Fountain Valley

Researchers are evaluating the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

Researchers are evaluating the effectiveness of delgocitinib cream 20 mgg applied twice daily compared to a cream vehicle in treating adults with mild to severe palmoplantar pustulosis PPP. This trial is a phase 2a, double-blind study focusing on this skin condition characterized by pustules on the palms and soles. The main goal is to see how well delgocitinib cream improves symptoms over a 16-week treatment period. Participants will be randomly assigned to one of two groups one group will apply delgocitinib cream twice a day for 16 weeks, while the other group will use a matching vehicle cream twice daily for the same duration. The study includes a total of approximately 18 weeks for each participant, involving around 9 visits. The trial compares the active cream to the placebo cream to assess efficacy and safety. During the study, participants will attend scheduled visits to monitor their condition and collect data on skin symptoms, pustule counts, and quality of life measures. Researchers will assess the improvement in PPP severity using specific scales such as the PPP Area and Severity Index PPPASI. Safety is monitored through reports of any treatment-emergent side effects. Overall participation lasts about 18 weeks, including screening and treatment phases.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are evaluating the long-term safety and effectiveness of APG777 in adults with moderate-to-severe atopic dermatitis who have completed treatment in a previous APG777 study. This phase 2 extension study involves participants who, according to their doctors, would benefit from continued treatment with APG777. The study is designed as a multicenter, double-blind trial to assess ongoing treatment outcomes and safety over several years. Participants in this study will continue receiving APG777 through three main periods a screening visit coinciding with the last visit of the prior studys maintenance period, an extended treatment period, and a post-treatment follow-up period. Participants who met certain skin improvement criteria and did not use topical rescue medication during the prior study will maintain their previous dose and injection frequency. Those who did not meet these criteria or used rescue medication will receive APG777 according to a specific dosing plan in an open-label escape arm. During the study, participants will be closely monitored for treatment-emergent adverse events up to 3 years. The research team will also measure skin improvements using tools such as the Eczema Area and Severity Index EASI and the Investigator Global Assessment for Atopic Dermatitis vIGA-AD, as well as tracking itch severity, use of rescue therapy, and serum drug concentrations. The overall participation time includes up to 3 years of follow-up to evaluate long-term safety and efficacy outcomes.

Researchers are studying how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it. The study is divided into two parts Part A includes both children and teenagers, while Part B includes only children. Initially, only teenagers who meet the study requirements can participate, with children joining after sufficient information is collected from other studies. Participants in Part A will be randomly assigned to receive either zasocitinib or a matching placebo daily for the first 16 weeks, followed by open-label zasocitinib treatment until the study ends. In Part B, all children will receive zasocitinib throughout the study. The treatment doses for children will be based on their weight, and adolescents will receive a fixed dose. The study lasts up to 4 years and 2 months, including screening, treatment, and safety follow-up periods. During the study, participants will visit the study site multiple times for assessments. Researchers will measure improvements in skin condition using tools like the Static Physicians Global Assessment and Psoriasis Area and Severity Index at Week 16 and throughout the open-label period. Safety and drug levels in the body will also be monitored. After treatment, there is a 4-week safety follow-up. Overall, participants will be involved for up to 217 weeks, including screening, treatment, and follow-up.

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating a combination therapy of ruxolitinib, steroids, and lenalidomide in adults with relapsed or refractory multiple myeloma MM who have progressive disease despite previous treatments. MM is a cancer of plasma cells in the bone marrow with complex causes and limited curative options. This phase 1, open-label, multicenter study aims to assess the safety and effectiveness of these drugs together in patients who have failed at least two prior therapies including immunomodulatory drugs and proteasome inhibitors. Participants receive varying doses of ruxolitinib orally twice daily, lenalidomide once daily, and methylprednisolone every other day. The study includes dose escalation periods and treatment adjustments based on disease progression. Some groups start with ruxolitinib and steroids, adding lenalidomide only if the disease worsens. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will have regular evaluations including blood tests and clinical assessments to monitor safety, side effects, and treatment response. Researchers will measure outcomes such as the maximum tolerated dose, adverse events, response rates, progression-free and overall survival over a follow-up period extending up to 54 months. Participants are expected to adhere to visit schedules and study requirements throughout the trial.

Researchers are evaluating XL309 previously ISM3091, alone and in combination with olaparib, in participants with advanced solid tumors. This first-in-human, multicenter, open-label Phase I trial aims to assess the safety, tolerability, preliminary antitumor activity, as well as how the body processes and responds to XL309 in these patients. The study is sponsored by Exelixis and targets advanced cancers that have progressed despite standard treatments or have no current therapies available. The study includes a Dose Escalation Stage where participants receive increasing doses of XL309 alone or combined with olaparib. Following this, a Cohort Expansion Stage will further study the recommended dose in specific advanced solid tumor groups both as a single agent and in combination. Both drugs are given orally according to assigned schedules in sequential cohorts. The trial is non-randomized and open-label, meaning all participants know which treatment they are receiving. Participants will undergo safety monitoring for treatment-related adverse events, dose-limiting toxicities, and laboratory abnormalities over approximately 24 months. Researchers will also measure drug levels in the blood and tumor response rates. Eligibility includes adults with specific genetic alterations related to their cancer type, adequate organ function, and performance status. The study excludes those with recent anticancer treatments, untreated brain metastases, or certain health conditions. Participants may be followed for up to several years to evaluate safety and preliminary efficacy.

Researchers are evaluating pocenbrodib alone and in combination with darolutamide for treating metastatic castration-resistant prostate cancer mCRPC in patients who have progressed after prior therapies including anti-androgen treatments. This Phase 1b2a open-label study aims to confirm safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor effects of these treatments. It includes dose escalation, optimization, and dose expansion phases to find appropriate dosing levels and assess treatment effects in patients who have also received lutetium-Lu-177-vipivotide-tetraxetan PLUVICTO prior to taxane-based therapy. The study has two main phases Phase 1b involves dose escalation with three arms exploring different dosing schedules of pocenbrodib alone or combined with darolutamide to find the maximum tolerated dose and recommended Phase 2 doses. Phase 2a expands the study with two cohorts receiving different recommended doses of pocenbrodib combined with darolutamide. Treatments are given orally with varying dosing schedules including daily and twice-daily regimens, and safety is closely monitored throughout. Participants undergo regular assessments including safety evaluations, pharmacokinetic sampling during treatment cycles each 28 days, and tumor response evaluations. The primary outcomes focus on safety, tolerability, and efficacy measures such as radiographic progression-free survival and prostate-specific antigen changes. The study lasts through the treatment duration, estimated to be around six months for Phase 2a, with ongoing safety monitoring and data collection to understand drug behavior and patient response.