Inflammatory Bowel Disease Therapeutic Trials

TAHOE Study: For the Treatment of Moderate to Severe Crohn’s Disease

This is a Phase 2 clinical trial designed to evaluate the safety and efficacy of RVT-3101, a subcutaneously administered anti-TL1A biologic, in adult participants with moderate-severe active Crohn’s Disease. Doses will be administered every four weeks for 56 weeks, followed by an 8 week follow up period. This study has no placebo arm, and all patients will be randomized to receive either high or low dose of the study drug.

Eligible participants are those aged 18 to 75 years of age diagnosed with moderate or severely active Crohn’s Disease and are either corticosteroid dependent or have inadequately responded to or are intolerant to conventional or advanced therapies.

Janssen Duet-UC: For the treatment of moderate to severe Ulcerative colitis

This is a Phase 2 clinical trial to evaluate the safety and efficacy of a dual biologic combination therapy of  Guselkumab and Golimumab in patients with moderately to severely active Ulcerative Colitis (UC). Duet-UC administers all doses subcutaneously via an infusion set every four weeks for up to 48 weeks. Patients who have achieved a clinical response at week 48 will have the option to enter a long-term extension lasting for approximately four years. 

Eligible patients include those 18-65 years of age with a diagnosis of moderate or severely active UC and must have demonstrated inadequate response, loss of response, or intolerance to at least one advanced therapy for the treatment of UC.

Janssen Duet-Crohn’s: For the treatment of moderate to severe Crohn’s Disease

A Phase 2 placebo-controlled (1:10), randomized, double-blind, parallel-group, multicenter clinical trial to evaluate the safety and efficacy of a dual biologic combination therapy of  Guselkumab and Golimumab in patients with moderately to severely active Crohn’s Disease (CD). Duet-CD administers all doses subcutaneously via an infusion set every four weeks for up to 48 weeks. Patients who have achieved a clinical response at week 48 will have the option to enter a long-term extension lasting for approximately four years. 

Eligible patients include those 18-65 years of age with a diagnosis of moderate or severely active CD and must have demonstrated inadequate response, loss of response, or intolerance to at least one advanced therapy for the treatment of CD.

AMG592: For the treatment of moderate to severe Ulcerative colitis

This is a Phase 2 clinical trial to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in subjects with moderately to severely active Ulcerative colitis utilizing subcutaneous injections every two weeks for twelve weeks. Responders to therapy will be offered up to 52 additional weeks of therapy with the option to opt into an open label long term extension arm after completion of the trial.

Eligible patients include those age 18-80 years of age with a diagnosis of moderate or severely active ulcerative colitis and must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule 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