Clinical trials on Ulcerative Colitis

Understanding Ulcerative Colitis

Ulcerative Colitis (UC) is a chronic condition characterized by the inflammation of the inner lining of the colon and rectum. It is a form of inflammatory bowel disease (IBD) that can have a profound impact on the daily lives of those affected. The exact cause of UC remains unknown, but it is believed to result from an abnormal response of the immune system. Environmental factors, genetics, and an imbalance of gut bacteria are also thought to play roles in its development.

Symptoms and Diagnosis

The symptoms of Ulcerative Colitis can vary significantly from person to person and can range from mild to severe. Common symptoms include persistent diarrhea, often with blood or pus, abdominal pain and cramping, rectal pain and bleeding, urgency to defecate, and weight loss. The severity of symptoms typically fluctuates over time, with periods of remission alternating with flare-ups. Diagnosis of UC involves a combination of blood tests, stool tests, colonoscopy, and imaging studies to rule out other conditions and confirm the presence of inflammation and ulcers in the colon.

Treatment and Management

While there is no cure for Ulcerative Colitis, treatment aims to reduce symptoms, induce and maintain remission, and prevent complications. Treatment strategies include medication, lifestyle changes, and sometimes surgery. Medications used to treat UC include anti-inflammatory drugs, immune system suppressors, and biologics. Dietary adjustments and stress management can also help manage symptoms. In severe cases, surgery to remove the colon and rectum may be necessary. With appropriate treatment and management, many individuals with Ulcerative Colitis can lead active, fulfilling lives.

Prognosis for Ulcerative Colitis

Ulcerative colitis is a chronic inflammatory bowel disease characterized by inflammation of the colon and rectum. The long-term prognosis for individuals with ulcerative colitis varies, as the disease can range from mild to severe. While there may be cases of infrequent flare-ups, there can also be instances of more persistent and debilitating symptoms. The course of the disease is unpredictable, with periods of remission interspersed with acute episodes of active disease. Over time, a proportion of individuals may require surgical intervention, such as a colectomy, to manage severe symptoms or complications. The risk of colorectal cancer is increased in individuals with ulcerative colitis, particularly in those with extensive colonic involvement or a long duration of the disease. Regular monitoring and medical management can help to control symptoms and improve quality of life, although it remains a condition that is typically managed throughout an individual’s life.

Complications in Ulcerative Colitis

Ulcerative Colitis can lead to various complications that impact health and daily living. A common issue is severe dehydration, which occurs when the body loses too much water due to frequent diarrhea. This can cause fatigue and affect overall energy levels. Another complication is the increased risk of colon cancer, especially after many years of living with the condition. There may also be inflammation in other parts of the body, such as the joints, skin, and eyes, leading to discomfort and mobility challenges. Additionally, sores or ulcers may develop beyond the colon, causing pain and potential complications if they become infected. Severe bleeding from the ulcers can lead to anemia, resulting in weakness and tiredness. Lastly, the chronic pain and the stress of managing a long-term illness can affect mental health, potentially leading to anxiety or depression, which can significantly reduce the quality of life.

Treatment Methods for Ulcerative Colitis

For the management of Ulcerative Colitis, several non-clinical trial alternatives are recommended. Dietary adjustments play a crucial role; the incorporation of a high-fiber diet may alleviate symptoms for some, while a low-fiber diet may be required during flare-ups for others. The use of probiotics can also support gut health. Regular physical activity is encouraged to reduce stress and maintain overall well-being.

Pharmacotherapy options include:

  • Anti-inflammatory drugs such as aminosalicylates and corticosteroids to control inflammation.
  • Immunomodulators and biologics are prescribed to target specific pathways in the immune system.

Modern technology offers innovative solutions such as telemedicine for remote consultations and symptom tracking applications to monitor health and treatment effectiveness. Biofeedback and stress management applications can assist in managing the psychological aspects of the disease. Consulting healthcare providers is essential to tailor treatment plans to individual needs.

  • CT-EU-00057553

    Studying the safety and effectiveness of a new drug for ulcerative colitis

    This study focuses on examining a drug called ABBV-668, administered in oral capsules, to evaluate its safety and effectiveness in the treatment of adults with ulcerative colitis, a gastrointestinal disease characterized by bleeding and inflammation in the large intestine. About 40 participants will take the capsules twice a day for 16 weeks. After this treatment period, doctors will continue to monitor participants for an additional month. The study involves visiting a doctor more often than usual, carefully checking for potential side effects, and asking participants-specific questions. To measure changes in participants’ condition, doctors will use a special scoring system.

