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

NCT03900325 | Unknown Phase 2 FDA Drug

• 1 other identifier: BRB-018-200DG
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 5

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.

Conditions

Diabetic Gastroparesis

Outcome Measures

Primary Outcomes (3)

• Frequency of clinically significant laboratory abnormalities

  Day 38

• Frequency of clinically significant vital signs

  Day 38

• Frequency of clinically significant ECGs

  Day 38

Secondary Outcomes (1)

• Nimacimab serum concentration

  Day 3, Day 8, Day 10, Day 38

Other Outcomes (3)

• 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.

  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

  Baseline and 15 days

Study Arms (2)

Nimacimab

EXPERIMENTAL

2.5 mg/kg

Drug: Nimacimab

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride

Drug: Placebo

Interventions

Nimacimab DRUG

2.5 mg/kg

Nimacimab

Placebo DRUG

0.9% sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 1 or type 2 diabetes
• Diagnosed with diabetic gastroparesis, defined by:
• 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

You may not qualify if:

• Participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.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.

Sponsors & Collaborators

• Bird Rock Bio, Inc.: lead

Study Sites (5)

Panax Clinical Research

Miami, Florida, 33014, United States

Location

International Research Associates, LLC

Miami, Florida, 33183, United States

Location

PRN of Kansas

Wichita, Kansas, 67205, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 3, 2019
• Study Start: August 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2019-08

Locations

US (5)