Novel Therapeutic Trials
A major goal of the Allegretti Lab is have a therapeutic option for any patient in need. We currently have ongoing trials for patients with IBD, C. difficile infection or both! Information regarding ongoing sponsored and investigator initiated trials below. Please reach out with any questions.
Inflammatory Bowel Disease Therapeutic Trials
VOICE: Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
The primary aim of this study is to explore the time course of response to Vedolizumab in participants with CD as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-short form (SF), as well as other PROMIS domain SFs (fatigue, anxiety, depression, sleep disturbance, physical function, and ability to participate in social roles and activities); other PRO measures will also be assessed.
Eligible patients are adults 18 years of age or older with confirmed active (Crohn’s Disease) CD, as per standard clinical criteria, including symptoms, endoscopy, histopathology, and imaging.
CHROMA CD: A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Crohn's disease. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks, including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants
Eligible patients are between 18 - 75 years old who have been experiencing moderate-to-severe Crohn’s Disease (CD) for at least 3 months by the time of screening. Must have also received and experienced an inadequate response to prior treatment for CD. Patients with an ostomy or ileoanal pouch, prior colectomy, or anticipated colectomy during their participation in the study are ineligible for this trial.
COLOR UC: A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Ulcerative Colitis. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate-to-severe Ulcerative Colitis. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks, including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants
Eligible patients are between 18 - 75 years old with moderate-to-severe UC at screening. Must have also received and experienced an inadequate response to prior treatment for UC. Patients with an ostomy or ileoanal pouch, or patients with surgical bowel resection within the past three months prior to screening, or a history of >3 bowel resections are ineligible for this trial.
FMT for treatment of Crohn’s Disease: Standardized Microbiota Transplant Therapy in Crohn's Disease
The MTTCD study is an open-label, randomized, double blind study that aims to assess if two forms of encapsulated FMT material (MTP101C and MTP101S) can effectively engraft in the ileum and colon of individuals with Crohn's Disease (CD). This study will also assess how the impact of CD phenotype impacts engraftment. Finally, it will explore the symptoms and endoscopic changes before and after these two therapies.
Eligible patients are at least 18 years old with inadequate response or loss of response to their current CD therapy. They will also currently be on maintenance dosing of their CD therapy.
Low Dose IL-2 for the treatment of Moderate to Severe Crohn’s Disease:
One promising new approach to treat IBD is through the manipulation of regulatory T cells (Tregs). Interleukin-2 (IL-2, Proleukin®) is a T cell growth factor. IL-2 is currently licensed for the treatment of metastatic renal cell carcinoma and metastatic melanoma. At low doses, IL-2 promotes the selective activation and expansion of Tregs in humans. Low-dose (LD) IL-2 selectively expands Tregs in humans and is safe in chronic GvHD and other phase 1 and 2 clinical trials.
This is a phase 1b/2a clinical trial to assess the safety and the efficacy of LD SC IL-2 for the treatment of CD utilizing daily subcutaneous injections for 8 weeks. Responders to therapy will be offered an additional 52 weeks of therapy.
Eligible patients include those age 18-80 years with a diagnosis of moderate-to-severe Crohn’s Disease and failure to tolerate or to respond to at least one conventional therapy
Roche UC: A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (Ametrine-1)
The Ametrine study is a phase III double-blind, placebo-controlled, study to evaluate the efficacy and safety of RO7790121 for induction and maintenance therapy in participants with moderately to severely active Ulcerative colitis.
Eligible patients must be 18 years of age with a demonstrated inadequate response, loss of response, and/or intolerance to at least one conventional or advanced UC therapy.
Roche CD: A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease (SIBERITE-1)
The Siberite study is a phase III double-blind, placebo-controlled, study to evaluate the efficacy and safety of RO7790121 for induction and maintenance therapy in participants with moderately to severely active Crohn’s disease.
Eligible patients must be 18 years of age with a demonstrated inadequate response, loss of response, and/or intolerance to at least one conventional or advanced CD therapy.
Clostridioides difficile Infection Trials
REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study
REBYOTA is a microbiota suspension prepared from human stool which is collected from prescreened and qualified donors, and addresses the GI dysbiosis, which is seen as the root cause of CDI. Unlike fecal microbiota transplantation (FMT), REBYOTA is not intended to treat actual episodes of symptomatic CDI but given only after antibiotic treatment to prevent recurrent CDI.
Eligible patients are adults who meet the following criteria:
Diagnosis of recurrent CDI as determined by the treating physician
Completed antibiotic treatment for the presenting recurrent CDI episode
AstraZeneca: An Observational Study in Adults with Clostridioides difficile Infection to Determine the Feasibility and Logistics of Biospecimen Collection, Transportation and Testing at Select US Study Sites
This is an exploratory, non-interventional, unblinded, observational study evaluating the acceptability, feasibility and performance of methods to collect, transport and test biospecimens in patients with active Clostridioides difficile infection. Participants will also be monitored for recurring episodes of diarrhea and will need to complete diaries and study evaluation questionnaires.
Eligible patients are at least 18 years of age and are currently being treated for a lab-confirmed episode of C. difficile.
VE303 for Prevention of Recurrent Clostridioides Difficile Infection (RESTORATiVE303)
This is a double-blind, placebo-controlled, Phase 3 study to evaluate safety and Clostridiodes difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303, an oral capsule that contains 8 well-characterized, nonpathogenic, nontoxigenic, commensal bacterial strains that are grown from pure clonal cell banks. There is a 22 week follow-up period after dosing is completed.
Eligible patients are at least 18 years of age and are currently receiving antibiotic treatment for a confirmed episode of C. difficile, and must have had at least one other confirmed and treated episode of C. difficile in the past 6 months.