Sandy Springs

Researchers are assessing the safety and effects of Ritlecitinib, a study medicine, for treating hidradenitis suppurativa (HS), a condition causing long-lasting, painful red skin lumps. This phase 2 study focuses on adults with moderate to severe HS who have not responded well to or cannot tolerate antibiotics. The goal is to compare experiences and outcomes between those receiving Ritlecitinib and those receiving a placebo. Participants will be randomly assigned to take either Ritlecitinib or a placebo pill once daily at home. The treatment involves an initial loading dose of Ritlecitinib for 8 weeks, followed by an 8-week maintenance dose, totaling 16 weeks of treatment. The placebo group will receive a matching pill with no active medicine. Over approximately 24 weeks, including screening and follow-up, participants will attend around 10 clinic visits for health evaluations, including physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. They will also track their medication intake and HS symptoms daily using an electronic diary on a mobile phone. The study will measure how many patients achieve at least a 50% improvement in HS symptoms by week 16 to evaluate treatment response and safety.

This research aims to better understand the long-term safety risks of lonapegsomatropin in children with growth hormone deficiency who are treated with this medication in real-world settings. The study focuses on patients aged 1 to 18 years and is conducted in Europe and the USA. It is designed as a prospective, non-interventional, long-term safety study following the drug's approval for use. Participants continue their regular treatment with lonapegsomatropin without any additional interventions from the study. The study does not involve changes to their therapy but observes patients who are already receiving lonapegsomatropin. Eligible participants are pediatric patients clinically managed with this medication, and the study follows them over time to monitor safety outcomes. Throughout the study, researchers will track the occurrence of benign, malignant, and unspecified tumors as well as the development of type 2 diabetes mellitus over a period of five years. Participants provide informed consent and agree to follow-up requirements, which include regular monitoring and data collection to assess these outcomes. The study aims to provide important safety information about lonapegsomatropin in its post-marketing use.

Researchers are evaluating the safety and side effects of LY4005130 in adults with non-segmental vitiligo (NSV). This Phase 2 study compares LY4005130 with a placebo to understand how well the drug is tolerated. Participants have NSV affecting certain areas of their body and face, with the condition being either active or stable for at least 3 months. Participants will receive LY4005130 or a placebo through an intravenous (IV) infusion into a vein in the arm. The treatment phase lasts 24 weeks, during which the effects and safety of the drug will be monitored. The entire study, including screening, will take about 48 weeks. Throughout the study, participants will undergo blood tests to assess how their body processes the drug and how the drug affects their body. Researchers will measure the percentage of participants achieving significant improvement in facial vitiligo after 24 weeks. Safety and side effects will be followed carefully during treatment and the study period.

Researchers are evaluating the effects of macupatide and eloralintide, alone or combined, on weight loss in adults who are overweight or have obesity along with type 2 diabetes. This Phase 2 study aims to understand how these treatments might help reduce body weight in this population. The study is designed as a parallel-group, double-blind, placebo-controlled trial to ensure unbiased results. Participants will receive either macupatide, eloralintide, both drugs together, or matching placebos. All treatments are administered by subcutaneous injection. The study treatment period lasts approximately 48 weeks, during which the effects of the drugs on weight and diabetes control will be assessed. During the study, participants will be monitored for changes in body weight from the start of the study to week 32 as the primary outcome. Researchers will also evaluate safety and other health measures throughout the nearly year-long participation. The study includes regular assessments to track the effects of treatment and to ensure participant health and safety.

Researchers are studying sleep patterns in adults with Major Depressive Disorder (MDD) who experience moderate to severe insomnia symptoms (MDDIS) or no to mild insomnia symptoms (non-MDDIS). The goal is to evaluate brain activity during sleep using an at-home sleep Electroencephalogram (EEG) device and to understand how these objective sleep measurements relate to participants' own sleep experiences. Participants will use a sleep EEG device at home to record brain activity during sleep over a specified period. Alongside this, subjective sleep data will be collected using various self-report tools including sleep diaries and standardized questionnaires like the Structured Interview Guide for the Hamilton Depression Rating Scale and Patient-Reported Outcomes Measurement Information System forms. During the study, participants will be assessed both objectively through the EEG recordings and subjectively through questionnaires and interviews about their sleep quality and disturbances. The researchers will analyze these data to characterize sleep features in participants with different levels of insomnia symptoms, monitoring safety and compliance throughout the study period.

