Tucson

Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a Deuterated Psilocin Analog, compared to a placebo when added to current antidepressant treatment in adults with moderate to severe Major Depressive Disorder (MDD). This Phase III trial focuses on participants aged 18 to 85 years who have had inadequate response to a stable antidepressant dose, aiming to better understand how CYB003 might improve depressive symptoms. Participants receive oral doses of CYB003 or matching placebo along with manualized psychological support provided by trained facilitators. The treatment period includes multiple dosing sessions with monitoring and assessments throughout. Placebo is used as a comparator to evaluate the combined safety and efficacy of CYB003 in this population. During the study, participants undergo evaluations using the Montgomery-Åsberg Depression Rating Scale (MADRS) at several time points, including screening, baseline, and multiple days up to the end of treatment at Day 42. Researchers monitor symptoms, side effects, and overall safety. Participants provide informed consent and are assessed regularly to track changes in depression severity and any adverse events over the course of the study.

Researchers are evaluating (Z)-endoxifen as a potential treatment for premenopausal women with estrogen receptor-positive (ER+) and HER2-negative breast cancer. This phase 2 open-label study includes two parts: a pharmacokinetic (PK) phase to understand how the body processes the drug and a treatment phase to assess the drug's effects on tumor growth. The study aims to see if (Z)-endoxifen can slow or stop tumor growth by measuring changes in a biomarker called Ki-67. Participants are premenopausal women who meet specific cancer and health criteria. Participants in the PK part will take (Z)-endoxifen capsules daily at varying doses (20 mg, 40 mg, or 80 mg). Some will also receive a monthly injection of goserelin, a drug that temporarily stops estrogen production in the ovaries. The treatment cohort will receive both (Z)-endoxifen and goserelin. Tumor tissue samples will be collected by breast biopsy after about 4 weeks to assess the Ki-67 biomarker. Participants showing tumor response may continue treatment for up to 24 weeks or until they undergo surgery. Throughout the study, participants will have blood draws to measure drug levels and tumor markers, breast biopsies, imaging scans, and safety assessments. The main outcomes include measuring (Z)-endoxifen levels after 4 weeks, the rate of Ki-67 reduction, and tumor response after 24 weeks. Study participation lasts up to 6 months, including treatment, surgery, and a follow-up visit one month after surgery.

Researchers are evaluating 4-aminopyridine (4-AP), a drug with a good safety profile, to see if it can help speed up the healing of both chronic and acute wounds in healthy adults. This Phase 2 study addresses the growing need for better wound treatments due to factors like aging populations, diabetes, obesity, and medications that slow healing. Previous animal studies showed that 4-AP improved wound healing and tissue regeneration without adverse effects, suggesting potential benefits for human wound care. Participants will receive either 4-AP or a placebo to assess its effects on wound healing. The study focuses on wounds healing by secondary intention, meaning wounds that close naturally without surgical intervention. The trial includes a treatment period and measures how quickly wounds close and skin integrity returns, particularly after a skin punch biopsy. During the study, participants will visit regularly for follow-up assessments, including evaluations of wound healing progress, sensory and motor function checks, and photographic documentation of wounds. Researchers will monitor safety and wound closure over six weeks, measuring the primary outcome of skin integrity and wound closure. The total study duration includes regular visits to ensure accurate tracking of healing and safety.

Researchers are studying adults with traumatic second-degree burns to evaluate a new treatment approach using 4-aminopyridine (4-AP), a drug with a promising safety profile. Current burn treatments mainly focus on infection control and fluid management, but they do not enhance the skin's ability to regenerate and heal faster. This trial aims to test whether applying 4-AP locally can speed up the healing process for burn wounds. Participants will be assigned to receive either the active drug 4-aminopyridine or a placebo. The study involves treating burns that are acute and have occurred within the last 7 days, covering at least 6 square centimeters of skin. The trial is conducted as a Phase 2 study to explore the effectiveness of 4-AP in helping skin wounds recover more quickly. During the study, participants will attend scheduled follow-up visits where their burn healing will be assessed through examinations and calibrated photographs. Researchers will monitor healing progress over a 12-month period to measure the healing rate. Participants will also report any sensory or motor changes. Safety and adherence to the study requirements will be closely observed throughout the trial.

