Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon and rectum. It is a type of inflammatory bowel disease (IBD) that causes inflammation and ulcers in the digestive tract, leading to symptoms like abdominal pain, diarrhea, and rectal bleeding. Managing UC can be challenging, as treatment options often vary depending on the severity of the disease and individual responses to therapy. For patients seeking advanced or alternative treatments, clinical trials offer a pathway to explore cutting-edge therapies under expert supervision.
This article provides a comprehensive list of clinical trials for ulcerative colitis available in the United States, alongside details about their purpose, eligibility criteria, and how to participate.
Understanding Clinical Trials for Ulcerative Colitis
Clinical trials are research studies designed to evaluate new medical treatments, drugs, or therapies. For ulcerative colitis, these trials aim to:
- Assess the efficacy and safety of new medications or biologics.
- Explore alternative therapies, such as dietary interventions or probiotics.
- Investigate long-term outcomes of existing treatments.
- Study the genetic or environmental factors contributing to UC.
Participating in a clinical trial can provide patients with early access to innovative treatments and contribute to advancing medical science.
Current Clinical Trials for Ulcerative Colitis in the USA
Clinical Trials.Gov allows you to search for clinical trials for ulcerative Colitis
VE202 in Patients with Mild-to-Moderate Ulcerative Colitis
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).Detailed DescriptionA Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.
Phase 2a To Evaluate PL-8177 in Subjects With Active Ulcerative Colitis (UC)
The purpose of this study is to compare PL8177 (a melanocortin receptor agonist) to placebo (in a 3:1 ratio-meaning that for every 3 people that get the active drug, one will receive placebo). The study treatment will be for 8 weeks. The study will measure safety and the body's ability to handle PL8177 and look at the improvement and healing of the intestine after 8 weeks of treatment. The study will include adult males and nonpregnant, nonlactating females with acute Ulcerative Colitis (UC).This study will have potential subjects participating for approximately 4 months: Subjects will be screened to assess their eligibility within 28 days prior to the first dose administration; Day 1 will be eligibility confirmation and in-clinic dosing; additional visits to occur at Weeks 2, 4, 8 and 12. Routine laboratory tests, vital signs and ECG will be measured as well as blood, stool and tissue samples obtained for biomarker and PK studies. Endoscopy is required at screening visit and week 8 visit. Patients will also be given an electronic diary to enter on a daily basis for the duration of their participation. Additional patient questionnaires will be done at clinic visits. Optional genomics testing will also be completed for this study to help look at genes and their effect on inflammation.
The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).Detailed DescriptionThe study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.Official TitleAn Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination With Mirikizumab for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis
How to Participate in a Clinical Trial
Step 1: Search for Trials
Use online platforms like:
- ClinicalTrials.gov: A comprehensive database of clinical trials in the USA.
- CenterWatch: Focused on research opportunities for patients.
Search for “ulcerative colitis” and refine results based on location and eligibility criteria.
Step 2: Contact the Research Team
Once you identify a trial of interest, reach out to the study coordinators using the contact information provided. They will explain the trial’s purpose, procedures, and requirements.
Step 3: Pre-Screening
Before enrolling, participants undergo a pre-screening process to determine eligibility. This includes medical history reviews, physical exams, and diagnostic tests.
Step 4: Informed Consent
Participants are required to sign an informed consent form, ensuring they understand the study’s details, potential risks, and benefits.
Benefits of Joining a Clinical Trial
- Access to Innovative Treatments:
- Participants may receive cutting-edge therapies not yet available to the public.
- Expert Care:
- Trials are conducted under the supervision of top medical professionals and researchers.
- No Cost for Treatment:
- Many trials cover treatment costs, including medications, tests, and doctor visits.
- Contributing to Science:
- By participating, you help advance research and improve treatments for future patients.
Considerations Before Joining a Clinical Trial
- Potential Risks:
- As with any medical treatment, there may be side effects or unforeseen risks.
- Time Commitment:
- Trials often require regular visits, follow-ups, and adherence to specific protocols.
- Uncertain Outcomes:
- Not all experimental treatments are successful, and some may have limited benefits.
- Eligibility Restrictions:
- Participants must meet strict criteria, which may exclude some patients.
Tips for Choosing the Right Trial
- Consult Your Doctor: Discuss clinical trial options with your gastroenterologist to ensure they align with your treatment goals.
- Review the Protocol: Understand the procedures, duration, and potential risks.
- Consider Location: Choose a trial site that is convenient and accessible.
Conclusion
Clinical trials offer hope for patients with ulcerative colitis by providing access to groundbreaking therapies and expert care. From biologics and diet-based interventions to cutting-edge microbiome research, there are numerous opportunities to participate in studies tailored to UC patients’ needs. By joining a clinical trial, you not only explore potential treatments for yourself but also contribute to advancing care for others living with UC.
Explore available trials today and take the first step toward improved health and well-being.