Researchers are evaluating the safety, effectiveness, and drug levels of Deucravacitinib (BMS-986165) in adolescents aged 12 to less than 18 years with moderate to severe plaque psoriasis. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand how this treatment affects this condition in younger patients. Participants must have had stable plaque psoriasis for at least six months and meet specific severity criteria. Participants will receive either Deucravacitinib or a placebo at specified doses on designated days. The study compares the drug to placebo to assess its impact on psoriasis symptoms. No additional details about dosing schedules are provided, but the intervention period includes monitoring drug levels and safety. This design allows researchers to evaluate the treatment in a controlled and blinded manner. Throughout the study, participants will be monitored for improvement in their psoriasis using measures like the Psoriasis Area and Severity Index (PASI) and the static Physicians Global Assessment (sPGA) at week 16. Safety will also be assessed. The primary outcomes include the number of participants achieving at least 75% improvement in PASI and those reaching clear or almost clear skin with a significant reduction in sPGA score. Participants are observed from screening through the intervention period with regular assessments to track efficacy and safety.

This research aims to evaluate the safety and effectiveness of ruxolitinib cream in children aged 2 to 11 years with nonsegmental vitiligo, a condition that causes loss of skin color in patches. The study is a Phase 3 trial focusing on this pediatric population to better understand how well the treatment works and how safe it is for young patients. Participants will be randomly assigned to receive either ruxolitinib cream or a matching vehicle cream, both applied as a thin layer twice daily to the affected skin areas. The treatment is topical and focuses on areas of skin depigmentation, including the face and other body parts. The study measures progress over 24 weeks to determine the proportion of participants who achieve significant improvement in facial vitiligo. Throughout the study, participants will have regular assessments including skin evaluations and safety monitoring. Researchers will track changes in the affected skin areas using the Facial Vitiligo Area Scoring Index. Participants must stop all other vitiligo treatments before starting and during the study. Safety follow-ups will continue after treatment to ensure participant well-being and gather comprehensive data on treatment effects.

This research aims to gather long-term evidence on how effective and safe SKYTROFA (lonapegsomatropin) is for patients with growth hormone deficiency during regular clinical care in the United States. The study is designed as a multi-center, prospective, non-interventional trial, focusing on patients who are already receiving treatment with SKYTROFA. Patients will continue their treatment as part of their routine clinical practice without any additional visits, tests, or examinations beyond their usual care, except for completing questionnaires related to clinical outcomes. No new interventions will be introduced, allowing researchers to observe the natural course of treatment and patient outcomes over time. Throughout the study, researchers will monitor the safety and effectiveness of SKYTROFA treatment for up to five years. Data will be collected from routine clinical visits and patient-reported outcomes to assess how well the treatment works and its safety profile. This long-term observation will help understand treatment impacts during everyday medical care.

Researchers are evaluating the safety and effectiveness of AGN-193408 SR in people with open-angle glaucoma or ocular hypertension. This Phase 1/2 study includes different study designs such as an initial open-label dose escalation and later randomized, masked, parallel groups to compare treatments. The study focuses on participants with these eye conditions and aims to measure changes in intraocular pressure and monitor any treatment-related side effects over 36 months. The study uses an implant called AGN-193408 SR, which contains a preservative-free drug dispersed in a biodegradable polymer. The implant is inserted into the front chamber of the study eye using a preloaded applicator. Comparator treatments include topical eye drops of Lumigan 0.01% in the fellow eye and sham administrations using a needleless applicator that simulates the implant procedure. Vehicle eye drops are used for masking in certain cohorts. Treatment schedules vary by cohort, with daily evening eye drops starting from Day 1 in some groups. Participants will be involved in regular assessments to track intraocular pressure changes and any adverse events from baseline up to 36 months. Evaluations include eye exams, monitoring for side effects, and adherence to treatment protocols. Researchers will measure the main outcomes by comparing intraocular pressure at hour 0 from baseline to 36 months and counting participants who experience treatment emergent adverse events during this time frame. The study includes safety follow-up and long-term monitoring throughout the 3-year period.

This multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease. The study includes three sub-studies focusing on induction treatment, with specific co-primary endpoints assessing clinical remission and endoscopic response at 12 weeks. Participants will receive either duvakitug or a placebo via subcutaneous injection during the treatment periods. The study duration can last up to 35 weeks and consists of a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 (open-label feeder induction) or Sub-Study 2 (pivotal induction). Non-responders may enter a 12-week extended induction phase in Sub-Study 3. After treatment, participants not enrolling in the maintenance study will have a 6-week follow-up period. Throughout the study, participants will have scheduled visits for assessments, including monitoring of clinical remission and endoscopic response using standardized scoring systems at 12 weeks. The total number of visits varies depending on sub-study participation, with up to 15 visits for those in Sub-Study 3. Safety and treatment effects will be closely monitored during these visits and follow-up periods.