This study is evaluating the safety and effectiveness of an investigational medication called Afimkibart for people with moderate to severe Crohn’s disease. Researchers hope to learn whether targeting the TL1A inflammatory pathway can help reduce symptoms and inflammation while providing a safe long-term treatment option.

You may be eligible for this study if you meet the following criteria.

Inclusion Criteria:

• Adults ages 18 to 80 with a confirmed diagnosis of moderate to severe Crohn’s disease
• Have tried previous advanced therapy that did not work well, stopped working, or caused side effects, or have not yet received advanced therapy
• Currently experiencing Crohn’s disease symptoms such as abdominal pain, bowel urgency, or fatigue
• Willing to use contraception during the study (if applicable)

Exclusion Criteria:

• Diagnosed with ulcerative colitis or certain other inflammatory bowel diseases
• Have short bowel syndrome or an ileostomy or colostomy
• Have an abdominal or perianal abscess, bowel obstruction, or require surgery for Crohn’s disease
• Diagnosed with primary sclerosing cholangitis (PSC)

If you qualify, you may participate in the study for approximately 1 year, with the option to continue in an extension phase where all participants receive the investigational medication.

During the study, you will attend scheduled visits at Penn State Milton S. Hershey Medical Center. At these visits, you may:

• Complete a screening visit and endoscopy to determine if you qualify
• Receive the study medication or placebo through IV infusions during the early part of the study
• Receive study injections approximately every 4 weeks during the maintenance phase
• Have your vital signs checked and complete physical exams during select visits
• Provide blood, urine, and stool samples
• Undergo study procedures such as endoscopies and ECGs
• Meet with the study team to review your symptoms, medications, and any questions you may have
• Remain for a short observation period after receiving study treatment

Between visits, you will be asked to:

• Complete a daily symptom diary or questionnaire
• Continue taking any approved medications as instructed by the study team
• Report any changes in your health or medications

Additional Information

Study-related procedures, including blood work, endoscopies, ECGs, and physical exams, are provided at no cost. Participants receive travel reimbursement with receipts and can enjoy private rooms and snacks during study visits.

No video or audio recordings are part of this study.

Participants will receive $75 for each completed study visit. Travel reimbursement of up to $50 per visit is available with submitted receipts.

In addition to compensation, participants receive study-related medical care at no cost, including blood work, endoscopies, ECGs, physical examinations, and other required procedures. Private rooms with snacks are provided during study visits, and participants may discuss their care with study physicians and receive applicable test results.

No. There is no cost to participate in this study.