Mason

Researchers are studying the long-term safety and effects of APG777 in adults with moderate-to-severe atopic dermatitis (AD) who have already completed treatment in a prior APG777 study. This Phase 2, multicenter, double-blind extension study aims to understand how well APG777 works and how safe it is when used over a longer period in patients who might benefit from continued treatment. The study includes three periods: a screening visit aligned with the end of the parent study's maintenance phase, an extended treatment period, and a post-treatment follow-up phase. Participants who met certain response criteria and did not use rescue medication in the parent study will continue with the same dosing schedule of APG777 injections. Those who did not meet these criteria or used rescue medication will be assigned to an open-label escape arm and receive APG777 according to a set dosing regimen. Treatment involves subcutaneous injections of APG777 every 12 or 24 weeks. Participants will be closely monitored throughout the study, which may last up to three years. Researchers will evaluate treatment-emergent adverse events, measure improvements in eczema severity using the Eczema Area and Severity Index (EASI), assess skin clearance via Investigator Global Assessment scores, and track itch severity using a numeric rating scale. Use of rescue therapy, treatment discontinuations related to adverse effects, and serum drug levels will also be recorded. The study aims to track long-term safety and ongoing benefits of APG777 in this patient group.

Researchers are evaluating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid levels in adults with hyperuricemia related to gout. This phase 3, randomized, double-blind study focuses on adults aged 18 to 75 who have had gout for at least one year and experienced at least two gout flares in the past year. The study aims to measure how well dotinurad lowers serum uric acid at 24 weeks compared to allopurinol. Participants will stop their current allopurinol treatment and be assigned to one of three groups: continuing allopurinol at the same dose once daily for 64 weeks, starting dotinurad 1 mg daily for four weeks then 2 mg daily through week 64, or starting dotinurad 1 mg daily for four weeks, 2 mg daily for eight weeks, and then 4 mg daily through week 64. Both dotinurad and allopurinol are given as oral tablets. This treatment period is followed by ongoing monitoring up to week 68. During the study, participants will have regular visits to assess serum uric acid levels and record gout flares needing treatment. Safety will be monitored by tracking adverse events throughout the study. The main outcome is the percentage of participants achieving serum uric acid levels below 6.0 mg/dL at week 24. Other measures include gout flare rates, changes in uric acid levels over time, and safety assessments. The total participation time spans from screening through week 68, including treatment and follow-up visits.

Researchers are evaluating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid levels in adults with tophaceous gout. This Phase 3 study focuses on patients who have had gout for at least one year and have measurable tophi. The primary goal is to see how well dotinurad lowers uric acid by Week 24 compared with allopurinol. Participants will stop taking their current allopurinol and begin study-supplied allopurinol once daily through Week 76 or start dotinurad with a dose escalation from 1 mg daily in the first 4 weeks, to 2 mg daily for the next 8 weeks, and then 4 mg daily through Week 76. The study is randomized and double-blind, comparing these two treatments over this period. During the study, participants will have their serum uric acid levels measured at various points, including Week 24 and up to Week 80. Researchers will also monitor tophi response, gout flare rates, and safety outcomes such as adverse events. The total participation could last up to 80 weeks, with ongoing assessments to track treatment effects and tolerability.

Researchers are evaluating the safety and effectiveness of upadacitinib, an oral medication, in adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded well or are intolerant to anti-tumor necrosis factor (TNF) therapy. HS is a painful inflammatory skin disease affecting areas such as the underarms, groin, and anal/genital regions. This phase 3 study is double-blinded, meaning neither participants nor doctors know who receives upadacitinib or placebo. The trial includes three periods and involves about 1328 participants worldwide. Participants will take oral tablets of upadacitinib or placebo once daily for 36 weeks during the first two periods. In Period 1, they are randomly assigned to receive either upadacitinib Dose A or placebo for 16 weeks. In Period 2, based on their response in Period 1, participants are divided into six groups receiving various combinations of upadacitinib doses or placebo for 20 weeks. Eligible participants continue to Period 3, a long-term extension, taking upadacitinib or placebo daily for 68 weeks, followed by a 30-day follow-up. During the study, participants will have regular outpatient visits for medical assessments, side effect monitoring, and questionnaires to track changes in disease activity and adverse events. The main outcomes include the percentage achieving clinical response (HiSCR 50) by week 16 and the number of adverse events up to week 108. Secondary outcomes measure changes in draining fistula count, symptom assessments, skin pain, odor, quality of life, and flare occurrence. This thorough monitoring helps evaluate treatment impact and safety over time.

Alopecia areata (AA) is a condition where the immune system attacks hair follicles causing hair loss, typically on the head and face but possibly anywhere on the body. This research aims to evaluate how safe, effective, and tolerable the drug upadacitinib is for adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled trial involving about 1500 participants worldwide with severe AA, sponsored by AbbVie. Participants will be randomly assigned to one of three groups receiving either one of two doses of upadacitinib or a placebo. In the initial period, some participants receive placebo for 24 weeks, then based on their hair loss severity measured by the Severity of Alopecia Tool (SALT) score, they may be re-randomized to continue placebo or start one of the upadacitinib doses. Those on upadacitinib continue their assigned dose. Participants who complete the first studies can join an extension study with upadacitinib treatment for up to 108 weeks. Tablets are taken orally once daily for up to 160 weeks. Throughout the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in hair loss using the SALT score and track any adverse events during treatment and up to 30 days after the last dose. The study also evaluates other patient-reported outcomes related to hair growth and quality of life over time.

