Mill Creek

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

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 and safety of subcutaneous amlitelimab compared with placebo in people aged 12 years and older who have moderate-to-severe atopic dermatitis (AD) and have not responded well to prior biologic or oral Janus kinase inhibitor (JAKi) therapies. This Phase 3, multinational, randomized, double-blind, placebo-controlled study includes participants who are also using background topical corticosteroids (TCS). The goal is to see how well amlitelimab works in improving AD symptoms in this group. Participants will be randomly assigned to one of three groups receiving either amlitelimab or placebo by subcutaneous injection while continuing their topical treatments, which may include corticosteroids, tacrolimus, or pimecrolimus. The total treatment period lasts up to 36 weeks during a double-blind phase. After the treatment phase, participants can choose to join a long-term safety study. The full study duration is up to 56 weeks for those not entering the safety study and up to 40 weeks for those who do, including screening, treatment, and safety follow-up periods. During the study, participants will attend up to 13 visits (or 12 for those continuing into the long-term safety study) for assessments including the Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD), Eczema Area and Severity Index (EASI), and symptom scoring. Safety monitoring and follow-up visits will track progress, side effects, and treatment response. The primary outcomes focus on improvements in skin clearing and reduction of AD severity at Week 36.

This research aims to evaluate the effects of povorcitinib on reducing itch and improving skin lesions in adults with prurigo nodularis, a chronic skin condition characterized by itchy nodules. The study is a Phase 3 trial designed to assess the safety and efficacy of this treatment compared to a placebo in participants aged 18 to 75 years with a confirmed diagnosis of prurigo nodularis lasting at least three months. Participants will receive either oral povorcitinib tablets or placebo tablets as part of the randomized, double-blind study. Key eligibility includes having significant itch severity and at least 20 pruriginous lesions on multiple body regions. The study monitors the treatment effects over 24 weeks, focusing on improvements in itch intensity and skin lesion severity. During the study, participants will be closely monitored for changes in their itch scores and skin condition. Researchers will assess the proportion of participants achieving specified improvements by Week 24. Safety and tolerability will also be evaluated throughout the trial. Participants will undergo regular assessments including clinical evaluations, laboratory tests, and adherence monitoring to track progress and any side effects over the course of the study.

Researchers are evaluating the safety, effectiveness, and drug levels of Deucravacitinib (BMS-986165) in adolescents aged 12 to less than 18 years with moderate to severe plaque psoriasis. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand how this treatment affects this condition in younger patients. Participants must have had stable plaque psoriasis for at least six months and meet specific severity criteria. Participants will receive either Deucravacitinib or a placebo at specified doses on designated days. The study compares the drug to placebo to assess its impact on psoriasis symptoms. No additional details about dosing schedules are provided, but the intervention period includes monitoring drug levels and safety. This design allows researchers to evaluate the treatment in a controlled and blinded manner. Throughout the study, participants will be monitored for improvement in their psoriasis using measures like the Psoriasis Area and Severity Index (PASI) and the static Physicians Global Assessment (sPGA) at week 16. Safety will also be assessed. The primary outcomes include the number of participants achieving at least 75% improvement in PASI and those reaching clear or almost clear skin with a significant reduction in sPGA score. Participants are observed from screening through the intervention period with regular assessments to track efficacy and safety.

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.

Alopecia areata (AA) is a long-lasting autoimmune condition that causes nonscarring hair loss affecting people of all ages, races, and genders. It mainly impacts the scalp but can also involve nails, eyelashes, eyebrows, and other hair areas on the body. The three main types of AA are patchy alopecia, alopecia totalis, and alopecia universalis. Ritlecitinib is a recently approved medication targeting specific enzymes involved in AA, and this study aims to assess its effectiveness and patient outcomes in a real-world setting. Patients in this study will receive ritlecitinib as prescribed by their doctors according to the approved product label and standard care practices. Treatment will be given in routine clinical practice without influence from the study. The study does not include a comparison group but will monitor how patients are treated with ritlecitinib and their response over time. Participants will have regular clinic visits as part of their standard care, during which data on their disease and treatment will be collected. This includes patient-reported outcomes and questionnaires. The main outcome measured is the percentage change in hair loss severity using the Severity of Alopecia Tool (SALT) score after 24 weeks of treatment. The study will help provide insights into patient characteristics, treatment patterns, and clinical results with ritlecitinib in everyday medical practice.

Researchers are conducting a multicenter, randomized, double-blinded, placebo-controlled study to find the best dose of ORKA-002 for adults with moderate-to-severe plaque psoriasis. The study aims to evaluate the effectiveness and safety of ORKA-002 compared to a placebo. Approximately 160 adult participants diagnosed with plaque psoriasis for more than 6 months, who are candidates for systemic therapy or phototherapy, will take part in this Phase 2 trial. Participants will receive one of three induction dosing regimens of ORKA-002 or a placebo, both administered by subcutaneous injection. The study consists of three periods: a screening period, an induction period where treatment is given, and a post-treatment follow-up period to monitor outcomes and safety. The goal is to identify the optimal dosing regimen that provides the best balance of efficacy and safety. During the study, participants will be assessed for the proportion achieving complete clearance of psoriasis skin symptoms (100% reduction in PASI score) by week 16. Researchers will also monitor for any treatment-emergent adverse events or serious side effects through week 48. Participants will undergo various evaluations including clinical assessments and safety monitoring throughout the study duration.

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.