Clinical Drug Trial Studies //

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Currently Open

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1. Duet-UC (Guselkumab/Golimumab co-formulation)

• Moderate to Severe UC

• Combo therapy vs mono therapy vs placebo using guselkumab, golimumab, and Guselkumab/Golimumab co-formulation

• Treatment experienced or intolerant to 1-2 classes of biologics such as Humira or Inflectra, Stelara, or Entyvio

• 1:2:2:2:2:2 ( 10% placebo), 48-week treatment period, with extension up to 4 years of treatment

• Monthly subcutaneous infusions (5 min), Week 24 change of dose or drug for nonresponders

 

 

2. Duet-CD (Guselkumab/Golimumab co-formulation) Crohn’s Disease

• Moderate to Severe CD

• Combo therapy vs mono therapy vs placebo using guselkumab, golimumab, and Guselkumab/Golimumab co-formulation

• Treatment experienced or intolerant to 1-2 classes of biologics such as Humira or Inflectra, Stelara, or Entyvio

• 1:2:2:2:2:2 ( 10% placebo), 48-week treatment period, with extension up to 4 years of treatment

• Monthly subcutaneous infusions (5 min), Week 24 change of dose or drug for nonresponders

 

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3. TEV-48574 CD and UC 

• Moderate to Severe CD or UC

• Dose-ranging mono therapy vs placebo using TEV-48574

• Treatment experienced or intolerant to up to 2 classes of biologics, or never tried a biologic and have failed/been intolerant to steroids or immunomodulators like methotrexate or Azathioprine 

• 1:1:1:1 (25% placebo), 14-week treatment period, with 44-week extension study available Spring 2024

• Subcutaneous infusions every 2 weeks

 

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4. IBS Probiotic B. longum (BL)

• Diagnosis with IBS and self-reported psychological symptoms (no formal diagnosis)

• Randomized 1:1 probiotic vs placebo for 14 weeks

• Exclusion if diagnosed with celiac disease or use of drugs to control IBS symptoms

 

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Coming Soon Drug Trials:

5. ABX464 UC *Spring 2024*

• Moderate to Severe UC, Once Daily oral pill Obefazimod or placebo (25%) for 8-weeks, then 44-week open label.

• Can have failed/been intolerant to steroids or immunomodulators like methotrexate or AZA, or failed any biologics

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Currently Open Trials (non-drug):

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1. SHARP Pancreas Divisum (in partnership with Dr. Dana Moffatt and Dr. Jean-Gerard Coneys)

• Randomized trial of ERCP for treatment of recurrent acute pancreatitis

• Must have had a documented pancreatitis attack within the last 2 years, plus one other attack prior

• 1:1 randomization for ERCP or SHAM procedure

• Must have the study procedure scheduled at HSC only

 

2. IBD Dysplasia surveillance

• Scheduled Colonoscopy for surveillance only, UC or CD

• IBD in remission, or mild-moderate flare, no active severe disease

• 1:1 randomization targeted biopsies vs random biopsies for IBD Dysplasia surveillance

• Must have a scope scheduled at HSC only

 

3. FMT in Pouchitis

• Enema Fecal Transplant for active Pouchitis 

• 1:1 randomization, 7-weeks Fecal Transplant or placebo, then 7 weeks open-label Fecal Transplant

• Pouchoscopy is done at start, week 7 and week 14 of the study

• Must have the scopes scheduled at HSC only

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