Bexley

Researchers are evaluating the safety and effectiveness of baricitinib, a medication taken by mouth, for treating severe or very severe alopecia areata, a type of hair loss, in children aged 6 to less than 18 years. This Phase 3 study involves children and adolescents who have had alopecia areata for at least one year and are experiencing a current episode lasting at least six months with significant hair loss. The study aims to see how well baricitinib works compared to a placebo. The study is divided into four distinct periods: a 5-week screening period to determine eligibility, a 36-week double-blind treatment period where participants receive either baricitinib or placebo, an approximately 2-year long-term extension period for continued treatment, and a 4-week post-treatment follow-up period to monitor participants after stopping the medication. Both baricitinib and placebo are administered orally. Participants will undergo various assessments throughout the study, including measuring the severity of hair loss using the Severity of Alopecia Tool (SALT) score. The main outcome is the percentage of participants achieving a SALT score of 20 or less after 36 weeks of treatment. Safety and pharmacokinetics of baricitinib will also be monitored during the study. The total participation may last over two years, including treatment and follow-up phases.

Vitiligo is a long-term autoimmune condition where the immune system mistakenly attacks skin cells that produce pigment, leading to patches of skin that lose color. This study focuses on adults with nonsegmental vitiligo, where symmetrical patches of depigmentation appear on both sides of the body. The trial aims to evaluate the safety, effectiveness, and tolerability of zasocitinib in treating this condition in adults aged 18 to 75 years. Participants will receive either zasocitinib capsules or placebo capsules that look identical but contain no medicine. The treatment period lasts up to one year (52 weeks). Those initially receiving placebo will switch to zasocitinib after about six months. During the study, participants will visit the clinic 11 times for treatment and monitoring. Throughout the trial, researchers will assess how well participants respond to treatment by measuring improvement in facial vitiligo using a standardized scoring index at baseline and after 24 weeks. Additional evaluations include safety monitoring and adherence to the study procedures. Participants will undergo clinical assessments, laboratory tests, and provide informed consent before starting the trial.

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.

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 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 conducting a global, multicenter Phase 3b long-term extension study to evaluate barzolvolimab's effects in adults with Chronic Spontaneous Urticaria (CSU) who have completed previous Phase 3 trials. The study aims to determine the time until disease worsening or treatment failure over one year and fulfill a commitment to provide continued access to treatment for eligible participants. The study includes two groups: Group 1 observes participants with a low symptom score (UAS7 less than 16) who do not receive barzolvolimab unless rescue treatment is needed, and Group 2 treats participants with higher symptom scores (UAS7 16 or greater) with barzolvolimab given by subcutaneous injection. Group 1 participants without rescue treatment participate for about 52 weeks, while those requiring rescue and all Group 2 participants may participate for up to 68 weeks. Participants will complete daily symptom diaries and undergo regular assessments to monitor disease activity and treatment effects. The main outcomes include measuring the time until disease worsening, treatment failure, or need for prohibited medications over the study period. Safety and efficacy data will be collected throughout the study duration to understand long-term outcomes with barzolvolimab in CSU.

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.

This research focuses on participants with Hidradenitis Suppurativa (HS) who have previously taken part in specific Incyte-sponsored clinical trials of povorcitinib. The study is a Phase 3b rollover trial designed to continue monitoring these individuals to gather further information on the treatment. It aims to evaluate the safety of povorcitinib over an extended period, including the proportion of participants experiencing treatment-emergent adverse events for up to about three years. Participants will continue taking the study drug povorcitinib orally as specified by the study protocol. This rollover study includes individuals who completed the treatment period in the parent studies without safety or tolerability issues and who showed clinical benefit from povorcitinib. During this study, participants will follow the protocol-defined dosing and procedures while avoiding pregnancy or fathering children as required. Throughout the study, participants will attend scheduled visits and assessments to monitor their health and treatment effects. Researchers will track adverse events and adherence to the treatment plan. The study involves ongoing evaluation for up to approximately three years to ensure safety and collect important long-term data on povorcitinib use in this group of patients with HS.

Researchers are evaluating the effectiveness and safety of ruxolitinib cream in people with hidradenitis suppurativa (HS), a chronic skin condition. This Phase 3 study compares ruxolitinib cream to a vehicle cream, aiming to see if the treatment helps clear HS symptoms better than a non-active cream. The study focuses on participants with mild to moderate HS who have had the condition for at least six months. Participants will apply either ruxolitinib cream or a matching vehicle cream as a thin layer twice daily to the affected areas. The study is double-blind and randomized, meaning neither the participants nor the researchers know who receives the active or vehicle cream during the treatment period. Participants must avoid using antibiotics or topical antiseptics on HS areas during the study and extension periods. Throughout the study, participants will be monitored to evaluate the proportion achieving a clinical response, specifically a 75% improvement in HS symptoms by week 16. Safety and treatment effects will be assessed through regular visits, and participants will be observed for any side effects or changes in their condition. The study's total duration includes the treatment and extension phases, with careful adherence to treatment application and restrictions to ensure accurate results.