Blankenfelde Mahlow

Researchers are studying the dose-response effects of galvokimig compared with a placebo in adults with moderate-to-severe atopic dermatitis, a chronic skin condition lasting at least one year. The study focuses on adults aged 18 years and older who have significant disease activity as measured by specific clinical scores and a history of inadequate response to topical treatments or contraindications to them. This phase 2 trial aims to evaluate the safety, effectiveness, and how the drug behaves in the body. Participants will receive either galvokimig or a placebo as an injection. The study uses a randomized, double-blind, placebo-controlled design with multiple doses tested in parallel groups. Treatments are given as solutions for injection, and the study monitors participants over a defined period to assess how the drug works and its safety profile. During the study, participants will undergo assessments including clinical scoring of their skin condition such as the Eczema Area and Severity Index at week 16 to measure response. Researchers will also monitor safety through physical exams, laboratory tests, and medical history reviews. The study requires stopping other systemic or topical treatments before starting and tracks participant adherence and outcomes carefully throughout the study duration.

Researchers are investigating the long-term safety and effectiveness of APG777, a treatment for moderate-to-severe atopic dermatitis (AD), in patients who have already completed an initial APG777 study. This phase 2, multicenter, double-blind study focuses on those who may benefit from extended treatment with APG777 to better understand its ongoing effects and safety over time. The study includes three main periods: a screening visit that occurs at the end of the previous study's maintenance period, an extended treatment period where participants receive APG777 subcutaneous injections every 12 or 24 weeks, and a post-treatment follow-up period. Participants will continue using their chosen non-medicated moisturizer from the previous study throughout this extension. During the study, participants' health and response to treatment will be closely monitored, including tracking any treatment-emergent adverse events for up to three years. Researchers will assess the long-term safety and efficacy of APG777 while ensuring participants remain compliant with study protocols. This ongoing observation aims to provide detailed information on how APG777 affects patients over extended use.

Researchers are evaluating the safety and effectiveness of NT 201, a botulinum toxin drug, compared with a placebo in adults who have moderate to severe platysma prominence, which involves prominent neck bands. This Phase 3 study is conducted in Europe and focuses on improving the appearance of these neck muscles. The study aims to see how well NT 201 works and how safe it is for participants with this condition. Participants will receive either NT 201 or a matching placebo injection, which contains Clostridium Botulinum neurotoxin A without complexing proteins. The study has two parts: the Main Period (MP), where the initial treatment is given and evaluated, and an Open Label Extension Period (OLEX) that follows. The effectiveness is primarily measured by improvement on the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) at two weeks after treatment. During the study, participants will be assessed by both investigators and themselves for platysma band severity and improvement. Safety and treatment outcomes will be monitored throughout the study periods. The total involvement includes screening, treatment, and follow-up assessments to observe the drug's impact and any side effects over time.

This research aims to evaluate the effectiveness and safety of a single dose of IPN10200 compared to a placebo in adults with moderate to severe glabellar lines, which are wrinkle-like lines that appear between the eyebrows and may affect appearance and confidence. The study includes a double-blind phase to assess initial treatment effects and an open-label phase to evaluate the safety and effectiveness of repeat doses over time. This Phase III study focuses on adult participants aged 18 to 80 years with moderate to severe lines who are dissatisfied with their appearance. Participants will receive injections of either IPN10200 or placebo during the first treatment cycle in the double-blind phase. In the open-label phase, new participants and those rolling over from the double-blind phase will receive IPN10200, with some eligible for up to four treatment cycles. Each treatment involves local injections of a lyophilised powder solution into several sites across the glabellar region. The study consists of three periods: a screening period of up to 20 days, a treatment period with multiple visits especially in the first month followed by monthly visits, and a 24-week follow-up after the last injection. Throughout the study, participants will have health evaluations including blood tests, physical exams, clinical assessments, and electrocardiograms. They will complete questionnaires and keep diaries to monitor their condition and response to treatment. The main outcome measured is the percentage of participants showing improvement in glabellar lines by week 4. Safety and long-term effects will be monitored for up to 107 weeks, with participants free to withdraw consent at any time.

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 safety and effectiveness of SAR445399 in adults with moderate to severe hidradenitis suppurativa, a chronic skin condition. This multinational, randomized, double-blind, placebo-controlled Phase 2 study aims to compare two doses of SAR445399 against a placebo to find the best dosing. The study involves participants who have had symptoms of hidradenitis suppurativa for at least six months and have lesions in multiple areas of their body. Participants will receive SAR445399 or a placebo as an injection. The treatment period lasts 32 weeks, split into a 16-week initial double-blind phase followed by a 16-week treatment-blinded extension phase. The study includes 16 visits over a total duration of up to 46 weeks per participant, during which doses and responses will be carefully monitored. During the study, researchers will assess how many participants achieve significant clinical improvement in their condition by Week 16, using a measure called HiSCR75. Participants will undergo regular evaluations including physical exams and monitoring for safety. The study tracks efficacy and side effects throughout the treatment and extension periods to understand the impact of SAR445399 on hidradenitis suppurativa over time.

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.