    • ABBV-668- new potential medication for inflammatory bowel diseases
  • Assessing obefazimod treatment for active ulcerative colitis

    This is a study that aims to understand if a drug called obefazimod (ABX464) can help increase the health and wellness of patients who struggle with a bowel disease known as ulcerative colitis. This illness can be moderate, or it can be severe, but either way, it’s tough on people. This drug trial will include a group of people who have tried using common treatments for this disease but didn’t respond well or had an allergic reaction. Obefazimod will be taken once a day, either 25 or 50mg. The end goal is to compare how well the drug did compare to the placebo. They want to see if obefazimod can help patients feel better and see a decrease in their disease symptoms.

    • Obefazimod/ABX464
  • Study on the effectiveness of Ozanimod in treating Ulcerative Colitis

    This study is focused on evaluating the effectiveness and safety of ozanimod, a medication, in children with active ulcerative colitis, a challenging gastrointestinal condition associated with intense pain. The primary objective of the study is to investigate whether ozanimod, administered orally, can provide relief from the symptoms of active ulcerative colitis in children. Additionally, the study aims to assess the safety profile of ozanimod in this pediatric population.

    • Ozanimod
  • Testing ustekinumab treatment for severe ulcerative colitis

    This clinical trial is focused on understanding the safety and effectiveness of a medication named Ustekinumab in children and adolescents who are experiencing moderate to severe Ulcerative Colitis (UC), a type of inflammatory bowel disease that causes long-lasting inflammation and ulcers in the digestive tract. The study administers Ustekinumab initially through an IV (intravenous infusion) and then as a subcutaneous injection. The main aims are to determine whether Ustekinumab can help these young patients achieve clinical remission, meaning their UC symptoms are reduced or completely go away, and to monitor how the drug behaves in their bodies. Throughout the trial, the health and safety of the participants are closely monitored.

    • Ustekinumab
  • Study of etrasimod in treating intense ulcerative colitis

    This study is a follow-up to previous research for the treatment of people with moderate to serious ulcerative colitis (UC). UC is a condition that inflames the large intestine and causes sores on the inside. The study will monitor the effects and safety of a medicine called etrasimod. This research is for people who have been part of past research trials and wish to continue treatment. Doctors will track a few things like side effects and how the medicine affects the disease in ways they have designed.

    • Etrasimod
  • Study on a new combination therapy for active ulcerative colitis

    This study aims to assess the effectiveness and safety of new combination therapy with JNJ-78934804 (Guselkumab/Golimumab) in comparison to guselkumab and golimumab administred alone for individuals with moderately to severely active ulcerative colitis. Participants who have shown inadequate response, loss of response, or intolerance to approved advanced therapies will be included. The trial includes various treatment groups: placebo, Guselkumab, Golimumab, and different doses of JNJ-78934804. All participants meeting inadequate response criteria will be escalated to an active treatment. The study will last for 48 weeks and the progress will be tracked over this period. The primary focus is to evaluate the efficacy and safety of the different doses of new therapy in managing ulcerative colitis over the course of the study.

    • JNJ-78934804/guselkumab + golimumab
    • Golimumab
    • Guselkumab
  • Testing obefazimod as long-term treatment for Ulcerative Colitis

    This is a medical test called ABTECT – Maintenance. Scientists are trying a new treatment for people with severe cases of ulcerative colitis, a type of intestinal disease. Some people’s bodies do not respond well to common therapies, or the treatments stop working overtime. Scientists will give these people a drug called obefazimod (ABX464) in two different doses to see if it helps. The treatment lasts almost a year, followed by a follow-up visit. It is important to see whether obefazimod (ABX464) can help these people feel better without having to continue with their normal treatment, and whether it can improve gut health when viewed on camera.

    • Obefazimod/ABX464
  • Exploring the effect and safety of a new treatment for Severe Ulcerative Colitis

    This clinical trial aims to explore the potential of NX-13, a new oral medication, in providing relief to adults suffering from moderate to severe ulcerative colitis, a chronic condition that causes inflammation and ulcers in the digestive tract, leading to discomfort and other debilitating symptoms. The study is designed to test two different doses of NX-13, 250mg and 750mg, comparing them with a placebo to determine the medication’s effectiveness in managing the symptoms of this condition.

    Participants in the study will be carefully monitored to assess how well NX-13 controls the inflammation and symptoms associated with ulcerative colitis, and to ensure the safety and tolerability of the medication. The study also aims to understand the long-term impacts of the medication, with an extension period included to gather more comprehensive data on its sustained effects.

