Sandy Springs

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 the long-term safety of lonapegsomatropin in children with growth hormone deficiency who are already being treated with this medication. This study is observational and aims to gather real-world safety data over time after the drug has been authorized for use. The focus is on monitoring potential risks such as the development of tumors and type 2 diabetes over a period of five years. Participants receive lonapegsomatropin, administered once weekly by subcutaneous injection as part of their usual care. The study does not involve additional interventions but observes patients who are already treated with this therapy. The observational period extends for at least five years to collect safety data and compare it with historical information from previous studies. During the study, researchers will monitor for the occurrence of benign and malignant tumors, type 2 diabetes, and other adverse events affecting the kidneys, liver, immune system, and nervous system. They will also track medication errors and measure the response of Insulin-like Growth Factor-1 IGF-1 to treatment. Participants are followed up regularly to collect this information, with the study lasting until March 2033.

Researchers are evaluating the safety and side effects of LY4005130, a drug given through a vein, in adults with non-segmental vitiligo NSV. This study compares LY4005130 to a placebo to better understand how well the drug is tolerated. The trial is a Phase 2, randomized, double-blind study lasting about 48 weeks, including screening, to provide detailed information on treatment effects. Participants receive either LY4005130 or a placebo intravenously during the 24-week treatment period. Blood tests will be used to see how the drug moves through and affects the body. The study measures changes in vitiligo skin area using scoring indexes and also examines gene expression from skin biopsies. The comparison between the drug and placebo aims to provide clear insights into treatment effects. Throughout the study, participants will have assessments including blood tests and skin biopsies at the start and after treatment. Researchers will track side effects and changes in vitiligo by measuring the affected skin area. The study includes regular evaluations of drug levels in the blood and gene activity related to vitiligo. Participation involves about 48 weeks total, covering screening, treatment, and follow-up to monitor safety and response.

Researchers are studying weight reduction in adults living with obesity or overweight who also have type 2 diabetes. The study evaluates two drugs, macupatide and eloralintide, given alone or together, to understand their effects on body weight. This Phase 2 trial is designed to assess these treatments in a controlled setting with participants randomly assigned to different groups. Participants will receive one of four treatments macupatide with an eloralintide placebo, eloralintide with a macupatide placebo, both macupatide and eloralintide together, or double placebo. All drugs are administered by subcutaneous injection. The main treatment period lasts about 32 weeks, during which the effects on body weight and diabetes-related measures are monitored. Throughout the study, participants will have evaluations including body weight, hemoglobin A1c levels, body mass index, and fasting glucose at the start and at week 32. The study involves a total participation duration of about 48 weeks, allowing for treatment, follow-up, and monitoring. The sponsor is Eli Lilly and Company, and the trial uses double-blind, randomized design to compare treatments fairly.

Researchers are evaluating the safety and effectiveness of D-2570 in adults with moderate to severe plaque psoriasis. This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to assess how well D-2570 works and how safe it is for participants with this skin condition. The study focuses on participants who have had stable disease without major flares for at least six months. Participants will be randomly assigned to receive either a low dose or a high dose of D-2570 tablets, or placebo tablets that look identical. Treatments are given over a 12-week period, during which participants and researchers will monitor their responses to the study drug or placebo. The study uses a quadruple-blind design where participants, care providers, investigators, and outcome assessors do not know which treatment is given. During the study, participants will undergo various assessments including measurement of psoriasis severity using the Psoriasis Area and Severity Index PASI, Physicians Global Assessment PGA, and evaluation of body surface area affected. The primary outcome is improvement in PASI-90 after 12 weeks of treatment or placebo. Laboratory tests and safety monitoring will also be performed throughout the study to track any changes and ensure participant safety.

Researchers are evaluating the effectiveness, safety, and drug levels of Deucravacitinib BMS-986165 in adolescents aged 12 to less than 18 years who have moderate to severe plaque psoriasis. This phase 3 study is randomized, double-blind, and placebo-controlled to thoroughly assess the treatments impact on this skin condition. The study is sponsored by Bristol-Myers Squibb and aims to provide detailed information on how Deucravacitinib works in this younger population. Participants will receive either Deucravacitinib or a placebo, with doses given on specified days as part of the treatment. The study groups include an active drug group and a placebo group, and the design is parallel to compare these treatments directly. The treatment period includes monitoring drug levels and observing the participants responses over time. During the study, participants will be regularly assessed for improvements in their psoriasis using measures such as the Psoriasis Area and Severity Index PASI and the static Physicians Global Assessment sPGA at week 16. Additional evaluations include body surface area involvement, itch severity, quality of life, and antibody protection. Safety is closely monitored through laboratory tests, physical exams, vital signs, and adverse event tracking for up to five years, with ongoing measurement of growth and sexual maturation during this time.

