Back to resultsStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
Primary Purpose
Diabetic Gastroparesis
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nimacimab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Gastroparesis
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with type 1 or type 2 diabetes
Diagnosed with diabetic gastroparesis, defined by:
- 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)
- 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- Participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.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.
Sites / Locations
- Panax Clinical Research
- International Research Associates, LLC
- PRN of Kansas
- Mayo Clinic
- ClinSearch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nimacimab
Placebo
Arm Description
2.5 mg/kg
0.9% sodium chloride
Outcomes
Primary Outcome Measures
Frequency of clinically significant laboratory abnormalities
Frequency of clinically significant vital signs
Frequency of clinically significant ECGs
Secondary Outcome Measures
Nimacimab serum concentration
Area under the plasma concentration versus time curve (AUC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03900325
Brief Title
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
Official Title
A Single-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bird Rock Bio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single blind phase 2a study to evaluate the safety, tolerability, pharmacokinetics, and exploratory efficacy of nimacimab in patients with diabetic gastroparesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Gastroparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nimacimab
Arm Type
Experimental
Arm Description
2.5 mg/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride
Intervention Type
Drug
Intervention Name(s)
Nimacimab
Intervention Description
2.5 mg/kg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride
Primary Outcome Measure Information:
Title
Frequency of clinically significant laboratory abnormalities
Time Frame
Day 38
Title
Frequency of clinically significant vital signs
Time Frame
Day 38
Title
Frequency of clinically significant ECGs
Time Frame
Day 38
Secondary Outcome Measure Information:
Title
Nimacimab serum concentration
Description
Area under the plasma concentration versus time curve (AUC)
Time Frame
Day 3, Day 8, Day 10, Day 38
Other Pre-specified Outcome Measures:
Title
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
Time Frame
Baseline, Day 10
Title
Gastric emptying half-time as measured by gamma scans (scintigraphy) after ingestion of a radio-labeled meal.
Description
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.
Time Frame
Baseline, Day 10
Title
Change from baseline in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Composite Score at 15 days
Description
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).
Time Frame
Baseline and 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with type 1 or type 2 diabetes
Diagnosed with diabetic gastroparesis, defined by:
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)
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.
Facility Information:
Facility Name
Panax Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
International Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
PRN of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
We'll reach out to this number within 24 hrs