
Do you have moderately to severely active ulcerative colitis (UC)?
Active Ulcerative Colitis
What is a clinical trial?
A clinical trial, also known as a research study, helps researchers answer questions about certain conditions and diseases and their treatments.
By choosing to participate in clinical trials, participants help the research team answer questions about how the drug works and monitor to see if it is safe to use before it is released into the market.
The information provided on this website will give you details about the ALTB-268-201 Clinical Trial and help you decide if you want to become involved.
Why are clinical trials important?
Clinical trials are important because they help discover new treatments for a disease and aid in detecting, diagnosing, and preventing the disease from becoming worse. Clinical trials assist doctors in understanding a potential treatment’s safety and how effective the treatment is, what the potential side effects may be, and what works or doesn’t work before they begin prescribing them to more people.
PHASE 1
Safety of the treatment and understanding possible side effects
Small number of participants
Usually healthy volunteers
PHASE 2
Examines if the treatment does what it intends to do
Looks at the safety, effectiveness and dosage
Participates are subjects
PHASE 3
Investigates if the results are reproducible in a larger number and broader mix of participants (usually from a larger population of people from multiple countries)
Looks at the safety, effectiveness and dosage
PHASE 4
Evaluates the treatment in the “real-life” setting, or to look more closely at how specific groups of people with specific medical conditions respond to the treatment after approval by regulatory authorities
Identifies the long-term effects of a medication.
If clinical trials are not conducted, doctors will not be able to determine if new treatments actually work.
What is ALTB-268?
ALTB-268 is an engineered antibody that helps regulate the immune system by activating a receptor called PSGL-1. When the immune system is imbalanced, certain T-cells (white blood cells that help the immune system protect the body from disease) can become overactive. ALTB-268 regulates these cells by inhibiting their function, which helps restore balance to the immune system.
ALTB-268 works similarly to AltruBio’s first-generation antibody, ALTB-168. ALTB-168 has shown promise in treating various conditions, including ulcerative colitis, psoriasis, psoriatic arthritis, and graft-versus-host disease (GVHD). A
recent study of ALTB-268 in healthy volunteers found that the drug was safe and well-tolerated without any serious side effects.
The ALTB-268-201 Clinical Trial aims to see how well ALTB-268 can reduce your UC disease activity.
How do I sign up for the ALTB-268-201 Clinical Trial?
If you are suffering from moderately to severely active UC and are interested in participating in the ALTB-268-201 Clinical Trial, ask your doctor for more information. Your doctor will be able to tell you more about the study and answer any
questions you may have. If you decide to participate in this trial, your doctor will discuss an Informed Consent Form with you.
Further tests are completed by your doctor to see if you will qualify for the ALTB-268-201 Clinical Trial. If you meet all the requirements, you will be provided with next steps for study participation. If, at any point, you decide that you do not want to proceed with the study, you can opt-out.
What should I ask before entering a clinical trial?
Some questions you may want to ask your UC treatment center include the following:
• How may the trial benefit people with my condition?
• What are the risks associated with participation in the trial?
• What effect will the trial have on my current treatment(s)?
• Where will the trial take place?
• How long will the trial go on for?
• How often will I have to visit the trial site?
What will happen during the ALTB-268-201 Clinical Trial?
Once the ALTB-268-201 Clinical Trial begins, regular tests are done during clinic visits by the doctors and nurses to find out how the study treatment is working. At these visits, tests will include taking samples of your blood, and stool, and checking your vital signs.
Doctors and nurses may also ask you a series of questions to monitor for any side effects. An ediary will be provided to you so that you can record important information to help researchers answer questions about ALTB-268 and its effectiveness in treating symptoms of UC.
What are the benefits of the ALTB-268-201 Clinical Trial?
The study treatment you will receive may or may not improve your disease condition. However, during the trial, you will have regular check-ups and frequent blood tests, and receive more medical supervision than you would under normal treatment procedures.
The information obtained from this study may help treat future patients with UC and will provide important information about how well people respond to ALTB-268.
Are clinical trials safe?
In the ALTB-268-201 Clinical Trial, like in all approved clinical trials, the research team is required to follow strict rules to make sure that participants are safe. If there are severe side effects, you may be closely monitored, or the doctor may stop your participation in the trial.
There is a chance that the study treatment may not work as well as anticipated. The doctor and nurse will make sure you are safe throughout the entire duration of the trial. If, at any point, you decide that you do not want to proceed with the
study, you can opt-out.
Interested?
If you meet the listed eligibility criteria and would like to learn more about the ALTB-268-201 Clinical Trial, please call (318) 525-3233 to speak with the clinical research coordinator