A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of an Investigational Drug in participants with Moderately to Severely Active Crohn's Disease (CD): AIM-CD
To assess the efficacy, safety, and tolerability of the investigational drug in comparison with placebo in participants with moderately to severely active CD who had inadequate response to or were intolerant of prior biologics.
- Confirmed diagnosis of Crohn's Disease (CD) for at least 3 months prior to Baseline of the Induction Period.
- Crohn's Disease Activity Index (CDAI) score 220 to 450 at Baseline of the Induction Period.
- Endoscopic evidence of mucosal inflammation as documented by a Simple Endoscopic Score for Crohn's Disease (SES-CD) of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease as scored by a central reader. All eligible scores must exclude the presence of narrowing component.
- Demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, or ustekinumab.
- Participants with prior intolerance to adalimumab.
Study description/explanation of participation:
If you take part, you will be in the AIM|CD Study for up to 1.5 years (18 months). The study is comprised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non- responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or investigational drug in 2 different doses every other week. Participants in the placebo group who are initial responders will receive the investigational drug in the maintenance period.
Description of treatment or intervention (mechanism of action):
The investigational drug is an antibody-drug conjugate, which means it is composed of an antibody linked to another drug called a glucocorticoid receptor modulator (GRM). The antibody component is designed to target and deliver the GRM into activated immune cells that are present in inflammation. The GRM component is designed to act similarly to a steroid (such as prednisone) by reducing inflammation in the body, with the goal of having less side effects than typically seen with steroids.
- Attend all study visits
- Tell the study doctor if you are feeling bad or worse than before
- Do not change your basic treatment for Crohn's disease before discussing it with the study doctor
- Tell the study doctor if you have any changes in any medications during the study
- Follow the directions of the study doctor and research team
- Refrain from participation in other research studies while you are a participant in this study
- Fill out the electronic questionnaires and electronic diary completely and honestly and bring the electronic diary to the study doctor's office at each visit
- Carry your participant card with you as long as you are in the study and show it to any medical staff that may be involved in your healthcare
Possible risks and side effects:
In past clinical studies of the investigational treatment, the most common side effects included headache and viral upper respiratory tract infection. Other potential risks associated with drugs that affect the immune response are serious infections, allergic reactions, malignancies, and injection site reactions. The informed consent form will have a full list of possible side effects.