Scottsdale

Researchers are evaluating the safety, tolerability, pharmacometrics, and effectiveness of Claseprubart (DNTH103) in adults with multifocal motor neuropathy (MMN) in this Phase 2 clinical trial. The study aims to understand how this drug works and its safety profile compared to a placebo in people diagnosed with definite or probable MMN who have shown responsiveness to immunoglobulin (Ig) treatment. Participants receive an initial intravenous loading dose on Day 1, followed by subcutaneous doses of Claseprubart or placebo every two weeks from Week 1 through Week 15. This randomized, double-blind, placebo-controlled setup allows researchers to carefully compare the effects of the drug versus placebo over the course of the treatment period. Throughout the study, participants will be monitored for any treatment-emergent adverse events or serious adverse events from baseline to Week 17. Researchers will collect safety and efficacy data, including pharmacometric assessments, to evaluate the drug's impact. Participants are involved in regular assessments and follow-ups during this time to ensure thorough observation and data collection related to safety and treatment response.

Researchers are evaluating a collaborative pain management program called ASCENT to help cancer survivors manage their pain more effectively. Cancer pain is common and often not treated well, leading to suffering and disability. The study focuses on improving pain control, reducing inappropriate opioid use, and addressing social factors that may limit access to care. This research is conducted remotely through Mayo Clinic locations and affiliated health systems, allowing participants to join without needing to travel. Participants are randomly assigned to one of two groups. One group receives enhanced usual care, including access to the ASCENT educational guide about pain management. The other group receives the ASCENT guide plus three scheduled video or phone calls with community health workers and pain care managers. These calls help identify barriers, develop personalized pain management plans, and discuss specialist recommendations. After these calls, participants may receive ongoing support and monitoring every two weeks or as needed. During the study, researchers will monitor participants' pain levels at the start, and again at three and six months. Participants will complete questionnaires and have their electronic health records reviewed. The study aims to understand how collaborative care and education can improve pain outcomes and reduce opioid risks in cancer survivors. The total study participation is conducted remotely, with regular check-ins and assessments over six months.

Researchers are investigating BGB-16673, a targeted protein degrader aimed at treating various B-cell cancers including marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström macroglobulinemia, and diffuse large B-cell lymphoma. The study includes both Phase 1 and Phase 2 parts to determine safe and effective dosing and to evaluate the drug's response in patients. The trial is conducted under the new company name BeOne Medicines, previously known as BeiGene. The treatment involves oral administration of BGB-16673. Phase 1 focuses on dose escalation and safety expansion to identify the maximum tolerated dose and recommended dose for expansion over approximately 28 days to 3 years. Phase 2 includes expansion cohorts to assess overall response rates over about 3 years. Participants may have prior treatments including Bruton tyrosine kinase inhibitors and other anticancer therapies depending on their cancer type and study phase. Participants will be monitored closely with assessments of adverse events from the first dose until 30 days after the last dose or before starting new therapy, whichever comes first, for up to 47 weeks. The study measures tolerability, dosing recommendations, and treatment response. Eligibility assessments include performance status and measurable disease, with safety and response evaluations continuing through both phases for up to three years.

Researchers are evaluating intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). This Phase 2, randomized, dose-masked study includes four patient cohorts: treatment-naive NVAMD participants, incomplete responder (IR) NVAMD participants as monotherapy, IR NVAMD participants receiving EYE103 combined with aflibercept 2.0 mg, and treatment-naive BRVO participants. The study aims to assess safety and efficacy of different doses of EYE103 in these conditions. Participants in each cohort will be randomly assigned to receive either a low or high dose of EYE103 via intravitreal injection. All participants will receive three injections spaced four weeks apart. IR NVAMD participants in the combination therapy cohort will also receive an injection of aflibercept 2.0 mg on Day 1. The timing of enrollment into each cohort is determined by the Sponsor. Participants will undergo safety and efficacy assessments at each injection visit, with some cohorts returning two weeks after injections for further evaluations. Assessments include measuring best-corrected visual acuity using the ETDRS chart, slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT) to measure central subfield thickness. The study concludes at Week 12, which is the end-of-study visit for all participants.

Researchers are investigating whether buntanetap/Posiphen can help treat early Alzheimer's disease in adults aged 55 to 85 years. This Phase 3 study aims to find out if buntanetap/Posiphen improves thinking abilities and daily functioning compared to a placebo. It also evaluates the safety of buntanetap/Posiphen by monitoring any medical issues that participants may experience during the trial. Participants will take either a 30 mg capsule of buntanetap/Posiphen or a placebo capsule by mouth once daily for 18 months. The study includes regular clinic visits at screening, enrollment, and months 1, 3, 6, 9, 12, 15, and 18. During some visits, participants will have brain MRI scans. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Throughout the study, participants will complete tests and questionnaires to measure cognitive function and daily living activities, including the ADAS-Cog13 and ADCS-iADL scales. Phone calls before and after visits help track progress and adherence. Safety is closely monitored with ongoing assessments from screening through the 18-month treatment period.

