. Researchers will measure skin disease improvement using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), focusing on the percentage of participants who achieve at least a 70% reduction in skin disease activity by Week 24. Safety and other health evaluations will also be conducted throughout the study period.

Researchers are evaluating KT-621, an oral drug, in adults with uncontrolled moderate to severe eosinophilic asthma. This Phase 2b study aims to assess the safety, tolerability, and how well KT-621 works in treating this condition. The study also looks at how KT-621 behaves in the body to better understand its effects. Participants will receive either KT-621 or a matching oral placebo in a randomized, double-blind, placebo-controlled design. The study focuses on assessing various doses to find the most effective and safe amount. Treatment effects will be measured over 12 weeks to observe changes in lung function and asthma control. During the study, participants will undergo regular visits including lung function tests (pre-bronchodilator FEV1), asthma control questionnaires, and blood tests to monitor eosinophil levels. Researchers will track participants’ adherence through electronic diaries and assess safety throughout the study. The main outcome is the change in lung function from baseline to Week 12, with continuous monitoring to ensure participant safety and study integrity.

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.