East Windsor

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.

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.

30 subjects will be treated with increasing doses of Narrowband Ultraviolet phototherapy three times weekly for 12 weeks. Patients will then be evaluated every 6 weeks through week 36 to determine maintenance of response.

This research aims to evaluate the use of Duobrii in combination with biologic therapy for adults with chronic plaque-type psoriasis affecting 2% to 10% of their body surface area. The study is a Phase 4, open-label pilot involving 25 participants who have been receiving biologic therapy for at least 24 weeks. The goal is to assess how adding Duobrii might impact their psoriasis over a 12-week period. Participants will apply Duobrii daily for the first 4 weeks, followed by every other day for the next 4 weeks. All participants continue their existing biologic therapy during this time. This treatment schedule is designed to evaluate the effects of Duobrii as an add-on therapy in a real-world setting. During the study, participants will be monitored for improvements in their psoriasis, specifically measuring the percentage of body surface area affected after 8 weeks. The study includes assessments to track safety and response to treatment throughout the 12-week period. Participants must be willing and able to provide informed consent and comply with study procedures during the trial.

Researchers are studying adults with moderate to severe atopic dermatitis to evaluate the effectiveness and safety of combining dupilumab with narrowband UVB phototherapy. This Phase 4 open-label study aims to observe improvements in skin condition using both treatments together and then dupilumab alone. The study focuses on adults diagnosed with significant symptoms as measured by standard clinical scores. Participants will receive dupilumab 300 mg along with narrowband UVB phototherapy three times a week for the first 12 weeks. Following this combination treatment phase, they will continue with dupilumab monotherapy for an additional 12 weeks, making the total study duration 24 weeks. The treatment is designed to assess how well the combination and then the single drug manage atopic dermatitis symptoms. During the study, participants will be regularly assessed for their skin condition, including the Investigator's Global Assessment score at 12 weeks to track treatment response. Researchers will monitor safety, treatment effectiveness, and any side effects throughout the 24 weeks. The study involves clinical evaluations to measure disease severity and response to the therapies used.

This research aims to evaluate the use of Enstilar4 foam in adults with plaque psoriasis who have been treated with the medications etanercept or adalimumab for at least 24 weeks. Participants have a body surface area affected by psoriasis between 2% and 10% and a physician global assessment score of 2 or higher. The study is an open-label, phase 4 trial focusing on the combination of topical foam with ongoing biologic treatments. Participants will apply Enstilar4 foam once daily for the first 4 weeks. Following this, they will apply the foam every other day for an additional 12 weeks while continuing their existing etanercept or adalimumab treatment. This regimen is designed to investigate the effects of this adjunctive therapy over a total of 16 weeks. During the study, participants will be monitored for improvements in their psoriasis, specifically looking at changes in physician global assessment combined with the affected body surface area after 16 weeks. The trial includes regular assessments to track treatment response and safety. Participants are expected to remain in the study for the full 16-week treatment period, with evaluations conducted throughout to observe any changes.

This trial involves adult patients with moderate to severe plaque psoriasis, a chronic skin condition characterized by large, red, scaly patches. The study evaluates the effects and safety of the drug Ilumya, either alone or combined with Halog ointment 0.1%, in treating this condition. It is a Phase 4 single-center study aiming to assess treatment outcomes and monitor patient safety. Participants will receive Ilumya 100 mg as a subcutaneous injection at weeks 0, 4, and 16. At week 16, those with 3% or more body surface area (BSA) affected will start applying Halog ointment 0.1% twice daily for four weeks alongside Ilumya. Participants with less than 3% BSA involvement at week 16 will continue with Ilumya alone. The study includes follow-up evaluations at weeks 20 and 24. Throughout the study, patients will be monitored for changes in the extent of psoriasis, measured by body surface area affected. Safety and effectiveness will be assessed during regular visits, including week 16 and beyond. The total participation time covers at least 24 weeks, with careful observation for treatment response and side effects.

This research aims to evaluate the effects of combining Enstilar Foam with Taltz in adults with chronic plaque psoriasis who have been treated with Taltz for at least 24 weeks and have a body surface area (BSA) affected between 3% and 8%. The study is conducted at a single center and involves 25 participants to assess the addition of Enstilar Foam to their ongoing Taltz treatment. Participants receive topical Enstilar foam alongside their continued Taltz treatment. The study monitors the combination's impact over a treatment period with a primary focus on psoriasis severity measured by body surface area involvement. The Enstilar foam contains calcipotriene and betamethasone dipropionate, and its use is assessed together with Taltz. During the study, participants undergo evaluations including assessment of body surface area affected by psoriasis at 4 weeks to measure treatment response. Researchers monitor safety and effectiveness while ensuring participants meet health criteria and maintain appropriate contraceptive measures if applicable. The study spans the treatment and observation period necessary to determine changes in psoriasis severity with the combined therapy.

Researchers are evaluating upadacitinib in adults aged 18 to 64 with moderate-to-severe prurigo nodularis, a chronic skin condition characterized by itchy nodules. This phase 4, open-label study aims to assess the effectiveness and safety of upadacitinib over 24 weeks in patients who have not adequately responded to topical corticosteroids or for whom such treatments are not suitable. All participants will start treatment with 15 mg of upadacitinib. At week 8, the dose may be increased to 30 mg if deemed necessary by the investigators. The study focuses on monitoring participants throughout 24 weeks of treatment to observe changes in itch severity and other symptoms. Participants will undergo assessments including evaluation of their prurigo nodularis lesions, safety monitoring, and measurements of itch severity using a numeric rating scale at week 12. Researchers will also monitor overall health through medical history, physical exams, and pregnancy tests when applicable. The study involves regular follow-up visits and safety checks to evaluate treatment response and adverse effects.