Colitis

Researchers are studying whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohns disease in the small bowel. This early phase 1 case-control study aims to understand if early or developing fibrosis areas take up the tracer, which binds to fibroblast activation protein FAP. Participants with small bowel Crohns disease will be grouped based on imaging results to compare tracer uptake between those with and without strictures. Participants will receive a PETCT scan using the radioactive tracer Gallium-68-labeled fibroblast activation protein inhibitor-46 68Ga-FAPI-46, administered intravenously at a dose of 5 mCi 10%. Cases include participants with small bowel strictures or probable strictures, while controls include those without strictures but may have other disease features. This design allows researchers to investigate different stages of fibrosis development in Crohns disease. During the study, participants will complete the PETCT scan with 68Ga-FAPI-46. Researchers will monitor the completion rates of these scans over an average of 2 years. Participants will be evaluated through imaging and clinical assessments related to their Crohns disease status. Safety, tracer uptake patterns, and disease characteristics will be documented throughout the study period.

Researchers are investigating the specific targets of T cells involved in autoimmune diseases by studying tissues from patients with active organ inflammation caused by autoimmune conditions. The study aims to identify which T cells are activated and expanding in diseased tissues compared to blood or normal tissues. This information will help discover new peptide targets and their associated T cell receptors TCRs to develop potential new therapies for autoimmune diseases. Participants will provide tissue samples and matched blood samples during clinical procedures such as endoscopy, arthrocentesis, lumbar puncture, skin biopsy, bronchoscopy, or surgery, depending on their autoimmune condition. The study includes several groups covering diseases like Crohns disease, ulcerative colitis, celiac disease, ankylosing spondylitis, multiple sclerosis, scleroderma, systemic sclerosis, and other autoimmune diseases. Samples may come from excess clinical materials or research-specific biopsies, with the possibility of serial sampling over time. During the study, participants will undergo standard clinical procedures with collection of additional tissue or fluid samples and companion blood draws. Researchers will analyze these samples to identify peptide targets linked to disease-reactive T cells over a period of up to three years. The study includes comprehensive assessments of tissues and blood to understand T cell activity in autoimmune disorders, with monitoring of participant safety and no interventions beyond routine clinical care.

Researchers are studying TAK-279, an oral medicine aimed at reducing inflammation in adults with moderately to severely active Ulcerative Colitis UC or Crohns Disease CD, both serious long-term inflammatory bowel diseases. This study is an extension of previous parent studies and focuses on the long-term safety and tolerability of TAK-279, as well as its effects on reducing bowel inflammation and symptoms over time. Participants who responded to TAK-279 in the parent studies and completed specified treatment periods are invited to continue treatment in this open-label extension trial. All participants will receive Zasocitinib TAK-279 capsules orally for up to 156 weeks about 3 years. This includes those from different parent studies who completed either 12 or 52 weeks of treatment. During the study, participants will visit the clinic around 15 times. Researchers will monitor safety by tracking adverse events, vital signs, lab results, and heart function. They will also evaluate symptom improvements and quality of life using detailed clinical scores and questionnaires. The study aims to understand long-term effects and maintain careful follow-up through regular assessments over the treatment period.

This observational study focuses on children under 18 years with inflammatory bowel diseases IBD, specifically Crohns disease CD and ulcerative colitis UC. The research aims to determine how many children develop these conditions each year, how the diseases affect different age groups, and how treatments vary over time as children grow. It also evaluates healthcare service use and associated costs for these patients. Data will be collected from a health insurance database without affecting routine care. The study includes children newly or previously diagnosed with CD or UC. Only data recorded during regular medical practice will be used to analyze disease incidence, treatment patterns, healthcare utilization, and costs over multiple years. Participants medical records will be reviewed for diagnosis codes, medication prescriptions, hospital visits, surgeries, and costs related to IBD. The study will assess annual incidence and prevalence rates, treatment changes, hospitalization frequency, emergency visits, and medical expenses. Data will be de-identified and analyzed for up to 13 years to understand long-term trends in pediatric IBD management.

This research aims to evaluate the safety of ALLO-ASC-CD, an intravenous infusion containing allogenic adipose-derived mesenchymal stem cells, in subjects with Crohns disease who participated in a previous phase 1 clinical trial ALLO-ASC-CD-101. These stem cells target injured tissue and help reduce inflammation, which may be important for treating immune-related diseases like Crohns disease. This open-label follow-up study will monitor participants for 36 months to assess safety. The study involves only those subjects who received ALLO-ASC-CD injections during the earlier phase 1 trial. There is no new intervention in this follow-up phase it serves to observe the long-term safety of the stem cell treatment previously given. The infusion studied contains cells aimed at modulating the immune response and aiding tissue repair. Participants will be observed over 36 months with regular monitoring to record any adverse events as a measure of safety and tolerability. The study includes assessments to ensure compliance and informed consent. Researchers will track safety outcomes without additional treatments or procedures, allowing thorough long-term evaluation of the original therapys effects.