Researchers are evaluating the safety and immune response of a group B streptococcus (GBS) vaccine in healthy pregnant women and their babies. The study is a phase 3, randomized, placebo-controlled, double-blinded trial aiming to understand how the vaccine works in pregnancy and the infant's early life. The focus is on pregnant participants aged 49 or younger between 24 and 36 weeks of gestation with no major fetal abnormalities and negative tests for HIV, syphilis, and hepatitis B. Participants will receive a single injection of either the GBS6 vaccine or a saline placebo. The study also involves vaccines for infants, including combinations protecting against diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b, and pneumococcal strains, given according to each country's immunization schedule. Pregnant participants are followed for up to 14 months, including 6 months after delivery. A subset of infants will have additional follow-up for up to 19 months receiving standard vaccines with blood samples taken after primary and booster doses. Participants will attend 3 to 4 visits, some by telephone, for safety and immune response assessments. Researchers will monitor local and systemic reactions, adverse events, and serious adverse events in mothers and infants for up to one year after birth. Key measures include antibody levels against GBS serotypes and vaccine effectiveness predictions based on infant antibody concentrations. Infant immunity to other vaccines is also compared between groups. This careful monitoring provides safety and immune response data throughout the study duration.

Researchers are studying the effects and safety of ORKA-001, a drug given by injection, in adults with moderate-to-severe plaque psoriasis. This multicenter, randomized, double-blinded, placebo-controlled Phase 2 study aims to find the best initial dosing plan of ORKA-001 by comparing three different doses against a placebo. The study includes about 160 adult participants who have had plaque psoriasis for more than six months and meet specific disease severity criteria. The study consists of four periods: a screening period lasting up to six weeks, an induction treatment period lasting up to 28 weeks, a maintenance period of approximately 72 weeks, and a post-treatment follow-up. During the induction period, participants receive one of three doses of ORKA-001 or placebo by subcutaneous injection. In the maintenance period, participants receive either 300 mg or 600 mg ORKA-001 or placebo based on their response to the initial treatment. After treatment ends, participants may enter an open-label extension or be followed for 48 weeks after early termination. Throughout the study, participants will be monitored for treatment effects and safety. Researchers will measure the proportion of participants achieving complete clearance of psoriasis symptoms at 16 weeks and the maintenance of skin clearance at 100 weeks. Other assessments include skin severity scores and recording adverse events. Participants will have regular visits for evaluations, and women of childbearing potential will have pregnancy testing to ensure safety during the trial.

Researchers are observing treatment patterns, effectiveness, and side effects in adults with schizophrenia who have started using xanomeline and trospium chloride (KarXT) in the United States. This study aims to describe real-world use and outcomes of KarXT treatment for schizophrenia based on clinical practice. Participants diagnosed with schizophrenia will receive xanomeline and trospium chloride (KarXT) as prescribed by their clinician. The study follows participants from baseline up to 20 weeks, monitoring treatment changes and switches, adverse events, weight changes, clinical improvement scores, relapse rates, treatment continuation, and reasons for stopping treatment. During the study, researchers will collect data on demographics, family history, previous treatments, and clinical outcomes. Participants will be monitored for treatment titration, adverse events, use of antiemetics for gastrointestinal symptoms, and schizophrenia-related hospital visits. Data will be gathered from baseline through 20 weeks to evaluate treatment patterns and patient experiences over this period.

Researchers are evaluating solriamfetol, a drug that affects TAAR-1, dopamine, and norepinephrine, for treating binge eating disorder (BED) in adults. This Phase 3 trial is randomized, double-blind, and placebo-controlled, designed to assess both the effectiveness and safety of solriamfetol in people diagnosed with BED according to DSM-5 criteria. Participants will be randomly assigned to one of three groups: solriamfetol 150 mg, solriamfetol 300 mg, or placebo. Each participant will take their assigned tablets once daily for up to 12 weeks. The study compares these doses with placebo to understand the drug's impact on BED symptoms. During the 12-week treatment period, researchers will monitor changes in the number of binge eating episodes from the start of the study to week 12. Participants will also undergo assessments to check safety and adherence. The total duration of participation will be up to 12 weeks, during which the effects of the treatment will be carefully evaluated.

This research aims to assess the rate of Hydrus Microstent malposition and related clinical effects within 24 months after surgery in patients with primary open angle glaucoma undergoing cataract surgery. Participants will have an age-related cataract with vision of 20/40 or worse and will be treated with no more than four glaucoma medications. The study is sponsored by Alcon Research and involves a prospective, non-randomized, single-arm design. Participants will receive standard cataract surgery with placement of a monofocal intraocular lens (IOL), followed immediately by implantation of the Hydrus Microstent device. The Hydrus Microstent is a crescent-shaped device placed through the trabecular meshwork into Schlemm's canal to help fluid outflow from the eye. The study includes one treatment group receiving this combined surgical intervention. Participants will attend a screening visit, surgery day (Day 0), and eight follow-up visits over two years at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24. During these visits, researchers will monitor device positioning, visual acuity, eye pressure, and any adverse events. The main outcome is the rate of significant device malposition related to clinical problems within 24 months after surgery. Safety and eye health will be closely followed throughout the study period.