Waltham

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 Crohn's 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 evaluating the safety and effectiveness of the drug LY4065967 for treating diabetic peripheral neuropathic pain (DPNP), which is pain caused by nerve damage due to diabetes. This trial is part of a larger chronic pain master protocol aimed at speeding up the development of new treatments for chronic pain conditions. The study is a randomized, placebo-controlled Phase 2 clinical trial sponsored by Eli Lilly and Company. Participants in this study will be randomly assigned to receive either LY4065967 or a placebo, both taken by mouth. The treatment period includes regular dosing, and the study compares the effects of the drug against placebo to assess its impact on pain relief. The trial uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo during the study. During the trial, participants will have their pain intensity tracked using the Numeric Rating Scale, along with other assessments such as sleep quality, emotional functioning, and pain interference with daily activities. These evaluations will occur from baseline through week 8 to monitor changes. Researchers will also measure the use of rescue medication and overall patient improvement. Safety monitoring and follow-up will be part of the study to ensure participant well-being throughout the trial duration.

Researchers are evaluating Xeomin injections as a treatment to prevent chronic migraine in adults. This Phase 3 clinical trial compares the change in monthly migraine days between participants receiving Xeomin injections and those receiving placebo injections. The study involves participants diagnosed with chronic migraine who meet specific migraine frequency criteria. Participants will receive four treatments approximately 12 weeks apart, with injections administered into muscles in the head and neck at specific points. The trial includes a placebo-controlled period with two Xeomin dose groups and a placebo group, followed by an extension period where all participants may receive Xeomin. Treatments involve Xeomin or placebo injections prepared by reconstitution with saline. The study lasts about 52 to 55 weeks, including a 4 to 5 week screening period and multiple visits. Four visits are on-site for treatments, while others are remote via phone or video call. Researchers will monitor changes in migraine days and headache days, use of acute migraine medication, and any treatment-related side effects. The primary outcome is the change in monthly migraine days from before treatment to six months after the first injection.

Researchers are studying the use of Xeomin injections to prevent episodic migraine by comparing its effects to placebo injections. The study focuses on adults with episodic migraine who experience a limited number of migraine and headache days per month. The main goal is to measure changes in the number of monthly migraine days after treatment. Participants receive Xeomin or placebo injections in muscles of the head and neck at specific points. The study includes two Xeomin dose groups and a placebo group, with an extension period where placebo participants may receive Xeomin. Four treatments are given roughly 12 weeks apart during a trial lasting about 52 to 55 weeks. Participants attend 14 visits over the course of the study, with the first, last, and four treatment visits conducted in person. The remaining visits occur remotely via phone or video call. Researchers monitor migraine frequency changes, medication use, and any treatment-related adverse events. The primary outcome is the change in monthly migraine days after six months of treatment.

Researchers are evaluating the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis (UC) or Crohn's disease (CD). This Phase 3, open-label, multicenter study aims to understand how well mirikizumab works over an extended period, lasting about 172 weeks with up to 44 visits. The study is sponsored by Eli Lilly and Company and includes participants aged 2 to 19 years who have previously been treated with mirikizumab in earlier studies. Participants receive mirikizumab administered subcutaneously (under the skin), with dosing based on their weight. There are multiple doses, numbered Dose 1 through Dose 6, with an additional intravenous rescue dose available if a participant loses response to the treatment. The study follows an open-label design without randomization or masking. Throughout the study, participants undergo regular assessments including clinical remission and response measured by the Modified Mayo Score for UC and the Pediatric Crohn's Disease Activity Index for CD at Week 52. Other outcomes include endoscopic remission and response, corticosteroid-free remission, and changes in inflammatory markers. Safety is monitored continuously, and additional treatment may be offered during a continued access period. The total participation time can last over three years, with extensive follow-up visits and evaluations.

