Pflugerville

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.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase 2b study to evaluate the safety and effectiveness of GIA632 in adults aged 18 years and older with non-segmental vitiligo (NSV). The study aims to find the best dose of GIA632 for further testing in a Phase 3 program. Participants must have a confirmed diagnosis of NSV with specific body surface area and Facial Vitiligo Area Scoring Index (F-VASI) scores. Participants will receive either GIA632 or a placebo during a 48-week core treatment period. This period is designed to establish the dose-response relationship and compare the effects of GIA632 with placebo. After this, there will be an extension phase to assess the longer-term safety and efficacy of the treatment. During the study, participants will be monitored for changes in their facial vitiligo through F-VASI scores from baseline to week 24. Researchers will also observe overall safety and treatment effects throughout the 48 weeks and the extension period. Participants will complete study-related questionnaires and follow study procedures to support the research assessments.

This research aims to evaluate the effectiveness and safety of IPN10200 compared to a placebo in improving the appearance of moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows. These lines can become more noticeable with age or repeated facial expressions and may affect a person's appearance and confidence. The study is a Phase III trial involving adult participants with these moderate to severe glabellar lines. Participants will receive a single injection of either IPN10200, a lyophilised powder for solution injected into several sites across the glabellar region, or a placebo injection containing excipients without the active substance. The study consists of three periods: a screening period lasting up to 20 days to determine eligibility; a treatment period on Day 1 when the injection is given; and a follow-up period lasting 52 weeks with regular visits and one telephone call to monitor participants' health. During the study, participants will undergo various health assessments including blood sampling, physical exams, clinical evaluations, and electrocardiograms. They will also complete questionnaires and keep diaries to record their experience. The main outcome measured is the percentage of participants responding to treatment four weeks after baseline. Participants may stay in the study for up to 55 weeks and can withdraw consent at any time.

Researchers are evaluating the safety and effectiveness of ELAPR002f injectable gel in adults with atrophic acne scars, which are flat or indented scars that develop after acne heals. These scars can significantly affect quality of life by lowering self-esteem and causing self-consciousness. This Phase 3 study involves participants with moderate to severe scars on both cheeks, aiming to assess how well ELAPR002f works compared to a saline control. Participants are divided into two cohorts. In Cohort 1, all participants receive ELAPR002f injectable gel through intradermal injections. In Cohort 2, participants are randomly assigned to receive either ELAPR002f or a saline active control, with a 1 in 4 chance of getting the saline. Each participant will receive three treatments over two months. The study involves approximately 395 adult participants at around 25 sites across the United States. During the study, participants will attend regular visits at clinics or hospitals for medical assessments, blood tests, and to check for side effects. Questionnaires will also be completed to monitor the treatment's effects. Participants will be followed for up to 12 months after the treatments to observe the long-term safety and effectiveness, including measuring changes in acne scar area, side effects, and any bodily changes.

Researchers are evaluating the effectiveness of adding tirzepatide to ixekizumab therapy in people with moderate-to-severe plaque psoriasis who are also overweight or obese with at least one related health condition. This study is a phase 4, open-label, single-arm trial focused on real-world clinical practice. The goal is to see how well this combination works over a 12-month period. Participants will continue treatment with ixekizumab and start tirzepatide, which is given by injection under the skin. To join, participants must have started ixekizumab about three months before adding tirzepatide. The study monitors treatment beginning at baseline and follows participants for up to one year to assess outcomes. During the study, researchers will measure how many participants improve their skin-related quality of life using the Dermatology Life Quality Index and how many achieve at least a 10% weight reduction after 12 months. Participants will be regularly evaluated to track these outcomes and monitor safety throughout the study period.

Researchers are evaluating the safety and effects of the medicine ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years. Alopecia areata is a condition that causes significant hair loss. This study aims to compare how well ritlecitinib works for hair regrowth compared to a placebo, along with assessing its safety and impact on patient quality of life. The study includes three groups: one receiving a higher dose of ritlecitinib, one receiving a lower dose, and one receiving a placebo. All treatments are given as oral capsules taken once daily at home for 24 weeks. Participants eligible for the study have at least 50% scalp hair loss and specific vaccination or virus exposure history. After the 24-week treatment, participants may join a long-term extension study or complete a 4-week follow-up if not eligible. Participants will attend 8 clinic visits during the 6-month study and receive about 8 phone calls for monitoring. Assessments include measuring scalp hair loss using the Severity of Alopecia Tool (SALT), evaluations of eyebrows and eyelashes, patient-reported outcomes on anxiety, depression, and quality of life, and pharmacokinetic sampling. Safety monitoring is ongoing to watch for potential risks associated with ritlecitinib.

This Phase 3 study investigates the use of HyBryte, a topical gel containing 0.25% hypericin, combined with visible light therapy to treat patients diagnosed with patch/plaque phase cutaneous T-cell lymphoma (CTCL), including stages IA, IB, or IIA. The goal is to evaluate whether an 18-week treatment course can induce a treatment response compared to placebo gel with visible light. The study focuses on assessing disease severity changes in selected skin lesions using a modified Composite Assessment of Index Lesion Severity (mCAILS) score. Participants receive either HyBryte gel or placebo gel applied twice weekly to all readily accessible lesions for 18 weeks. After application, treated areas are covered with opaque material, such as clothing, and about 21 hours later, participants undergo visible light exposure. Three to five index lesions per participant are identified and monitored throughout the study to evaluate treatment effects. Following the 18-week treatment period, participants are followed every 4 weeks for an additional 12 weeks to monitor ongoing outcomes. Throughout the study, several assessments are performed including evaluation of lesion severity using mCAILS, monitoring of safety and adverse effects, and documentation of treatment response at 18 weeks. The study closely tracks participants' adherence to treatment schedules and visible light exposure protocols. The total participation duration spans 30 weeks, including the treatment and follow-up periods, allowing comprehensive evaluation of HyBryte's effects on CTCL skin lesions.

Researchers are evaluating the safety and effects of a topical cream called RLS-1496 1.0% for adults with actinic keratoses (AK) on their arms. This open-label study focuses on applying the cream to lesions and nearby skin on the left forearm, while the right forearm remains untreated as a control. The main goals are to determine if it is safe to use the cream once daily for 28 days and whether it can reduce or clear AK lesions. Participants will apply RLS-1496 cream to the affected area on the left forearm once daily for 28 consecutive days. The first dose will be supervised at the clinic, with the following doses applied at home each evening. After treatment, participants will be observed for an additional 28 days. The study includes a screening period of up to 28 days before dosing begins, making the total participation time approximately 85 days. During the study, participants will attend clinic visits for evaluations including counting AK lesions on both forearms, physical exams, vital signs, laboratory tests, and skin biopsies. Researchers will also assess local skin reactions and biomarkers related to the disease and treatment effects. Safety will be closely monitored through reports of adverse events and clinical assessments throughout the treatment and follow-up periods.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in patients who have elevated lipoprotein(a) levels and established atherosclerotic cardiovascular disease (ASCVD). It is an open-label, non-randomized rollover extension study involving participants who have completed previous double-blind parent studies related to pelacarsen treatment. Participants will receive pelacarsen 80 mg administered subcutaneously once a month during this extension phase. The study offers continued access to pelacarsen for those who successfully finished the parent studies, allowing researchers to monitor its effects over a longer period. Throughout the study, participants will be monitored for adverse events and serious adverse events for up to 48 months. Researchers will assess safety and tolerability through ongoing evaluations, ensuring continuous observation of participants' health and responses to the treatment during this extended timeframe.