Cumming

Researchers are evaluating a combination of disitamab vedotin and tucatinib for treating patients with advanced or metastatic breast cancer or gastric cancer that express the HER2 protein. These solid tumors, which arise in organs like the breast or stomach, are challenging to treat once they have spread or grown larger. The trial focuses on patients whose tumors have HER2, a marker that can make the cancer grow and spread faster. The study aims to assess the safety and effectiveness of this drug combination in these cancers. The study includes a dose escalation phase where disitamab vedotin is given intravenously while tucatinib is taken orally twice daily at 300 mg. After determining two appropriate dose levels, the study proceeds to a dose optimization phase to evaluate safety and efficacy in different patient groups based on HER2 expression and cancer type. Following this, an expansion phase will test the treatment in four specific cohorts, including HER2-low and HER2-positive breast and gastric cancers. Participants will have regular assessments including monitoring for side effects, laboratory tests, and scans to evaluate tumor response using RECIST criteria. Safety will be followed for up to approximately five years after the last treatment dose. Key outcomes measured include the number of participants experiencing dose-limiting toxicities, adverse events, laboratory abnormalities, and dose changes. The study also tracks the objective response rate to the treatment over about three years.

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to \<18 Years Old) with moderate atopic dermatitis.

Researchers are evaluating the effectiveness of remibrutinib compared to dupilumab in adults with moderate to severe chronic spontaneous urticaria (CSU) that is not adequately controlled by second generation H1-antihistamines (sgH1-AHs). This Phase 3b, multi-center, randomized, double-blind, double-dummy study is conducted in the US and focuses on early treatment effects at 4 weeks and earlier. The study includes a screening period of up to 4 weeks, followed by a 12-week core treatment period where about 400 participants are randomly assigned to receive either remibrutinib (25 mg twice daily by mouth) with a placebo injection or dupilumab (a 600 mg loading dose followed by 300 mg every 2 weeks by injection) with a placebo tablet. All participants continue their stable dose of sgH1-AH during this period, with the option to add rescue doses if needed, not exceeding four times the standard dose per day. After the core period, participants may join an optional open-label extension to receive remibrutinib for an additional 12 weeks if the drug is not commercially available. Participants will complete daily diaries and regular assessments to track urticaria symptoms and treatment effects. Researchers will measure changes in the Weekly Urticaria Activity Score (UAS7) from the start to Week 4. Safety follow-up will occur for 12 weeks after treatment ends, with phone calls and site visits as needed, continuing longer if participants join the extension. The total study duration includes screening, treatment, optional extension, and safety follow-up phases.

This research aims to evaluate the safety and effectiveness of ruxolitinib cream in children aged 2 to 11 years with nonsegmental vitiligo, a condition that causes loss of skin color in patches. The study is a Phase 3 trial focusing on this pediatric population to better understand how well the treatment works and how safe it is for young patients. Participants will be randomly assigned to receive either ruxolitinib cream or a matching vehicle cream, both applied as a thin layer twice daily to the affected skin areas. The treatment is topical and focuses on areas of skin depigmentation, including the face and other body parts. The study measures progress over 24 weeks to determine the proportion of participants who achieve significant improvement in facial vitiligo. Throughout the study, participants will have regular assessments including skin evaluations and safety monitoring. Researchers will track changes in the affected skin areas using the Facial Vitiligo Area Scoring Index. Participants must stop all other vitiligo treatments before starting and during the study. Safety follow-ups will continue after treatment to ensure participant well-being and gather comprehensive data on treatment effects.

