Clinical Research Studies
Crohn's Disease

We’re aiming to take Crohn’s treatment out of the hospital.

Clinical Study FAQs

What is the AFFIRM Study?

The AFFIRIv1 Study is a clinical research study (also called a "clinical trial") that is looking at a study drug to see if it can safely be given subcutaneously (an injection under the skin) with the goal of inducing "remission" in adults with moderate to severe Crohn's disease (CD). Remission is the point where CD symptoms improve significantly or

disappear completely.

The study drug is designed to target a protein that is responsible for inflammation when your body produces too much of it. This can lead to CD symptoms. The study drug aims to block t his protein in your body and reduce inflammation.

The study drug has been tested in multiple countries for CD in adults. It is first given as an intravenous (directly into the vein) infusion with the goal of inducing remission (known as "induction therapy"). This is followed by a subcutaneous injection with the goal of keeping the patient in remission (known as "maintenance therapy").

Alt hough the study drug has been tested in multiple countries, giving the study drug as a subcutaneous injection for induction therapy is investigational.

The study will last for up to 93 weeks (about 22 months).

What is the HORIZON Study?

The HORIZON Study is a clinical research study (also called a "clinical trial") looking at an investigational study drug to see if it is safe and effective, when compared to an approved drug, at treating moderate to severe ulcerative colitis (UC).

The investigational study drug is designed to block 2 proteins in the body that contribute to inflammation and are thought to play a role in UC.

The first-time participants receive the assigned study treatment (either the investigational study drug or the approved drug). they will be given:

1 intravenous infusion {a slow drip into a vein), and
2 subcutaneous (under the skin) injections.

After this. the study treatment will be given only as a subcutaneous injection. Participants will continue to receive the study treatment at study center visits, or a supply will be given to take at home by self-injection.

Approximately 200 adults with moderate to severe UC will take part in this study. This study will specifically enroll adults who have tried at least 1 previous therapy for UC that did not work.

The study will last for about 1 year and 4 months.

What is the TARGET-CD Study?

The TARGET-CD Study is a clinical research study (also called a "clinical trial") that is evaluating multiple targeted therapies for moderate to severe Crohn's disease (CD) in adults. The study will look at the targeted therapies (the "study drugs") to find out if they:

are safe, and
work to induce remission in adults with moderate to severe CD. Remission is the point where CD symptoms improve significantly or disappear completely.

The study drugs are different types of targeted biologic drugs. They work by blocking different proteins in the body that cause inflammation. which can help reduce CD symptoms.

All the study drugs will be given either as a subcutaneous (under the skin) injection or an intravenous (IV) infusion (directly into the vein in your arm).

The study will last for approximately 28 weeks (7 months) with an option to join a 72-week extension study, if recommended by the study doctor.

What is a clinical research study?

A clinical research study, also called a clinical trial or research study, helps to answer important questions about a potential new medication or a new use of an approved medication, such as:

Does it work?
How safe is it?
What amount, or dose, may work best?
VVhat are the possible risks and benefits?
Does it affect people differently based on their age, sex, gender, race, or ethnicity?

What is an investigational medication or study drug?

An investigational medication, also sometimes called an "investigational drug" or o ''study drug," has been tested in a laboratory. Based on those results, it has been approved by health regulatory authorities for testing in people. It also may be a medication or drug that is approved for the treatment of one disease or condition but is still under investigation in other diseases or conditions. An investigational drug can only be used in clinical research studies.

All investigational drugs must be tested in clinical research studies before they can be approved by health regulatory authorities to be prescribed to patients. V..Je need people to take part in clinical research studies so that new medicines can be developed.

I have read all of the information on this website, and I still have questions about trying a study drug that may not work. Can you give me more information?

There are always risks and benefits of participating in a clinical research study. There is always a chance that the study drug could cause side effects or will not work. However. you should know that there are strict rules in place to monitor the safety of study participants. Before joining any clinical research study, it is important to consider the risks and understand what they arc. The study site staff will explain all of the risks and benefits at the first study visit. Throughout the study, participants will be closely monitored by a team of doctors and nurses. They will be there to answer any questions you may have.

What happens if I decide to take part?

If you would like to know whether you might be eligible for the study, please fill out the form. If you are eligible, we will match you to a clinical research study center in your area that is participating in the study. We will also help you schedule your first study appointment at the study center. Please note that before being enrolled in the study, additional eligibility criteria will be checked by the study doctor or study site staff during the screening process.

Is there a cost to take part?

The study-required investigational drug drug will be provided at no cost. Study-related care from a team of experienced doctors and nurses will also be provided throughout the study at no cost to study participants.

Will participant confidentiality be protected?

All personal information will remain confidential, and data will only be collected once used if necessary to support an individual's match to participate in a study. Participants' names will not be included in any data reported. For more information, including how and why we process personal data, please read our Privacy Policy.

Are clinical research studies safe?

Clinical research studies must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any study.