Researchers are conducting a master protocol study to evaluate multiple independent pain treatments for people with chronic pain conditions such as osteoarthritis of the knee, diabetic neuropathic pain, and chronic low back pain. This study aims to compare different interventions within a structured framework that includes specific criteria and unique assessments for each condition. The study is designed as a randomized, placebo-controlled Phase 2 clinical trial to better understand these treatments. Participants are randomly assigned to receive one of several investigational drugs or matching placebos. These drugs include LY3016859, administered intravenously, and LY3556050, LY3526318, and LY3857210, all given orally. The interventions are organized in separate appendices focusing on each pain condition, allowing some to begin independently as they become available for testing. During the study, participants will be monitored from baseline up to 8 weeks to track allocation to each intervention-specific appendix. Researchers will assess pain levels, functional status, and safety through various scales and tests. The study involves maintaining stable non-drug therapies and discontinuing current pain medications except rescue medications. Participants will undergo physical exams, lab tests, and screening for medical history to ensure safety throughout the trial, which is led by Eli Lilly and Company and is expected to continue until April 2027.

Researchers are collecting and preserving leukopak biospecimens along with detailed medical data from up to 20,000 participants. This large, multi-center observational study aims to support biomedical research projects focused on discovering and developing new treatments, diagnostics, and preventative methods for complex and specific conditions. The collected biospecimens are not intended for transfusion but for research purposes. Participants may have up to two visits: a screening visit and an apheresis visit where blood components are collected. The biospecimens gathered through apheresis may be processed, stored frozen, or delivered unfrozen to approved researchers. All samples are anonymized before distribution. The study uses electronic or paper consent forms administered by study staff, and health data is collected by self-report and medical records. During participation, health questionnaires, physical exams, and laboratory tests including blood counts and viral screenings are performed to ensure suitability. Venous access is checked for successful collection. Researchers will measure outcomes related to leukopak collection from September 2022 to September 2024. Participant involvement includes vital sign checks, hemoglobin measurements, and ongoing safety assessments. The study continues until December 2026.

Researchers are evaluating the comparative effectiveness of two drugs, deucravacitinib and apremilast, in adults with plaque psoriasis. This observational study aims to understand how these treatments perform in real-world settings to help improve management of plaque psoriasis. The study is sponsored by Bristol-Myers Squibb and focuses on adults who have recently started treatment with either drug. Participants are grouped based on the treatment they have initiated: one group taking deucravacitinib and another taking apremilast. Each medication is prescribed by the participant's clinician as part of their regular care. The study observes participants for up to 60 months, tracking changes over time while participants remain on their prescribed treatment or until they discontinue. During the study, participants will have assessments at baseline and every six months, including measurements of body surface area affected by psoriasis, investigator global assessment, and quality of life using the Dermatology Life Quality Index. Researchers will also monitor treatment continuation time and various psoriasis severity scores. This long-term follow-up aims to capture comprehensive data on treatment effects and participant well-being throughout the study period.

Researchers are studying whether the medicine NNC0487-0111 is safe and effective for adults with excess body weight and knee osteoarthritis. The trial focuses on how this treatment may help reduce weight and knee pain compared to a placebo, which contains no active medicine. This is a Phase 3 randomized study sponsored by Novo Nordisk A/S.

Researchers are evaluating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid levels in adults with hyperuricemia related to gout. This phase 3, randomized, double-blind study focuses on adults aged 18 to 75 who have had gout for at least one year and experienced at least two gout flares in the past year. The study aims to measure how well dotinurad lowers serum uric acid at 24 weeks compared to allopurinol. Participants will stop their current allopurinol treatment and be assigned to one of three groups: continuing allopurinol at the same dose once daily for 64 weeks, starting dotinurad 1 mg daily for four weeks then 2 mg daily through week 64, or starting dotinurad 1 mg daily for four weeks, 2 mg daily for eight weeks, and then 4 mg daily through week 64. Both dotinurad and allopurinol are given as oral tablets. This treatment period is followed by ongoing monitoring up to week 68. During the study, participants will have regular visits to assess serum uric acid levels and record gout flares needing treatment. Safety will be monitored by tracking adverse events throughout the study. The main outcome is the percentage of participants achieving serum uric acid levels below 6.0 mg/dL at week 24. Other measures include gout flare rates, changes in uric acid levels over time, and safety assessments. The total participation time spans from screening through week 68, including treatment and follow-up visits.