    • Amelenodor/NX-13
  • Testing oral tofacitinib for kids with ulcerative colitis

    This study tests a medicine tofacitinib in kids 2-17 with serious ulcerative colitis (UC) issue. The attempt here is to evaluate how well the medicine works, how safe it is, and how it interacts with a child’s body. All kids in the study will first get tofacitinib similar to the release rate in adults. This dose could be increased later based on need. The main goal is to examine if the medicine can handle the disease. To measure this, researchers will assess the health status after approximately 44 weeks using a Mayo score. This score will reflect the intensity of UC symptoms and overall improvement in health. The ultimate aim is to make UC less active.

    • Tofacitinib
  • Long-term study on Mirikizumab for active ulcerative colitis

    The study aims to evaluate the effectiveness and safety of the drug mirikizumab in individuals with a severe form of Ulcerative Colitis (UC). This comprehensive study involves many patients across various medical centers. Health improvement will be assessed using a specialized scoring method (MMS). The study will also closely monitor for any adverse effects.

    • Mirikizumab
  • Study on obefazimod for ulcerative colitis treatment

    This study aim is to test a new medication named obefazimod (ABX464), which might help people with a bowel condition called Ulcerative Colitis. Currently, the medicine is being tested in a large-scale study involving many centers to understand how effective and safe it is. The study will involve people who have moderate to severe Ulcerative Colitis, whose current treatment options aren’t working well. Each day, participants will be given either 25 or 50 mg of obefazimod or a placebo, which doesn’t contain the medication. The researchers will then compare outcomes between the two groups to see how well the medication works, and if it contributes to an improvement in symptoms.

    • obefazimod/ABX464
  • Testing efavaleukin alfa’s effect on moderately to severely active ulcerative colitis

    This trial is about a drug named efavaleukin alfa, which might be helpful for people suffering from ulcerative colitis. Participants will either receive one of three doses of this drug or placebo for 12 weeks. If the treatment works, participants can choose to continue it for up to 52 weeks. If initially received placebo didn’t work, treatment will be switched to efavaleukin alfa.

    • Efavaleukin alfa
  • Understanding new medicine in moderate to severe ulcerative colitis or Crohn’s disease

    This is a study about a medicine called TEV-48574, used to treat serious bowel diseases called ulcerative colitis and Crohn’s disease. The main purpose of this study is to see how well the medicine works and how much of it should be given to patients, specifically, every 4 weeks. The study aims to test two different doses of TEV-48574 while assessing its safety and the ease with which patients can manage it. Additionally, the research aims to analyze the long-term reactions of the body to the medication. Each participant will be observed for up to 66 weeks, and the entire study is expected to span approximately 37 months. The success of the treatment will be gauged through various tests, including the Mayo score, which considers symptoms such as rectal bleeding, stool frequency, and inflammation within the gut.

    • TEV-48574
  • Mirikizumab’s role in treating active ulcerative colitis

    The study investigates the impact of mirikizumab in adults with moderately to severely active ulcerative colitis. Spanning 36 weeks, the trial evaluates the drug’s effectiveness in controlling symptoms and improving patients’ quality of life.

    • Mirikizumab
  • Testing etrasimod for teenagers with ulcerative colitis

    This study is about a medicine called etrasimod for teenagers with a disease called ulcerative colitis. Ulcerative colitis is a sickness where your gut gets inflamed and can cause stomach pain, diarrhea, and weight loss. In this study, all patients will be given etrasimod to see how well it works and how safe it is. The treatment period will take about a year, but if things go well, patients could stay in the study for up to four more years (for a total of five years from when they joined).

    • Etrasimod
  • Study of tofacitinib for young patients with ulcerative colitis

    A study is underway to understand the effects of tofacitinib on children with ulcerative colitis (UC). This medication, which has been used in adults, is now being tested in children aged 2 to 17 to see if it can safely help them manage their UC symptoms. The treatment involves an initial dose adjusted for children, with monitoring for up to 180 weeks. Researchers are looking to see if the treatment can induce remission, which would mean a significant reduction in UC symptoms and inflammation.

    • Tofacitinib
  • Testing effectiveness of hydrocortisone acetate suppositories for ulcerative colitis

    This trial involves the administration of hydrocortisone acetate suppositories to treat ulcerative colitis in the rectum—an inflammation of the bowel. The study covers adults over 18 years of age. This scientific method ensures unbiased results. Over a span of 28 days, participants will receive a rectal suppository in the morning and evening. The trial aims to measure the safety and effectiveness of the administered drug compared to a placebo. The final goal is to alleviate the symptoms of ulcerative colitis and improve the quality of life for patients suffering from this condition.

    • Hydrocortisone acetate