Chesapeake

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating the efficacy and safety of azenosertib ZN-c3, an oral drug that inhibits WEE1, in people with platinum-resistant, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. This Phase 2 study includes patients whose tumors test positive for Cyclin E1 protein. The study is designed to understand how azenosertib affects cancer cell growth by allowing damaged cells to continue the cell cycle, leading to cancer cell death. The study has two parts Part 1 included all patients regardless of biomarker status and has completed enrollment. Part 2 focuses on patients with Cyclin E1 positive tumors. Participants receive azenosertib orally at doses of either 300mg or 400mg daily, following a schedule of five days on treatment followed by two days off. Several study arms explore different dosing groups within this intermittent treatment plan. Participants will be monitored for up to approximately 12 months after the last patients enrollment. The study includes regular assessments of tumor response using RECIST criteria, measurement of biomarkers like CA-125, and tracking of side effects. Researchers will measure objective response rate as the primary outcome, along with duration of response, progression-free survival, clinical benefit rate, and treatment-emergent adverse events. This comprehensive monitoring aims to understand the treatments effects and safety profile over time.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are evaluating the safety and effectiveness of induction therapy using Afimkibart also called RO7790121 in people with moderately to severely active ulcerative colitis UC. This Phase III study is designed as a multicenter, double-blind, placebo-controlled trial to compare Afimkibart with a placebo. The study aims to understand how well Afimkibart works to induce remission in UC and its safety profile. Participants will be randomly assigned to one of two groups. One group will receive Afimkibart through an intravenous IV infusion followed by a subcutaneous SC injection, while the other group will receive matching placebo infusions and injections. The treatment period lasts 12 weeks, during which researchers will assess the effects of the therapies. Throughout the study, participants will undergo various assessments including evaluations of clinical remission, endoscopic improvement, histologic changes, and symptom severity at specified time points such as baseline, Week 2, and Week 12. Safety will be monitored by tracking adverse events for up to 30 weeks after starting treatment. The total participation duration spans the treatment and follow-up periods to gather comprehensive data on outcomes and safety.

Researchers are evaluating the efficacy and safety of Afimkibart also known as RO7790121 compared with placebo in adults with moderate to severe rheumatoid arthritis RA who have not responded well to or cannot tolerate tumor necrosis factor TNF inhibitors andor Janus kinase JAK inhibitors. This Phase II, double-blind, placebo-controlled study aims to better understand how Afimkibart works for patients with this challenging form of RA. Participants in this study will receive Afimkibart or a matching placebo by subcutaneous injection. The study uses a randomized, parallel design with multiple groups receiving either Afimkibart or placebo. Dosing schedules and injection details are consistent across groups, with treatment effects assessed over a period including baseline, Week 14, and Week 24 timepoints. The study also includes monitoring of drug concentration and immune response markers up to Week 38. During the study, participants will be regularly assessed for changes in RA disease activity using scores such as DAS28-CRP and DAS28-ESR, joint counts, global assessments, pain levels, disability questionnaires, and inflammation markers. Safety is monitored through adverse event tracking and antibody testing. The total study duration includes treatment and follow-up periods lasting up to 38 weeks, allowing researchers to evaluate both short- and longer-term effects of the study drug.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 23, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone TSH levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

Researchers are evaluating the safety and effects of the study medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This study focuses on participants whose breast cancer has worsened after prior treatment with CDK46 inhibitor-based therapy. The trial compares PF-07248144 plus fulvestrant to the current standard treatment involving everolimus and endocrine therapy. Participants will be randomly assigned to one of two groups. One group will take PF-07248144 tablets daily at home in 28-day cycles along with fulvestrant injections administered at the clinic. The other group will receive everolimus tablets daily plus either exemestane tablets or fulvestrant injections, based on the study doctors choice. Treatments will continue according to the schedule for each participant. During the study, participants will undergo regular evaluations including scans to measure tumor response, lab tests, electrocardiograms, and monitoring of side effects. Researchers will track progression-free survival up to about two years, as well as overall survival and response duration up to about five years. Safety and drug levels will also be monitored throughout and after treatment. The total duration of participation may span several years depending on individual outcomes.

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.