Huntington Beach

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.

Researchers are evaluating the effectiveness, safety, tolerability, and pharmacodynamics of multiple doses of APL-3007 combined with Syfovre/Pegcetacoplan (APL-2) in patients aged 60 years and older diagnosed with geographic atrophy secondary to age-related macular degeneration. This Phase 2, randomized, placebo-controlled, multicenter, masked study focuses on measuring changes in retinal pigment epithelium lesions using advanced artificial intelligence-based SD-OCT imaging. Participants will receive either the combination of APL-3007 with pegcetacoplan (APL-2) or a placebo. The study includes a treatment period with multiple doses administered, aiming to assess the impact on geographic atrophy lesions over a 12-month period. Syfovre injections at 6-8 week intervals prior to enrollment are part of the inclusion criteria. During the study, participants will undergo various eye imaging assessments such as OCT and FAF to monitor lesion size and progression. Researchers will evaluate changes in lesions at month 12 compared to baseline. Safety and tolerability will be closely monitored through laboratory tests, clinical evaluations, and vaccination status requirements. The study duration includes regular visits for treatment administration and monitoring over at least one year.

Researchers are conducting a Phase IIb randomized clinical trial to evaluate the safety and effectiveness of the CPCB-RPE1 implant in people with advanced dry age-related macular degeneration (AMD) who have geographic atrophy affecting the fovea. The trial aims to compare outcomes between those receiving the implant and those undergoing a simulated sham procedure. This study involves multiple surgical implantation sites and may include additional referral or follow-up locations. Participants will be randomly assigned in a 3:1 ratio to either receive the CPCB-RPE1 implant through a surgical procedure or to a control group receiving a sham implantation. Up to 18 participants will receive the implant, and up to 6 will be in the control group. The implant is surgically placed under the retina using a pars plana vitrectomy technique. Participants must be pseudophakic in the study eye and medically fit for surgery and anesthesia. During the study, participants will undergo baseline and follow-up retinal sensitivity testing using microperimetry to assess changes over one year after implantation. Researchers will monitor visual acuity, retinal sensitivity, and safety outcomes throughout the study. Participants must be able to attend all required visits and complete the assessments, including microperimetry testing and providing informed consent. The total participation duration includes screening, treatment, and follow-up evaluations.

Researchers are evaluating 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 aims to assess the clinical efficacy, safety, and tolerability of azetukalner compared to placebo. Participants must be adults between 18 and 74 years old, experiencing a current major depressive episode confirmed by standard diagnostic criteria and lasting between 6 weeks and 24 months. Participants are randomly assigned to receive either azetukalner 20 mg or a placebo, both taken orally once daily with food (preferably with the evening meal) for 6 weeks. The study compares these two groups to determine the impact of azetukalner on depressive symptoms. The trial maintains double-blinding to ensure unbiased assessment of outcomes. During the study, participants undergo regular assessments including evaluations of depressive symptoms using the Hamilton Depression Rating Scale (HAMD-17) at baseline and at Week 6. Safety and tolerability are monitored throughout the treatment period. The total participation time corresponds to the 6-week treatment phase, during which symptom changes and adverse events are closely observed.

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.

Researchers are evaluating the safety, tolerability, and biomarker effects of VS-041 in adults aged 50 years and older who have Heart Failure with Preserved Ejection Fraction (HFpEF). This phase 1 trial focuses on participants diagnosed according to established criteria and classified as NYHA Functional Class II or III, with specific heart function and biomarker thresholds. The study aims to better understand how VS-041 works in this population by monitoring heart-related biomarkers and side effects over time. Participants will receive either a high dose or low dose of VS-041, or a matching placebo tablet, taken twice daily. The study treatment lasts for 28 days, during which researchers will track changes in specific blood biomarkers such as NordicPRO-C6, endotrophin, and NT-proBNP. These biomarkers help measure the heart condition and response to the treatment. The trial includes careful dosing and monitoring to assess safety and tolerability. During the study, participants will undergo regular assessments to check for any treatment-emergent adverse events and changes in biomarker levels from baseline up to day 28. The evaluations may include blood tests and clinical exams to monitor heart function and overall health. Participants are required to maintain stable doses of their usual heart failure medications and comply with trial procedures for the entire duration. The total participation period is focused on the 28-day treatment and observation window.

Researchers are evaluating corneal endothelial cells in people aged 50 and older who have neovascular age-related macular degeneration (nAMD). The study focuses on participants treated with the Port Delivery System (PDS) refilled every 24 weeks. This Phase IV, open-label trial aims to understand changes in corneal endothelial cell density over time in the eye receiving treatment compared to the fellow eye. The study involves delivering ranibizumab 100 mg/mL via the PDS implant. Supplemental treatment with intravitreal injections of ranibizumab (0.5 mg of a 10 mg/mL formulation) in the study eye may be given if needed. If participants stop the study treatment, they may receive intravitreal ranibizumab injections based on the investigator's judgment. Treatment and monitoring occur over at least 48 weeks. Participants will undergo detailed eye examinations including specular microscopy to measure corneal endothelial cell density at baseline and week 48. Historical visual acuity and imaging data will be reviewed. Researchers will monitor safety, disease activity, and treatment response through visual acuity assessments, optical coherence tomography, and other imaging techniques. The main outcome is the percent change in corneal endothelial cell density in the treated eye compared to the fellow eye after 48 weeks.

Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that blocks multiple pro-inflammatory cytokines involved in atopic dermatitis. This phase 2, double-blind, placebo-controlled study focuses on adults with moderate to severe atopic dermatitis that has not responded adequately to topical treatments. Participants are observed over approximately 36 to 40 weeks to compare BFB759 with a placebo. Participants are randomly assigned to receive either BFB759 or a placebo, with dosing aimed at assessing different levels of the drug's effects. The study is designed as a parallel-arm trial, meaning groups receive different treatments simultaneously without crossover. The investigational drug targets key inflammatory pathways believed to drive symptoms in atopic dermatitis. During the study, participants attend regular visits for monitoring and assessments. Researchers evaluate the drug's efficacy at 16 and 32 weeks using specific outcome measures. Safety is closely monitored throughout the treatment period. Participants are also expected to follow study instructions, avoid certain medications, and complete all scheduled visits during the study duration.

Researchers are evaluating the safety, how the body processes the drug (pharmacokinetics), and the activity of divarasib alone or combined with other anti-cancer treatments in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have not received previous treatment. This study focuses on patients with a specific KRAS G12C mutation and includes both Phase Ib and II stages to understand the drug effects better. Participants will receive divarasib orally once daily on days 1 to 21 during each 21-day treatment cycle. Depending on the treatment group, participants may also receive pembrolizumab, an intravenous infusion given every three weeks, and chemotherapy drugs such as carboplatin or cisplatin administered intravenously every three weeks for four cycles. Pemetrexed, another chemotherapy drug, may be given intravenously every three weeks as well. These treatments are designed to be studied either alone or in combination. Throughout the study, participants will be monitored for any adverse events from the start of treatment until 60 days after the last dose or until they begin another anti-cancer therapy, up to about five years. Researchers will conduct evaluations including tumor measurements, safety assessments, and pharmacokinetic sampling. The study requires participants to have measurable disease and good performance status. Close monitoring will ensure participant safety and collect data to understand the drug’s activity and side effects over time.