Cedar Park

Researchers are evaluating the safety and effectiveness of three different doses of MORF-057 in adults with moderately to severely active Crohn's disease (CD). This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. It aims to compare MORF-057 to placebo to see how well it works in reducing disease activity and symptoms in this patient population. Participants will first go through a 14-week induction period where they receive one of three doses of MORF-057 or a matching placebo, all given orally. After this, all participants will enter a 38-week maintenance phase where they receive open-label MORF-057. Those who complete these 52 weeks of treatment may continue in a 52-week long-term extension to further monitor treatment effects and safety. Throughout the study, participants will have evaluations to assess their response to treatment using endoscopic scoring at Week 14. Researchers will monitor safety, symptom changes, and disease activity over the full treatment and extension periods. Study visits will include assessments, questionnaires, and clinical monitoring to track participants' health and treatment adherence over time.

Researchers are evaluating the safety and effectiveness of oral brepocitinib in adults with lichen planopilaris, a condition affecting the scalp. This Phase 2/3 study aims to compare brepocitinib with a placebo to understand its impact on disease symptoms and progression. Participants will receive either oral brepocitinib or a placebo, taken by mouth. The trial is randomized and double-blind, meaning neither the participants nor the researchers know who receives the active drug or placebo during the study. The study focuses on adults with active and symptomatic lichen planopilaris. During the study, researchers will monitor participants to see how many achieve an Investigator Global Assessment (IGA) score of 0 or 1 and experience at least a 2-step improvement from baseline by Week 24. Safety and symptom evaluations will be conducted throughout the treatment period to assess the drug's effects and participants' well-being.

Researchers are evaluating an investigational drug called ALN-HSD for adults with Metabolic dysfunction-Associated SteatoHepatitis (MASH), a type of liver disease where fat buildup causes liver cell damage, inflammation, and scarring. This condition can lead to serious complications like cirrhosis and liver failure. The study aims to assess how ALN-HSD affects liver scarring associated with MASH and to explore its impact on liver function, inflammation, side effects, and how the drug and its breakdown products appear in the blood. Participants will receive either ALN-HSD or a placebo according to the study protocol in this Phase 2, randomized, double-blind, placebo-controlled trial. The treatment is given based on the protocol's schedule, but specific dosing details are not provided. The study focuses on adults with specific genetic risk factors for MASH and with certain disease stages, ensuring a targeted precision medicine approach. During the study, participants will be monitored for changes in quantitative liver fibrosis from the start of the study to week 52. Researchers will evaluate liver scarring, liver function, inflammation, drug levels in the blood, and any side effects. The study includes genetic testing and specific liver assessments like FibroScan and FAST scores. Participants will be followed closely to understand the drug's effects and safety over the one-year period.

Researchers are evaluating the safety and effectiveness of vonoprazan 20 mg taken once daily compared to a placebo in adults with eosinophilic esophagitis (EoE). The main goal is to see how many participants achieve a peak eosinophil count of less than 15 eosinophils per high-power field in the esophagus after 12 weeks of treatment. This is a Phase 2, randomized, double-blind study involving adult participants with EoE. Participants will receive either vonoprazan 20 mg tablets or matching placebo tablets taken orally once daily. The study includes a primary treatment period of 12 weeks, with an additional evaluation of vonoprazan safety and efficacy up to 24 weeks. Treatment is closely monitored to assess the effects on esophageal inflammation. During the study, participants will be monitored through endoscopic biopsies to measure eosinophil counts in the esophagus. They will also complete electronic diaries to document symptoms like dysphagia. Safety assessments and other clinical evaluations will be conducted throughout the study. The primary outcome is the number of participants achieving the target eosinophil count at week 12, with ongoing monitoring to ensure safety and compliance.

