Castle Rock

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with Cutaneous Lupus Erythematosus, including Subacute and Chronic forms. The study focuses on participants who have active disease and have not responded adequately to conventional treatments. This Phase 2b trial aims to better understand how IMVT-1402 performs compared to a placebo in this patient group. The study includes three treatment periods. In Period 1, participants are randomly assigned to receive either IMVT-1402 Dose 1 or a placebo injection once weekly for 12 weeks. In Period 2, all participants who finished the first period receive IMVT-1402 Dose 1 once weekly for 14 weeks. In Period 3, after completing Period 2, participants are re-randomized to receive either IMVT-1402 Dose 1 or Dose 2 weekly for 26 weeks. All treatments are given as subcutaneous injections. Participants will be involved for about 61 weeks total. Researchers will measure changes in disease severity using the Cutaneous Lupus Erythematosus Disease area and Severity Index (CLASI-A) score from the start to Week 12. Throughout the study, safety and tolerability will be monitored, along with other assessments to track disease activity and participant health.

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 long-term safety of two drugs, Deucravacitinib and Ustekinumab, in adults with moderate-to-severe plaque psoriasis. This Phase 3b/4 study focuses on participants who are candidates for phototherapy or systemic treatment and have specific cardiovascular risk factors such as smoking, hypertension, diabetes, obesity, or a family history of heart disease. Participants will receive either Deucravacitinib or Ustekinumab at specified doses on set days. This open-label, randomized study compares these treatments over an extended period to monitor their safety profiles, including cardiovascular health. Throughout the study, researchers will track major adverse cardiovascular events, including heart attacks, strokes, and related procedures, for up to five years. Participants will undergo regular assessments to monitor their psoriasis and cardiovascular status, ensuring comprehensive safety evaluation during the long-term treatment.

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.

Researchers are evaluating the real-world effectiveness of nemolizumab in treating moderate-to-severe Prurigo Nodularis (PN) in adults. This non-interventional, prospective, multicenter study focuses on physician assessments and patient-reported outcomes over approximately 12 months in routine clinical settings. The study aims to measure improvements using both investigator and patient evaluations at Month 6. Treatment with nemolizumab (Nemluvio) is decided by the participant's physician before enrollment, with no additional visits or tests beyond usual care. Visit schedules follow standard medical practice rather than study requirements. A sub-study in Germany and the UK involves daily remote completion of Peak Pruritus Numerical Rating Scale (PP NRS) and Sleep Disturbance NRS from Day -1 to Day 14 without clinic visits. Participants will be involved in routine clinical visits where physician assessments and patient-reported outcomes are collected. The main outcomes measured include the Investigator Global Assessment of chronic Prurigo (IGA-CPG stage) and Peak Pruritus Numerical Rating Scale at 6 months. Data collection relies on standard practice, with no extra procedures, and monitoring occurs throughout the study duration of about one year.

Researchers are evaluating the real-world effectiveness of nemolizumab for treating moderate-to-severe atopic dermatitis (AD) in adolescents and adults. This study is a prospective, multicenter, non-interventional trial that aims to measure treatment outcomes through physician assessments and patient-reported outcomes over approximately 12 months. The goal is to understand how nemolizumab works in routine clinical practice, focusing on physician evaluations and patient experiences at Month 6. Treatment with nemolizumab is determined solely by the participant's physician before joining the study, with no extra visits, procedures, or lab tests beyond standard care. The study does not define a specific visit schedule; instead, visits follow routine medical practice to collect data systematically. A sub-study in Germany and the UK will have participants complete daily questionnaires on itch severity, sleep disturbance, and pain from Day -1 to Day 14 remotely, without requiring clinic visits. Participants will be involved in routine clinical visits where physician assessments and patient-reported outcome measures will be gathered. Key outcomes measured include the Investigator Global Assessment (IGA) and the Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6. The study observes participant responses and safety under normal care conditions, with data collection lasting about a year to evaluate nemolizumab's effectiveness in everyday treatment settings.

