Plainfield

Researchers are assessing the safety and effects of Ritlecitinib, a study medicine, for treating hidradenitis suppurativa (HS), a condition causing long-lasting, painful red skin lumps. This phase 2 study focuses on adults with moderate to severe HS who have not responded well to or cannot tolerate antibiotics. The goal is to compare experiences and outcomes between those receiving Ritlecitinib and those receiving a placebo. Participants will be randomly assigned to take either Ritlecitinib or a placebo pill once daily at home. The treatment involves an initial loading dose of Ritlecitinib for 8 weeks, followed by an 8-week maintenance dose, totaling 16 weeks of treatment. The placebo group will receive a matching pill with no active medicine. Over approximately 24 weeks, including screening and follow-up, participants will attend around 10 clinic visits for health evaluations, including physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. They will also track their medication intake and HS symptoms daily using an electronic diary on a mobile phone. The study will measure how many patients achieve at least a 50% improvement in HS symptoms by week 16 to evaluate treatment response and safety.

Researchers are evaluating the safety, tolerability, and levels of the study drug SYX-5219 in healthy volunteers and people with moderate to severe atopic dermatitis (AD). This multi-part, Phase 1, first-in-human study includes participants aged 18 to 65 years. The study aims to understand how SYX-5219 behaves in the body and to assess its safety in different dosing scenarios, including single and multiple doses as well as food effects. The study is divided into three parts. Part 1 involves single ascending doses (SAD) and a food effect evaluation in up to 48 healthy volunteers, who receive oral capsules of SYX-5219 or placebo. Part 2 tests multiple ascending doses (MAD) in up to 24 healthy volunteers with multiple oral doses given over a treatment period. Part 3 enrolls up to 45 participants with confirmed active AD to receive SYX-5219 or placebo daily for up to 42 days. This part is conducted at multiple global sites. Participants will undergo safety and exploratory efficacy assessments during treatment and follow-up periods. Researchers will monitor adverse events from the date of consent through various time points depending on the study part, including up to 10 days after dosing in Part 1 and up to 56 days in Part 3. Assessments include laboratory tests, vital signs, ECGs, and clinical evaluations to gather information on safety, tolerability, and drug levels in blood and urine throughout the study duration.

Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that blocks multiple pro-inflammatory cytokines involved in atopic dermatitis. This phase 2, double-blind, placebo-controlled study focuses on adults with moderate to severe atopic dermatitis that has not responded adequately to topical treatments. Participants are observed over approximately 36 to 40 weeks to compare BFB759 with a placebo. Participants are randomly assigned to receive either BFB759 or a placebo, with dosing aimed at assessing different levels of the drug's effects. The study is designed as a parallel-arm trial, meaning groups receive different treatments simultaneously without crossover. The investigational drug targets key inflammatory pathways believed to drive symptoms in atopic dermatitis. During the study, participants attend regular visits for monitoring and assessments. Researchers evaluate the drug's efficacy at 16 and 32 weeks using specific outcome measures. Safety is closely monitored throughout the treatment period. Participants are also expected to follow study instructions, avoid certain medications, and complete all scheduled visits during the study duration.

This research aims to evaluate the effectiveness and safety of BFB759 in adults with moderate to severe hidradenitis suppurativa, a chronic inflammatory skin condition. The study is a Phase 2 and Phase 3, dose-ranging, randomized, double-blind, placebo-controlled trial comparing BFB759, a biological treatment that blocks multiple pro-inflammatory cytokines, to a placebo. Participants have had hidradenitis suppurativa for at least one year and have disease that is not well controlled by antibiotics. Participants receive either BFB759 or a placebo in a blinded manner over the course of the study. The study lasts approximately 36 to 40 weeks during which the treatment's effects and safety are assessed. The trial evaluates the drug's impact on hidradenitis suppurativa symptoms and monitors for any adverse reactions. Throughout the study, participants attend regular visits to assess their condition and safety. Researchers monitor the efficacy of BFB759 from the start to Week 16 and Week 32. Participants are asked to follow study instructions carefully, attend scheduled visits, and avoid certain other medications. The trial includes adults aged 18 to 75 years and collects data on treatment effectiveness and safety over the full study period.

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 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 conducting a Phase 3, double-blind, randomized, vehicle-controlled study to evaluate the safety and effectiveness of YCANTH (VP-102) in treating common warts (verruca vulgaris). The study aims to compare YCANTH with a placebo vehicle to see how well it clears treatable warts caused by the human papilloma virus. This research includes participants aged 2 years and older who have common warts suitable for treatment. Participants will receive either YCANTH or the vehicle applied by a medical professional to all treatable warts, covering the wart and a small margin of healthy skin. The treated area is then covered with occlusive tape overnight. Treatment sessions occur every 21 days for up to four sessions during a 75-day treatment period, or until all warts clear. Wart paring may be done before application if needed. Follow-up visits include in-person and telephone assessments to monitor treatment response and side effects. After the treatment period, participants enter a 63-day follow-up phase. Those who complete the study may join a long-term follow-up for up to 54 weeks with additional open-label YCANTH treatments. Throughout the study, participants will have dermatologic examinations, wart measurements, and evaluations of treatment response and skin reactions. Safety is monitored through assessments of adverse events during visits and phone calls. The main outcome is the proportion of participants with complete clearance of all treatable warts by Day 84. Participants must attend all scheduled visits and follow all study instructions, with assessments continuing even if warts clear before the study ends.

Researchers are conducting a multicenter, randomized, double-blinded, placebo-controlled Phase 2 study to evaluate the safety and effectiveness of ORKA-001 in adults with moderate-to-severe plaque psoriasis. The study aims to find the best induction dosing regimen of ORKA-001 by comparing three different dosing schedules to placebo. Participants in this study have a diagnosis of plaque psoriasis lasting more than 6 months and meet specific severity criteria. The study involves four periods: a screening phase lasting up to 6 weeks; an induction period up to 28 weeks where participants receive one of three ORKA-001 dosing regimens or placebo via subcutaneous injection; a maintenance phase lasting about 72 weeks from week 28 to week 100; and a post-treatment follow-up phase. After the end of treatment or if a participant withdraws, they may choose to enter an open-label extension study or be followed for 48 weeks. During the study, participants will have regular assessments to measure the proportion achieving complete clearance of psoriasis symptoms by week 16, using the PASI score. Safety and other clinical evaluations will also be monitored throughout the study and follow-up periods to track treatment effects and participant health over time.

This research is focused on people who previously took part in the COVE-2 or COVE-3 studies for common warts. The goal is to assess the long-term safety and effectiveness of YCANTH (also known as VP-102 or TO-208), a topical treatment applied to common warts. The study specifically looks at side effects, including skin reactions, medication use, and the success of clearing warts over time. Participants with common warts at the start of this long-term follow-up will receive YCANTH applied by a trained team member every 21 days, for up to 4 additional treatments or until all treatable warts are gone. Treated warts are covered with occlusive tape overnight and may be pared if thick scale is present. Once warts clear, participants attend observation visits every 42 days without treatment. If new warts appear after clearance, treatment resumes under the same schedule. The study lasts approximately 378 days, with follow-up visits continuing until the final day. During the study, participants will have regular evaluations including assessments of wart clearance, monitoring of side effects like skin reactions, vital signs such as body temperature and pulse, and medication use. Researchers will also track any new warts and measure the proportion of participants who achieve complete wart clearance by the end of the study. Safety and efficacy data will be collected until the final visit on Day 378, ensuring thorough long-term monitoring.

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.