Mayfield Heights

Researchers are evaluating the effects of delgocitinib cream 20 mg/g applied twice daily compared to a non-active cream (vehicle) in adults aged 18 years and older with mild to severe palmoplantar pustulosis (PPP). This skin condition involves pustules on the palms and soles and can persist for more than three months. The study aims to determine if delgocitinib improves the severity and symptoms of PPP over 16 weeks. Participants will be randomly assigned to one of two groups: one applying delgocitinib cream twice a day and the other applying a matching vehicle cream twice a day, both for 16 weeks. The study is double-blind, meaning neither participants nor researchers know which treatment is given. The total study duration for each participant is about 18 weeks, including approximately 9 visits. During the study, participants will attend regular visits where their skin condition will be evaluated using several measures, including the Palmoplantar Pustulosis Area and Severity Index (PPPASI) and Physician Global Assessment (PGA). Researchers will also assess symptoms like pustule counts, itch, pain, quality of life, and work productivity. Safety and any side effects will be monitored throughout the study period.

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL), a fast-growing blood cancer affecting immature B-cells. This phase 2 study compares the effects of zilovertamab vedotin combined with R-CHP chemotherapy versus polatuzumab vedotin combined with R-CHP in people newly diagnosed with this type of lymphoma. The goal is to see if the cancer responds better to one treatment over the other. Participants will be randomly assigned to receive either zilovertamab vedotin or polatuzumab vedotin, both given by intravenous infusion on the first day of each 3-week cycle for up to six cycles (about 4 months). Alongside these drugs, participants will receive cyclophosphamide, doxorubicin, and rituximab or a rituximab biosimilar by IV infusion, plus prednisone or prednisolone orally for five days each cycle. Those with high-risk DLBCL may receive two additional cycles of rituximab or its biosimilar. During the study, participants will have scans and tests to measure cancer response using established criteria over up to 31 months. Researchers will also monitor survival rates, quality of life, and side effects for up to several years. Safety assessments and treatment adherence will be tracked throughout the study and follow-up periods, ensuring thorough evaluation of each treatment's impact.

Researchers are evaluating 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 a Phase 3 trial that includes two parts: Part A with both children and teenagers, and Part B with only children. Initially, only teenagers who meet the study rules can participate, and children may join once enough information from other studies is available. Participants in Part A will be randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks, after which all participants will receive zasocitinib for the remainder of the study. Participants in Part B will receive zasocitinib throughout the study. Dosages are given orally once daily, with doses adjusted by weight for children aged 4 to under 12 years, and a fixed dose for teenagers aged 12 to under 18 years. The study includes a double-blind placebo-controlled period followed by an open-label period. Participants will be involved for up to 4 years and 2 months, including up to 35 days for screening, 208 weeks of treatment, and a 4-week safety follow-up. During this time, participants will visit the study site multiple times for assessments, including skin evaluations, quality of life questionnaires, and blood tests to monitor drug levels and safety. Researchers will measure how many participants achieve clear or almost clear skin, improvements in psoriasis severity scores, quality of life improvements, and monitor the medicine's concentration in the body.

Researchers are evaluating BFB759, a biological drug that inhibits multiple pro-inflammatory cytokines, in adults with moderate to severe atopic dermatitis. This phase 2, double-blind, placebo-controlled study aims to compare how well BFB759 works and its safety against a placebo over about 36 to 40 weeks. The study is sponsored by Bluefin Biomedicine, Inc. and includes participants aged 18 to 75 years with atopic dermatitis lasting at least one year. Participants are randomly assigned to one of three groups: a high dose of BFB759, a low dose of BFB759, or placebo given every two weeks. The treatment period lasts through Week 14, followed by a placebo period for the active groups from Weeks 16 to 30. Those initially receiving placebo are re-randomized at Week 16 to receive BFB759 through Week 30. This design allows comparison of different doses and assessment of treatment effects over time. During the study, participants attend regular visits for up to 40 weeks to monitor how well the treatment works, assessed at Weeks 16 and 32, as well as to track safety and tolerability over about 21 months with around 22 visits. Researchers will collect data on disease improvement and any side effects. Participants are expected to follow study instructions, attend all visits, and avoid certain medications during the trial to help ensure accurate results.

Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that targets multiple inflammatory cytokines, in adults with moderate to severe hidradenitis suppurativa (HS) that is not well controlled by systemic antibiotics. This double-blind, placebo-controlled study involves participants aged 18 to 75 years and aims to understand how well BFB759 works compared to a placebo over approximately 36 to 40 weeks. Participants will be randomly assigned to one of several groups. Some will receive a loading dose of BFB759 followed by either a high or mid maintenance dose every two weeks through Week 14. Others will receive a placebo every two weeks for 14 weeks, then, if still enrolled, be re-randomized to receive either a low or mid dose of BFB759 every two weeks from Week 16 through Week 30. This design allows comparison of different dosing regimens and the placebo effect. During the study, participants will attend about 22 visits over 21 months to monitor safety and effectiveness. Researchers will measure clinical activity using scales such as HiSCR50, the International Hidradenitis Suppurativa Severity Score System (IHS4), Skin Pain Numerical Rating Scale, and the Hidradenitis Suppurativa-Investigator Global Assessment (HS-IGA). Participants are expected to follow study instructions carefully, attend regular visits, and avoid certain medications. The primary outcomes focus on efficacy at Weeks 16 and 32, with ongoing safety assessments throughout the study.

