Patients
Shattuck Labs is focused on our mission of improving the lives of patients with inflammatory bowel disease (IBD) and other inflammatory and immune-mediated diseases. We believe that novel protein engineering can produce potentially transformative medicines such as SL-325 that can impact the lives of these patients in a meaningful way.
We believe innovation begins by listening — to patients living with disease, to caregivers providing support, and to the communities who inspire our mission every day. Our commitment includes:
We are honored by the trust patients and caregivers place in clinical research and in our company. Together, we are working toward a world where better treatment options — and better outcomes — are possible for all who need them.
Prioritizing patient safety and well-being in every stage of research and development
Designing clinical trials with accessibility, transparency, and the patient experience in mind
Engaging with patient advocacy groups and healthcare communities to better understand unmet needs
Communicating clearly and responsibly about our science, studies, and progress
Pursuing therapies that have the potential to make a difference for patients and families
Clinical trials help researchers discover new ways to prevent, diagnose, and treat diseases. A clinical trial is a research study involving human volunteers. These studies evaluate investigational drugs, devices, or medical approaches to determine their safety and effectiveness. Clinical trials are conducted under strict medical and ethical guidelines and closely monitored by healthcare professionals, regulatory agencies, and ethics committees.
People choose to participate in clinical trials for many reasons. Participation may offer:
Access to Investigational Treatments
You may receive therapies not yet approved or widely available.
Helping Future Patients
Your participation may contribute to medical advances that benefit others.
It is best to start your search for a clinical trial by speaking with your physician. Talk to them about any trials that might be right for your condition. You can also search for trials online at www.clinicaltrials.gov, https://euclinicaltrials.eu, or a similar clinical trials database in your country.
SL-325 and other Shattuck products are investigational drugs currently being studied in clinical trials. The safety and effectiveness of Shattuck’s investigational drugs have not been established. They have not been approved for any use by the FDA, European Commission, or any other health authority.
Phase 2 Trial of SL-325 in adults with moderately to severely active Crohn’s disease
This study will evaluate the safety and efficacy of SL-325 in adult patients with moderately to severely active Crohn’s disease. It includes a 3-month placebo-controlled induction period, 9-month active treatment maintenance period, and a 12-month long-term extension. About one in four participants will receive placebo during the induction period, but all placebo participants will receive SL-325 during the maintenance period and beyond.
Shattuck Labs does not currently provide any investigational drugs for expanded access-sometimes referred to as compassionate use, individual patient use, or named patient use programs. To establish an expanded access program, we must first have sufficient data on the dosing, safety, and potential efficacy of the drug in patients to allow for an informed risk-benefit assessment for any expanded access requests. We do not expect this to occur before the end of any Phase 2 studies that we undertake.
We will provide a more detailed expanded access policy on our website and the FDA’s Expanded Access Navigator website (www.reaganudall.org) before advancing a product into Phase 3.