A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With afimkibart in Patients With Moderately to Severely Active Crohn's Disease (SIBERITE-2)
General Information:
This study is testing a medicine called afimkibart. Afimkibart is an investigational medicine being developed to treat Crohn’s Disease (CD). This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved afimkibart for treating CD. This study aims to compare the effects of afimkibart as long-term treatment against ‘placebo’. A placebo is a medicine that contains no active ingredients but looks the same as the study medicine. Researchers want to see if afimkibart works, how well it works and how safe it is when given over a long period of time. This is compared to a placebo in people living with moderately to severely active CD.
Eligibility:
Key Inclusion Criteria:
-People aged 16 to 80 years old, with moderately to severely active CD can take part in the study.
-CD diagnosis must have been confirmed by an ‘endoscopy’. An endoscopy is a procedure where a doctor uses a flexible tube with a camera on it to look inside the large intestine (colon).
-To take part, people also must have taken at least 1 other medicine for CD that didn’t work very well, stopped working, or caused unacceptable unwanted effects.-People aged 16 to 80 years old, with moderately to severely active CD can take part in the study.
-People aged 16 to 80 years old, with moderately to severely active CD can take part in the study.
-CD diagnosis must have been confirmed by an ‘endoscopy’. An endoscopy is a procedure where a doctor uses a flexible tube with a camera on it to look inside the large intestine (colon).
-To take part, people also must have taken at least 1 other medicine for CD that didn’t work very well, stopped working, or caused unacceptable unwanted effects.
Key Exclusion Criteria:
-People cannot take part in this study if they have had 3 or more surgeries to remove part of the intestines, or they are taking certain medicines for CD.
-People who have certain other medical conditions such as ulcerative colitis, abnormal cells in their bowel (known as ‘dysplasia’), some types of cancer within the last 5 years, or certain infections such as HIV, hepatitis B, hepatitis C, or tuberculosis, also cannot take part.
-People who are pregnant, planning to get pregnant, planning to donate eggs or sperm, or are currently breastfeeding cannot take part in the study.
-People cannot take part in this study if they have had 3 or more surgeries to remove part of the intestines, or they are taking certain medicines for CD.
-People who have certain other medical conditions such as ulcerative colitis, abnormal cells in their bowel (known as ‘dysplasia’), some types of cancer within the last 5 years, or certain infections such as HIV, hepatitis B, hepatitis C, or tuberculosis, also cannot take part.
-People who are pregnant, planning to get pregnant, planning to donate eggs or sperm, or are currently breastfeeding cannot take part in the study.
Study Details:
Study description/explanation of participation:
This study has three parts:
1. Screening (to see if you are eligible for the study)- Up to 5 weeks
2. Treatment- Up to 12 weeks (without participation in open label extension)
The treatment part of the study will have two phases:
Induction phase
Optional open-label extension phase
3. Follow-up (to check on you after treatment is finished)- 12 weeks
Description of treatment or intervention (mechanism of action):
Afimkibart is an antibody directed against a protein called TL1A. TL1A is a protein found naturally in the body that has a role in inflammation. It has been found that TL1A levels and activity are increased in patients with Crohn's disease. This increase is thought to lead to the development and worsening of the disease. Although there have been no completed clinical trials to investigate afimkibart for treating Crohn’s disease, other early research has shown that patients with ulcerative colitis, a disease similar to Crohn's disease, have benefited from treatment with afimkibart. Afimkibart is an investigational drug, which means health authorities have not approved afimkibart for the treatment of Crohn's disease.
Patient Participation Requirements:
The study doctor will review all participation requirements with you to help you determine if you would like to participate in the trial. In general, patients on this study should:
Attend all study-related visits
Complete all tests and procedures required by the study
Complete required diaries and questionnaires
Take the investigational study treatments as directed
Tell the study doctor if you are feeling bad or worse than before
Tell the study doctor if you have any changes in medications during the study
Refrain from participating in another research study while participating in this study
Possible risks and side effects:
Participants may have unwanted effects of the investigational drug used in this study. These unwanted effects can be mild to severe, even life-threatening, and vary from person to person. During this study, participants will have regular check-ups to see if there are any unwanted effects.
Afimkibart has had limited testing in CD. The potential unwanted effects of this medicine are based on human and laboratory studies, or knowledge of similar medicines. These include allergic reactions, feeling sick and joint pain. There might be other unwanted effects that are not known at this time. Known unwanted effects of infusions include pain, bruising, redness, warmth, burning, stinging or itching on the skin where it has been pricked with a needle to give a treatment. Other unwanted effects of infusions can include throwing up, wanting to throw up, a feeling of coldness that makes the body shiver, low or high blood pressure, fever, pain or discomfort in the head. Known unwanted effects of injections under the skin include a reaction, swelling or rash on the skin where it has been pricked with a needle to give a treatment. The study medicine(s) may be harmful to an unborn baby. Women and men must take precautions to avoid exposing an unborn baby to the study treatment.