Participating in a clinical research study comes with risks as well as benefits. Before joining a study, potential participants must make sure they understand the benefits, such as getting access to study-related medical care and maybe helping others in t the future. They must also understand the risks, such as unknown side effects. Potential study participants can take as much time as they need to decide whether to take part and get as much information as they can. Before joining a study, the potential study participant will be asked to sign an informed consent form, which will include a full explanation of the study, including its potential risks. If the potential study participant is not capable of giving informed consent, a legally authorized representative may provide informed consent on their behalf. In this situation, the potential study participant would provide informed assent.

What else do I need to think about?

It is up to you to decide if you want to take part in the IBDiscover Studies. Participation in the study is voluntary. Please also consider:

If you decide to participate. you can withdraw at any time during the study.
The study site staff will explain the possible benefits and risks of the study during the informed consent process.
You do not have to take part in the study if you don't want to.
A team of doctors and nurses will monitor the health of participants carefully during the study.
The study drug(s) will be provided at no cost.
If you decide to participate. you may be helping people with IBD in the future.

Participants will need to follow all the instructions from the study doctor and nurses.

Crohn's Disease Study M23-784

Discover if you are eligible

Please select your age. ^*

Less than 18 years of age

18 years of age or older

Are you 18 to 75 years of age (inclusive)? ^*

Yes

No, I am 76 years of age or older

Have you ever been diagnosed by a medical professional with ulcerative colitis or Crohn's disease? ^*

Yes, I have been diagnosed w ith ulcerative colitis

Yes, I have been diagnosed w ith Crohn's disease

No, I have not been diagnosed with ulcerative colit is or Crohn's disease

Have you tried 1 or more of the following categories of drugs for your condition and they did not work or stopped working? Please select all that apply. ^*

Oral aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, balsalazide)

Oral locally acting steroids (for example, budesonide, beclomethasone))

lmmunomodulators (for example, azathioprine, mercaptopurine, methotrexate, tacrolimus)

Advanced therapies, including biologics and non-biologics (for example, infliximab, golimumab, vedolizumab, ustekinumab, tofacitinib, ozanimod, upadacitinib, filgotinib, etrasimod)

No, I have not demonstrated an intolerance or inadequate response to any of the drugs mentioned above

I don't know

Have you ever used the drug adalimumab (Humira®) or a biosimilar? ^*

Yes

I don't know

Have you ever used a type of drug called an IL-23 p19 inhibitor (for example, mirikizumab (Omvoh™), guselkumab (Tremfya®), or risankizumab (Skyrizi®))? ^*

Yes

I don't know

Have you had any of the medical procedures listed below? Please select all that apply. ^*

An organ transplant that requires continued immunosuppression

Current ostomy or ileoanal pouch

Major surgery in the past 3 months (for example, hip replacement, aneurysm removal, stomach ligation)

Surgical bowel resection within the past 3 months, OR a history of 3 or more surgical bowel resections

Total colectomy

Subtotal colectomy (defined as surgical removal of part of the large bowel) where 2 or fewer of the fol lowing segments of your colon were removed: terminal ileum, right colon, transverse colon, left colon and sigmoid, or rectum

Subtotal colectomy where more than 2 of the following segments of your colon were removed: terminal ileum, right colon, transverse colon, left colon and sigmoid, or rectum

None of the above

I don't know

Have you ever been diagnosed by a medical professional with any of the following health conditions? Please select all that apply. ^*

Stroke or heart attack in the past 6 months

Congestive heart failure

Lupus

Have you had cancer in the past 5 years

Indeterminate colitis or fulminant colitis

Radiation colitis or ischemic colitis

Inflammatory bowel disease-unclassified

Ongoing abscess (abdominal or perianal)

Toxic megacolon (swelling and inflammation of the colon)

Short gut or short bowel syndrome

Hepatitis B, hepatitis C, tuberculosis (TB), and/or C. difficile infection (please select only if you have these infections now)

None of the above

I don't know

Was the cancer you were diagnosed with: ^*

non-melanoma skin cancer or uterine cervical cancer that was successfully treated?

any other cancer?

Are you currently experiencing any symptoms of ulcerative colitis or Crohn's disease flare-up? Please select all symptoms in the list below that apply. ^*

Diarrhea (more bowel movements per day compared with periods of remission)

Abdominal pain/cramping

Blood in your stools (either mixed with stools or blood alone)

Fever

Fatigue (low energy)

Inflammation seen during a colonoscopy

None of the above

Please choose the race and/or ethnicity that describes you. Choose all that apply. ^*

Hispanic or Latino

American Indian or Alaskan Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

White

Other

Prefer not to say

Patient Information

Only the research study staff can fully determine if you qualify to enroll in the study. Please enter your information below and a study coordinator will contact you soon.

Patient First Name ^*

Patient Last Name ^*

Gender ^*

DOB ^*

Address ^*

City ^*

State ^*

Zip Code ^*

Home/Cell Phone ^*