Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis

A Single-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis

This is a single blind phase 2a study to evaluate the safety, tolerability, pharmacokinetics, and exploratory efficacy of nimacimab in patients with diabetic gastroparesis.

Study Overview

• Status: Unknown
• Conditions: Diabetic Gastroparesis
• Intervention / Treatment: Drug: Placebo; Drug: Nimacimab

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33183
      • International Research Associates, LLC
    • Miami, Florida, United States, 33014
      • Panax Clinical Research
  • Kansas
    • Wichita, Kansas, United States, 67205
      • PRN of Kansas
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with type 1 or type 2 diabetes

• Diagnosed with diabetic gastroparesis, defined by:

  1. 3 month past or current history of symptoms of gastroparesis (e.g. nausea, vomiting, bloating, abdominal pain, or feeling full earlier than normal after eating)
  2. Screening or historical scintigraphy (3 years prior to screening) with > 20% of solid contents retained at 4 hours.
• BMI >= 20.0 and < = 50.0 kg/m2

Exclusion Criteria:

• Participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.
• Participants with any active prokinetic device are excluded, unless device is turned off for at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.
• Participants who are currently participating in or have participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
• Participants with uncontrolled diabetes. Participants with controlled diabetes are allowed (insulin is allowed). HbA1c>9.9% at screening are excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 0.9% sodium chloride	Drug: Placebo; 0.9% sodium chloride
Experimental: Nimacimab; 2.5 mg/kg	Drug: Nimacimab; 2.5 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of clinically significant laboratory abnormalities	Day 38
Frequency of clinically significant vital signs	Day 38
Frequency of clinically significant ECGs	Day 38

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nimacimab serum concentration	Area under the plasma concentration versus time curve (AUC)	Day 3, Day 8, Day 10, Day 38

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure rate of gastric emptying after ingestion of a radio-labeled meal as measured by gamma scans (scintigraphy) at 0, 0.5, 1, 2, 3, and 4 hours post meal		Baseline, Day 10
Gastric emptying half-time as measured by gamma scans (scintigraphy) after ingestion of a radio-labeled meal.	Half time (t1/2) of gastric emptying (GE) of solids is the time for half of the ingested solids or liquids to leave the stomach.	Baseline, Day 10
Change from baseline in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Composite Score at 15 days	The ANMS GCSI-DD composite score includes score of nausea, early satiety, upper abdominal pain and postprandial fullness. The severity scores of these symptoms range from 0 ( none) to 4 (very severe).	Baseline and 15 days

Collaborators and Investigators

• Sponsor: Bird Rock Bio, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: BRB-018-200DG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No