📚 Part of the TILA-278 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.

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Mock / simulation document

This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.

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About this document — a plain-language guide

What it is. Trial Master File operational document for Study TILA278-201.

Why it exists. An operational trial document describing how the trial is run.

How it is produced here. It is an operational trial document — a plan, charter, or template of the kind kept in the Trial Master File. It describes how the trial is run, rather than reporting the trial's results.

Format & governing standard. ICH E6(R3) / GCP

Informed Consent Form (TILA278-201)

Field	Value
Document ID	TMF-001
Version	1.0
Compound	TILA-278 (anti-TL1A antagonist / IL-22R agonist bispecific)
Standard	ICH E6(R3) / GCP
Confidentiality	Confidential

Trial Master File operational document for Study TILA278-201.

Change History

Version	Date	Author	Summary
1.0	2026-07-08	Clinical Operations	Initial issue

Introduction and Invitation

You are being invited to take part in a clinical research study. Before you decide whether to join, it is important that you understand why the research is being done and what it will involve for you. Please take your time to read this form carefully. You may discuss it with your family, friends, your regular doctor, or anyone else you trust. A member of the study team will explain the study to you and answer any questions you may have.

This study is sponsored by Virtual Biopharma Inc. and is being carried out under Protocol TILA278-201. The study drug is called TILA-278.

Taking part is entirely your choice. If you decide not to join, or if you join and later decide to stop, your regular medical care and your relationship with your doctors will not be affected in any way.

Purpose of the Study

You are being asked to take part because you have moderate-to-severe ulcerative colitis (UC), a condition that causes inflammation and ulcers in the lining of the large intestine (colon), leading to symptoms such as diarrhea, blood in the stool, urgency, and abdominal pain.

The purpose of this study is to find out whether an investigational medicine called TILA-278 is safe and how well it works to reduce the signs and symptoms of ulcerative colitis over 12 weeks of treatment. "Investigational" means TILA-278 has not been approved by regulatory authorities for the treatment of ulcerative colitis and is still being studied.

TILA-278 is a laboratory-made antibody (a type of protein) designed to act in two ways at once: it blocks a molecule called TL1A that is involved in intestinal inflammation, and it stimulates a receptor for IL-22, a signal that may help the gut lining heal. This study is a Phase 2b study, meaning an earlier stage of testing focused on dose and effect. About 900 participants are planned across multiple study centers.

Voluntary Participation

Your participation in this study is completely voluntary. You are free to decide not to take part. If you agree to take part, you may change your mind and leave the study at any time, for any reason. Whatever you decide, there will be no penalty and no loss of any benefits or care to which you are otherwise entitled.

Study Procedures and Visit Schedule

If you agree to take part and sign this form, you will first have a screening evaluation to confirm that this study is suitable for you. This may include a review of your medical history, a physical examination, blood and urine tests, a pregnancy test if applicable, and a review of your current medications.

The treatment period lasts 12 weeks, with clinic visits at Week 0 (the first dose, called baseline), Week 2, Week 4, Week 8, and Week 12. At these visits, some or all of the following may be done:

Study drug administration: The study drug is given as an injection under the skin (subcutaneously) using a prefilled syringe or autoinjector, usually in the abdomen or thigh.
Physical examination and vital signs, including blood pressure, heart rate, and temperature.
Symptom and quality-of-life questionnaires, and a review of your bowel symptoms.
Blood draws to check your general health and safety. Some blood will be used to test for anti-drug antibodies, which shows whether your body is producing proteins that react against the study drug. A small amount of blood may be stored for additional testing related to the study.
Endoscopy (colonoscopy or flexible sigmoidoscopy): A thin, flexible tube with a camera is used to look directly at the lining of your colon and measure inflammation using a standard scoring method (the modified Mayo score). This is done at the start of the study (baseline) and again at Week 12. Endoscopy requires bowel preparation beforehand.
Review of side effects and any other medicines you are taking.

You will be asked to keep any scheduled visits and to tell the study team about changes in your health. Do not start new medicines without checking with the study doctor.

Randomization, Placebo, and Blinding

You will be placed into one of three groups purely by chance, like the flip of a coin. This process is called randomization. You will have an equal (1 in 3) chance of being assigned to:

TILA-278 High dose, or
TILA-278 Low dose, or
Placebo — an injection that looks identical to the study drug but contains no active medicine.

A placebo is used so that the study can reliably tell whether effects are truly due to TILA-278 rather than to other factors. This study is double-blind, which means that neither you nor the study staff who work with you will know which group you are in. This helps keep the results fair and unbiased. In an emergency, the study doctor can quickly find out which treatment you received if that information is needed for your medical care.

Duration of Participation

Your total time in the study is expected to be up to about 16 weeks: a screening period of up to a few weeks, followed by the 12-week treatment period ending at the Week 12 visit. Depending on the study design, you may be contacted or seen afterward for follow-up safety monitoring, and the team will explain any such contact to you.

