East Windsor

Researchers are evaluating the efficacy and safety of amlitelimab, given as a subcutaneous injection, for treating moderate-to-severe atopic dermatitis AD in participants aged 12 years and older. This Phase 3, randomized, double-blind, placebo-controlled study includes participants who have not responded adequately to prior biologic or oral Janus kinase inhibitor JAKi therapies while using background topical corticosteroids TCS. Participants are randomly assigned to one of three groups receiving subcutaneous injections of either one of two doses of amlitelimab or a placebo, all alongside background TCS therapy. The treatment period lasts up to 36 weeks, followed by either a 16-week safety follow-up for those not entering the long-term safety study or no further treatment period for those entering the extension study. The entire study duration ranges up to 56 weeks for participants not entering the long-term safety study and up to 40 weeks for those who do. Participants will attend up to 13 visits during the study, or 12 visits if they join the long-term safety study. Assessments include evaluating skin condition using standardized scales such as the Validated Investigator Global Assessment for AD and the Eczema Area and Severity Index. Researchers will monitor safety, side effects, skin symptoms, quality of life, and various patient-reported outcomes. Long-term safety and response to treatment will also be observed for those who continue into the extension 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 Narrowband Ultraviolet-B UVB phototherapy as a treatment for adults with moderate to severe chronic plaque-type psoriasis. This pilot study involves 30 patients and aims to assess the response to this phototherapy given three times a week over 12 weeks, followed by evaluations to see how well the treatment effects last through week 36. The study is conducted at a single center and sponsored by the Psoriasis Treatment Center of Central New Jersey. Participants will receive increasing doses of Narrowband UVB phototherapy three times weekly for 12 weeks. This open-label treatment phase is followed by periodic assessments every six weeks up to week 36 to monitor the maintenance of treatment response. The phototherapy is delivered using a device designed to emit ultraviolet B light, targeting the skin affected by psoriasis. During the study, patients will attend regular phototherapy sessions and follow-up visits. Researchers will evaluate changes in psoriasis severity using the Psoriasis Area Severity Index PASI score at 12 weeks as the primary outcome. Additional assessments include the Physicians Global Assessment, Body Surface Area affected, and a combined measure of these two at 12 weeks. Patients must be in good general health apart from psoriasis and able to comply with the treatment schedule and visits throughout the trial.

Researchers are evaluating the effects of DUOBRII in combination with biologic therapy in adults with psoriasis affecting 2% to 10% of their body surface area. This open-label pilot study involves 25 participants who have been receiving biologic treatments for at least 24 weeks. The study aims to assess how DUOBRII impacts psoriasis when added to ongoing biologic therapy. Participants will apply DUOBRII daily for the first 4 weeks, followed by every other day for the next 4 weeks, over a total treatment period of 12 weeks. This study does not include a placebo group and is conducted at a single center. The focus is on observing changes in the extent of psoriasis during and after the treatment period. During the study, participants will be monitored for improvements in their psoriasis, specifically measuring the percentage of body surface area affected at 8 weeks. Researchers will collect data on skin condition and treatment adherence. The study includes assessments at baseline and follow-up visits throughout the treatment period to evaluate safety and efficacy.

This research aims to evaluate the combination of dupilumab and narrowband UVB phototherapy for adults with moderate to severe atopic dermatitis. The study is a 24-week open-label trial sponsored by the Psoriasis Treatment Center of Central New Jersey, focusing on the safety and effectiveness of these treatments in improving skin condition. Participants will receive dupilumab 300mg along with narrowband UVB phototherapy three times a week for the first 12 weeks. Following this, they will continue with dupilumab alone for an additional 12 weeks. This treatment plan allows researchers to observe the effects of combined therapy followed by monotherapy. During the study, participants will be monitored for changes in their skin using the Investigators Global Assessment Score at 12 weeks. Researchers will assess skin improvements and monitor safety throughout the 24 weeks. Participants can expect regular visits for treatment and evaluations to track progress and any side effects.

This research aims to evaluate the use of Enstilar foam in adults with plaque psoriasis who have a body surface area affected between 2% and 10% and a physician global assessment score of 2 or higher. Participants are already receiving treatment with etanercept or adalimumab for at least 24 weeks. The study is an open-label phase 4 trial investigating the addition of Enstilar to these ongoing treatments. Participants will apply Enstilar topical foam once daily for the first 4 weeks, followed by every other day for the next 12 weeks, while continuing their etanercept or adalimumab treatments. This regimen is designed to assess how Enstilar works alongside these medications in managing psoriasis symptoms. Throughout the 16-week study, researchers will monitor participants skin condition using the Physician Global Assessment combined with body surface area improvement as the primary outcome. Secondary outcomes include body surface area improvement alone, quality of life changes measured by the Dermatology Life Quality Index, and itch severity using a numerical rating scale. Participants will have regular evaluations to track these measures and assess safety.

This research aims to evaluate the use of Ilumya, with or without Halog ointment, in adults with moderate to severe plaque psoriasis. The study focuses on patients who have this chronic skin condition characterized by widespread plaques and aims to assess the effectiveness and safety of combining these treatments. Participants will receive Ilumya injections of 100mg under the skin at the start of the study, week 4, and week 16. At week 16, if patients still have 3% or more of their body surface area affected by psoriasis, they will add Halog ointment 0.1%, applied twice daily for four weeks. Those with less than 3% affected will continue only with Ilumya. Follow-up visits will occur at weeks 20 and 24 to monitor progress. Throughout the study, participants will be regularly evaluated for changes in their affected skin area and overall condition. Researchers will measure body surface area affected by psoriasis at 16 weeks as the main outcome. Safety and effectiveness will be monitored until week 24. The total involvement spans from the initial treatment through the follow-up visits over 24 weeks.

This research aims to evaluate the effect of adding Enstilar Foam to patients with plaque psoriasis who have been treated with Taltz for at least 24 weeks. The study focuses on adults with a body surface area BSA affected by psoriasis between 3% and 8%. The trial is conducted at a single center and involves 25 participants to assess the combination treatment. Participants receive topical Enstilar foam while continuing their Taltz treatment. This is an open-label study, meaning both researchers and participants know the treatment being administered. The study focuses on how this combination affects psoriasis over a period of 4 weeks, with no placebo or masking involved. During the study, participants will undergo evaluations to measure the extent of their psoriasis, particularly looking at the body surface area affected. The main outcome measure is achieving a BSA score of 0 or 1 at 4 weeks. Participants will be monitored for safety and treatment adherence throughout the study duration. The total participation lasts for the time of treatment and follow-up within the 4-week period.