Researchers are evaluating the safety and effectiveness of SAR445399 in adults with moderate to severe hidradenitis suppurativa, a chronic skin condition. This multinational, randomized, double-blind, placebo-controlled Phase 2 study aims to compare two doses of SAR445399 against a placebo to find the best dosing. The study involves participants who have had symptoms of hidradenitis suppurativa for at least six months and have lesions in multiple areas of their body. Participants will receive SAR445399 or a placebo as an injection. The treatment period lasts 32 weeks, split into a 16-week initial double-blind phase followed by a 16-week treatment-blinded extension phase. The study includes 16 visits over a total duration of up to 46 weeks per participant, during which doses and responses will be carefully monitored. During the study, researchers will assess how many participants achieve significant clinical improvement in their condition by Week 16, using a measure called HiSCR75. Participants will undergo regular evaluations including physical exams and monitoring for safety. The study tracks efficacy and side effects throughout the treatment and extension periods to understand the impact of SAR445399 on hidradenitis suppurativa over time.

This research aims to evaluate the safety and effectiveness of tapinarof cream, 1%, in young children aged 3 months to less than 24 months who have atopic dermatitis. This global Phase 3 study focuses on infants and toddlers with this skin condition, assessing improvements in their skin from baseline through up to 56 weeks. The study compares tapinarof cream with a vehicle cream (placebo) to better understand its effects. Participants will be randomly assigned to receive either tapinarof cream, 1%, or a vehicle cream applied once daily to affected skin areas during the initial Double-Blind period lasting up to 8 weeks. Following this, all participants may enter an Open-Label Period lasting up to 56 weeks, where tapinarof cream will be applied once daily as needed to skin lesions. This design allows researchers to monitor responses to the medication over time and assess longer-term safety and efficacy. Throughout the study, caregivers and researchers will monitor the children's skin condition using a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score, focusing on the proportion of participants achieving clear or almost clear skin and a significant improvement from baseline. Safety assessments and adherence to treatment protocols will be observed. The total study duration includes both the Double-Blind and Open-Label periods, with evaluations spanning up to 56 weeks to gather comprehensive data on treatment outcomes.

Researchers are evaluating the effects of an experimental treatment called corneal crosslinking (CXL) for conditions where the cornea becomes thin, steep, and misshapen, leading to blurred vision. This Phase 3 trial focuses on participants aged 8 years and older with diagnoses such as keratoconus, ectasia after LASIK or PRK, pellucid marginal degeneration, progressive ectasia after previous CXL, or forme fruste keratoconus. The study aims to determine whether CXL can prevent or slow the progression of these corneal conditions and associated vision loss. The treatment involves applying riboflavin (vitamin B2 eye drops) to the eye followed by exposure to ultraviolet (UV-A) light. Participants are divided into two groups: one receives UV-A treatment for 18 minutes, and the other for 24 minutes. This procedure is designed to strengthen the cornea and potentially halt disease progression. Participants will attend up to 7 office visits over 6 months, undergoing various eye and vision tests. The main outcomes measured are changes in corneal curvature using Kmax via Pentacam imaging and changes in corrected distance visual acuity (CDVA) from enrollment through the 6-month treatment period. The study monitors participants closely to assess treatment effects and safety throughout this timeframe.

Researchers are evaluating an experimental treatment called corneal crosslinking (CXL) for people with conditions where the cornea becomes thin, steep, and misshapen, leading to blurred vision. This study focuses on participants aged 8 years or older with Down syndrome and related corneal diseases such as keratoconus, pellucid marginal degeneration, and forme fruste keratoconus. The main goal is to determine if CXL can prevent or slow the worsening of corneal shape and vision loss. The treatment involves applying riboflavin (Vitamin B2 eye drops) to the eye, followed by exposure to ultraviolet (UV-A) light for 20 minutes, aiming to strengthen the cornea. Participants will receive this treatment during the study, which is a phase 3 compassionate use trial. The study includes up to 7 office visits over 6 months for treatment and follow-up evaluations. During these visits, participants will undergo several eye and vision tests, including measuring corneal curvature with the Pentacam device and assessing vision improvement through corrected distance visual acuity. The study monitors changes from enrollment through the 6-month treatment period to evaluate the treatment's effects. Participants must comply with visit schedules and follow instructions to support the study's goals.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

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.