This research aims to evaluate the safety and effectiveness of ruxolitinib cream in children aged 2 to 11 years who have nonsegmental vitiligo. The study focuses on pediatric participants with depigmented areas of skin caused by this condition and seeks to better understand how the cream may impact these areas. Participants will be randomly assigned to receive either ruxolitinib 1.5% cream or a matching vehicle cream. Both creams are applied topically as a thin film twice daily to the affected skin areas according to the study protocol. The trial includes a 24-week treatment period during which improvements in skin pigmentation and safety outcomes are monitored. During the study, children will have regular assessments including evaluations of the affected skin areas using the Facial Vitiligo Area Scoring Index and Total Body Vitiligo Area Scoring Index. Safety is monitored through reports of any side effects and laboratory tests at various timepoints up to 52 weeks. Participants are followed closely for adherence to treatment and overall health throughout the study duration.

Researchers are evaluating whether the medicine spesolimab can help adults with ulcerative pyoderma gangrenosum PG, a skin condition characterized by painful ulcers. The main goal is to see if spesolimab can lead to healing and closure of these ulcers. This Phase 3 study includes adults with at least one ulcer measuring between 5 cm and 80 cm and is sponsored by LEO Pharma. The study has two parts. In Part 1, participants are randomly assigned to receive either spesolimab or a placebo infusion every 4 weeks, with a 2 in 3 chance of receiving spesolimab. Alongside this, all participants take corticosteroid medicine by mouth for the first 8 weeks. In Part 2, participants are grouped again, where those without open ulcers have an equal chance of receiving spesolimab or placebo, while those with open ulcers receive spesolimab. Treatment infusions continue every 4 weeks throughout the study. Participants will be involved in the study for about 1.5 years, attending around 20 visits to the study site. During visits, doctors will examine their skin for signs of PG, monitor their overall health, and check for any side effects. The study team will compare results between groups, focusing especially on the complete closure of ulcers up to 28 weeks, among other measures of skin healing and pain reduction.

This research aims to gather long-term evidence on the safety and effectiveness of SKYTROFA lonapegsomatropin in patients with growth hormone deficiency who are receiving routine clinical care. The study focuses on understanding how patients respond to this treatment over time without altering their usual medical management. It is a non-interventional observational study conducted across multiple centers in the USA. Patients will continue their regular treatment with SKYTROFA as managed by their healthcare providers, with no additional visits, examinations, or tests required beyond standard clinical care. The study will collect data from clinical outcome assessments COAs to evaluate treatment results and safety over a period of five years. No experimental interventions or placebos are involved. Participants will be monitored through their routine clinical visits, with researchers reviewing their health status and treatment effectiveness using standard assessments. The primary outcomes include measuring safety and treatment effectiveness over five years, along with evaluating clinical outcomes through COAs. This approach allows for natural observation of patient experiences without extra procedures or disruptions to their care.

Researchers are investigating the efficacy and safety of duvakitug in people with moderately to severely active Crohns Disease in a multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. The trial includes three sub-studies aiming to evaluate duvakitugs effects compared to placebo during induction treatment phases, focusing on clinical remission and endoscopic response at 12 weeks. Participants receive subcutaneous injections of duvakitug or placebo following the study protocol. The study duration can be up to 35 weeks, including a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 open-label, Sub-Study 2 pivotal induction, or Sub-Study 3 extended induction for non-responders. A 6-week follow-up period applies to participants not entering the maintenance study. Throughout the trial, participants undergo scheduled visits for assessments including clinical remission based on Crohns Disease Activity Index and endoscopic scores. Safety is monitored with reports of adverse events and serum drug levels. Up to 8 to 15 visits are planned depending on the sub-study, with follow-up continuing for 45 days after the last dose for those not moving to maintenance treatment.