Researchers are evaluating the role of 4-aminopyridine (4-AP) in helping men recover nerve function after injuries caused by nerve traction or crush during robot-assisted radical prostatectomy (RP) for prostate cancer. The study focuses on men with organ-confined, non-metastatic prostate cancer undergoing this surgery, as nerve injury during RP can lead to erectile dysfunction and urinary issues. This phase 2/3 trial tests whether 4-AP can speed up the often slow and unpredictable recovery process. Participants will receive either FDA-approved 4-aminopyridine tablets or a placebo that looks similar to the drug during the perioperative period around their prostate surgery. The study compares these two groups to see how 4-AP affects recovery after nerve injury related to the surgery. The treatment is given in a controlled way as part of the trial to understand its impact on nerve healing. During the study, men will be assessed before surgery and then weekly for up to six months using measures like the Michigan Incontinence Symptom Index (M-ISI) and the International Index of Erectile Function (IIEF). These assessments will track changes in urinary and erectile function. Participants will also complete questionnaires comparing the placebo and active drug experiences throughout the study, which may last about one year. Researchers will monitor safety, adherence, and recovery progress closely to evaluate the effects of 4-AP on nerve injury recovery.

Researchers are evaluating the role of a single 10mg dose of 4-aminopyridine (4-AP) in diagnosing whether peripheral nerve injuries caused by traction or crush are complete or incomplete. This phase 2, double-blind, randomized crossover trial aims to determine if 4-AP can speed up the identification of nerve continuity earlier than standard electrodiagnostic and clinical assessments in patients with trauma to one or two limbs. The study is conducted at the University of Arizona College of Medicine, Tucson, and includes patients aged 18 to 90 with unclear nerve continuity on physical exam and a closed soft tissue injury. Participants are randomly assigned to receive either the 4-AP drug or a matched placebo first, followed by the alternate treatment in a crossover design on the main trial day. Each treatment session involves baseline sensory and motor evaluations, intravenous blood sampling for serum 4AP levels, and hourly sensory and motor tests for three hours after dosing. After completing both treatment arms, participants undergo follow-up monitoring for 20 weeks post-injury to assess recovery. During follow-up visits at 2, 6, 12, 18, and 20 weeks, participants receive physical exams, and telephone interviews are conducted at 9 and 15 weeks to assess subjective motor and sensory function. Researchers measure the return of sensation and motor abilities over time, review participant diaries, and monitor safety. Each visit or call lasts about 30 minutes, and the study tracks progress to better understand nerve injury recovery and the diagnostic value of 4-AP.

Researchers are evaluating 4D-710, an investigational gene therapy, in adults with cystic fibrosis (CF) lung disease who cannot use or tolerate CFTR modulator therapy. This Phase 1/2, multicenter, open-label trial also includes a sub-study assessing 4D-710 in adults with advanced CF lung disease or frequent lung flare-ups despite using CFTR modulators. The study aims to assess the safety, tolerability, and early effectiveness of this gene therapy in these populations. The trial involves a single dose of 4D-710, which is a gene therapy using a specialized virus to deliver a modified CFTR gene. Participants receive this treatment once, and those in the sub-study must be on a stable CFTR modulator regimen for at least 60 days before screening and continue it during a 24-month observation period. The study monitors participants with CF lung disease ranging from moderate to advanced stages. During the study, participants undergo regular evaluations including lung function tests, oxygen level checks, and monitoring for adverse effects. Researchers track the occurrence and severity of any side effects over a 60-month period. The study also includes assessments of lung health, medication adherence, and clinical status to understand the therapy's impact and safety over time.

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.