This research aims to evaluate the safety and tolerability of PRTH-101, alone or combined with pembrolizumab, in adults with advanced or metastatic solid tumors that are resistant to standard treatments. PRTH-101 is a humanized antibody that targets DDR1, a protein on tumor cells that creates a barrier preventing immune cells from attacking tumors. By blocking DDR1, this barrier may be weakened, allowing immune cells to better reach and fight the cancer. The study is a Phase 1, open-label trial focusing on adults with advanced cancers including non-small cell lung cancer. Participants receive PRTH-101 either by itself or together with pembrolizumab. The study uses a dose-escalation and expansion design to find the recommended Phase 2 dose for both treatments. PRTH-101 is given as a monoclonal antibody, and pembrolizumab is used in combination in some groups. Treatment effects and safety are monitored closely throughout the study. Participants will undergo various assessments including monitoring for adverse events and serious adverse events, pharmacokinetic testing to understand how the drugs behave in the body, and evaluation of anti-tumor activity. The study involves tumor biopsies before and after treatment, laboratory tests, and clinical evaluations. The total monitoring period can extend up to four years to assess long-term safety and effectiveness.

This research aims to establish a Phase-2 master protocol framework to evaluate the safety and effectiveness of various investigational treatments for chronic weight management in adults with obesity or overweight. The study sets common entry criteria for participants across multiple specific intervention groups, called intervention-specific appendices (ISAs), which may begin independently as new treatments become available for clinical testing. The overall results will be reported after all ISAs are completed. The study involves multiple investigational drugs administered either by injection (subcutaneously) or orally. These include LY3305677, LY3841136, Tirzepatide, LY3549492, LY3532226, and placebo treatments matching the administration methods of the active drugs. Each ISA will detail the specific intervention procedures. Treatments are given according to the ISA schedules as participants are assigned to different groups. Participants will be involved from screening through treatment and monitoring phases, where their body weight stability and other health parameters are assessed. Researchers will track the number of participants allocated to each ISA during the first six weeks. Safety and efficacy will be evaluated throughout the study, which includes regular assessments and adherence monitoring. The study includes adults aged 18 to 75 with specific body mass index (BMI) criteria and weight stability prior to enrollment.

Researchers are evaluating the safety, tolerability, and effectiveness of two treatments, inebilizumab and blinatumomab, in adults with active and difficult-to-treat autoimmune diseases. This includes systemic lupus erythematosus (SLE) with nephritis, SLE with and without nephritis, and active refractory rheumatoid arthritis (RA). The study is a Phase 2, open-label, multicenter platform trial designed to assess these treatments across different subprotocols based on the specific condition and disease activity. Participants receive inebilizumab through intravenous infusion or blinatumomab via subcutaneous injection, depending on their assigned subprotocol. The study includes several parts: Subprotocol A focuses on SLE with nephritis treated with inebilizumab; Subprotocol B Part A and Part B assess blinatumomab in SLE with and without nephritis; and Subprotocol C Parts A and B evaluate blinatumomab in rheumatoid arthritis. The treatments are administered over specified periods, with some groups receiving treatment for up to 52 weeks. During the trial, participants undergo various assessments to monitor safety and disease response, including evaluation of treatment-emergent adverse events, serious adverse events, and measures of disease remission or activity. For example, kidney response and remission in SLE and disease activity scores in RA are measured at specific time points. Safety monitoring continues through the treatment period, with data collected on adverse events from Day 1 to Week 52. Participants' health status, laboratory tests, and disease activity are regularly evaluated to understand the treatments' effects and tolerability.

Researchers are conducting a Phase 2, multicenter platform study to evaluate the safety and effectiveness of several investigational treatments for adults with moderately to severely active Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. The study focuses on assessing multiple experimental oral or injectable therapies to better understand their effects on these conditions. Participants will receive one of the study drugs, MT-501 or MT-201, as part of this evaluation. The study aims to gather data on how these treatments perform in terms of safety, how the body processes them (pharmacokinetics), and their biological effects (pharmacodynamics). Treatment effects will be measured over a period of up to 13 weeks. During the study, participants will be monitored for any side effects, serious adverse events, and laboratory test changes. Researchers will also assess the participants' clinical remission status and improvements seen through endoscopic evaluations at 12 to 13 weeks. The total involvement duration includes screening and treatment periods, with careful tracking of outcomes and safety throughout.

Researchers are evaluating the effectiveness, safety, and tolerability of two different doses of remibrutinib compared to a placebo in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). This phase 3 study aims to determine how well remibrutinib works in treating this chronic skin condition characterized by painful abscesses and inflammatory nodules. The study lasts a total of 76 weeks and includes several phases: up to 4 weeks for screening, followed by a 16-week double-blind treatment period where participants receive either remibrutinib Dose A, Dose B, or a matching placebo. After this, there is a 52-week treatment period where all participants receive remibrutinib (Dose A or Dose B). Finally, a 4-week safety follow-up period occurs without treatment. Participants who stop treatment early are encouraged to stay in the study and complete the safety follow-up. During the study, participants will be regularly assessed for clinical response to treatment, focusing on the proportion achieving a 50% improvement in HS symptoms by week 16. Researchers will monitor safety and tolerability throughout the study, including during the follow-up period. Various evaluations such as physical exams and clinical assessments will be conducted to measure treatment effects and ensure participant safety over the entire 76-week duration.