Gastroenterology Trials

1. A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis (NASH).

Type of Study: Investigational medicine (Chance of placebo)

Who: Individuals with Stage 2 or 3 NASH, ages 18-75

Duration: Minimum 1 Year

Compensation: Yes

2. **CLOSED TO ENROLLMENT** A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Adult Subjects with Compensated Cirrhosis Due to Nonalcholic Steatohepatitis (NASH).

Type of Study: Investigational medicine (Chance of placebo)

Who: Individuals with NASH, ages 18 and older

Duration: Minimum 18 Months

Compensation: Yes

3. A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Study of Resmetirom (MGL-3196) in Patients with Non-Alcoholic Steatohepatitis (NASH) stages 1,2,3 to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation.

Type of Study: Investigational medicine (Chance of placebo)

Who: Individuals with Stages 1,2,3 NASH, ages 18 and older

Duration: Up to 54 Months

Compensation: Yes

4. A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) (MAESTRO-NAFLD1).

Type of Study: Investigational medicine (Chance of placebo)

Who: Individuals with NAFLD, ages 18 and older

Duration: 52 Week Treatment

Compensation: Yes

5. A Phase 2B study to evaluate the safety, tolerability and efficacy of Viking (VK2809) in patients with NASH with fibrosis.

Type of Study: Investigational medicine (Chance of placebo)

Who: Individuals with NASH with fibrosis, ages 18 and older

Duration: 52 Week Treatment

Compensation: Yes

6. A phase 2, dose finding study to evaluate efficacy and safety of PF-06865571 alone and when co-administered with PF-05221304 in patients with NASH with fibrosis stage 2 or 3.

Type of Study: Investigational medicine (Chance of placebo)

Who: Individuals with NASH with fibrosis stage 2 or 3, ages 18 and older

Duration: 42 Week Treatment

Compensation: Yes

7. A phase 2 study to evaluate efficacy, safety and tolerability of HM15211 in patients with biopsy confirmed NASH.

Type of Study: Injection administered subcutaneously (Chance of placebo)

Who: Individuals with NASH confirmed by biopsy, ages 18 and older

Duration: 52 Week Treatment

Compensation: Yes

ULCERATIVE COLITIS

A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis.

Type of Study: Investigational medicine (Chance of placebo)

Who: Individuals with UC, ages 18-80

Duration: 54 Week Treatment

Compensation: Yes

CROHN'S DISEASE

A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Operationally Seamless 2b/3, Parallel-Group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease.

Type of Study: Investigational medicine (Chance of placebo)

Who: Individuals with Moderately to Severely Active Crohn’s Disease, ages 16-80

Duration: 52 Week Treatment

Compensation: Yes

CELIAC DISEASE

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Larazotide for the Relief of Persistent Symptoms in Patients with Celiac Disease on a Gluten-Free Diet (GFD).

Type of Study: Investigational medicine (Chance of placebo)

Who: Individuals with Celiac Disease on GFD, ages 18 and older

Duration: Minimum 12 Weeks

Compensation: Yes

EOSINOPHILIC ESOPHAGITIS

A Phase 3, 3 part study to investigate the efficacy and safety of Dupilumab in adult and adolescents with Eosinophilic Esophagitis (EoE).

Type of Study: Injection administered subcutaneously (Chance of placebo)

Who: Individuals with Eosinophilic Esophagitis, ages 12 and older

Duration: 24 Week Treatment

Compensation: Yes

ESOPHAGEAL VARICES

A phase 2b/3 study to evaluate the efficacy and safety of Belapectin for the prevention of Esophageal varices.

Type of Study: Injection administered subcutaneously (Chance of placebo)

Who: Individuals with confirming nonalcoholic steatohepatitis (NASH) cirrhosis, ages 18 and older

Duration: 78 Week Treatment

Compensation: Yes

**CLOSED TO ENROLLMENT** A Phase 3 Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Prevention of Recurrent Clostridium Difficile Infection (CD3-2).

**CLOSED TO ENROLLMENT** A phase 3 clinical trial to assess the safety and efficacy of Cenicriviroc (CVC) for the treatment of NASH in adult patients.

**CLOSED TO ENROLLMENT** A phase 3 study to evaluate the efficacy of a new oral medication for Gastroesophageal Reflux Disease (GERD) in patients who are also receiving PPI.

**CLOSED TO ENROLLMENT** A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relamorelin in Patients with Diabetic Gastroparesis.

*There are three separate arms of this study: short term, long term, and one arm for patients that have fewer episodes of vomiting.

Upcoming Trials: A Phase 3 Idiopathetic Gastroparesis Study Coming in 2020!

For a complete list of trials KMC is participating in, click here.

Interested in participating in or learning more about a clinical trial? Please call Susie Roeder at 785-295-0938.