Researchers are evaluating a vaccine called BLB-201 for respiratory syncytial virus (RSV) in infants and children aged 8 to 59 months. This Phase 1/2a randomized, placebo-controlled trial aims to study the safety, tolerability, and immune response after vaccination. Children included may have had prior RSV infection or not, allowing assessment in both seronegative and seropositive groups. The trial tests two doses of the BLB-201 vaccine: a low dose (10^6 PFU) and a high dose (10^7 PFU). Participants receive either one dose on Day 1 or two doses on Day 1 and Day 57. A placebo group receives a saline solution matching the low dose diluent. The study compares these groups to monitor how the vaccine is handled by the body and whether it produces an immune response. During the study, children are carefully monitored for side effects, including solicited adverse events from Day 1 to 15 and unsolicited events through Day 29. Their health is assessed through medical history, physical exams, and laboratory tests. Researchers track vaccine safety and immune response over the study period, with parents or guardians providing consent and helping with participation. The total study duration and follow-up ensure thorough evaluation of vaccine effects in young children.

Researchers are studying the safety and effectiveness of long-acting antibodies given alone or in combinations to adults with moderately to severely active ulcerative colitis (UC). This Phase 2, multicenter platform trial aims to find treatments that can improve symptoms and induce remission in people diagnosed with UC for at least 3 months. The study includes participants with active disease confirmed by endoscopy and histology and with moderate to severe symptoms based on a scoring system. The trial has two parts. Part A is an open-label phase testing three different monotherapy drugs to assess safety and initial effectiveness. Part B will be a randomized, placebo-controlled phase where participants receive one of six interventions (three monotherapies or three combinations) or placebo to compare outcomes. Treatments involve intravenous (IV) induction followed by subcutaneous (SC) maintenance dosing. Different treatment arms may start and finish at varying times during the study. Participants will undergo endoscopy and histology to confirm disease activity at screening, with regular monitoring throughout the study. Researchers will evaluate changes in disease severity using the Robarts Histopathology Index and measure the percentage of participants achieving clinical remission by Week 12. Safety and efficacy will be closely followed during and after treatment. The total study duration depends on treatment arm timelines and follow-up requirements.

The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderate to severe Crohn's disease who have experienced inadequate response, loss of response or intolerance to either one prior interleukin \[IL\] antagonist, and no other biologic/small molecule (Group A); one IL antagonist and either one Janus kinase inhibitor (JAKi) or one TNFi (other than adalimumab) \[Group B\] (Cohort 1) or one prior tumor necrosis factor inhibitor \[TNFi\] and no other biologic/small molecule (Group C); one TNFi and either 1 JAKi or one IL antagonist (other than UST) (Group D) (Cohort 2). The study will look at the efficacy and safety of dual targeted therapy. The study will enroll approximately 100 participants. Participants will be assigned to one of the two treatment groups in Part A: * Part A, Cohort 1: Vedolizumab + Adalimumab * Part A, Cohort 2: Vedolizumab + Ustekinumab All participants who achieve therapeutic benefit in Part A will receive vedolizumab IV 300 mg monotherapy from Week 30 until Week 46 in Part B. Participants will be followed for a further 20-week safety follow-up period to Week 72 (or 26 weeks post-last dose of study drug). This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is approximately 76 weeks.

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.

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.

Researchers are evaluating a machine learning model to analyze biometric data collected from wrist-worn devices to identify acute opioid use events and measure opioid withdrawal in individuals with opioid dependence. The study focuses on using physiological data gathered during the induction phase of medication for opioid use disorder (MOUD) to achieve accurate detection and withdrawal quantification. The model's performance will be compared to existing withdrawal measurement methods through statistical analysis. Participants will wear a Samsung Galaxy Watch, known as the OpiAID Strength Band Platform™, continuously for 14 days except during charging, showering, or water submersion activities. The device collects time-stamped biometric data used to train and evaluate the machine learning algorithm for detecting opioid dosing events and assessing withdrawal severity. Participants will also respond to prompts on the watch and complete daily Subjective Opioid Withdrawal Scale (SOWS) questionnaires. During the study, participants will be monitored through device data collection and daily questionnaires to track opioid use and withdrawal symptoms. Researchers will measure the algorithm's classification success by comparing true positive and false positive rates over 14 days. The study includes safety and compliance assessments, ensuring participants can operate the device and complete all procedures. The total participation duration is 14 days, focused on real-world outpatient settings.