Tamarac

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 applied twice daily compared to a cream vehicle for treating adults with mild to severe lichen sclerosus LS, a skin condition affecting mostly females in the anogenital area. The study is conducted in two parts Part 1 enrolls female participants to determine the best dose, and Part 2 includes both female and male participants to further assess the chosen dose and safety in males. Participants receive different dosing regimens of delgocitinib cream or cream vehicle applied twice daily during a 12-week initial treatment period, followed by a 40-week continuation treatment period. Different groups receive varying doses or sequences of delgocitinib cream and cream vehicle to compare effects. A substudy evaluates male participants separately to assess safety and efficacy. During the trial lasting between 55 and 60 weeks, participants undergo regular assessments including clinical evaluations of LS severity using IGA-LS scores, pain and itch numerical rating scales, and quality of life indexes. Safety is monitored through adverse event tracking and laboratory tests. The main outcome measured is the number of participants achieving a specific improvement in LS severity at Week 12, with additional evaluations continuing through Week 52.

Researchers are evaluating ONM-501, a drug given as intratumoral injections, alone and in combination with cemiplimab, an immune checkpoint inhibitor, in patients with advanced solid tumors and lymphomas. This phase 1 study aims to find the maximum tolerated dose, minimum effective dose, and recommended dose for expansion of ONM-501. The study includes patients with various advanced cancers who have no alternative standard therapies available. The trial has three parts monotherapy dose escalation, combination therapy dose finding, and combination therapy dose expansion. ONM-501 is given once per week for three weeks followed by three weeks off, in 21-day cycles. Cemiplimab is given intravenously every three weeks during the combination phases. Dose escalation uses special methods to gradually increase doses, and after doses are established, patients will enroll in expansion cohorts for specific tumor types. Participants will have regular assessments including monitoring for side effects, blood tests to measure drug levels, and evaluation of tumor response over up to 24 months. Researchers will track treatment-emergent adverse events, dose-limiting toxicities, and serious adverse events. Outcomes such as objective response rate, duration of response, progression-free survival, and overall survival will also be recorded. The study involves close safety monitoring and follow-up throughout the treatment and observation periods.

Researchers are evaluating the effectiveness of pegloticase administered by two different methodssubcutaneous under the skin injection versus intravenous into a vein infusioneach combined with methotrexate MTX in participants who have uncontrolled gout. The main goal is to compare how well these two treatment methods maintain normal serum uric acid levels over a six-month period. This Phase 3 trial is designed as a double-blind, randomized controlled study to provide reliable information on treatment responses.

Researchers are studying the long-term safety and effects of ritlecitinib, an oral medicine, for children with severe alopecia areata, a condition that causes significant hair loss. This Phase 3 trial focuses on participants who completed previous Pfizer studies and have notable scalp hair loss or specific vaccination history. The study aims to understand how well ritlecitinib is tolerated and its impact on hair regrowth and quality of life over time. Participants will take ritlecitinib capsules once daily at home for up to three years. Those who previously received different doses of ritlecitinib will continue the same dose, while others will be randomly assigned to either a higher or lower dose. Dose adjustments and treatment continuation will be evaluated at specific months, with some participants switched to placebo if they do not meet efficacy criteria, though they remain in the study. During the trial, participants will attend 17 clinic visits and receive monthly phone calls. Researchers will monitor safety by tracking adverse events and assess effectiveness using tools like the Severity of Alopecia Tool SALT, eyebrow and eyelash assessments, and patient-reported outcomes on anxiety, depression, behavior, and quality of life. The study includes ongoing safety checks and measures cognitive function at select points, ensuring thorough evaluation throughout the three-year participation period.

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 the safety and tolerability of DB-1303BNT323 in adults with advanced or metastatic solid tumors that express HER2. This Phase 12a trial focuses on patients with tumors that are advanced, unresectable, recurrent, or metastatic and have limited or no standard treatment options. The study aims to identify the best dose and explore early signs of effectiveness in a variety of HER2-expressing cancers. The trial has two parts an initial dose-escalation phase using an accelerated titration followed by a classic 33 design to find the maximum tolerated dose MTD or recommended Phase 2 dose RP2D, and a dose-expansion phase to further assess safety, tolerability, and potential effects at the established dose. Participants receive DB-1303BNT323 by intravenous infusion once every three weeks Q3W at various dose levels. Some groups are randomized to receive different dose levels or combinations with other drugs like Pertuzumab, Ritonavir, or Itraconazole to study drug interactions and responses. During the study, participants will have regular assessments including monitoring for dose-limiting toxicities, adverse events, and serious adverse events using standard criteria up to about one year after treatment. Researchers will also evaluate tumor responses using RECIST 1.1 criteria and collect pharmacokinetic and pharmacodynamic data. Other evaluations include heart function tests, organ function, and overall health status. The study duration varies per participant, with follow-up visits extending up to one year post-treatment to monitor safety and treatment effects.

Researchers are studying DB-1311BNT324 in adults with advanced solid tumors that have progressed after standard treatments or have no standard options available. This Phase 12a trial aims to evaluate the safety, tolerability, and early effectiveness of DB-1311BNT324, including its use alone or combined with new hormone therapies in prostate cancer. The study also investigates drug interactions with lopinavirritonavir and itraconazole. Participants receive intravenous doses of DB-1311BNT324 every three weeks at different dose levels to identify the best tolerated dose and recommended dose for further study. The trial includes various groups with specific tumor types, such as small cell lung cancer, non-small cell lung cancer, esophageal cancer, prostate cancer, melanoma, liver cancer, cervical cancer, ovarian cancer, head and neck cancer, and rare tumors. Some groups receive DB-1311BNT324 alone, while others receive it combined with oral hormone therapies or other drugs. During the study, participants undergo regular safety checks including vital signs, blood tests, heart function tests, and cancer status assessments. Researchers monitor side effects, serious adverse events, and tumor responses up to about one year after treatment. The main goal is to find the maximum tolerated dose and assess the drugs safety and preliminary antitumor activity. Participants health and cancer are closely followed throughout and after treatment.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months 4 years, followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry DXA. Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are studying HMPL-A251, a new drug, in adults with advanced or metastatic HER2-expressing solid tumors that cannot be removed by surgery. This phase 12a clinical trial aims to find the highest safe dose and the best dose to use in later studies. The study also explores the safety and preliminary effectiveness of HMPL-A251 in participants who have been previously treated for HER2-positive solid tumors. The study has two parts a Dose Escalation phase and a Dose ExpansionDose Optimization phase. In the Dose Escalation phase, participants receive increasing doses of HMPL-A251 through intravenous infusion to determine the maximum tolerated dose and recommended dose for further study. In the Dose Expansion phase, participants are assigned to one of two selected dose levels to further evaluate safety and effectiveness. Treatment continues until disease progression, intolerable side effects, or other study criteria are met. Participants will undergo regular assessments including monitoring for side effects and treatment response using criteria such as measurable lesions and performance status. Researchers will also collect data on dosing, adverse events, and tumor response over time. The main outcomes include determining safe dosage levels, overall response rate, and treatment-emergent adverse events. Participation may last up to about two years, with ongoing monitoring for safety and treatment effects.