Researchers are evaluating the effectiveness and safety of combining inavolisib with a CDK4/6 inhibitor and letrozole compared to a placebo combined with a CDK4/6 inhibitor and letrozole. This study focuses on participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive, HER2-negative advanced breast cancer. The trial is a Phase III, multicenter, randomized, double-blind, placebo-controlled study sponsored by Hoffmann-La Roche. Participants are assigned to one of two groups: one receiving oral inavolisib daily along with letrozole and a CDK4/6 inhibitor, and the other receiving a placebo with letrozole and a CDK4/6 inhibitor. The CDK4/6 inhibitor is given either on Days 1-21 or Days 1-28 of each 28-day cycle. Treatment will continue as per the study protocol while monitoring responses and safety. During the trial, participants will have measurable disease evaluated regularly using RECIST v1.1 criteria. Researchers will monitor progression-free survival from randomization up to seven years, alongside other outcomes such as overall survival, response rates, duration of response, and quality of life measures including pain and physical function. Safety will be assessed through adverse event tracking and patient-reported outcomes throughout the follow-up period.

This research aims to compare progression-free survival in adult participants with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer. The study evaluates two first-line treatment approaches: amivantamab combined with chemotherapy versus cetuximab combined with chemotherapy. This is a Phase 3 randomized, open-label trial assessing outcomes for this specific cancer type. Participants will be randomly assigned to one of two treatment groups. One group receives amivantamab along with chemotherapy cycles of either mFOLFOX6 (which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and oxaliplatin) or FOLFIRI (which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan hydrochloride). The other group receives cetuximab combined with the same chemotherapy options. Each treatment cycle lasts 28 days, and participants continue treatment until disease progression or other stopping criteria are met. During the study, participants will undergo regular assessments including imaging scans reviewed by a blinded independent committee to measure progression-free survival up to 4 years and 2 months. Additional outcomes such as overall survival, response rates, duration of response, and quality of life will be monitored for up to over 7 years. Safety is tracked through adverse event reporting and laboratory tests. Participants' symptoms and functioning will also be evaluated using quality of life questionnaires throughout the study period.

Researchers are evaluating the anti-tumor activity and safety of amivantamab given as a subcutaneous co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) in participants with advanced or metastatic non-small cell lung cancer (NSCLC), including those with specific EGFR mutations. This Phase 2, open-label study includes multiple cohorts with different treatment histories and EGFR mutation types to better understand how amivantamab works in combination with other therapies and to assess its safety profile. Participants receive amivantamab subcutaneously at varying doses based on body weight and specific treatment cohorts. Some cohorts combine amivantamab with oral lazertinib or intravenous chemotherapy drugs such as carboplatin and pemetrexed, administered on different schedules ranging from every two to three weeks in 21- or 28-day cycles. Additional treatments like prophylactic anticoagulation may also be given in certain cohorts. Participants may have the option to enter a long-term extension phase to continue receiving study treatments. During the study, participants undergo regular evaluations including tumor assessments based on RECIST criteria and safety monitoring through adverse event tracking and laboratory tests. Researchers will measure objective response rates and other outcomes up to 1 year and 6 months, and for some cohorts, safety will be monitored for up to nearly 5 years. Participants' quality of life and treatment satisfaction are also assessed. The total duration of participation varies according to cohort and treatment response, with follow-up continuing after treatment completion.

Researchers are evaluating the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has a specific genetic mutation called PIK3CA. This phase 3 study aims to assess both the effectiveness and safety of this combination treatment. Participants can remain in the study as long as the treatment is helping control the cancer without causing unbearable side effects. Participants will receive Tersolisib orally in combination with an oral CDK4/6 inhibitor and endocrine therapy (ET), which may be given orally or by intramuscular injection. The study includes different groups: one receiving two different doses of Tersolisib plus CDK4/6 inhibitor and ET, another receiving one dose of Tersolisib plus CDK4/6 inhibitor and ET, and a placebo group receiving placebo with CDK4/6 inhibitor and ET. The CDK4/6 inhibitors used include ribociclib, palbociclib, or abemaciclib, while ET options include anastrozole, letrozole, exemestane, or fulvestrant. During the study, participants will undergo evaluations that include measuring tumor response, progression-free survival, overall survival, and quality of life using questionnaires. Researchers will monitor participants regularly through scans, lab tests, and clinical assessments to track treatment response and side effects. The study may last up to 7 years to observe long-term outcomes, and participants will be closely followed to assess how the cancer responds and how the treatments affect their health and well-being over time.

Hidradenitis Suppurativa (HS) is a skin condition that causes painful bumps, abscesses, scars, and tunnels in areas where the skin rubs together. This condition may start when hair follicles become damaged, triggering the immune system and allowing bacteria to worsen the symptoms. Researchers are evaluating the safety, effectiveness, and tolerance of a drug called zasocitinib in adults with moderate to severe HS compared with a placebo in this Phase 2 clinical trial. Participants will be randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks in a double-blind period. After this, all participants will receive zasocitinib for an additional 36 weeks in an open-label period. The placebo capsules look like zasocitinib but contain no medicine. Treatment dosing involves a specific dose of zasocitinib labeled as Dose A. During the study, participants will visit the clinic 12 times for assessments. Researchers will monitor the percentage of participants achieving a 75% reduction in HS symptoms at week 16 as the primary outcome. They will also track safety through adverse events and other measures throughout the 56 weeks of treatment. Participants will undergo evaluations including clinical exams, questionnaires, and safety tests to understand treatment effects and tolerability.