Plainfield

Researchers are evaluating the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

Researchers are evaluating SYX-5219 in a multi-part, first-in-human Phase 1 study involving healthy volunteers and people with moderate to severe atopic dermatitis AD. The study aims to determine the safety, tolerability, and levels of SYX-5219 in blood and urine when given in different dosing schedules. This includes single ascending doses, multiple ascending doses, and multiple dose administrations in participants with AD. The study has three parts Part 1 involves single ascending doses and a food effect evaluation in healthy volunteers, with doses given once on Day 1 and again after a washout period. Part 2 involves multiple ascending doses given once or twice daily to healthy volunteers over a defined period. Part 3 enrolls participants with AD who receive SYX-5219 or placebo twice daily for up to 42 days. Each part includes randomization and placebo control to compare effects. Participants will undergo safety and exploratory efficacy assessments during and after treatment, including monitoring adverse events up to 10 days after dosing in Part 1, 14 days after the last dose in Part 2, and up to Day 56 in Part 3. Blood and urine samples are collected at multiple timepoints to measure SYX-5219 levels. The study includes follow-up visits to monitor participant health and drug effects for several weeks after treatment ends.

Researchers are evaluating the safety and effectiveness of ENV-294, an oral investigational drug, in adults with moderate-to-severe atopic dermatitis AD. This double-blind, placebo-controlled Phase 2b study compares three different doses of ENV-294 against a placebo over 12 weeks. The study aims to better understand how ENV-294 affects disease severity, symptoms, quality of life, and biological markers in people with chronic AD. Participants will be randomly assigned to one of four groups receiving either one of three doses of ENV-294 or a matching placebo. The treatment is taken once daily by mouth for 12 weeks. Before starting treatment, participants undergo screening to confirm eligibility based on their AD diagnosis, disease severity, and treatment history. During the study, participants complete regular assessments of their eczema severity using standardized scores like the Eczema Area and Severity Index EASI, patient-reported outcomes, safety checks, blood tests for drug levels, and biomarker analysis. Researchers monitor for any adverse events throughout the 12 weeks and for an additional 4 weeks following treatment. The total participation time includes screening, treatment, and follow-up assessments to evaluate both the effects and safety of ENV-294.

Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that targets multiple inflammatory cytokines, in adults with moderate to severe hidradenitis suppurativa HS that is not well controlled by systemic antibiotics. This double-blind, placebo-controlled study involves participants aged 18 to 75 years and aims to understand how well BFB759 works compared to a placebo over approximately 36 to 40 weeks. Participants will be randomly assigned to one of several groups. Some will receive a loading dose of BFB759 followed by either a high or mid maintenance dose every two weeks through Week 14. Others will receive a placebo every two weeks for 14 weeks, then, if still enrolled, be re-randomized to receive either a low or mid dose of BFB759 every two weeks from Week 16 through Week 30. This design allows comparison of different dosing regimens and the placebo effect. During the study, participants will attend about 22 visits over 21 months to monitor safety and effectiveness. Researchers will measure clinical activity using scales such as HiSCR50, the International Hidradenitis Suppurativa Severity Score System IHS4, Skin Pain Numerical Rating Scale, and the Hidradenitis Suppurativa-Investigator Global Assessment HS-IGA. Participants are expected to follow study instructions carefully, attend regular visits, and avoid certain medications. The primary outcomes focus on efficacy at Weeks 16 and 32, with ongoing safety assessments throughout the study.

Researchers are evaluating the effectiveness of adding the drug tirzepatide to the existing treatment with ixekizumab in adults with moderate-to-severe plaque psoriasis who are also overweight or obese and have at least one related health condition. This Phase 4 study aims to understand how well this combination works in routine clinical practice over a period of up to 12 months. During the study, participants will continue their treatment with ixekizumab and will start taking tirzepatide by subcutaneous injection according to the medication label. The study is open-label and involves a single group of participants receiving this combined treatment regimen. The main focus is to assess improvements in quality of life and weight reduction over the 12-month period. Participants will be monitored regularly to measure their skin condition using tools like the Dermatology Life Quality Index and body surface area affected by psoriasis. Weight changes and other health assessments will be tracked at 6 and 12 months. Safety and treatment adherence will also be observed throughout the study duration to gather comprehensive data on the effects of adding tirzepatide to ixekizumab therapy.

Researchers are evaluating the safety and effectiveness of YCANTH VP-102, a topical treatment, for people with common warts verruca vulgaris in a Phase 3 clinical trial called COVE-2. This study compares the active treatment to a placebo vehicle and includes participants aged 2 years and older who have at least one treatable common wart. The study aims to understand if YCANTH can clear all treatable warts by the end of the treatment period. The trial includes a Screening Period of up to 60 days, followed by a 75-day Treatment Period and a 63-day Follow-up Period. Participants receive topical applications of YCANTH VP-102 or a placebo every 21 days, up to four treatments. The study drug is applied to warts and a small area of surrounding skin, then covered with occlusive tape overnight. Wart paring may be done before application if needed. Warts are treated completely unless limited by the number of applicators. After each treatment, participants have in-person or telephone follow-ups to assess wart clearance and skin reactions. During the study, participants attend visits for dermatologic exams, wart measurements, and treatment assessments. Follow-up includes visual checks for complete wart clearance, monitoring of local skin reactions, adverse events, and medication use. Even if warts clear early, participants continue scheduled visits until the study ends. After this study, participants may join a long-term follow-up study to further evaluate YCANTH for up to 54 weeks. The primary outcome is the proportion of participants with complete clearance of all treatable warts by Day 84.