Researchers are evaluating the long-term safety of subcutaneous guselkumab injections in children with moderately to severely active ulcerative colitis, Crohns disease, or juvenile psoriatic arthritis. This Phase 3 study focuses on pediatric participants who have previously been treated with guselkumab and will continue therapy in this extension study to monitor safety over an extended period. Participants who completed dosing in one of three primary pediatric guselkumab studies and are deemed by their investigator to benefit from continued treatment will join this long-term extension. Guselkumab is administered as a subcutaneous injection either every 8 weeks or every 4 weeks, depending on prior study assignment and clinical status. Some participants may switch dosing frequency once during the extension before unblinding, after which dosing aligns with their original regimen. Dose adjustments are restricted based on the primary study they came from. During the study, participants will receive guselkumab injections regularly and be monitored for treatment-emergent adverse events for up to nearly seven years. Researchers will assess safety outcomes through ongoing clinical evaluations over this time. Parents or legal representatives provide consent for children to participate, and children capable of understanding the study will give assent. The total participation duration may extend up to six years and nine months, allowing long-term safety data collection.

Researchers are studying the long-term safety of vedolizumab given as a subcutaneous injection to children and teenagers aged 2 to 17 years with moderate to severe active ulcerative colitis UC or Crohns disease CD. The study aims to understand medical problems that may arise from extended use of vedolizumab SC, as well as its impact on hospital visits due to bowel inflammation and on the quality of life for these young participants. This Phase 3b extension study follows participants from an earlier study VedolizumabSC-3003 who have responded well or not to treatment. Participants who responded well to vedolizumab SC in the parent study will continue treatment in this extension study, receiving the same dose and frequency. They will be randomly assigned to receive vedolizumab 108 mg either via a prefilled syringe with an autoinjector pen or with a needle safety device. Dosage is every two weeks for participants weighing at least 30 kg and every four weeks for those weighing between 10 and under 30 kg. Those who did not respond well or recently used corticosteroids will not receive vedolizumab in this study but will be observed in an observational cohort. Throughout the study, participants will visit their study clinic multiple times over up to two years. Researchers will monitor adverse events and serious adverse events up to 18 weeks after the last dose, as well as special safety events in the observational group. They will also assess time to major inflammatory bowel disease-related events and changes in quality of life using the IMPACT-III questionnaire at regular intervals. Participants will have a safety follow-up visit after treatment ends, and those in the observational group will be followed for about two years after their last dose in the parent study.

Researchers are investigating the relationship between gut microbiota dysfunction and Alzheimers disease AD, focusing on how gut-derived short-chain fatty acids SCFAs may influence brain function through the gut microbiota-SCFAs-brain networks pathway. This observational study will explore differences in SCFAs among people across the AD spectrum, including cognitively normal individuals, those with subjective cognitive decline SCD, mild cognitive impairment MCI, and AD dementia. The project aims to clarify the interactions between gut microbiome, metabolites, and brain changes using high-throughput metabolomics and multi-modal MRI techniques. Participants will be grouped into four categories cognitively normal, SCD, MCI, and AD dementia. The study involves collecting multi-omics data, including gut microbiome analysis, metabolomics, and neuroimaging, to establish a diagnostic model for SCD due to preclinical AD using machine learning methods. The study spans five years, during which gut microbiome changes, SCFAs levels, and multi-omics biomarkers related to cognitive impairment conversion will be monitored. Participants will undergo cognitive tests and brain imaging scans, along with gut microbiome and metabolite sample collection. Researchers will assess the interaction mechanisms of the gut microbiota-SCFAs-brain networks over five years. The study includes both healthy volunteers and patients aged 60 to 80. Outcome measures focus on changes in gut microbiome, SCFAs, and biomarkers linked to cognitive decline, with long-term follow-up to better understand the disease progression and its early detection.

This research aims to evaluate the safety and effectiveness of duvakitug injection in people with moderately to severely active Crohns Disease. It is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study focused on maintaining treatment benefits. The study includes participants aged 16 to 80 years and is sponsored by Sanofi. Participants receive subcutaneous injections of duvakitug or placebo according to the study protocol. The trial includes a 40-week pivotal maintenance sub-study followed by a 240-week open-label extension sub-study for those who continue. The total treatment duration may be up to 280 weeks, with up to 43 on-site visits throughout the study. During the study, participants will have regular assessments including clinical remission, endoscopic response, and other measures related to Crohns Disease activity. Safety is monitored by tracking adverse events and antidrug antibody levels. There is a 45-day follow-up visit after treatment ends. The study duration may be up to 286 weeks depending on participation in the extension phase.

This research aims to evaluate the efficacy and safety of duvakitug in people with moderately to severely active Ulcerative Colitis UC. It is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study that includes participants aged 16 to 80 years. The study is sponsored by Sanofi and focuses on assessing clinical remission and other important health outcomes in UC. Participants receive subcutaneous injections of duvakitug or placebo according to protocol. The study includes a 40-week Pivotal Maintenance Sub-Study followed by a 240-week Open-Label Extension OLE Sub-Study for those who continue. Those not entering the OLE will have a 45-day follow-up after the maintenance period. There are up to 32 on-site visits in total, with 21 visits during the maintenance phase and 11 during the extension. During the study, participants will have clinical assessments including endoscopy to evaluate remission and mucosal healing, symptom tracking such as bowel urgency and abdominal pain, and quality of life questionnaires. Safety is monitored through adverse event reporting and blood tests for drug concentrations and antibodies. The primary outcome is the proportion of participants achieving clinical remission by the modified Mayo Score at Week 40, with follow-up continuing up to 286 weeks for some participants.