Previous Clinical Trials

Huron Gastro has participated in many clinical trials since 2009. Previous Clinical Trials completed at Huron Gastro are listed below.  If you have any questions about our previous research, please contact our research department at twheeler@jointopo.com or call (734) 418-7736 Ext. 18.

Previous Clinical Trials

 

  • An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn’s Disease Stratified at Higher Risk for Developing Complications; Triple Combination Therapy in High Risk Crohn’s Disease (Vedolizumab-4006) Takeda Development Center Americas, Inc.
     
  • A Phase 2, Randomized , Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate  the Efficacy, Safety, and  Pharmacokinetics  of  BFKB8488A Compared  With Placebo In  Patients  With  Nonalcoholic  Steatohepatitis (GC41033 BANFF) Genentech, Inc. 
     
  • A 52-Week, Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients with Non-alcoholic Fatty Liver Disease (NAFLD) (MAESTRO-NAFLD-1 (MGL-3196-14) Madrigal Pharmaceuticals
     
  • A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Crohn's Disease (LATTICE, IM011023) Bristol-Myers Squibb Company
     

  • A Phase 2b/3, Multicentered, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis (M14-234 I/M) AbbVie, Inc.

  • A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis IND#127846 (Reverse, 747-304) Intercept Pharm, Inc. / Syneos Health
     

  • An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy with Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects with Crohn's Disease Stratified at Higher Risk for Developing Complications (Takeda EXPLORER) Alimentiv, Inc.

  • A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis (AbbVie M14-675) AbbVie, Inc.

  • A Randomized, Placebo-controlled, Double-blind, Parallel group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis (Oral AMT-101-202) Assembly Biosciences, Inc.
     

  • A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Microbiological Response of Orally Administered ABI-M201-101 in Subjects with Mildly-to-Moderately Active Ulcerative Colitis with Ongoing Mesalamine Treatment (Oral FMT) Assembly Biosciences, Inc.

  • Phase III, Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Multicenter Study to Evaluate the Efficacy (Induction Of Remission) and Safety of Etrolizumab Compared with Adalimumab and Placebo in Patients with Moderate to Severe Ulcerative Colitis who are Naive to TNF Inhibitors - GA28948 (Hibiscus)
    F. Hoffmann-LaRoche / Genentech, Inc.

  • A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (Lucent 3) Eli Lilly / Quintiles

  • A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis – AMBG (Lucent 2) 
    Eli Lilly / Quintiles

  • A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis – AMAN (Lucent 1) Eli Lilly / Quintiles

  • A phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease (Seavue)
    Janssen R&D / Johnson & Johnson Services, Inc.

  • A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis (UNIFI) Janssen R&D / Parexel

  • A Multicentre, Open-label Study of Oral CP-690, 550 in subjects with Moderate to Severe Ulcerative Colitis (OCTAVE-Extention) Pfizer / ICON Clinical Research
     

  • A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis   (GS-US-384-1943) Gilead / Gilead Science, Inc.

  • A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects with Active Crohn's Disease (SERENITY) Eli Lilly / Quintiles

  • A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study 
    to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease (IMUNITI) Janssen R&D / Parexel
     

  • A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)  (GS-US-384-1944) Gilead / Gilead Science, Inc.

  • Genetic Sucrase-Isomaltase Deficiency (GSID) Screening & Patient Survey Study (Protocol: GiHF-15-10)

  • A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy. Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease (VISIBLE Maintenance) 
    Takeda / Quintiles
     
  • A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneousin Subjects with Ulcerative Colitis and Crohn's Disease Vedolizumab SC Long-Term Open-Label Extension Study (VISIBLE Long Term) Takeda / Quintiles
     
  • A Phase 2, Multi-Center, Open-Label Induction Trail with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC 1063 as Induction Therapy (RECEPTOS) Celgene / Quintiles
     
  • A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral
    CP-690,550 as a Maintenance Therapy in Subjects with Moderate to Severe Ulcerative Colitis (OCTAVE) 
    Pfizer / ICON Clinical Research
     
  • A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral CP-690,550 as an Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (OCTAVE) 
    Pfizer / ICON Clinical Research
     
  • A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of
    PF-04236921 in Subjects with Crohn’s Disease Who Are Anti-TNF Inadequate Responders (ANDANTE) 
    Pfizer / ICON Clinical Research
     
  • A Multicenter Open-Label Extension Study for Subjects Who Participated in Study B0151003 (ANDANTE 2) 
    Pfizer / ICON Clinical Research
     
  • A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy an Safety of Oral Budesonide MMX 9mg Extended Release Tablets versus Placebo as Add-on Therapy in Patients with Active Mild to Moderate Ulcerative Colits not Adequately Contolled on a Background Oral 5-ASA Regimen (CONTRIBUTE) 
    Santarus Inc. / TRIO Clinical Research Quintiles, Inc. 
     
  • A Phase 3, Randomized,Double-Blind, Placebo-Controlled, Multicenter Study to Assess  the Efficacy and Safety of Budedonide Foam (2mg/25 mL BID for 2 weeks, followed by 2mg/25 mL QD for 4 weeks) Versus Placebo in Subjects with Active Mild to Moderate  Ulcerative Proctitis or Proctosigmoiditis Salix Pharmaceuticals
     
  • A Phase 3, Open Label, Multicenter Study to Assess the Safety and Tolerability of Budesonide Foam in
    Subjects with Active Ulcerative Proctitis or Proctosigmoiditis Salix Pharmaceuticals
     
  • A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerablility of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome Furiex Pharmaceuticals / PPD Development, LLC
     
  • A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease (UNITI 2) Janssen R&D / Parexel
     
  • Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6mg and 9mg Extended Release Tablet Formulations in Patients with Mild or Moderate, Active Ulcerative Colitis.  A Multicenter, Randomized,
    Double-Blind, Double Dummy Comparative Study Versus Placebo, with an Additional Reference Arm
    Evaluating Asacol® 2400mg
    COSMO Technologies Ltd. Santarus Inc. / ICON Clinical Research
     
  • Randomised, Double-Blind, Multi-Centre, 12 month Extension Study to Evaluate the Safety and Efficacy of Daily Budesonide MMXÔ 6mg vs Placebo in the Maintenance of Remission in Subjects with Ulcerative Colitis
    COSMO Technologies Ltd. Santarus Inc. / ICON Clinical Research
     
  • SECURE (C87075) / A Non-Interventional Long-term Post-Marketing Registry of Patients Treated with Certolizumab Pegol (Cimzia®) for Crohn’s Disease
    UCB, Inc. / PRA International, Inc.
     
  • A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers  POZEN, Inc. / Novella Clinical Resourcing
     
  • A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease 
    Millennium Pharmaceutical,s Inc. / Quintiles 
     
  • A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease 
    Millennium Pharmaceutical,s Inc. / Quintiles
     
  • HALO Patient Registry:  Ablation of Barrett’s Esophagus BARRX Medical, Inc.