Foreseeable Risks and Discomforts

Because TILA-278 is still being studied, not all of its risks are known. The following risks are considered foreseeable:

Injection-site reactions: redness, pain, itching, swelling, or bruising where the injection is given. These are generally mild and are more common in participants receiving the active drug than placebo.
Infections: Because TILA-278 affects the immune system, you may be at higher risk of infections, including respiratory or other infections. Tell the study team promptly if you develop fever, chills, cough, or other signs of infection.
Hypersensitivity and immunogenicity (allergic and immune reactions): Some people may develop an allergic reaction, which can range from mild (rash, itching) to, rarely, severe reactions that can affect breathing or blood pressure and require emergency treatment. Your body may also make anti-drug antibodies that could reduce how well the drug works or increase the chance of a reaction.
Worsening of your ulcerative colitis: Your UC symptoms could get worse during the study. This can happen in any group, including if you receive placebo, and can include increased diarrhea, bleeding, pain, or, uncommonly, serious complications of UC.
Blood draws: may cause pain, bruising, bleeding, lightheadedness, or, rarely, infection at the needle site.
Endoscopy: may cause discomfort, bloating, or cramping; rare but serious risks include bleeding or a tear in the bowel wall. Bowel preparation can cause nausea and dehydration.
Unknown risks: There may be side effects and long-term risks that are not yet known. If new information becomes available that could affect your willingness to continue, you will be told.

If you are able to become pregnant or father a child, you must discuss contraception with the study doctor, because the effects of TILA-278 on an unborn baby are not known. Tell the study team right away if you or your partner becomes pregnant during the study.

Potential Benefits

You may or may not benefit from taking part. If you receive TILA-278, your UC symptoms may improve, but this cannot be guaranteed. If you are assigned to placebo, you will not receive active study drug. The information gained from this study may help doctors better understand and treat ulcerative colitis in the future.

Alternatives to Participation

You do not have to join this study to be treated for your ulcerative colitis. Other treatments are available and may be suitable for you. These include approved medicines such as aminosalicylates, corticosteroids, immunosuppressants, biologic therapies, and other targeted drugs, as well as surgery in some cases. The study doctor will discuss these alternatives with you so that you can make an informed decision.

Confidentiality and Data Protection

Your privacy will be protected to the extent allowed by law. Information collected about you will be labeled with a study code rather than your name. Your coded study data may be reviewed by the sponsor and its representatives, the ethics committee/Institutional Review Board (IRB), and regulatory authorities to confirm that the study is conducted properly. Any results that are published or shared will not identify you personally. By signing this form, you authorize the collection, use, and sharing of your health information for the purposes of this study.

Costs and Compensation

The study drug and study-related procedures required by the protocol will be provided at no cost to you. You may be reimbursed for reasonable study-related expenses, such as travel, according to local practice; the study team will explain what is available. You will not be charged for taking part, and taking part does not entitle you to any share of profits from products developed as a result of the research.

Injury and What Happens If You Are Harmed

If you are injured as a direct result of taking part in this study, you should seek medical care and tell the study doctor right away. The sponsor and study team will arrange for appropriate medical care for study-related injuries in accordance with applicable requirements. Signing this form does not waive any of your legal rights.

Right to Withdraw Without Penalty

You may stop taking part at any time without giving a reason and without any penalty or loss of benefits. If you withdraw, the study team may ask to perform a final safety assessment for your protection. Data collected before you withdrew may still be used to preserve the integrity of the study. The study doctor or sponsor may also end your participation if it is in your best interest, if you do not follow the study procedures, or if the study is stopped.

Contacts

If you have questions about the study, your rights, or a possible study-related injury, please contact:

Principal Investigator: ______________________ Telephone: ______________________
Study Team (24-hour contact): ______________________
Ethics Committee / Institutional Review Board (IRB): ______________________ Telephone: ______________________

You may contact the ethics committee/IRB independently if you have concerns or complaints about the study and wish to speak with someone not directly involved in conducting it.

Statement of Consent

By signing below, I confirm that:

I have read this form, or it has been read to me, in a language I understand.
I have had the opportunity to ask questions, and my questions have been answered to my satisfaction.
I understand that my participation is voluntary and that I may withdraw at any time without penalty or loss of benefits.
I understand the purpose, procedures, risks, and potential benefits of this study.
I agree to the collection, use, and sharing of my health information as described above.
I will receive a signed and dated copy of this form.

Name of Participant (print)	Signature of Participant	Date / Time
______________________	______________________	____________

Name of Person Obtaining Consent (print)	Signature	Date / Time
______________________	______________________	____________

If applicable — legally authorized representative or witness:

Name (print)	Signature	Date / Time
______________________	______________________	____________

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