Dawsonville

Researchers are evaluating the safety and effectiveness of an experimental drug called PTX-022, which is a topical gel containing 3.9% sirolimus, for treating angiokeratomas. This phase 2, baseline-controlled study focuses on assessing how well the treatment works and how safe it is for patients affected by this condition. Participants will receive PTX-022 applied topically to the affected areas. The study monitors patients over a period of three months to observe any treatment-emergent adverse events and to evaluate changes in angiokeratoma severity using investigator and patient global assessments. During the study, participants will be closely monitored for side effects and improvements in their skin condition. Researchers will collect data on adverse events, overall changes in the angiokeratomas as assessed by investigators, and patient-reported impressions of change. The study requires participants to comply with all study procedures, including treatment application and follow-up assessments.

Researchers are evaluating the effectiveness and safety of upadacitinib at different doses in adults with moderate to severe atopic dermatitis (AD) who have not responded adequately to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation, and some people require systemic treatments beyond topical therapies. This phase 3b/4 study aims to provide data on upadacitinib's impact on AD symptoms in this specific population. The study is conducted in two open-label periods. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg orally once daily or dupilumab 300mg by subcutaneous injection every two weeks. After two weeks, those on upadacitinib 15mg may have their dose increased to 30mg based on their response. Period 2 lasts 24 weeks, during which participants either continue their assigned dose or switch doses depending on their eczema severity scores. The entire treatment duration is 32 weeks with follow-up for 30 days after treatment ends. Participants will undergo regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires to evaluate treatment effects. The main outcome measured is the number of participants achieving at least a 90% improvement in their eczema severity index by week 8. The study includes a 35-day screening period before treatment begins and monitors safety and efficacy throughout the study duration.

This trial investigates treatments for children aged 2 to less than 12 years with moderate to severe atopic dermatitis, a skin condition causing rash and itching due to inflammation. It compares oral upadacitinib, a drug approved for patients 12 years and older, with subcutaneous dupilumab, focusing on safety, adverse events, and changes in disease activity. The study is phase 3, open-label, and efficacy-assessor-blinded, enrolling about 675 participants worldwide who require systemic anti-inflammatory treatment beyond topical therapies. Participants will be randomly assigned to receive upadacitinib daily as oral tablets or oral solution for 160 weeks, or dupilumab by injection according to its approved dosing every 2 or 4 weeks for 52 weeks. Participants are stratified by disease severity, age, and previous treatment response. After completing treatment, follow-up visits occur for 30 days after upadacitinib and at least 12 weeks after dupilumab. The trial may involve more treatment visits than standard care. Throughout the study, participants attend regular hospital or clinic visits for clinical assessments, blood tests, and questionnaires to monitor disease severity and side effects. Researchers measure the percentage of participants achieving significant improvement in eczema severity by week 16 and track adverse events up to about week 172. This careful monitoring helps evaluate the safety and efficacy of the treatments over the long term.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

Researchers are evaluating the safety, effectiveness, and tolerability of upadacitinib in adolescents and adults with severe alopecia areata (AA), a condition where the immune system attacks hair follicles causing hair loss on the head, face, or other body parts. This phase 3 study involves about 1500 participants worldwide and compares upadacitinib to a placebo to assess treatment impact on severe AA. Participants are randomly assigned to one of three groups receiving either upadacitinib or placebo oral tablets once daily for up to 160 weeks. There is a chance for re-randomization at weeks 24 and 52 based on Severity of Alopecia Tool (SALT) scores. Those completing initial studies may join an extension study to receive upadacitinib for up to an additional 108 weeks. Follow-up occurs for 30 days after the last dose. Throughout the study, participants attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers measure the percentage of participants achieving a SALT score of 20 or less at week 24 and track adverse events up to 164 weeks. The study may involve a higher treatment burden compared to usual care due to frequent visits and evaluations.