Researchers are evaluating the efficacy and safety of ORKA-001 in adults with moderate-to-severe plaque psoriasis. This multicenter, randomized, double-blinded, placebo-controlled phase 2 study aims to identify the best induction dosing regimen of ORKA-001 by comparing three different dose levels with a placebo. The study includes approximately 160 adult participants who have had plaque psoriasis for more than six months and meet specific severity criteria. Participants will be assigned to receive one of three doses of ORKA-001 or a placebo during the induction period, which lasts up to 28 weeks. Following this, they may enter a maintenance period lasting up to about 72 weeks, where three maintenance regimens are evaluated based on participant response. ORKA-001 and placebo are given by subcutaneous injection. After treatment, participants can opt to join an open-label extension study or enter a follow-up period of 48 weeks if they withdraw or do not join the extension. During the study, participants will undergo multiple assessments including skin evaluations using PASI and IGA scores to measure psoriasis severity and improvement. Safety will be monitored throughout the study and during follow-up by tracking adverse events. The primary outcome focuses on the proportion of participants achieving complete clearance of psoriasis at week 16. Total participation may last up to nearly two years, including screening, treatment, maintenance, and follow-up phases.

Researchers are evaluating the long-term safety and effectiveness of a treatment called YCANTH also known as VP-102 or TO-208 for people with common warts who previously participated in related studies COVE-2 or COVE-3. This phase 3, open-label study aims to monitor side effects, including expected local skin reactions, and to assess how well repeated applications of YCANTH clear common warts over time. Participants with warts at the start of the study will receive YCANTH applied directly to each wart every 21 days, up to four additional treatments or until all warts clear. After clearance, participants will have observation visits every 42 days without treatment, but if new warts appear, treatment will resume. The study includes careful wart preparation, application of the drug with occlusive tape overnight, and monitoring of skin reactions. The entire study lasts approximately 294 days from parent study completion to the final visit on Day 378. Throughout the study, participants will attend treatment and observation visits where researchers will evaluate wart clearance, skin reactions, vital signs, and medication use. Detailed assessments include wart counts, photographic documentation for those who consent, and monitoring for adverse events. Participants must follow study instructions, including limiting certain water exposures after treatment, and will be observed until the study ends on Day 378.

Researchers are evaluating the safety and effectiveness of VDPHL01, an investigational oral drug, in female subjects with Androgenetic Alopecia AGA, a genetic condition causing hair loss due to an excessive response to hormones called androgens. This Phase 3, multi-center, double-blind study aims to better understand treatment outcomes for women aged 18 to 65 with mild to moderate AGA. The study is sponsored by Veradermics, Inc. and includes about 13 months of participation with 11 scheduled visits. Participants will be randomly assigned to one of several groups receiving different regimens of VDPHL01 or placebo. Some groups take VDPHL01 twice daily BID for the entire 12 months, while others begin with placebo or a combination of VDPHL01 once daily QD and placebo before switching treatments after 6 months. The study maintains a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo during the first 6 months. Throughout the study, participants will attend visits for screening, baseline assessment, and follow-ups at weeks 2, months 1, 2, 4, 6, 8, 10, 12, and 13. Researchers will evaluate hair counts in target areas at 6 months and participants own assessment of treatment benefit. Participants agree to maintain consistent hair length, style, and color, and will have a small tattoo placed on their scalp for photographic monitoring. Safety and treatment effects will be carefully monitored during the study period.

Researchers are evaluating the efficacy and safety of reformulated Levulan Kerastick aminolevulinic acid HCl 20% combined with photodynamic therapy PDT for treating actinic keratosis AK lesions on the face or bald scalp. This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study involves about 160 adult patients having 4 to 8 mild to moderate AK lesions. The study aims to compare different treatment approaches and incubation times to understand their effects on AK clearance and patient satisfaction. Participants will be assigned to one of four groups based on treatment typeeither the active drug Levulan or a vehicle without active ingredientand one of two incubation times before blue light therapy is applied. Up to two PDT sessions may be given depending on how the lesions respond. The study includes both drug and device interventions, specifically topical solutions and a blue light PDT device. During the study, participants will undergo multiple assessments including evaluations of lesion clearance, changes in lesion count and size, cosmetic response, and patient satisfaction at various time points up to 24 weeks. Safety will be monitored through adverse event reporting, skin reaction assessments, vital signs, and laboratory tests. The main outcome measure is the complete clearance rate of AK lesions at 12 weeks. Participants will be followed closely to assess treatment effects and safety over the study period.