Researchers are evaluating the safety and effectiveness of VDPHL01, an oral investigational drug, in treating female patients with Androgenetic Alopecia (AGA), a genetic condition causing hair loss due to an excessive hair follicle response to hormones. This Phase 3, multi-center, double-blind study involves adult women aged 18 to 65 with mild to moderate AGA. The study aims to assess changes in hair counts and participants' evaluation of treatment benefit after 6 months. Participants will be randomly assigned to receive either VDPHL01 extended release tablets once daily or twice daily, or a placebo tablet. The study includes 11 visits over approximately 13 months: screening, baseline (day 1), weeks 2, months 1, 2, 4, 6, 8, 10, 12, and a final visit at month 13. During the study, participants must maintain consistent hair length, style, and color, and agree to have a micro dot tattoo placed on the scalp for photography and assessment. Throughout the trial, researchers will monitor hair growth through non-vellus target area hair counts and collect participants' feedback on treatment benefits at 6 months. The study involves multiple assessments including photography of the scalp, questionnaires, and general health evaluations. Safety and efficacy data will be collected until the final visit at month 13.

Researchers are evaluating the safety and effectiveness of a reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for treating actinic keratosis (AK) on the upper arms. This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study involves about 260 adults who have 4 to 8 mild to moderate AK lesions on one arm. The study aims to compare the active treatment to a placebo vehicle control, with the main goal of measuring the complete clearance of all AK lesions by Week 12. Participants will receive either the active Levulan Kerastick solution or a vehicle solution applied topically to the treatment area on one arm, followed by exposure to blue light using a BLU-U4170E device. Depending on how well the lesions clear, up to two photodynamic therapy sessions may be given during the study. The treatments focus on the extensor surface of a single upper extremity, covering about 25 cm8. Throughout the study, patients will undergo evaluations including lesion clearance rates, changes in lesion count and area, recurrence, cosmetic responses, and satisfaction. Safety will be monitored through adverse event reporting, local skin reactions, vital signs, and laboratory tests. The study period includes screening, treatment sessions, and follow-up to measure outcomes at Week 12.

Researchers are evaluating the effectiveness and safety of ruxolitinib cream in people with hidradenitis suppurativa (HS), a chronic skin condition. This Phase 3 trial focuses on participants with mild to moderate HS who have had the condition for at least six months. The study aims to see how well the cream works in reducing HS symptoms compared to a placebo cream (vehicle cream). Participants will be randomly assigned to apply either ruxolitinib cream or a matching vehicle cream as a thin layer twice daily on affected areas. The study specifically includes those with a certain number of abscesses and nodules but no draining tunnels, affecting at least two different body areas. The study also requires participants to avoid using antibiotics or antiseptic products on affected areas during the vehicle-controlled period and part of an extension phase. During the study, researchers will monitor participants closely through assessments of the skin condition and safety checks. They will measure the proportion of participants who achieve a significant clinical response by week 16. The total body surface area treated must not exceed 20%, and participants will be followed to ensure adherence and safety throughout the trial period.

Researchers are evaluating the use of ruxolitinib cream in adults and adolescents with hidradenitis suppurativa, a chronic skin condition. This Phase 1 trial aims to assess the maximal use of this topical treatment to better understand its safety and effects in this population. Participants must have had hidradenitis suppurativa for at least six months and show specific disease characteristics to be eligible. Participants will apply ruxolitinib cream as a thin layer twice daily on affected areas of the skin. The treatment focuses on individuals with a significant body surface area affected by the condition. During the study, participants agree to avoid other topical or systemic antibiotics for hidradenitis suppurativa, and pregnancy prevention measures must be followed as outlined in the study protocol. Throughout the study, researchers will monitor participants for treatment-emergent adverse events up to 24 weeks, including any events that lead to treatment interruption or discontinuation. The study involves careful assessments to ensure safety and to evaluate the treatment's impact on the condition. Participants' health and laboratory values will be regularly checked, and the total study duration includes this monitoring period.